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Full text of "Comprehensive cervical cancer control : a guide to essential practice"

Integrating Health Care for 

Sexual and Reproductive Health and Chronic Diseases 



Comprehensive 
Cervical Cancer Control 



A guide to essential practice 





Comprehensive 
Cervical Cancer Control 

A guide to essential practice 




World Health 
Organization 



WHO Library Cataloguing-in-Publication Data 

Comprehensive cervical cancer control : a guide to essential practice. 

1 .Uterine cervical neoplasms - diagnosis. 2.Uterine cervical neoplasms - prevention 
and control. S.Uterine cervical neoplasms - therapy. 4.Guidelines. I.World Health 
Organization. 



ISBN 92 4 1 54700 6 (NLM classification: WP 480) 

ISBN 978 92 4 1547000 

World Health Organization 2006 

All rights reserved. Publications of the World Health Organization can be obtained from 
WHO Press, World Health Organization, 20 Avenue Appia, 1 21 1 Geneva 27, Switzerland 
(tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests 
for permission to reproduce or translate WHO publications - whether for sale or for 
noncommercial distribution - should be addressed to WHO Press, at the above address 
(fax: +41 22 791 4806; e-mail: permissions@who.int). 

The designations employed and the presentation of the material in this publication do 
not imply the expression of any opinion whatsoever on the part of the World Health 
Organization concerning the legal status of any country, territory, city or area or of its 
authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on 
maps represent approximate border lines for which there may not yet be full agree- 
ment. 

The mention of specific companies or of certain manufacturers' products does not 
imply that they are endorsed or recommended by the World Health Organization in 
preference to others of a similar nature that are not mentioned. Errors and omissions 
excepted, the names of proprietary products are distinguished by initial capital letters. 

All reasonable precautions have been taken by the World Health Organization to verify 
the information contained in this publication. However, the published material is being 
distributed without warranty of any kind, either expressed or implied. The responsibil- 
ity for the interpretation and use of the material lies with the reader. In no event shall 
the World Health Organization be liable for damages arising from its use. 

Printed in Switzerland. 



ACKNOWLEDGEMENTS 

This practice guide has been developed by the Department of Reproductive Health and 
Research and the Department of Chronic Diseases and Health Promotion ofthe_ 
World Health Organization (WHO), with the International Agency for Research on 
Cancer (IARC), the Pan American Health Organization (PAHO), and in collaboration with 
the Alliance for Cervical Cancer Prevention (ACCP), the International Atomic Energy 
Agency (IAEA), the International Federation of Gynecology and Obstetrics (FIGO), the 
International Gynecologic Cancer Society (IGCS), and the European Association for 
Palliative Care (EAPC). 

The guide is based on the work of a large group of experts, who participated in 
consultations or reviews. WHO gratefully acknowledges the contributions of: 

the members of the Technical Advisory Group (TAG) panel: Rose Ann August, 
Paul Blumenthal, August Burns, Djamila Cabral, Mike Chirenje, Lynette Denny, 
Brahim El Gueddari, Irena Kirar Fazarinc, Ricardo Fescina, Peter Gichangi, 
Sue Goldie, Neville Hacker, Martha Jacob, Jose Jeronimo, Rajshree Jha, 

Mary Kawonga, Sarbani Ghosh Laskar, Gunta Lazdane, Jerzy Leo wski, Victor Levin, 
Silvana Luciani, Pisake Lumbiganon, Cedric Mane, Anthony Miller, Hextan Ngan, 
Sherif Omar, Ruyan Pang, Julietta Patnick, Herve Picard, Amy Pollack, 
Frangoise Porchet, You-Lin Qiao, Sylvia Robles, Eduardo Rosenblatt, 
Diaa Medhat Saleh, Rengaswamy Sankaranarayanan, Rafaella Schiavon, 
Jacqueline Sherris, Hai-Rim Shin, Daiva Vaitkiene, Eric Van Marck, 
Bhadrasain Vikram, Thomas Wright, Matthew Zarka, Eduardo Zubizarreta. 

the external reviewers: Jean Ahlborg, Marc Arbijn, Xavier Bosch, Elsie Dancel, 
Wachara Eamratsameekool, Susan Garland, Namory Keito, Ntokozo Ndlovu, 
Twalib Ngoma, Abraham Peedicayil, Rodrigo Prado, John Sellers, Albert Singer, 
Eric Suba, Jill Tabutt Henry. 

the many reviewers who assisted in field-testing the guide in China, Egypt, India, 
Lithuania, Trinidad, and Zimbabwe. 




FIGO 



WHO coordinating team: 

Patricia Claeys, Nathalie Broutet, Andreas Ullrich. 

WHO writing and designing team: 

Kathy Shapiro, Emma Ottolenghi, Patricia Claeys, Janet Petitpierre. 

Core group: 

Martha Jacob (ACCP), Victor Levin (IAEA), Silvana Luciani (PAHO), Cedric Mahe (IARC), 
Sonia Pagliusi (WHO), Sylvia Robles (PAHO), Eduardo Rosenblatt (IAEA), Rengaswamy 
Sankaranarayanan (IARC), Cecilia Sepulveda (WHO), Bhadrasain Vikram (IAEA), as well as 
the members of the coordinating and writing teams. 

WHO is grateful to the Flemish Government (Belgium) for providing the main funding for 
this document. Other donors, who are also gratefully acknowledged, include the Alliance 
for Cervical Cancer Prevention, the International Atomic Energy Agency, Grounds for 
Health, and the European Coordination Committee of the Radiological and Electromedical 
Industry. 



CONTENTS 

Abbreviations and acronyms used in this Guide 1 

Preface 3 

Introduction 5 

About the Guide 5 

Levels of the health care system 9 

Essential reading 10 

WHO Recommendations 11 

Chapter 1: Background 13 

Key points 15 

About this chapter 15 

Why focus on cervical cancer? 16 

Who is most affected by cervical cancer? 18 

Barriers to control of cervical cancer 19 

The four components of cervical cancer control 20 

A team approach to cervical cancer control 22 

Additional resources 23 

Chapter 2: Anatomy of the female pelvis and natural history 

of cervical cancer 25 

Key points 27 

About this chapter 27 

Anatomy and histology 28 

Natural history of cervical cancer 35 

Additional resources 42 

Chapter 3: Health promotion: prevention, health education and 
counselling 43 

Key points 45 

About this chapter 45 



Health promotion 45 

The role of the provider 46 

Prevention of HPV infection 46 

Health education 48 

Counselling 53 

Health education and counselling at different levels 55 

Additional resources 56 

Practice sheet 1: Health education 59 

Practice sheet 2: Frequently asked questions (FAQs) about 

cervical cancer 63 

Practice sheet 3: How to involve men in preventing cervical cancer 67 

Practice sheet 4: Counselling 69 

Practice sheet 5: How to use male and female condoms 73 

Chapter 4: Screening for cervical cancer 79 

Key points 81 

About this chapter 81 

Role of the health care provider 81 

Screening programmes 83 

Screening tests 92 

Follow-up 101 

Screening activities at different levels of the health system 1 03 

Additional resources 105 

Practice sheet 6: Obtaining informed consent 107 

Practice sheet 7: Taking a history and performing a pelvic 
examination 109 

Practice sheet 8: Taking a Pap smear 115 

Practice sheet 9: Collecting samples for HPV DNA testing 119 

Practice sheet 10: Visual screening methods 123 



Chapter 5: Diagnosis and management of precancer 125 

Key points 127 

About this chapter ..........127 

Role of the provider 127 

Management options for precancer 129 

Diagnosis 130 

Treatment of precancer 133 

Follow-up after treatment 142 

Diagnosis and treatment activities at different levels 143 

Additional resources 145 

Practice sheet 11: Colposcopy, punch biopsy and endocervical 
curettage 147 

Practice sheet 12: Cryotherapy 151 

Practice sheet 13: Loop electrosurgical excision procedure (LEEP) 155 

Practice sheet 14: Cold knife conization 161 

Chapter 6: Management of invasive cancer 165 

Key points 167 

About this chapter 167 

The role of the provider 167 

Diagnosis 169 

Cervical cancer staging 170 

Principles of treatment 176 

Treatment modalities 179 

Patient follow-up 186 

Special situations 187 

Talking to patients who have invasive disease and to their families ... 188 

Management of invasive cancer: activities at different levels 190 

Additional resources ... ..191 



Practice sheet 15: Hysterectomy 193 

Practice sheet 16: Pelvic teletherapy 199 

Practice sheet 17: Brachytherapy 205 

Chapter 7: Palliative care 209 

Key points 211 

About this chapter 211 

The role of the health care provider 212 

A comprehensive approach to palliative care 214 

Managing common symptoms of extensive cancer 21 7 

Death and dying 220 

Organization of palliative care services 222 

Palliative care at different levels of the health system 223 

Additional resources 224 

Practice sheet 18: Pain management 225 

Practice sheet 19: Home-based palliative care 231 

Practice sheet 20: Managing vaginal discharge and fistulae 

at home 237 

Annex 1: Universal precautions for infection prevention 241 

Annex 2: The 2001 Bethesda system 245 

Annex 3: How is a test's performance measured? 247 

Annex 4: Flowcharts for follow-up and management of patients 
according to screen results 249 

4a. Standard approach and example based on pap smear screening 249 

4b.The "screen-and-treat" approach, based on visual inspection 
with acetic acid as screening test 251 

Annex 5: Standard management of cervical precancer 253 



Annex 6: Cervical cancer treatment by stage 255 

6a. Treatment of microinvasive carcinoma: Stage IA1 and IA2 255 

6b. Treatment of early invasive cancer: Stage IB1 and IIA < 4 cm^...^. 256 

6c. Treatment of bulky disease: Stage IB2-IIIB 257 

6d. Treatment of Stage IV 258 

6e. Cervical cancer management during pregnancy 259 

Annex 7: Sample documents 261 

7a. Sample letter to patient with an abnormal Pap smear 

who did not return for results at expected time 261 

7b. Sample card that can be used as part of a system 

to track clients who need a repeat Pap smear. 262 

7c. Sample card that can be used as part of a system to 

track patients referred for colposcopy 263 

7d. Sample letter informing referring clinic of the outcome 

of a patient's colposcopy 264 

Annex 8: Treatment of cervical infections and pelvic inflammatory 
disease (PID) 265 

8a. Treatment of cervical infections 265 

8b. Outpatient treatment for PID 266 

Annex 9: How to make Monsel's paste 267 

Glossary 269 



ABBREVIATIONS AND ACRONYMS USED IN THIS GUIDE 

AGC atypical glandular cells 

AIDS acquired immunodeficiency syndrome 

AIS adenocarcinoma in situ 

ANC antenatal care 

ASC-H atypical squamous cells: cannot exclude a high-grade 

squamous intra-epithelial lesion 

ASC-US atypical squamous cells of undetermined significance 

CHW community health worker 

GIN cervical intraepithelial neoplasia 

CIS carcinoma in situ 

CT computerized tomography 

DMA deoxyribonucleic acid 

EBRT external beam radiotherapy 

ECC endocervical curettage 

FAQ frequently asked question 

FIGO International Federation of Gynecology and Obstetrics 

FP family planning 

HBC home-based care 

HDR high dose rate 

HIV human immunodeficiency virus 

HPV human papillomavirus 

HSIL high-grade squamous intraepithelial lesion 

HSV herpes simplex virus 

IEC information, education and communication 

IUD intrauterine device 

LDR low dose rate 

LEEP loop electrosurgical excision procedure 

LLETZ large loop excision of the transformation zone 

LSIL low-grade squamous intraepithelial lesion 

MRI magnetic resonance imaging 



NCCP national cancer control programme 

NSAID nonsteroidal anti- inflammatory drug 

OC oral contraceptives 

PHC primary health care 

PID pelvic inflammatory disease 

PS practice sheet 

RTI reproductive tract infection 

SCJ squamocolumnar junction 

SIL squamous intraepithelial lesion 

STI sexually transmitted infection 

VIA visual inspection with acetic acid 

VILI visual inspection with Lugol's iodine 



PREFACE 

Cancer is being diagnosed more and more frequently in the developing world. The 
recent World Health Organization report, Preventing chronic diseases: a vital investment, 
projected that over 7.5 million people would die of cancer in 2005, and that over 70% 
of these deaths would be in low- and middle-income countries. The importance of the 
challenge posed by cancer was reiterated by the World Health Assembly in 2005, in 
Resolution 58.22 on Cancer Prevention and Control, which emphasized the need for 
comprehensive and integrated action to stop this global epidemic. 

Cervical cancer is the second most common type of cancer among women, and was 
responsible for over 250 000 deaths in 2005, approximately 80% of which occurred 
in developing countries. Without urgent action, deaths due to cervical cancer are 
projected to rise by almost 25% over the next 1 years. Prevention of these deaths by 
adequate screening and treatment (as recommended in this Guide) will contribute to the 
achievement of the Millennium Development Goals. 

Most women who die from cervical cancer, particularly in developing countries, are 
in the prime of their life. They may be raising children, caring for their family, and 
contributing to the social and economic life of their town or village. Their death is both a 
personal tragedy, and a sad and unnecessary loss to their family and their community. 
Unnecessary, because there is compelling evidence - as this Guide makes clear - that 
cervical cancer is one of the most preventable and treatable forms of cancer, as long as 
it is detected early and managed effectively. 

Unfortunately, the majority of women in developing countries still do not have access 
to cervical cancer prevention programmes. The consequence is that, often, cervical 
cancer is not detected until it is too late to be cured. An urgent effort is required if 
this situation is to be corrected. All women have a right to accessible, affordable and 
effective services for the prevention of cervical cancer. These services should be 
delivered as part of a comprehensive programme to improve sexual and reproductive 
health. Moreover, a concerted and coordinated effort is required to increase community 
awareness about screening for the prevention and detection of cervical cancer. 

A great deal of experience and evidence-based knowledge is available for the 
prevention (and treatment) of cervical cancer and related mortality and morbidity. 
However, until now, this information was not available in one easy-to-use guide. 
This publication - produced by WHO and its partners - is designed to provide 
comprehensive practical advice to health care providers at all levels of the health care 
system on how to prevent, detect early, treat and palliate cervical cancer. In particular, 
the Guide seeks to ensure that health care providers at the primary and secondary 
levels will be empowered to use the best available knowledge in dealing with cervical 
cancer for the benefit of the whole community. 



We call on all countries that have not already done so to introduce effective, organized 
control programmes for cervical cancer as recommended in this Guide. Together, we can 
significantly reduce the heavy burden of this disease and its consequences. 

Catherine Le Gales-Camus Joy Phumaphi 

Assistant Director-General Assistant Director-General 

Noncommunicable Diseases and Mental Health Family and Community Health 






INTRODUCTION 

ABOUT THE GUIDE 

Scope and objectives of the Guide 

This Guide is intended to help those responsible for providing services aimed at 
reducing the burden posed by cervical cancer for women, communities and health 
systems. It focuses on the knowledge and skills needed by health care providers, at 
different levels of care, in order to offer quality services for prevention, screening, 
treatment and palliation of cervical cancer. The Guide presents guidelines and up- 
to-date, evidence-based recommendations covering the full continuum of care. Key 
recommendations are included in each chapter; a consolidated list is given on pages 
11-12. 

The four levels of care referred to throughout this Guide are: 

the community; 

the health centre or primary care level; 

the district hospital or secondary care level; 

the central or referral hospital or tertiary care level. 
A detailed description of each level is given on page 9. 

The Guide does not cover programme management, resource mobilization, or the 
political, legal and policy-related activities associated with cervical cancer control. 

Adaptation 

This Guide provides broadly applicable recommendations and may need to be adapted 
to local health systems, needs, language and culture. Information and suggestions on 
adaptation are available elsewhere (see list of additional resources). The Guide and 
its recommendations can also be used as a basis for introducing or adapting national 
protocols, and for modifying policies and practices. 

The target audience 

This Guide is intended primarily for use by health care providers working in cervical 
cancer control programmes in health centres and district hospitals in settings with 
limited resources. However, it may also be of interest to community and tertiary-level 
providers, as well as workers in other settings where women in need of screening or 
treatment might be reached. 

The health care team 

In an ideal cervical cancer control programme, providers work as a team, performing in 
a complementary and synergistic manner, and maintaining good communication within 



and between levels. In some countries, the private and the nongovernmental sectors are 
important providers of services for cervical cancer. Providers in these sectors should be 
integrated in the health care team where relevant. Some possible roles of health care 
providers at different levels of the health care system are as follows: 

Community health workers (CHWs) may be involved in raising awareness of cervical 
cancer in the community, motivating and assisting women to use services, and 
following up those who have been treated at higher levels of care when they return 
to their community. 

Primary health care providers can promote services and conduct screening and 
follow-up, and refer women to higher levels as necessary. 

District-level providers perform a range of diagnostic and treatment services, and 
refer patients to higher and lower levels of care. 

Central-level providers care for patients with invasive and advanced disease, and 
refer them back to lower levels, when appropriate. 

Using the Guide 

This Guide can be used by health care providers, supervisors and trainers: 

as a reference manual, providing basic, up-to-date information about prevention, 
screening, diagnosis and treatment of cervical cancer; 

to design preservice and in-service education and training, and as a self-education 
tool; 

as a review of prevention and management of cervical cancer; 

to find evidence-based advice on how to handle specific situations; 

to understand how the roles of different providers are linked with each other at the 
various levels of the health care system. 

The Guide can be used as a whole, or users can focus on the sections that are relevant 
to their practice. Even if it is used selectively, we strongly recommend that readers 
should review the recommendations appearing on pages 1 1-12 in their entirety. 

The contents 

The Guide is composed of seven chapters and associated practice sheets, nine annexes 
and a glossary. 

Each chapter includes: 

a description of the role and responsibilities of first- and second-level providers in 
relation to the specific topic of the chapter; 

a story illustrating and personalizing the topic of the chapter; 



essential background information on the subject of the chapter, followed 
by discussion of established and evolving practices in clinical care, and 
recommendations for practice, as appropriate; 

information on services at each of the four levels of the health care system; 

counselling messages to help providers communicate with women about the 
services they have received and the follow-up they will need; 

a list of additional resources. 

Most of the chapters have associated practice sheets. These are short, self-contained 
documents containing key information on specific elements of care that health care 
providers may need to deliver, for example, how to take a Pap smear or how to perform 
cryotherapy. Counselling is included as an integral part of each procedure described. 
Practice Sheets 13-17 relate to procedures carried out by specialists. The information 
provided in these sheets can help other health care providers to explain the procedure 
to the patient, to counsel her, and to treat particular problems that may arise after the 
intervention. 

The practice sheets can be individually copied or adapted. 1 

The annexes detail specific practice components, using internationally established 
protocols (e.g. management flowcharts and treatment protocols) and strategies to 
enhance service quality (e.g. infection prevention). 

The glossary contains definitions of scientific and technical terms used in the Guide. 

Key principles and framework for this document 

Principles 

The approach of this Guide is based on the following principles: 

the right of everyone to equitable, affordable and accessible health care; 

reproductive health rights, as formulated in the Programme of Action adopted at the 
1994 International Conference on Population and Development in Cairo (paragraph 
7.6); 

the ethical principles of justice, autonomy and beneficence as defined and discussed 
in the Declaration of Helsinki and the International Ethical Guidelines for Biomedical 
Research Involving Human Subjects prepared by the Council of International 
Organizations of Medical Sciences (CIOMS) and WHO; 



The practice sheets are not intended to be used by a novice to learn how to carry out a procedure. 
They are intended as job aids, to remind trained providers of the essential steps and to help them to 
educate, counsel and correctly explain services to women and their families. They can also be used as 
a checklist to document competency as part of supportive supervision. 



a gender-based perspective: the discussion considers gender-related factors that 
may affect the power balance between men and women, reduce women's power of 
self-determination, and affect the provision and receipt of services. 

Underlying framework 

The following assumptions and context underlie the presentation of material in this 
Guide: 

All the interventions recommended are based on sound scientific evidence. 

Comprehensive control of cervical cancer should be undertaken in the context of a 
national cancer control programme (NCCP). 

Cervical cancer control should, as far as possible, be integrated into existing sexual 
and reproductive health services at the primary health care level. 

Screening and early diagnosis will lead to reduced morbidity and mortality only if 
they are integrated with follow-up and management of all preinvasive lesions and 
invasive cancers detected. 

Resources are available or will be developed to strengthen health infrastructure, and 
make available the following: 

- well trained providers; 

- necessary equipment and supplies; 

- a functional referral system and communication between different teams, 
services, health system levels and the community; 

- a quality assurance system. 

The Guide's development 

Evidence for the information in the Guide is based on the following: 

a review of the relevant literature; 

input from a Technical Advisory Group (TAG), consisting of experts in different 
disciplines from developing and developed countries, who elaborated and reviewed 
the Guide; 

extensive written review of drafts by a large number of external experts; 

review by WHO staff; 

information provided by the International Agency for Research on Cancer (IARC), 
including the handbook, Cervix cancer screening, published in 2005; 

in-country review (pre-field-testing) in six countries. 

The evidence base for all the guidance presented in this Guide will be published 
separately as a companion document. 



LEVELS OF THE HEALTH CARE SYSTEM 



In the community 




COMMUNITY LEVEL 

Includes individuals and organizations; community-based, 
faith-based and other nongovernmental organizations; and 
community and home-based palliative care services. Also 
included are health posts or "cases de sante", usually staffed by 
an auxiliary nurse or community health worker. 



At the health centre 




HEALTH CENTRE - PRIMARY CARE LEVEL 

Refers to primary care facilities with trained staff and regular 
working hours. Maternity and minimal laboratory services may 
be available. 

Providers at this level include nurses, auxiliary nurses or nursing 
assistants, counsellors, health educators, medical assistants, 
clinical officers and, sometimes, physicians. 



At the district hospital 




DISTRICT HOSPITAL - SECONDARY CARE LEVEL 

Typically, a hospital that provides general medical, paediatric, 
and maternity services, limited surgical care, inpatient and 
outpatient care, and, sometimes, intermittent specialized care. 
Patients may be referred from health centres and private 
practitioners in the district. Laboratory services may include 
cytology and histopathology. 

Providers include generalist physicians or clinical officers, 
nurses, pharmacy technicians or dispensing clerks, medical 
assistants, nurse assistants, and laboratory technology 
assistants, possibly a gynaecologist and a cytotechnologist. 
Private and mission hospitals are often present at this level. 



At the central hospital 




CENTRAL OR REFERRAL HOSPITAL - TERTIARY CARE LEVEL 

Tertiary care hospitals provide general and specialized care 
for complex cases and acutely ill patients, including surgery, 
radiotherapy and multiple outpatient and inpatient services. 
General medical, acute and chronic care clinics are offered. 
The most complete public-sector diagnostic and reference 
laboratory services are available with pathologists and 
cytotechnologists, radiology, and diagnostic imaging. 

Providers may include gynaecologists, oncologists and 
radiotherapists, as well as those present at lower levels of care. 



This description does not include services and providers outside the formal health system: 
traditional healers, traditional birth attendants, medicine sellers, etc., who also play important roles. 



10 



ESSENTIAL READING 

Alliance for Cervical Cancer Prevention. Planning and implementing cervical cancer 
prevention programs: a manual for managers. Seattle, WA, 2004. 

IARC. Cervix cancer screening. Lyon, lARCPress, 2005 (IARC Handbooks of Cancer 
Prevention, Vol. 10). 

WHO. Cervical cancer screening in developing countries. Report of a WHO Consultation. 
Geneva, 2002. 

WHO. Comprehensive cervical cancer control. A guide for essential practice, evidence 
base. Geneva (in preparation). 

Alliance for Cervical Cancer Prevention (www.alliance-cxca.org). 

International Agency for Research on Cancer (www.iarc.fr). 

Program for Appropriate Technology in Health (www.path.org). 

EngenderHealth (www.engenderhealth.org). 

JHPIEGO (www.JHPIEGO.org). 

Cancer prevention and control. Resolution 58.22 of the 58th World Health Assembly 
(www.who.int/gb/ebwha/pdf_files/WHA58/WHA58_22-en.pdf). 

WHO Cancer Control Programme (www.who.int/cancer). 

WHO Department on Reproductive Health and Research (www.who.int/reproductive- 
health). 



11 







WHO RECOMMENDATIONS 

Health education should be an integral part of comprehensive cervical cancer 
control. 

Cytology is recommended for large-scale cervical cancer screening 
programmes, if sufficient resources exist. 

Recommended target ages and frequency of cervical cancer screening: 

- New programmes should start screening women aged 30 years or more, 
and include younger women only when the highest-risk group has been 
covered. Existing organized programmes should not include women less 
than 25 years of age in their target populations. 

- If a woman can be screened only once in her lifetime, the best age is 
between 35 and 45 years. 

- For women over 50 years, a five-year screening interval is appropriate. 

- In the age group 25-49 years, a three-year interval can be considered if 
resources are available. 

- Annual screening is not recommended at any age. 

- Screening is not necessary for women over 65 years, provided the last two 
previous smears were negative. 

Visual screening methods (using acetic acid (VIA) or Lugol's iodine (VILI)), at this 
time, are recommended for use only in pilot projects or other closely monitored 
settings. These methods should not be recommended for postmenopausal 
women. 

Human papillomavirus (HPV) DMA tests as primary screening methods, at this 
time, are recommended for use only in pilot projects or other closely monitored 
settings. They can be used in conjunction with cytology or other screening 
tests, where sufficient resources exist. HPV DNA-based screening should not 
begin before 30 years of age. 

There is no need to limit the use of hormonal contraceptives, despite the 
small increased risk of cervical cancer noted with use of combined oral 
contraceptives. 

Women should be offered the same cervical cancer screening and treatment 
options irrespective of their HIV status. 

Colposcopy is recommended only as a diagnostic tool and should be performed 
by properly trained and skilled providers. 

continued next page 



Precancer should be treated on an outpatient basis whenever possible. Both 
cryotherapy and the loop electrosurgical excision procedure (LEEP) may 
be suitable for this purpose, depending on eligibility criteria and available 
resources. 

Histological confirmation of cervical cancer and staging must be completed 
before embarking on further investigations and treatment. 

Surgery and radiotherapy are the only recommended primary treatment 
modalities for cervical cancer. 

Brachytherapy is a mandatory component of curative radiotherapy of cervical 
cancer. 

Surgery for treatment of cervical cancer should be performed only by surgeons 
with focused training in gynaecological cancer surgery. 

The needs of women with incurable disease should be addressed by using 
existing palliative care services or establishing new ones. Providers at all care 
levels need to be trained and must have the resources necessary to manage 
the most common physical and psychosocial problems, with special attention 
to pain control. 

A comprehensive cervical cancer programme should ensure that opioid, non- 
opioid and adjuvant analgesics, particularly morphine for oral administration, 
are available. 



o 



CHAPTER 1: BACKGROUND 



Chapter 1 : Background 15 

CHAPTER 1: BACKGROUND 



Key points 



Cervical cancer is one of the leading causes of cancer death in women in the 
developing world. 

The primary underlying cause of cervical cancer is infection with human 
papillomavirus (HPV), a very common virus that is sexually transmitted. 

Most HPV infections resolve spontaneously; those that persist may lead to the 
development of precancer and cancer. 

It usually takes 1 to 20 years for precursor lesions caused by HPV to develop 
into invasive cancer. 

Effective interventions against cervical cancer exist, including screening for, and 
treatment of, precancer and invasive cancer. 

An estimated 95% of women in developing countries have never been screened 
for cervical cancer. 

Over 80% of women newly diagnosed with cervical cancer live in developing 
countries; most are diagnosed when they have advanced disease. 

The cure rate for invasive cervical cancer is closely related to the stage of 
disease at diagnosis and the availability of treatment. If left untreated, cervical 
cancer is almost always fatal. 

Because of its complexity, cervical cancer control requires a team effort and 
communication between health care providers at all levels of the health care 
system. 

ABOUT THIS CHAPTER 

Cancer control programmes can go a long way in preventing cervical cancer and 
reducing its morbidity and mortality. This chapter explains why organized cervical 
cancer control programmes are urgently needed. It outlines the burden that the disease 
places on women and on health services, summarizing global statistics and describing 
regional and intracountry inequities. The chapter also describes essential elements of 
successful programmes, including the rationale for selection of the target group for 
screening, as well as barriers to their implementation, concluding that cancer control 
needs to be based on a constant team effort. 



16 Chapter 1 : Background 



WHY FOCUS ON CERVICAL CANCER? 

In 2005, there were, according to WHO projections, over 500 000 new cases of cervical 
cancer, of which over 90% were in developing countries. It is estimated that over 1 
million women worldwide currently have cervical cancer, most of whom have not been 
diagnosed, or have no access to treatment that could cure them or prolong their life. In 
2005, almost 260 000 women died of the disease, nearly 95% of them in developing 
countries, making cervical cancer one of the gravest threats to women's lives. In many 
developing countries, access to health services is limited and screening for cervical 
cancer either is non-existent or reaches few of the women who need it. In these areas, 
cervical cancer is the most common cancer in women and the leading cause of cancer 
death among women. 

The primary underlying cause of cervical cancer is infection with one or more high-risk 
types of the human papillomavirus (HPV), a common virus that is sexually transmitted. 
Most new HPV infections resolve spontaneously; if it persists, infection may lead to the 
development of precancer which, left untreated, can lead to cancer. As it usually takes 
10-20 years for precursor lesions caused by HPV to develop into invasive cancer, most 
cervical cancers can be prevented by early detection and treatment of precancerous 
lesions. 

Experience in developed countries has shown that well planned, organized screening 
programmes with high coverage can significantly reduce the number of new cases of 
cervical cancer and the mortality rate associated with it. There is also evidence that 
general awareness about cervical cancer, effective screening programmes, and the 
improvement of existing health care services can reduce the burden of cervical cancer 
for women and for the health care system. There is a huge difference in the incidence 
of, and mortality from, cervical cancer between developed and developing countries, as 
shown in Figures 1.1 and 1.2. 

The main reasons for the higher incidence and mortality in developing countries are: 

lack of awareness of cervical cancer among the population, health care providers 
and policy-makers; 

absence or poor quality of screening programmes for precursor lesions and 
early-stage cancer. In women who have never been screened, cancer tends to be 
diagnosed in its later stages, when it is less easily treatable; 

limited access to health care services; 

lack of functional referral systems. 

The difference between developed and developing countries reflects stark inequalities 
in health status, and represents a challenge for health services. 



Chapter 1 : Background 



17 



Figure 1.1 Age-standardized Incidence rates of cervical cancer in developed and 
developing countries (2005) 




o 
3 



Developed countries 
Developing countries 



15-44 45-69 

age groups 
Source: WHO. Preventing chronic diseases: a vital investment. Geneva, 2005. 



Figure 1 .2 Age-standardized mortality rates of cervical cancer in developed and 
developing countries (2005) 




Developed countries 
Developing countries 



15-44 45-69 

age groups 
Source: WHO. Preventing chronic diseases: a vital investment. Geneva, 2005. 



18 



Chapter 1 : Background 



o 

s 

1 



WHO IS MOST AFFECTED BY CERVICAL CANCER? 

Cervical cancer is rare in women under 30 years of age and most common in women 
over 40 years, with the greatest number of deaths usually occurring in women in their 
50s and 60s. Cervical cancer occurs worldwide, but the highest incidence rates are 
found in Central and South America, eastern Africa, South and South-East Asia, and 
Melanesia. Figure 1 .3 shows the global incidence of cervical cancer. 



Figure 1.3 Worldwide incidence rates of cervical cancer per 100,000 females (all ages), 
age-standardised to the WHO standard population (2005) 




Legend I I <8.0 

r~i 8.0-14.9 
BB 15.0-29.9 
30.0-44.9 
I >45.0 



s 



/ 



Over the past three decades, cervical cancer rates have fallen in most of the developed 
world, probably as a result of screening and treatment programmes. In contrast, rates 
in most developing countries have risen or remained unchanged. Inequalities also exist 
in the developed world, where rural and poorer women are at greatest risk of invasive 
cervical cancer. 

Left untreated, invasive cervical cancer is almost always fatal, causing enormous pain 
and suffering for the individual and having significant adverse effects on the welfare of 
their families and communities. 



Chapter 1 : Background 19 



BARRIERS TO CONTROL OF CERVICAL CANCER 

A number of countries have implemented cervical cancer control programmes in recent 
decades; some of these have produced significant decreases in incidence and mortality, 
while others have not. Among the reasons for failure are the following: 

Political barriers: 

- lack of priority for women's sexual and reproductive health; 

- lack of national policies and appropriate guidelines. 

Community and individual barriers: 

- lack of awareness of cervical cancer as a health problem; 

- attitudes, misconceptions and beliefs that inhibit people discussing diseases of 
the genital tract. 

Economic barriers (lack of resources). 

Technical and organizational barriers, caused by poorly organized health systems 
and weak infrastructure. 

Lack of priority for women's health 

The lack of priority given to women's health needs, particularly those not related 
to maternity and family planning, was a focus of the International Conference on 
Population and Development, held in Cairo in 1994. At this Conference, countries 
made strong commitments to reframe women's health in terms of human rights and 
to promote an integrated vision of reproductive health care. Significant advances have 
occurred in some areas, but cervical cancer has still not received sufficient attention in 
many countries, despite its high incidence, morbidity and mortality. 

Lack of evidence-based national guidelines 

National guidelines for cervical cancer control may not exist or may not reflect 
recent evidence and local epidemiological data. Generic guidelines, available in the 
literature, are often not used or not adapted to local needs. In many programmes, 
scarce resources are wasted in screening young women attending family planning and 
antenatal clinics, and in screening more frequently than necessary. Resources would 
be better used to reach older women, who are at greater risk and who generally do not 
attend health services. 

Poorly organized health systems and infrastructure 

A well functioning health system, with the necessary equipment and trained providers, 
is essential for prevention activities, screening, diagnosis, linkages for follow-up and 
treatment, and palliative care. 



20 Chapter 1 : Background 



Lack of awareness 

In many places, cervical cancer has been ignored by decision-makers, health care 
providers and the population at large. Decision-makers may not be aware of the 
tremendous burden of disease and magnitude of the public health problem caused by 
this cancer. Providers may lack accurate information on its natural history, detection 
and treatment. Many women and men have not heard of cervical cancer and do not 
recognize early signs and symptoms when they occur. Women at risk may not be aware 
of the need to be tested, even when they do not have any symptoms. 

Attitudes, misconceptions and beliefs 

Attitudes and beliefs about cervical cancer among the general population and health 
care providers can also present barriers to its control. Cancer is often thought to be an 
untreatable illness, leading inevitably to death. In addition, the female genital tract is 
often considered private and women may be shy about discussing symptoms related 
to it. This is especially true in settings where the health care provider is a man, or is 
from a different culture. Destigmatizing discussion of the female genital tract may be an 
important strategy in encouraging women to be screened and to seek care if they have 
symptoms suggestive of cervical cancer. 

Lack of resources 

In the vast majority of settings where competition for limited funds is fierce, cervical 
cancer has remained low on the agenda. In these settings, cervical cancer is often not 
considered a problem or a funding priority. 

THE FOUR COMPONENTS OF CERVICAL CANCER CONTROL 

Within a national cancer control programme, there are four basic components 
of cervical cancer control: 

primary prevention; 

early detection, through increased awareness and organized screening programmes; 

diagnosis and treatment; 

palliative care for advanced disease. 

Primary prevention means prevention of HPV infection and cofactors known to 
increase the risk of cervical cancer, and includes: 

education and awareness-raising to reduce high-risk sexual behaviours; 

implementation of locally appropriate strategies to change behaviour; 



Chapter 1 : Background 21 



the development and introduction of an effective and affordable HPV vaccine; 

efforts to discourage tobacco use, including smoking (which is a known risk factor 

for cervical and other cancers). ^ 

g 

Early detection includes: w 

organized screening programmes, targeting the appropriate age group and with 

effective links between all levels of care; ^ 

education for health care providers and women in the target group, stressing the p. 
benefits of screening, the age at which cervical cancer most commonly occurs, and 

its signs and symptoms. 

Diagnosis and treatment includes: 

follow-up of patients who are positive on screening, to ensure that a diagnosis is 
made and the disease appropriately managed; 

treatment of precancer, using relatively simple procedures, to prevent the 
development of cancer; 

treatment of invasive cancer, including surgery, radiotherapy and chemotherapy. 

Palliative care includes: 

symptomatic relief for bleeding, pain and other symptoms of advanced cancer and 
for the side-effects caused by some treatments; 

compassionate general care for women whose cancer cannot be cured; 

involvement of the family and the community in caring for cancer patients. 



Cervical cancer control can be achieved if: 

A national policy on cervical cancer control exists, based on the natural history of 
the disease and on local prevalence and incidence in different age groups. 

Financial and technical resources are allocated to support the policy. 

Programmes of public education and advocacy for prevention are in place to 
support national policies. 

Screening is organized, rather than opportunistic, and follow-up and quality control 
are assured (see Chapter 4). 

The largest possible number of women in the target group are screened. 

Screening services are linked to treatment of precancer and invasive cancer. 

A health information system is in place to monitor achievements and identify gaps. 



22 Chapter 1 : Background 

A TEAM APPROACH TO CERVICAL CANCER CONTROL 

^ Because of its complexity, cervical cancer control requires a multidisciplinary team 
p effort and communication between providers at all levels of the health care system. 

o Community health workers (CHWs) need to communicate with nurses and 

g physicians from primary health care settings, and sometimes with laboratory 

sf personnel and specialists at the district and central levels. 

^ Communication within and between health facilities, and links with community- 

o based workers, are essential to coordinate services, to give women the best possible 

care, and to improve outcomes. Two-way communication is particularly important 
for the management of women with invasive cancer, who are treated in hospital and 
then return to the community to recover or to be cared for. 

Secondary and tertiary care providers, such as surgeons, radiotherapists and 
nurses, need to communicate in plain language with primary care providers and 
CHWs. It can be helpful, for example, for central hospital -based physicians to go 
to communities from time to time to talk with CHWs and to see for themselves the 
problems in low-resource settings of caring for women who have been treated for 
cancer. 

Facility managers and supervisors can foster links by communicating with providers, 
and by monitoring and improving the quality of the existing system. 

Managers must ensure that supplies are available and that there are adequate 
incentives for good work. 

The cervical cancer control team must obtain the support and commitment 
of regional and national decision-makers. 

Tips for building a team 

Ensure good communication between team members through regular meetings 
where information is exchanged and staff can air and solve work-related problems. 

Foster mutual trust and caring among staff, including supervisors, to stimulate 
genuine interest in each other. 

Keep motivation high by providing training and support, with regular updates, 
supervision and mentoring. 

Ensure a pleasant, clean, safe work environment, with adequate supplies and 
staffing. 

Reward staff adequately for their work. 



Chapter 1 : Background 23 



ADDITIONAL RESOURCES 

Alliance for Cervical Cancer Prevention. Planning and implementing cervical cancer 
prevention programs: a manual for managers. Seattle, WA, 2004. 

Alliance for Cervical Cancer Prevention Website: www.alliance-cxca.org. 

sr 

International Agency for Research on Cancer Website: www.iarc.fr. H 

World Bank. World development Indicators 2003. Washington, DC, 2003. ^ 

World Health Organization. National cancer control programmes, 2nd ed. Geneva, g> 
2002. S- 



24 







CHAPTER 2: ANATOMY OF THE 

FEMALE PELVIS AND NATURAL HISTORY 

OF CERVICAL CANCER 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 27 



CHAPTER 2: ANATOMY OF THE FEMALE PELVIS 
AND NATURAL HISTORY OF CERVICAL CANCER 



Key points 



Basic knowledge of the anatomy of the female pelvis and the natural history of & 
cervical cancer is essential for understanding the disease and communicating rs> 
messages about prevention, screening, treatment and care. =f 

The cervix undergoes normal changes from birth until after the menopause. 

The cervical transformation zone is the area where the great majority of ^ 
precancers and cancers arise. 5 

The transformation zone is larger during puberty and pregnancy and in women 51 
who have used oral contraceptives (DCs) for a long time, which may increase | 
exposure to HPV. This may explain why early sexual activity, multiple pregnancies 
and, to a lesser extent, long-term use of DCs, are cofactors for the later 2. 
development of cervical cancer. 

After the menopause, the transformation zone may extend into the inner cervical 

canal, requiring the use of an endocervical speculum to see it completely. |F 

From the time that mild dysplasia is identified, it usually takes 1 to 20 years for 3 
invasive cancer to develop; this means that cervical cancer control is possible g; 
through screening and treatment 8" 

HPV infection is a necessary, but not a sufficient, cause of cervical cancer; host o 
factors, as well as behavioural and environmental factors, may facilitate cancer > 
development. i. 

ABOUT THIS CHAPTER | 

The natural history of cervical cancer, with its usually slow progression from early 
precancer to invasive disease, provides the rationale for screening, early detection and 
treatment. To understand how cervical precancer and cancer develop and progress, 
it is necessary to have a basic understanding of female pelvic anatomy, including the 
blood vessels, lymphatic drainage systems and nerve supply. This chapter describes 
the pelvic anatomy, and contains additional information for non-specialists on normal 
and abnormal changes that occur in the cervix and how these relate to screening and 
treatment for precancer and cancer. With this understanding, health care providers will 
be able to communicate accurate information on cervical cancer prevention, screening 
and management to women, patients, and their families. 



28 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



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ANATOMY AND HISTOLOGY 

This section describes the female pelvic anatomy, the covering layers of the cervix or 
epithelia, and the normal physiological changes that take place during a woman's life 
cycle, and identifies the area most likely to develop precancerous abnormalities. 

Female pelvic anatomy 

An understanding of the anatomy of the female pelvic structures will help providers 
involved in cervical cancer programmes to: 

perform their tasks, including screening and diagnosis; 

interpret laboratory and treatment procedure reports and clinical recommendations 
received from providers at higher levels of the health care system; 

educate patients and families on their condition and plan for their follow-up; 

communicate effectively with providers at other levels of care. 

The external genitalia 

Figure 2.1 Female external genitalia 




minor labia 
major labia 



bartholin glands 



clitoris 

urethra 
vaginal introitus 

perineum 
anus 



As seen in Figure 2.1 , the external genitalia include the major and minor labia, the clitoris, 
the urinary opening (urethra), and the vaginal opening or introitus. The area between the 
vulva and the anus is called the perineum. Bartholin glands are two small bodies on either 
side of the introitus. 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



29 



The internal organs 

As shown in Figure 2.2, the vagina and uterus lie behind and above the pubic bone in 
the pelvis. The urinary bladder and urethra are in front of the vagina and uterus, and the 
rectum is behind them. The ureters (small tubes that deliver urine from the kidney ta 
the bladder) lie close to the cervix on each side. 

Figure 2.2 Front and side view of female internal organs 



-, fallopian tube ovary 



\ uterus 
ectocervix 




endpYnetrium 
endocervix 
vagina, 
vujva / 



sacrum 



rectum 
cervix 




uterus 

urinary bladder 
pubic bone 

urethra 
vagina 



30 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



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The vagina is an elastic fibromuscular tube leading from the introitus to the cervix; its 
walls form multiple folds, allowing it to expand during sexual activity and childbirth. 
The walls of the vagina are normally in contact with each other. The lower portion of 
the cervix (ectocervix) protrudes into the upper end of the vagina and the vaginal area 
surrounding it comprises the anterior, posterior and lateral fornices. 

The uterus and cervix 

The uterus or womb is a thick-walled, pear-shaped, hollow organ made of smooth 
muscle. It is supported by several connective tissue structures: transverse ligaments, 
uterosacral ligament and broad ligament (a fold in the peritoneum spanning the area 
between the uterus and the side walls of the bony pelvis which enfolds the fallopian 
tubes and round ligaments within it). The ovaries are attached to the back of the broad 
ligament. The cavity of the uterus is lined by the endometrium, a glandular epithelium 
which goes through dramatic changes with the menstrual cycle. When not enlarged by 
pregnancy or tumours, the uterus measures approximately 10 centimetres from its top 
(fundus) to the bottom of the cervix. 

The cervix is the lower one-third of the uterus and is composed of dense, fibromuscular 
tissue (Figure 2.3) lined by two types of epithelium (see below). It is about 3 cm in 
length and 2.5 cm in diameter. 

The lower part of the cervix (outer cervix or ectocervix) lies within the vagina and is 
visible with a speculum; the upper two-thirds (inner cervix or endocervix) lies above 
the vagina. The cervical canal runs through the centre of the cervix from the internal 
os (opening) leading into the uterine cavity to the external os, which can be seen in the 
centre of the cervix on speculum examination. The external os is seen as a small round 
opening in nulliparous women and as a wide, mouth-like, irregular slit in women who 
have given birth. The lower portion of the endocervical canal can be visualized using an 
endocervical speculum. 

Figure 2.3 Uterus of a woman of reproductive age 




vagina 



| fundus 



internal os 
endocervix 
cervical canal 
external os 
ectocervix 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



31 



The blood and lymph vessels 

The arteries that supply the uterus and cervix derive from the internal iliac arteries and 
their uterine, cervical and vaginal branches. The cervical branches descend along the 
length of the cervix at the 3 and 9 o'clock positions. It is important to keep thisTn mind 
when injecting local anaesthetic, in order to avoid injecting into the artery. The veins 
draining the cervix run parallel to the arteries. The lymph nodes and ducts draining the 
pelvic organs lie close to the blood vessels and may act as a pathway for the spread of 
cervical cancer. In late stages of cancer, large tumours may block lymphatic drainage 
and cause the legs to swell (lymphoedema). 



The nerves 

The ectocervix has no pain nerve endings; thus, procedures involving only this area 
(biopsy, cryotherapy) are well tolerated without anaesthesia. The endocervix, on the 
other hand, is rich in sensory nerve endings, and is sensitive to painful stimuli, injury 
and stretching. Networks of nerve fibres are found around the cervix and extend to 
the body of the uterus. A paracervical block, to produce local anaesthesia for certain 
procedures, is performed by injecting anaesthetic at various points between the cervical 
epithelium and the vaginal tissue. Because sympathetic and parasym pathetic nerves 
are also present, procedures involving the endocervical canal (such as insertion of an 
endocervical curette) may sometimes cause a vasovagal reaction (sweating, slow heart 
rate and fainting). 



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The cervical epithelia 

The surface of the cervix is lined by two types of epithelium: squamous epithelium and 
columnar epithelium (Figure 2.4). 

Figure 2.4 The two types of cervical epithelium and the squamocolumnar junction (SCJ) 




squamous 
epithelium 



columnar 
epithelium 



basement membrane 



Adapted from: Sellers JW, Sankaranarayanan R. Colposcopy and treatment of cervical 
intraepithelial neoplasia: a beginners' manual. Lyon, France, lARCPress, 2002. 



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32 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



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55" 



The stratified squamous epithelium is a multilayered epithelium of increasingly flatter 
cells. It normally covers most of the ectocervix and vagina and, in premenopausal 
women, appears pale pink and opaque. Its lowest (basal) layer, composed of rounded 
cells, is attached to the basement membrane, which separates the epithelium from the 
underlying fibromuscular stroma. In postmenopausal women, the squamous epithelium 
has fewer layers of cells, appears whitish-pink, and is prone to trauma, which is often 
visible as small haemorrhages or petechiae. 

The columnar epithelium lines the cervical canal and extends outwards to a variable 
portion of the ectocervix. It consists of a single layer of tall cells sitting on the basement 
membrane. This layer is much thinner than the squamous lining of the ectocervix. When 
seen with an endocervical speculum, it appears shiny red. 

The original squamocolumnar junction (SCJ) appears as a sharp line, with a step 
produced by the different thicknesses of the columnar and squamous epithelia. The 
location of the original SCJ varies with the woman's age, hormonal status, history of 
birth trauma, pregnancy status, and use of oral contraceptives (Figures 2.5 and 2.6). 



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Figure 2.5 The transformation zone of the cervix of a parous woman of reproductive age 



original (native) 
squamocolumarju 



transformation zon 
new squamocolumnar junction 




original (native) 
squamous epithelium 

metaplastic 
squamous epithelium 

columnar epithelium 
external os 



Source: Sellers JW, Sankaranarayanan R. Colposcopy and treatment of cervical intraepithelial neoplasia: 
a beginners' manual. Lyon, France, lARCPress, 2002. 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 33 



Squamous metaplasia and the transformation zone 

When exposed to the acidic environment of the vagina, the columnar epithelium is 
gradually replaced by stratified squamous epithelium, with a basal layer of polygonal- 
shaped cells derived from the original columnar cells. This normal replacementprocess 
is termed squamous metaplasia and gives rise to a new SCJ. When mature, the new 
squamous epithelium closely resembles the original squamous epithelium. However, the 
newly formed SCJ and the original SCJ are distinct on examination. The transformation 
zone is the area between the original and the new SCJ, where the columnar epithelium 
is being or has been replaced by squamous epithelium (Figures 2.5 and 2.6). 

Development of precancer and cancer 

The stratified squamous epithelium covering the cervix provides protection from toxic 
substances and infection. Under normal circumstances, the top layers are continually 
dying and sloughing off, and the integrity of the lining is maintained by the constant, 
orderly formation of new cells in the basal layer. However, in the presence of persistent 
HPV infection and other cofactors, the metaplastic squamous cells of the transformation 
zone take on an abnormal appearance, cervical squamous precancer (dysplasia). These 
cells later multiply in a disorderly manner typical of cancerous change to produce 
squamous cell carcinoma. 

During puberty and pregnancy, and in women using oral contraceptives, the 
transformation zone on the ectocervix is enlarged. Exposure to HPV at such times may 
facilitate infection, which may explain the association between squamous cell cervical 
cancer and early sexual activity, multiple pregnancies and, to a lesser extent, long-term 
use of oral contraceptives. Ninety per cent of cervical cancer cases are squamous cell 
carcinomas arising from the metaplastic squamous epithelium of the transformation 
zone; the other 1 0% are cervical adenocarcinomas arising from the columnar 
epithelium of the endocervix. 



34 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



Figure 2.6 The process of squamous metaplasia 



original SCJ 



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a. From birth to prepuberty: 
The original squamocolumnar junction is 
present in girls at birth, and is found at or 
near the external os. 



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columnar epitheli 
original SCJ 
squamous epithelium 




b. From menarche to early 
reproductive age: 

At puberty when the ovaries begin to 
secrete estrogen, the cervix grows in size, 
columnar cells from the endocervix and 
the original SCJ become visible on the 
outer cervix. 



CO 



Q. 




columnar epithelium 

transformation 
/ zone 

original SCJ 
squamous epithelium 
new SCJ 




c. In women in their 30s: 
Under the influence of estrogen, the 
normal maturing process, known as 
squamous metaplasia, takes place, and 
both original and new SCJs are visible. 



o 

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O3_ 
O 




new SCJ 
original SCJ 

transformation 
zone 




d. In perimenopausal women: 
As women age and the influence of 
estrogen decreases around menopause, 
the cervix shrinks, and the columnar 
epithelium and transformation zone 
retreat back from the outer cervix into the 
endocervical canal. 




new SCJ 

transformation 
zone 

original SCJ 




e. In postmenopausal women: 
Without estrogen stimulation, the 
original SCJ is still visible on speculum 
examination, but the new SCJ and 
a variable portion of the metaplastic 
epithelium of the transformation zone 
have retreated into the cervical canal. 



Adapted from: Sellers JW, Sankaranarayanan R. Colposcopy and treatment of cervical intraepithelial 
neoplasia: a beginners' manual. Lyon, France, lARCPress, 2002. 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 35 



NATURAL HISTORY OF CERVICAL CANCER 

What is cancer? 

Cancer is a term used for the malignant, autonomous and uncontrolled growth of cells 
and tissues. Such growth forms tumours, which may invade surrounding and distant 
parts of the body, destroying normal tissues and competing for nutrients and oxygen. 
Metastases occur when small groups of cells become detached from the original 
tumour, are carried to distant sites via the blood and lymph vessels, and start new 
tumours similar to the original one. 

The development of cervical cancer 

The primary cause of squamous cervical cancer is persistent or chronic infection with 
one or more of the so-called high-risk or oncogenic types of human papillomavirus. 
The most common cancer-causing types are 16 and 18, which are found in 70% of all 
cervical cancers reported. Other oncogenic types (e.g. 31 , 33, 45, and 58) are found 
less commonly and may have different prevalence in different geographical areas. 
Low-risk HPV types 6 and 1 1 are not associated with cancer, but cause genital warts. 
The key determinants of HPV infection for both men and women are related to sexual 
behaviour, and include young age at sexual initiation, a high number of sexual partners, 
and having partners with multiple partners. High-risk HPV infection is most common in 
young women, with a peak prevalence as high as 25-30% in women under 25 years of 
age. In most sites, prevalence decreases sharply with age. 

While infection with a high-risk HPV is the underlying cause of cervical cancer, most 
women infected with high-risk HPV do not develop cancer. Most cervical HPV infections, 
regardless of type, are short-lived, with only a small number persisting and even fewer 
progressing to precancerous lesions or invasive cancer. The conditions or cofactors that 
lead HPV infection to persist and progress to cancer are not well understood, but the 
following probably play a role. 

HPV-related cofactors: 

- viral type; 

- simultaneous infection with several oncogenic types; 

- high amount of virus (high virus load). 



36 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



Host-related cofactors 

- immune status: people with immunodeficiency (such as that caused by HIV 
infection) have more persistent HPV infections and a more rapid progression to 
precancer and cancer; 

- parity: the risk of cervical cancer increases with higher parity. 

Exogenous cofactors: 

- tobacco smoking; 

- coinfection with HIV or other sexually transmitted agents such as herpes simplex 
virus 2 (HSV-2), Chlamydia trachomatis and Neisseria gonorrhoea?, 

- long-term (> 5 years) use of oral contraceptives. 

This last cofactor is of particular concern since limiting the use of oral contraceptives 
could have far-reaching effects on women's choice of contraceptive and hence on the 
rates of unwanted pregnancy, unsafe abortion and maternal mortality. A WHO expert 
group, convened to examine the evidence and formulate recommendations, concluded 
that all methods of contraception, including DCs, carry risks and benefits. With respect to 
cervical cancer, the benefits of OCs outweigh the risks, because the number of cervical 
cancers that result from their use is likely to be very small; therefore, women who choose 
to use OCs should not be prevented or discouraged from doing so. 



RECOMMENDATION 

There is no need to limit the use of hormonal contraceptives, despite the small 
increased risk of cervical cancer noted with use of combined oral contraceptives. 




Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 37 



Natural history of precancer 

During early adolescence and first pregnancy, when squamous metaplasia is occurring, 
infection with HPV may induce changes in the newly transformed cells, with viral^ 
particles being incorporated into the DMA of the cells. If the virus persists, it may cause 
precancerous and, later, cancerous changes by interfering with the normal control of 
cell growth (Figures 2.7 and 2.8). 

Estimates of the time it takes for cancer to develop from HPV infection vary. Sixty per 
cent or more of cases of mild dysplasia resolve spontaneously and only about 10% 
progress to moderate or severe dysplasia within 2-4 years; in some cases, moderate 
or severe dysplasia may occur without an earlier detectable mild dysplasia stage. Less 
than 50% of cases of severe dysplasia progress to invasive carcinoma, with much 
lower rates seen in younger women. 

The usual 10-20-year natural history of progression from mild dysplasia to carcinoma 
makes cervical cancer a relatively easily preventable disease and provides the rationale 
for screening. 



Figure 2.7 Natural history of cervical cancer 



Exposure Transient infection Persistent infection 



Progression 
Normal cervix 




Normal GIN 1 GIN 2 GIN 3 



CIN: cervical intraepithelial lesion 

Adapted from: Cervix cancer screening. Lyon, lARCPress, 2005 (IARC Handbooks of Cancer Prevention, 
Vol.10). 



38 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



Figure 2.8 Progress from normal epithelium to invasive cancer 



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13 



Normal CIN1 CIN2 CIN3 '^nr'X 6 



cancer 



superficial layer 



intermediate layer 



basal layer 



basement membrane 




CIN: cervical intraepithelial lesion 



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Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



39 




Bethesda System 



Precancer classification systems 

There are many systems in use in different parts of the world for 
classifying and naming precancerous conditions of the cervix, based 
on cytology and histology (Table 2.1). Some are more useful than 
others because they incorporate knowledge of the disease's natural 
history acquired over the past few decades. The classification system 
of cervical intraepithelial neoplasia (CIN) evolved in 1 968, to take into account the 
different natural histories seen with different degrees of dysplasia. It is still used in 
many countries for cytological reports, although strictly speaking it should only be used 
for histological reports (results of microscopic examination of tissue samples). The 
Bethesda system was developed in the 1990s at the United States National Cancer 
Institute. In this system, which should be used only for cytological reports, CIN 2 and 
3 are combined into one group, termed high-grade squamous intraepithelial lesions 
(HSIL). Cytologically (i.e. on microscopic examination of a smear), it is difficult, if not 
impossible, to distinguish CIN 2 and 3. In the 2001 Bethesda classification, atypical 
cells are divided into ASC-US (atypical squamous cells of undetermined significance) 
and ASC-H (atypical squamous cells: cannot exclude a high-grade squamous epithelial 
lesion). This classification is recommended by WHO for cytological reports. 



Table 2.1 Cervical precancer: different terminologies used for cytological and histological 
reporting 



Cytological classification 
(used for screening) 


Histological classification 
(used for diagnosis) 


Pap 


Bethesda system 


CIN 


WHO descriptive 
classifications 


Class I 


Normal 


Normal 


Normal 


Class II 


ASC-US 
ASC-H 


Atypia 


Atypia 


Class III 


LSIL 


CIN 1 including flat 
condyloma 


Koilocytosis 


Class III 


HSIL 


CIN 2 


Moderate dysplasia 


Class III 


HSIL 


CIN 3 


Severe dysplasia 


Class IV 


HSIL 


CIN 3 


Carcinoma in situ 


Class V 


Invasive carcinoma 


Invasive carcinoma 


Invasive carcinoma 



CIN: cervical intraepithelial neoplasia; LSIL: low-grade squamous intraepithelial lesion; HSIL: high-grade 
squamous intraepithelial lesion; ASC-US: atypical squamous cells of undetermined significance; ASC-H: 
atypical squamous cells: cannot exclude a high-grade squamous epithelial lesion. 



40 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 

How often are screening abnormalities found? 

The number of precancerous lesions found in a population depends on: 
^P the frequency of disease in the population; 

g the age group screened (for example, if many young women are screened, more 

B LSIL will be found); 

CD" 

^ the previous screening status of the women (if women are screened regularly, less 

> HSIL will be found); 



the prevalence of HIV in the screened population (more precancerous lesions are 
found when HIV prevalence is high). 



In a previously unscreened population of women aged between 25 and 65 years, the 
following percentages of abnormal results are likely: 

1- LSIL: 3-10%; 
HSIL: 1-5%; 

invasive cancer: 0.2-0.5%. 

3 

Q. 

f Natural history of invasive cervical cancer 

eL Invasive cervical cancer is defined by the invasion of abnormal cells into the thick 

& fibrous connective tissue underlying the basement membrane. It starts with a 

? microinvasive stage, which is not visible with the naked eye on speculum examination 

g, and has to be diagnosed historically, using a tissue sample from a cone biopsy or 

> hysterectomy. It then evolves into larger lesions, which may extend to the vagina, pelvic 

i. walls, bladder, rectum and distant organs. If left untreated, cervical cancer progresses 

2- in a predictable manner and will almost always lead to death. The International 

Federation of Gynecology and Obstetrics (FIGO) system is often used to describe the 

CD extent of cancer invasion and to select treatment options (see Chapter 6). 

There are four, usually sequential, routes through which invasive cancer progresses. 
The disease is generally confined to the pelvis for a long period, where it is accessible 
to treatment. 

1 . Within the cervix. Spread from a tiny focus of microinvasive cancer, eventually 
involving the entire cervix which can enlarge to 8 cm or more in diameter. The 
cancer can be ulcerating, exophytic (growing outwards) or infiltrating (invading 
inwards). 

2. To adjacent structures. Direct spread in all directions is possible: downwards to 
the vagina, upwards into the uterus, sideways into the parametrium (the tissues 
supporting the uterus in the pelvis) and the ureters, backwards to the rectum, and 
forwards to the bladder. 



Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 41 



3. Lymphatic. Spread to pelvic lymph nodes occurs in 1 5% of cases when the cancer 
is still confined to the cervix, and increases as the cancer spreads. Lymph node 

metastases are at first confined to the pelvis and are later found in the chain of A 
nodes along the aorta, eventually reaching the supraclavicular fossa (the space- 
above the collar bone). If the cancer has advanced into the lower third of the vagina, 5 
the groin nodes may become involved and will be palpably enlarged. |l 

4. Distant metastases through the bloodstream and lymph channels. Cervical cancer IS> 
cells may spread through the blood stream and lymphatic system to develop distant 

metastases in the liver, bone, lung and brain. 

*< 

Cervical cancer and human immunodeficiency virus infection 5 

CD 

Immunosuppression, resulting from HIV infection or other causes (e.g. use of 51 

antirejection drugs after transplantation), presents particular problems. |[ 

HIV-infected women have: ^ 

a higher prevalence of HPV; the risk of infection increases with the degree of ^ 
immunosuppression; ^ 

a higher prevalence of persistent infection and infection with multiple high-risk HPV z 
types; 

a greater risk of precancer, which increases with the degree of immunosuppression ^ 
and might be 2-6 times the risk in uninfected women; g 

an increased risk of developing cervical cancer; *< 

o 

diagnosis of invasive disease up to 1 years earlier than the average; o 

more frequent presentation with advanced disease with poor prognosis. i. 

o 
It is still unclear if treatment of HIV-positive women with highly active antiretroviral 

therapy (HAART) substantially affects the natural history of SIL. 



42 Chapter 2: Anatomy of the Female Pelvis and Natural History of Cervical Cancer 



ADDITIONAL RESOURCES 

^^ Berek JS et al., eds. Novak's textbook of gynecology, 1 2th ed. Baltimore, MD, 
Lippincott, Williams & Wilkins, 1 996. 

g IARC. Cervix cancer screening. Lyon, lARCPress, 2005 (IARC Handbooks of Cancer 

Prevention, Vol. 10). 

^ Shaw RW, Soutter WP, Stanton SL, eds. Gynaecology, 3rd ed. Edinburgh, Churchill 

> Livingstone, 2003. 

Tavassdi FA, Devilee P, eds. Pathology and genetics of tumours of the breast and 
M female genital organs. Lyon, lARCPress, 2003 (WHO Classification of Tumours). 

o 

^ WHO. Cervical cancer screening in developing countries. Report of a WHO 

Consultation. Geneva, 2002. 

c? 



I 

55' 

03 

a 



IE 



8 







CHAPTER 3: HEALTH PROMOTION: 

PREVENTION, HEALTH EDUCATION 

AND COUNSELLING 



Chapter 3: Health Promotion: Prevention, Health Education and Counselling 45 



CHAPTER 3: HEALTH PROMOTION: PREVENTION, 
HEALTH EDUCATION AND COUNSELLING 



Key points 



Health promotion, including education and counselling of women and men, " 
should be an integral part of all cervical cancer control programmes. Zi 

Health education should aim to ensure that women, their families and the of 
community at large understand that cervical cancer is preventable. ^ 

Health education messages about cervical cancer should reflect national policy 3 
and should be culturally appropriate and consistent at all levels of the health care 
system. 

Providers should be trained to discuss sexuality in a non-judgemental way and ^ 
be able to address behavioural issues related to cervical cancer and HPV. 

Privacy and confidentiality during counselling are essential elements of quality o 
care. "^ 

ABOUT THIS CHAPTER m 

This chapter addresses the importance of integrating heath promotion into cervical 

cancer control activities, through health education, primary prevention and counselling. 

These three strategies transmit similar messages and require related and overlapping | 

communication skills. The key messages related to behaviour change are outlined, 

as well as the evidence for the effectiveness of condoms and vaccines in reducing 

the harm done by HPV. The practice sheets (PS) at the end of the chapter list the key j| 

messages to be included in health education about cervical cancer, provide answers g 

to frequently asked questions (FAQs) about cervical cancer and HPV, indicate how to 

involve men in preventing cervical cancer, and give more information on counselling. 

HEALTH PROMOTION 

Promoting health at the personal and societal levels, by helping people to understand 
and reduce their personal risk of illness, avoid harmful behaviours and adopt healthier 
lifestyles, is a key role of health programmes at all levels. In many countries, prevention 
has traditionally taken a secondary role to curative care, but is gradually becoming 
more evident; continuing efforts in this direction are needed. Health promotion can 
be implemented in multiple ways. Three strategies are particularly useful in relation 
to cervical cancer: primary prevention (of HPV infection), health education, and 
counselling. 



46 Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



THE ROLE OF THE PROVIDER 

^^ Providing correct information on cervical cancer in the community and in health 
^p services is key to raising awareness and reducing illness and deaths. All categories 
of health care providers, in whatever setting they work, should provide correct and 
sf consistent information to women and men on cervical cancer, how it can be prevented, 

1| reasons for screening, and the significance and management of any abnormalities 

co detected. The language used should be tailored to the audience and in line with the 

J provider's function and training. Providers should always make sure that the information 

H is fully understood by the woman and her support network. To be able to do this, 

^ providers must keep their own knowledge up to date and improve their communication 

skills. 

1' To change behaviour, knowledge is necessary but is not sufficient. Behaviour change 

:o will be more likely if providers assist women to assess their own risk of disease and 

empower them to reduce this risk. Communication skills are required for educating and 
g. counselling women, and for helping those in the target group to understand their need 

for screening, follow-up and treatment. If cancer is discovered, the women need to be 
g told about the nature and prognosis of their disease. Once clear messages have been 

B developed in simple language, health education in the clinic setting should not take 

2 much time, and can be done in group settings as well as in private consultations. 

I 

I PREVENTION OF HPV INFECTION 

BO 

a. HPV is a common virus, which is transmitted by close contact, including penetrative and 

|> non-penetrative sexual contact. A large proportion of men and women are infected with 

| HPV at some time in their life. The only certain way to prevent genital HPV infection is to 

abstain completely from genital skin-to-skin contact and sexual intercourse. However, 

certain changes in sexual behaviour (e.g. using condoms, delaying first intercourse) 

offer some protection against HPV. 

Using condoms 

Condoms only offer partial protection against HPV transmission, because the virus can 
exist on body surfaces not covered by the condom, such as the perianal area and anus 
in men and women, the vulva and perineum in women, and the scrotum in men. 

Despite this, consistent and correct condom use has been shown to provide important 
benefits: 

It allows faster HPV clearance in both men and women. 

It increases regression of cervical lesions. 

It reduces the risk of genital warts. 

It reduces the risk of cervical precancer and cancer. 



Chapter 3: Health Promotion: Prevention, Health Education and Counselling 47 



It protects against other sexually transmitted infections (STIs), including chlamydia 
and HSV-2 infection, which are possible cofactors for cervical cancer. 

It protects against HIV infection, a known facilitator of both high-risk HPV infection ^ 

and progression to high-grade lesions. 

o 

It protects against unwanted pregnancy. g" 

Condoms may reduce the risk of developing HPV-related diseases ^^g^ 5T 

because they decrease the amount of HPV transmitted or because they yss^-^ 

reduce the likelihood of re-exposure. Whether female condoms (which VBfiF 
cover part of the vulva) offer the same or additional HPV protection as Condoms 

male condoms is as yet unknown. 3 

Condom promotion and distribution are essential o 

components of all STI control efforts 



The future: vaccination against HPV infection 

Since most people are exposed to HPV once they become sexually active, an ideal way 

to prevent HPV infection would be through vaccination prior to exposure. The vaccine & 

should protect against at least the most common high-risk types (HPV 1 6 and HPV m 
18), and preferably all the high-risk types. Recently developed candidate HPV vaccines 

designed to protect against infections with HPV 1 6 and HPV 1 8 have given promising 
results. However, many questions and programme concerns still need to be addressed 

before any vaccine can be effectively used. For example, it will be important to ensure o. 

equitable access to HPV vaccines, in order to attain high coverage of adolescents before S* 

they become sexually active. w 

Any effect of a vaccine on the incidence of cervical cancer would not be detectable for d' 

some decades after its introduction. Widespread screening for cervical cancer would 
therefore need to continue, even after an HPV vaccine programme is fully implemented, 
in order to detect cervical abnormalities in the unvaccinated and previously infected 
population, and to monitor and evaluate progress towards the goals of the vaccination 
programme. 

Prevention of possible cofactors 

Men, women and adolescents need to be aware of the other factors associated with 
the development of cervical cancer in women infected with HPV (see Chapter 2). Even 
though understanding of cofactors remains incomplete, health care providers should 
develop strategies to reach individuals and communities, to disseminate information 
and provide advice on changing behaviour, e.g. reducing number of sexual partners, 




48 Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



stopping smoking, delaying first intercourse, and using condoms. Cervical cancer risk is 
also increased in women who use oral contraceptives for five years or more; however, 

the increase is very small and the benefits of preventing unwanted pregnancy and 

unsafe abortion greatly outweigh the risk. There is, therefore, no need to limit the use of 

hormonal contraceptives. 

I 

w HEALTH EDUCATION 

Health education involves communicating up-to-date general 

information and messages about changing behaviour in simple, ^^^^^ 

3 understandable language, to individuals or groups. Messages should HeartheScatton 

use locally and culturally appropriate terms, and should be developed 

in collaboration with the community and in accordance with national guidelines. It is 
'-^ important that the core of the messages is always the same, regardless of where, by 

1 whom and to whom they are given. Health education is not an isolated event; it should 

tbe a continuous activity and requires constant effort from managers and providers to 
maintain their knowledge up to date. 

8_ Health education is needed to ensure optimal programme coverage, which in turn, will 

lead to increased programme impact. Many barriers to cancer screening programmes 
g- can be addressed through education of the community. For example, numerous studies 

. have shown that many women do not attend screening programmes because they are 

not aware of their risk of cervical cancer or of the benefits of screening in its prevention 

3 and early detection. Women in developing countries and rural areas may not have heard 

o of cervical cancer or screening tests, or may not be aware that a positive test result 

does not necessarily mean that they have cancer or that they are certain to die. Many 
H misconceptions and beliefs about cancer reflect fears about the discovery of a disease 

ci they have heard is fatal. Often there is also stigma related to diseases 

of the reproductive tract, particularly sexually transmitted infections, 
including HPV. Fear and embarrassment about genital examinations, 
and concerns about lack of privacy and confidentiality, may keep 
women from attending services. Such fears and misconceptions can 
be dealt with by reassuring women about what is involved in an examination and 
screening. If such information is backed up by skilful, respectful provision of services, 
women will be more likely to attend and will be more likely to recommend screening to 
their friends and family. 



RECOMMENDATION 

Health education should be an integral part of comprehensive cervical cancer control. 




Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



49 



Some misconceptions and facts about cervical cancer 



Misconception 



Intrauterine devices (lUDs) cause cervical 
cancer. 



In screening, part of your body is 
removed. 



Screening is like a vaccine: once you 
have had it, you will not get cervical 
cancer. 



There is no point in going for cancer 
screening, because it only tells a woman 
that she has a fatal condition and nothing 
can be done for it. 



Cervical cancer is seen in women with 
poor hygiene practices. 



Use of tampons and herbs can cause 
cancer of the cervix. 



Fact 



IDDs are not linked to any increase in 
cervical cancer. 



Cervical cancer screening involves a 
gentle collection of cells from the surface 
of the cervix; no pieces of tissue are 
removed. 



Screening in itself does not prevent 
cervical cancer, but it does detect if the 
cervix is normal or not. If abnormalities 
are detected early and are treated, 
cancer can be prevented. 



Screening can detect abnormalities 
before they become cancer. Also, if 
cancer itself is detected early, it can be 
cured with proper treatment. 



There is no evidence that poor hygiene 
causes cervical cancer. 



Cervical cancer is caused by a virus 
infection. Smoking and having multiple 
sexual partners can increase the risk, but 
use of tampons and herbs has not been 
shown to have any effect. 



CO 



o' 



I 

^ 
m 

Q. 
I 




In cervical cancer control programmes, health education includes: 

informing people about cervical cancer, its causes and natural 
history; 

promoting screening for women in the target group; Health education 

increasing awareness of signs and symptoms of cervical cancer, and encouraging 
women to seek care if they have them; 

reducing ignorance, fear, embarrassment and stigma related to cervical cancer. 




50 Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



How to provide health education 

^^ Messages should be developed to address common fears and misconceptions, as 
^P well as the stigma attached to STIs. 

o Providers should make efforts to overcome their own discomfort in talking about 

|[ sexual matters and diseases that affect the genital organs. 

Providers should give accurate information in an acceptable and non-judgemental 
^ manner. 

H Answers to frequently asked questions need to be developed locally, in consultation 

^ with the community and in harmony with local beliefs and practices. 

The fact that cervical cancer is linked to HPV, a sexually transmitted 
infection, raises some difficult questions that providers need to be 
^ prepared to answer. Some examples and answers are provided in 

3 Practice Sheet 2. FAQs 

CD 

Where can health education take place? 

g Information on cervical cancer can be provided within or outside the health facility, by a 

variety of health workers: doctors, nurses, health educators, nursing assistants, clinical 
2 officers, counsellors and community health workers. Other people, such as community 

S leaders and traditional healers, can also provide health education if they are trained in 

the key messages formulated by the health authorities. 



S> Health education in health facilities 

| Information can be provided to groups in waiting areas through posters, health talks, 

videos and written materials. Messages should be consistent, and should always 

be designed and pretested with the particular audience in mind. Information and 
education on cervical cancer for men and women can be integrated into health talks on 
antenatal and postnatal care, family planning, acquired immunodeficiency syndrome 
(AIDS), chronic care and STIs. In groups consisting mostly of young women at low risk, 
messages can be framed simply to inform the group and promote screening for women 
in the target age. To deliver messages effectively, skills in adult education are needed. 

Messages should also be given to individual women during their visits to health 
facilities, tailored to their age and other risk factors. For example, a woman over 30 
years of age, who presents with STI symptoms and who has never been screened 
should, in addition to receiving education and services specific to her symptoms, be 
given information on cervical cancer. If she cannot be screened immediately, she should 



Chapter 3: Health Promotion: Prevention, Health Education and Counselling 51 



be strongly encouraged to return soon for screening. On the other hand, a teenager 
who comes only for family planning can be given general information, assured that she 
will not need to be screened until she is 25-30 years old, and encouraged to tell older 
women in her family about the need for screening. 

Screening can be offered to all women at risk who attend health facilities for any 
service for themselves or their children. In addition, everyone who works in a health 
facility, including cleaners, secretaries, and drivers, can be enlisted in this effort and 
trained to deliver appropriate messages. For example, cleaners and drivers should know 
the hours and location of screening services; receptionists can be trained to answer 
questions on the recommended age for screening and on the nature of the procedure, 
and to help clients obtain more information. 

Outreach in the community 

Community education may take place in a variety of settings, such as with religious or 
community groups, in schools, at sports activities, on health awareness days, or in the 
context of a screening campaign. Various members of the community can be trained 
to deliver key messages: medical professionals, teachers, community leaders, health 
promoters, traditional healers and midwives. Written materials, radio and television 
messages, newspaper articles, posters and pamphlets are all ways to reach people 
in the community. The approach to educating the community about cervical cancer 
and the benefits of screening can be adapted to the audience and the setting, but the 
content of the messages must not vary. 



52 



Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



o 



CO 



! 



Q. 

s 




STORY 3 

Dawn, a 32-year-old Kenyan woman, was not sick. In fact 
she was in high spirits. Shortly before, a community health 
worker's announcement at a funeral had inspired her. He had 
spoken about a chronic disease that affects women - cancer 
of the cervix - and explained that the disease is preventable. If 
cervical cancer is not detected early and treated, a woman can 
die from the disease. 

The community worker gave Dawn a card 

and told her where she should go to have a 
screening test. "For some reason, I felt it was important for me 
to attend and find out if I had any risk because, after all, I could 
get help." When she returned two weeks later, she was told 
her test was negative meaning it was normal. "I was greatly 
relieved." Now, she was informed, she only needs to return for 
another test in three years' time. 

Because she was treated so kindly and learned so much, Dawn has begun to 
speak publicly about her experience whenever an opportunity arises. Many 
women she has spoken to have followed her advice and have been tested, even 
if they had no symptoms. Two of these women have reported to Dawn that they 
were being treated for precancer so they would not get cancer. Dawn is happy 
to be helping others. "I don't want anyone to die when there is opportunity for us 
to live longer," she says. 




Reaching men 

As with other aspects of reproductive health, it is crucial to reach men in clinical 
and community settings with messages about cervical cancer prevention, sexual 
transmission of HPV, and the importance of encouraging their partners 
to be screened and treated when necessary. Unsafe sexual behaviour in 
men is a risk factor for their partners. Thus, information about prevention 
of HPV and its role in cervical cancer should be included in STI and HIV 
prevention messages in all settings where men seek care. Condoms 
should be widely available. 




To Men 



Adapted from: Alliance for Cervical Cancer Prevention. Women's stories, women's lives: 
experiences with cervical cancer screening and treatment. Seattle, WA, 2004. 




Chapter 3: Health Promotion: Prevention, Health Education and Counselling 53 



COUNSELLING 

Counselling is face-to-face, personal, confidential communication, in 

which the counsellor helps the client to make decisions and act on them. 

Counselling requires listening and conversational skills and knowledge 

of the subject being discussed. All providers should be trained in Counselling =? 

counselling skills, to help them communicate effectively with clients. 

CO 

Counselling can help a person to make decisions only if: 

there is mutual trust between the client and the counsellor; 

there is a two-way transfer of relevant, accurate and complete information. | 

The content of counselling about cervical cancer will vary according to the client's 

problem or concern and her individual circumstances. It can cover prevention, 

screening, follow-up, referral, diagnosis, treatment of precancerous conditions, and 

treatment of invasive cancer. Counselling can also help patients and their families to 

cope with a diagnosis of invasive cancer and terminal disease. Such counselling may "^ 

involve only the patient, or also her partner and other family members, especially if 

decisions concerning severe disease or costly treatment need to be made. A good ^ 

counsellor uses verbal and non-verbal communication skills, and helps the client feel c" 

at ease by empathizing with her situation, reassuring her, and fostering a sense of . 

partnership in helping her solve her problem. Providers at all levels involved in cervical 

cancer control who have face-to-face contact with patients may provide counselling. 

The depth and detail of communication will vary according to the patient's situation o 

and needs and the category and level of provider. Counselling should be structured to 

educate the woman, review the results of screening and follow-up, present alternative = 

services and procedures, and discuss any follow-up she may need. This will give the <Q 

woman the tools she needs to make rational decisions for herself. 

Who needs to be counselled? 

All women who have to decide whether to have a service should receive counselling, 
as well as those who have chosen to have the service and need information on what it 
entails and how it relates to their present and future health. Some guidelines on good 
counselling are found in Practice Sheet 4. 







54 Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



Privacy and confidentiality 

Ensure privacy by conducting counselling in a setting where the woman and the 
provider will not be seen or heard, except by people specifically agreed to by the 
woman. Confidentiality Is also essential, which means that nothing that is discussed 
during a consultation or found during an examination may be disclosed to anyone, 
without prior authorization. 

Privacy and confidentiality are essential in counselling, as in all aspects of patient 
care, and are especially important in relation to conditions that involve the genital 
area and that may require an examination that is embarrassing to the patient. If a 
patient feels that there is lack of privacy in a clinic or that the provider is judgemental 
or disapproving, or might reveal information to others, she may choose to withhold 
important information, attend a distant clinic or not seek care at all. 

Ensure that no one can see or overhear consultations, counselling and examinations. 

Ensure confidentiality: special efforts are needed in many health care settings, 
particularly those that are busy or crowded. 

Store forms and records securely; only relevant staff should have access to them. 

Avoid talking about patients with other clinic staff, both inside and outside the clinic. 

Treat patients with respect, regardless of their age, illness, lifestyle and marital or 
socioeconomic status. 

Health care providers who know the extended families or neighbours of patients 
must take extra care to reassure patients that confidentiality will be respected. 



5- 

CQ 



Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



55 



HEALTH EDUCATION AND COUNSELLING AT DIFFERENT LEVELS 



In the community 




Assess gaps in knowledge, myths and negative attitudes 
prevalent in the community. 

Develop key messages about prevention and use them in 
health education and counselling. 

Give health talks tailored to specific audiences (young 
people, men, women of different ages) in different venues. 

Distribute information, education and communication (IEC) 
materials. 

Counsel individual women in the community about cervical 
cancer and its prevention, screening, and treatment 
(depending on individual needs). 



op 
8 



At the health centre 



At the district hospital 




Use every opportunity to provide information and education, 
and to promote behaviour change to groups of patients. 

Counsel individual women and men, as well as couples, on 
cervical cancer prevention and early detection. 

Promote screening for women in the target age group, in 
waiting rooms and outpatient clinics and by outreach to the 
community. 

Train and assist community health workers and community 
volunteers to educate the community. Ensure that they use 
agreed key messages. 

Educate and counsel women in waiting rooms, outpatient 
clinics and wards on cervical cancer, its prevention and 
early detection. 

Promote screening at all opportunities, including in outreach 
activities to the community. 

Train and supervise workers, and support education in 
communities and health centres, ensuring that messages on 
cervical cancer prevention are consistent. 



a 

I 



8 
| 
3 



At the central hospital 




Carry out all activities performed at district hospitals, plus: 

Develop clear information and education materials for 
patients and families on cervical cancer diagnosis, 
treatment and palliative care. 

Inform and educate policy-makers and decision-makers 
on cervical cancer, its effects on health in the population, 
and the costs to the system, as well as the cost-benefit of 
organized efforts to prevent and detect it. 



56 Chapter 3: Health Promotion: Prevention, Health Education and Counselling 



Counselling messages 



(9 The community health workers and other health care providers can talk to individual 

women who consult them about: 

-a the target group for cervical cancer screening; 

of 

^ the screening test that is used, how it is done and what it can tell about the 

i cervix; 

CD 

S whatns involved in a pelvic examination and screening test, and where and when 

:o screening is available. 

o 

They can also: 
ID help overcome women's reluctance to have a pelvic examination; 

stress the need to follow advice regarding return to the health centre for results or 
g"- follow-up; 

3 

~:r explain that she will be given a thorough explanation of the clinic procedures and 

S she can accept or decline to have any of them (informed consent); 

m tell her that she may bring someone with her if she wishes. 

8" 
I 

o 

3 

1 ADDITIONAL RESOURCES 

i* ACCP. Planning and implementing cervical cancer prevention and control programs: 

| a manual for managers. Seattle, WA, Alliance for Cervical Cancer Prevention, 2004. 

<|' Bradley J et al. Whole-site training: a new approach to the organization of training. 

New York, Association for Voluntary Surgical Contraception, 1998 (AVSC Working 
Paper, No. 1 1 ; www.engenderhealth.org). 

Burns A et al. Where women have no doctor: a health guide for women. Berkeley, 
CA, Hesperian Foundation, 1997. 

Cervical cancer prevention guidelines for low-resource settings. Baltimore, MD, 
JHPIEGO Corporation, 2001. 

GATHER guide to counselling. Baltimore, MD, Johns Hopkins School of Public Health, 
Population Information Program, 1998 (Population Reports, Series J, No. 48; www. 
jhuccp.org). 

Hubley J. Communicating health: an action guide to health education and health 
promotion. London, Macmillan, 1993. 



Chapter 3: Health Promotion: Prevention, Health Education and Counselling 57 



Prevention and management of reproductive tract infections (RTIs): the 
comprehensive reproductive health and family planning training curriculum. 
Watertown, MA, Pathfinder International, 2000. 

WHO. Sexually transmitted and other reproductive tract infections. A guide fcf 

essential practice. Geneva, 2005. 

Working with men. New York, EngenderHealth, 2005 (http://www.engenderhealth. 

org/ia/wwm/i ndex.html) [resources for male involvement in reproductive health 

programmes]. 



58 



PS 1: Health Education 59 

PRACTICE SHEET 1: HEALTH EDUCATION 

PS1 

This Practice Sheet provides key evidence-based messages that can lead to behaviour 
changes that will reduce the harm done by cervical cancer. 

To be an effective health educator about cervical cancer: 

You should have correct up-to-date knowledge about cervical cancer and good 
communication skills. 

You should transmit consistent messages about cervical cancer, tailored to the 
educational background and culture of the audience. 

You should be comfortable talking about sexuality and behaviour that increases 

risk of HPV infection and cervical cancer. g 

You should feel comfortable explaining how to use male and female condoms. 

Your messages must be in line with national policy and appropriate to the local 
situation. 

Key cervical cancer messages for men and women 

Cervical cancer is the leading cause of cancer deaths in women in their 40s, 50s 
and 60s in developing countries. 

Cervical cancer is caused by an infection with human papillomavirus, a very 
common viral, sexually transmitted infection. This infection very often occurs in 
young men and women who may not be aware of it. 

Condom use offers partial protection from HPV and may lower the risk of developing 
HPV-related diseases, such as genital warts and cervical cancer. 

Most HPV infections do not persist and do not cause cancer. 

The few HPV infections that do persist may lead to precancer; if not treated, this may 
become cancer. 

It usually takes many years for HPV infection to cause precancer and years longer 
for precancer to progress to cancer. 

Screening can detect precancer. Most abnormal conditions found on screening are 
curable. 

Women aged 25 years and older are more likely than younger women to have 
cervical precancer. Women should be screened at least once between the ages of 35 
and 45 years and, if possible, every 3 years from age 25 to 65 years (or according to 
national guidelines). 

Screening is relatively simple, quick and painless. 

Precancerous lesions can be treated simply, and a hospital stay is not usually 
required. 



60 PS 1 : Health Education 



If cancer is found and treated early, it can be cured. 

Po 1 Women need to seek medical care promptly if they have abnormal discharge, 
vaginal bleeding, bleeding after sexual intercourse, or any bleeding after 
menopause; these may be signs of cervical cancer. 

Women have a right to make their own decisions about their health (involving 
their partner or family if they so wish). While screening and follow-up are highly 

c/> recommended, women should be free to refuse any test or treatment. 

Messages about personal behaviour 

Delay first sexual intercourse: people who engage in early sexual activity are more 
likely to be infected with HPV. Younger women are more vulnerable to being infected 
with a single sexual act. 

Delay first childbearing: the hormones of pregnancy may increase the risk of 
developing cervical cancer. 

Limit the number of pregnancies: women who have had 5 or more children have a 
higher chance of developing cervical cancer. 

Reduce the number of sexual partners: the more partners a person has, the greater 
the chance of becoming infected with an STI, including HPV and HIV, both of which 
increase the risk of cervical cancer. 

Avoid partners who have multiple partners: women whose partners have or have 
had multiple partners have a higher rate of cervical cancer. 

Use condoms: condoms have been shown to protect against STI and to reduce the 
risk of cervical cancer. 

Do not smoke tobacco: women who smoke have a higher risk of almost all cancers, 
including cervical cancer. 

Seek treatment immediately if you have symptoms of an STI, or suspect that you 
have been exposed to an STI. Some STIs may facilitate the development of cervical 
cancer and cause other undesirable health effects, including infertility. Prompt 
treatment of STIs may protect against HPV and cervical cancer. 

If you are over 25, go for screening. Almost all women who have had sexual 
intercourse have probably been exposed to HPV. Screening can detect early lesions 
so they can be treated before they have a chance to progress to cancer. 

Special message to men and boys: reduce the number of your sexual partners, and 
always use condoms, especially with new partners. 



PS 1 : Health Education 



61 



Note to the educator 

Some of the above behaviours may be difficult to put into practice, especially 

for women who cannot control when, with whom, and how they have sexual 

intercourse. Making men aware of these facts may lead them 

to treat their partners more equitably. 



Supplies for health education 

Health education is best provided in face-to-face encounters. Using the following 
materials, if they are appropriate to your community, can assist: 

flipcharts; 

brochures; 

slide shows; 

drama and role-plays; 

videos; 

radio and television programmes; 

presentations by experts who can communicate in nontechnical language. 




I 

S 




62 



PS1 



& 
s 

5 



PS 1: Health Education 



PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer 63 



PRACTICE SHEET 2: FREQUENTLY ASKED QUESTIONS 

(FAQs) ABOUT CERVICAL CANCER PS 2 



Men, women and even health care providers often lack information on cervicaPcarr 
cer. This Practice Sheet lists some frequently asked questions and provides answers 
to them. You and your colleagues should add other questions relevant to the local 
situation, and their answers. 

CAUSES AND RISK FACTORS 
Q What is cancer? 

A Cancer is the uncontrolled growth of certain cells in the body, causing tumours or 
growths. Not all growths are cancer. Those that spread to other parts of the body 
and can interfere with normal functions are called cancer. 

Q What is cervical cancer? 

A It is cancer that begins on the cervix, which is the opening of the womb. Cells on 
the cervix begin to grow abnormally and sometimes, if they are not treated, they 
become cancer. However, these early (precancerous) changes can disappear on 
their own, without causing problems. 

Q What causes cervical cancer? 

A Cervical cancer is caused by infection with a virus called human papillomavirus 
or HPV. Most of the time, HPV infection disappears without treatment; sometimes, 
however, HPV stays in the cells for years and, in some women, eventually causes 
cervical cancer. Not much is known about why some women get cervical cancer 
and others do not. 

Q Is cervical cancer a sexually transmitted infection (STI)? 

A No, but HPV is a sexually transmitted infection, which is quite common in both 
men and women. Only a few women with HPV will go on to get precancer. If not 
treated, some of these women will develop cervical cancer, many years after they 
were infected with HPV. 



64 PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer 



Q Can cervical cancer be prevented? 

ro L. A Yes. Limiting the number of new sexual partners, using condoms, delaying first 
sexual relations and childbearing, and not smoking tobacco help prevent cervical 

^ cancer. HPV vaccines are now being tested and will probably be the most effective 

means of prevention, when they become widely available. Once they are available, 
they will need to be given to young people before they start to have sexual 

m relations. 

C/9 

The best way to prevent cervical cancer today is through screening of women for 
precaricer, which can be treated before it becomes cancer. 

'i? 

Q Who is at risk of cervical cancer? 

c 

A All women who have had sexual intercourse are potentially at risk because they 
might have been infected with HPV. Cervical cancer is most commonly found 
in women in their 40s and 50s. The women most at risk are those who have 
never been screened, had sexual intercourse and children at a young age, have 
had more than 5 children, have multiple partners or partners who have multiple 
partners, and smoke tobacco. Being infected with HIV also puts women at higher 
risk. 

=3 
Cft 

Q Are women who take hormonal contraceptives at increased risk for cervical 
cancer? 

fA There is a slightly increased risk when oral contraceptives are used for a long 

^ time. Women who take OC, as others, should be screened regularly. There is no 

reason to stop using contraceptives as the benefits outweigh the risks. 

i. 

o 

Q Do genital warts cause cervical cancer? 
o 

A No. Cancer is caused by certain high-risk types of HPV. Genital warts are caused 
by different low-risk HPV types, which do not cause cancer. 



SCREENING 

Q What is a screening test? 

A A screening test is a test done on people who are healthy and without symptoms, 
to identify those with a higher chance of getting a particular disease. A cervical 
cancer screening test can determine if a cervix is normal or not. It can detect early 
signs of disease before a woman has symptoms, when treatment can prevent the 
disease from developing. 



PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer 65 



Q Who should be screened for cervical cancer? 

A Women between the ages of 25 and 65 years (or according to national norms) 
should have a screening test to detect early changes. Women younger than_25 
almost never get cervical cancer and do not need to be screened. Women who have 
never had sexual intercourse do not need to be screened. 

Q What exactly is done during screening? 

A The most common screening test is the Papanicolaou (Pap) smear. The health care 
provider will do a genital examination to look at the cervix, collect a sample of 
cells from your cervix, and send it to the laboratory to be examined. Other tests are 
sometimes used to screen for cervical cancer, such as looking at the cervix after 
putting vinegar on it. The provider will tell you about the test used in your area. 

Q What if my test is negative? 

A If your screening test is negative, it means that you do not have any changes that 
might develop into cervical cancer. It is important to be screened at regular intervals 
(every 3-5 years, depending on local norms) to make sure that such changes do not 
develop. 

Q What if my test is positive? 

A In most cases a positive test means you have precancer, a condition that might go 
away on its own or that can be easily treated in an outpatient setting. You might 
need to have other tests to make sure that what you have is precancer, and not 
cancer. Sometimes a positive test means you have cancer. In this case, you will be 
referred to a hospital for treatment. 

PRECANCER AND CANCER 
Q What is precancer? 

A Precancer results when the cervix has been infected with high-risk HPV for some 
time. It is easily treated. Most precancer goes away on its own, but if it persists and 
is not treated, it can become cancer. 

Q What are the signs of cervical cancer? 

A Early cervical cancer usually has no signs, which is why screening is so important. 
Signs of cancer are: vaginal spotting or bleeding after sexual intercourse, between 
menstruations, or after menopause, and foul-smelling discharge that does not go 
away even with treatment. If you have any of these signs, you should see a health 
care provider, because the earlier cancer is found, the better your chance of being 
cured. 



66 PS 2: Frequently Asked Questions (FAQs) About Cervical Cancer 



PS 2 Q Can cervical cancer be treated? 

A Most cervical cancer can be successfully treated if it is found early. In middle- 
-o aged women who have never been screened, cancer may be discovered late, 

when it has already spread beyond the cervix and is more difficult to treat. 

I 

^ Q Can cervical cancer be cured? 

2. A Yes, cervical cancer is curable, if it is found before it has spread too far. The earlier 

IV cancer is found, the better your chance of being cured. 

-n 

CD 

Q How is cervical cancer cured? 

^ A There are two major ways to treat and cure cervical cancer by an operation 

> to remove it surgically, or by radiation therapy which kills the cancer cells. 

Sometimes both methods are used. 

o 

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CD 

5' 

3 
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PS 3: How to Involve Men in Preventing Cervical Cancer 67 



PRACTICE SHEET 3: HOW TO INVOLVE MEN 

IN PREVENTING CERVICAL CANCER PS 3 

Cervical cancer is exclusively a woman's disease, but men can play a key role 
in preventing and treating it. Infection with HPV is sexually transmitted, and men 
therefore can contribute to preventing it. This Practice Sheet provides basic 
information that men need, and suggests ways to involve them in cervical cancer 
control. 

BASIC INFORMATION FOR MEN ON CERVICAL CANCER 

o 

General messages can be found in Practice Sheet 1 on health f^jB^^ 

education. 




Cervical cancer is common and is usually seen in women aged < 

40 years or over. Cervical cancer develops from precancer, which Health education 
can be detected by screening and treated. Women over 25 years S 

should be screened. 

Most cervical cancer is caused by infection with a virus, the human papillomavirus 
(HPV). This virus is easily passed between people who have sexual contact. It 
causes no symptoms. 

HPV can also threaten men's health; if it persists, it can increase the risk of cancer 
of the penis. 

HPV is sexually transmitted, but penetration is not essential as the virus can live 
on the skin, outside the genital area. 

Using condoms does not offer complete protection, but it can cause infections to 
disappear faster, and thus has a role in the prevention of cervical cancer. 

Smoking tobacco can increase the risk of many cancers in men and women, 
including cervical cancer in women infected with HPV. 

Men can play a key role in the prevention of cervical cancer in women, by: 

- reducing the number of their sexual partners and using condoms if they have 
more than one relationship; 

- using condoms to prevent STIs, including HIV/AIDS; 

- encouraging their partners to be screened if they are over 25 years of age; 

- collaborating with partners to avoid unwanted pregnancies and pregnancy at 
very young age; 

- not smoking and helping their partners not to smoke. 

Men whose partner is found to have precancer or cancer can support and assist 
her in obtaining the recommended treatment, by accompanying her to clinical 
appointments, and by learning about cervical cancer. 



68 



PS 3: How to Involve Men in Preventing Cervical Cancer 



Men need to cooperate with their partners, if they are told in the clinic to abstain 
from sexual intercourse, as may be the case following certain tests and treatments. 

Men can reduce the work burden of their partner when she has had surgery, 
chemotherapy, or radiation for cervical cancer. These treatments can help cure the 
cancer, but they can make the woman feel tired and weak. She will need time for 
rest and recuperation. 

Where a woman has very advanced cervical cancer, her partner can assist by 
providing maximum comfort. 

Men can also contribute to reducing cervical cancer deaths in their community and 
country, by advocating for women's health programmes. 



To men: 

You have a very important role in the prevention and treatment of cervical cancer. 

Please use condoms consistently and correctly; this will lead to improved sexual 

and reproductive health for yourself and your partner. 



PS 4: Counselling 



69 



PRACTICE SHEET 4: COUNSELLING 

What is counselling? 

Counselling is face-to-face, personal and confidential communication, aimed at 
helping a person (and her family) to make informed decisions and then to act on 
them. It is a two-way exchange of relevant and accurate information. To be an 
effective counsellor, you should have the ability to listen, up-to-date knowledge, and 
conversational skills. 




PS 4 




What background knowledge on cervical cancer does the patient need to 
have? 

The counsellor should ensure that all women, especially those targeted for cervical 
cancer control programmes, have the following basic knowledge: 

the basic anatomy of the cervix, its location in the pelvis, the changes it undergoes 
at different ages, and how it can be examined; 

what cervical cancer is, what causes it, and the risk factors for developing it; 

how to prevent cervical cancer, with emphasis on screening and treatment of 
precancerous lesions; 

what screening test and which treatments for abnormalities detected 
on screening are used locally; 

options available for women who have invasive cancer detected by 

screening and diagnosis. Health educatjon 



Drawings and illustrations, as well as the information provided in this 
Guide and in Practice Sheets 1 and 2, are useful aids in explaining the 
above. 



What must the counsellor ensure? 

Privacy: no one, unless specifically permitted by the woman, should be able to see 
or hear anything that goes on between the woman and the counsellor. 

Confidentiality: nothing seen, heard or done during counselling and examination 
should be known by anybody else, unless the woman specifically authorizes it. 

Mutual trust between provider and patient. 

Sensitivity in addressing and discussing private topics, particularly related to 
sexuality and behaviour. 




70 PS 4: Counselling 

Suggestions for counselling on cervical cancer 

1 . Welcome the woman warmly by name and introduce yourself. 

2. Sit close enough that you can talk comfortably and privately. 

3. Make eye contact; look at her as she speaks. 

4. Assure her that nothing that is discussed will be repeated to anybody. 

5. Use language that she can understand and provide relevant information. 

6. Tailor the information you give and the discussion to the reason she is here today. 

7. Listen attentively and take note of her body language (posture, facial expression, 
eye contact). 

8. Try to understand her feelings and point of view. 

9. Use open-ended questions to invite more than "yes" or "no" answers. 

1 0. Be encouraging. Nod or say: "Tell me more about that." 

11. Try to identify her real concerns. 

1 2. Explain all the options available and respect her choices. 

1 3. Always verify that she has understood what was discussed by having her repeat 
the most important messages or instructions. 

14. Invite her to return if and when she wishes. 

Counselling "do's" 

Ensure privacy. 

Greet the woman by name and introduce yourself. 

Look the woman in the face unless culturally not appropriate. 

Use a natural, understanding manner. 

Be empathetic: place yourself in the woman's situation. 

Use approving body language (nod, smile, etc., as appropriate). 

Use simple language and terms the woman understands. 

Answer her questions truthfully. 

Allow enough time for the session. 

If she has doubts, invite her to return later to inform you of what she (and possibly 
her family) has decided. 



PS 4: Counselling 



71 



Counselling "don'ts" 

Appear to be distracted (looking at your watch, answering the phone). 

Use a harsh tone of voice, or act impatient. 

Allow interruptions during the visit. 

Interrupt the woman. 

Be critical, judgemental or rude. 

Overwhelm the woman with too much detail or irrelevant information. 

Use medical words the woman does not understand. 

Force a decision; if she has doubts, invite her to return later to inform you of what 
she (and possibly her family) has decided. 




PS 4 



STANDARD COUNSELLING STEPS FOR ANY WOMAN HAVING A TEST, 
PROCEDURE OR TREATMENT 



Before the procedure 




While you are doing the procedure 




After the procedure 




Explain again why it is important for 
her to be screened or to undergo 
the procedure or the treatment 
recommended. 



Explain what will be done: 
how it is done, what it can 
show, possible need for 
future tests or treatments. 




Informed consent 



Invite and respond to informed consent, 
including consent to be contacted at 
home or work if necessary. 

Tell the woman what you are doing 
at each step. If what you are about to 
do may cause pain, cramps or other 
discomfort, warn her in advance. This will 
help her feel comfortable. 

Explain what you did. 

Describe any noted abnormalities or 
reassure the woman that you did not see 
anything unusual. 

Agree a date for the return visit. 

Explain the importance of her returning to 
the clinic as planned. 




PS 4 



72 



PS 4: Counselling 



If you noted something for which you wish to refer her to a higher level for further 
examination or tests: 

Explain why, where and when she must go, and whom to see. 

Stress the importance of keeping this appointment. 

Answer any questions she has or, if you do not know the answer, find someone 
who does. 

Invite her to return if she has any questions or concerns about this appointment, 
and respond or find answers from someone who knows. 



PS 5: How to Use Male and Female Condoms 73 



PRACTICE SHEET 5: HOW TO USE MALE 

AND FEMALE CONDOMS 4 PS 5 

Messages about condoms to be communicated to men and women ^ 

Condoms are the most reliable available method of protection against STIs. 

Used correctly, a condom forms a barrier that keeps out even the smallest bacteria 
and viruses. 

Because HPV can infect tissue outside of the area normally covered by a condom, 
condoms cannot completely prevent HPV infection. 

However, the use of condoms has been shown to: 

- speed up HPV clearance; 

- reduce the risk of genital warts; 

- reduce the risk of cervical cancer; 

- protect against Chlamydia and HSV infection (possible cofactors for cervical 

cancer); Q 

- 

- protect against other STIs; 

- protect against HIV infection; 

- protect against pregnancy. 

Q 

O 

When should you recommend that a woman use condoms? 

If she is diagnosed with an HPV infection or a low-grade lesion (LSIL) which is 
being watched. 

When there is a risk of infection or bleeding and she is not able to follow advice 
to abstain from intercourse. This is the case after certain procedures, such as 
cryotherapy (see Chapter 5). 

For simultaneous prevention of most sexually transmitted infections, including HIV, 
and pregnancy (dual protection). 

While she is being treated for any STI. 

When her partner has symptoms or is being treated for an STI. 

Condoms only protect when they are used consistently and correctly! 



Adapted from: Sexually transmitted and other reproductive tract infections. A guide for essential 
practice. Geneva, WHO, 2005. 



74 



PS 5: How to Use Male and Female Condoms 



PS 5 

, 



I 

01 



MALE CONDOMS 

Male condoms are made of latex; they are widely available and inexpensive, highly 
effective in preventing STIs and partially effective in preventing HPV transmission. 



Instructions for use 





1 . Remove the condom from the 
package carefully, to avoid tearing. 



2. Squeeze the air out of the tip of the 
condom. 



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3 

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3. Unroll the condom onto the erect 
penis. 





4. After ejaculation, withdraw the penis 
from the vagina while the penis 
is still erect. Hold on to the rim of 
the condom while withdrawing to 
prevent it from slipping off and the 
semen spilling into the vagina. 



5. Remove the condom from the penis, and tie a knot in it to prevent spills or 
leaks. Dispose of the condom safely (where it cannot cause any hazard). 



PS 5: How to Use Male and Female Condoms 



75 



FEMALE CONDOMS 

The female condom is a soft, loose-fitting sheath with a flexible polyurethane ring 
at each end. The inner ring at the closed end is inserted into the vagina. The outeiL 
ring at the open end remains outside the vagina during intercourse and covers outer 
genitalia. Female condoms are made of polyurethane and come in only one size. They 
probably offer the same level of protection as male condoms, but are considerably 
more expensive. One advantage is that the woman has greater control in using them 
than in using male condoms. 



Instructions for use 




1 . Remove the female condom from 
the package, and rub it between two 
fingers to be sure the lubricant is 
evenly spread inside the sheath. If you 
need more lubrication, squeeze two 
drops of the extra lubricant included in 
the package into the condom sheath. 




2. The closed end of the female condom 
will go inside your vagina. Squeeze the 
inner ring (closed end) between your 
thumb and middle finger. Insert the 
ring into your vagina. 




3. Using your index finger, push the 
sheath all the way into your vagina as 
far as it will go. It is in the right place 
when you cannot feel it. 

Do not worry, it cannot go too far. 



76 



PS 5: How to Use Male and Female Condoms 




4. The ring at the open end of the female 
condom should stay outside your 
vagina and rest against your labia (the 
outer lip of the vagina). Be sure the 
condom is not twisted. Once you begin 
to engage in intercourse, you may 
have to guide the penis into the female 
condom. If you do not, be aware that 
the penis could enter the vagina 
outside of the condom's sheath. If this 
happens, you will not be protected. 




5. After intercourse you can safely 
remove the female condom at any 
time. If you are lying down, remove 
the condom before you stand to avoid 
spillage. 

Dispose of the female condom safely 
(where it cannot cause any hazard). Do 
not reuse it. 



PS 5 

i 



PS 5: How to Use Male and Female Condoms 77 

INSTRUCTIONS FOR COUNSELLING ON CONDOM USE 

Male and female condoms are only effective if they are used correctly every time r o 5 

when having intercourse. 

Providers need to overcome their own reluctance to talk about and touch condoms. 

They should show patients and their partners how a condom is used. 

When instructing and counselling patients and their partners in how to use condoms, 
use a model penis or vagina. These can be bought, or you could make one with 
locally available materials. 

Demonstrate how to open a condom package, how to unroll the condom, how to 
place it on the erect penis (for a male condom) or inside the vagina (for a female 
condom), how to remove the penis from the vagina when still erect, how to remove 
the condom, and how to dispose of it safely. 

During or after your demonstration, ask the patient and her partner to do the same 
actions using a new condom on the same or another model. Gently correct any 
errors. 

3 

Advise patients and partners to be particularly careful about the following: 

3J 1 

- When opening a condom package, avoid tearing the condom; do not use teeth or 
long nails. 

- Use condoms only once. 

3 

- Have a supply always available. 

Provide sufficient condoms to every patient, including those who have been advised 
to abstain from sexual intercourse. Make sure women and men know how to use 
them, and where to obtain them in the community. 




78 



PS 5: How to Use Male and Female Condoms 



Q3_ 
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0. 





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N 

CHAPTER 4: SCREENING FOR CERVICAL CANCER 



Chapter 4: Screening for Cervical Cancer 

CHAPTER 4: SCREENING FOR CERVICAL CANCER 



Key points 



o 
Screening is testing of all women at risk of cervical cancer, most of whom will be g" 

without symptoms. of 

Screening aims to detect precancerous changes, which, if not treated, may lead * 

to cancer. 

Screening is only effective if there is a well organized system for follow-up and =. 

treatment. ^ 

Women who are found to have abnormalities on screening need follow-up, ^ 

diagnosis and possibly treatment, in order to prevent the development of cancer 

or to treat cancer at an early stage. S 

Several tests can be used in screening for cervical cancer. The Pap smear > 

(cytology) is the only test that has been used in large populations and that has | 

been shown to reduce cervical cancer incidence and mortality. Other tests (VIA, 

VILI, HPV) show promise but there is as yet no comparable evidence on their 

effectiveness. Large studies are still under way. 

Regardless of the test used, the key to an effective programme is to reach the 

largest proportion of women at risk with quality screening and treatment. 

Organized screening programmes designed and managed at the central level to 
reach most women at risk are preferable to opportunistic screening. 



ABOUT THIS CHAPTER 

This chapter provides detailed information on screening, and explains why organized 
screening is superior to opportunistic screening. It describes available screening tests 
and their comparative advantages and disadvantages. 

ROLE OF THE HEALTH CARE PROVIDER 

The health care provider is a central figure in any coordinated public health effort to 
screen women for cervical cancer. Such an effort may include the ministry of health, 
programme planners, managers, laboratory technicians, health professionals and 
community workers. 

The role of health care providers is to ensure that: 

Women who come for screening receive appropriate information and counselling. 

National guidelines on cervical cancer screening and treatment are followed. 

Screening is well organized and no opportunity to screen targeted women attending 
services is missed. 



82 



Chapter 4: Screening for Cervical Cancer 



o 

IT 
CO 



i 

o 



Each woman who comes for screening understands what is involved and gives 
informed consent for screening and follow-up. 

The screening test, treatment and referral are performed competently; patients are 
properly assessed and infection control measures are strictly adhered to. 

Women screened are informed of their test results, especially if they are inadequate 
or positive (abnormal). 

Any sexual and reproductive health problems identified by either the patient or the 
provider are managed appropriately. 

Appropriate and confidential records are kept in the facility; the records may be 
given to the woman herself. 

Women who need repeat screening, further testing, referral, or care after treatment 
are followed up appropriately. 

These responsibilities are further explained in this chapter. 




STORY 5 

Pratibha is a 37-year-old woman living 
in Maharashtra, India. One day, when she 
returned home from fetching water, she 
found two women health workers talking 
with her husband. The health workers asked 
her many questions, such as how old she 
was, when she married, and how many 
children she had. Then they told her about 
cervical cancer and about an opportunity for 
her to be screened in the village. Pratibha asked why she was selected 
for this and she was relieved to learn that all women over 30 years old in 
the village were being visited and invited to attend the screening clinic. 
One of the advantages of attending this programme was that testing and 
treatment (if needed) were free. Almost all the women invited attended 
the clinic, including Pratibha. The test was fast and painless, as she had 
been told it would be. After the examination, the health worker empha- 
sized that she should return in two weeks to get the test results. When 
Pratibha returned, she was told that her test was normal and that it would 
be important for her to repeat the test every 3 years. 



Adapted from: Alliance for Cervical Cancer Prevention. Women's stories, women's lives: 
experiences with cervical cancer screening and treatment. Seattle, WA, ACCP, 2004. 



Chapter 4: Screening for Cervical Cancer 83 



SCREENING PROGRAMMES 
What is screening? 

Screening is a public health intervention used on a population at risk, or target- 
population. Screening is not undertaken to diagnose a disease, but to identify 
individuals with a high probability of having or of developing a disease. Women targeted 
for screening for cervical cancer may actually feel perfectly healthy and may see no 
reason to visit a health facility. 

Not all diseases can be screened for. The following criteria should be met by any 
disease that is the object of a screening programme: 

The disease must have serious public health consequences. 

The disease must have a detectable preclinical stage (without symptoms). 

The screening test must be simple, non-invasive, sensitive, specific, inexpensive and 
acceptable to the target audience. 

Treatment at the preclinical stage must favourably influence the long-term course 
and prognosis of the disease. 

Any further testing and treatment needed must be available, accessible and 
affordable for those who have a positive screening test. 

Cervical cancer meets these criteria. 

Screening programmes will only be successful if the following elements are present: 

high coverage 6 (80%) of the population at risk of the disease; 

appropriate follow-up and management for those who are positive on screening. 
Efforts to increase coverage will be wasted if those who test positive are not 
followed up correctly; 

effective links between programme components (e.g. from screening to diagnosis 
and treatment); 

high quality of coverage, screening tests, diagnosis, treatment, and follow-up; 

adequate resources. 

Cervical cancer screening aims to test the largest possible proportion of women at risk 
and to ensure appropriate follow-up for those who have a positive or abnormal test 
result. Such women will need diagnostic testing and follow-up or treatment. Colposcopy 
and biopsy are often used to reach a specific diagnosis of the extent of the abnormality 
in women with a positive screening test (see Chapter 5). 



c 

"Coverage" is the proportion of women in the target age group who are screened at the 
recommended intervals during a given time period. The number of screening tests done is not 
coverage, since this number may include women outside the target age, and women screened 
more often than recommended. 



84 Chapter 4: Screening for Cervical Cancer 



Organized and opportunistic cervical cancer screening 

f|9 Organized screening 

f Organized screening is designed to reach the highest possible number of women at 

greatest risk of cervical cancer with existing resources. It is usually planned at the 
national or regional level. An organized screening programme should specify: 

o> the target population; 

screening intervals; 

coverage goals; 

? a mechanism for inviting women to attend screening services; 

^ the screening test or tests to be used; 

8 the strategies to ensure that all women found positive on screening are informed of 



> their result; 



a mechanism for referring women for diagnosis and treatment; 

treatment recommendations; 

indicators for monitoring and evaluating the screening programme. 

Opportunistic screening 

Opportunistic screening is screening done independently of an organized or population- 
based programme, on women who are visiting health services for other reasons. 
Screening may be recommended by a provider during a consultation, or requested by a 
woman. Opportunistic screening tends to reach younger women at lower risk, who are 
attending antenatal, child health and family planning services. 

It is generally accepted that organized screening is more cost-effective than 
opportunistic screening, making better use of available resources and ensuring that 
the greatest number of women will benefit. However, both organized and opportunistic 
screening can fail because of poor quality-control, low coverage of the population at 
risk, overscreening of low-risk populations, and high loss to follow-up. 

Benefits and risks of screening 

The benefits and risks of screening should be discussed with women as part of general 
health education and before obtaining informed consent. The benefits of screening 
have been described in previous chapters. However, as with all large efforts directed 
towards healthy populations, screening for cervical cancer has the potential to produce 
undesirable outcomes, such as: 

psychological consequences - anxiety and fear about being tested for cancer; 

a mistaken belief that a positive test is a cancer diagnosis; 






Chapter 4: Screening for Cervical Cancer 85 



false positive test results (abnormalities reported in women whose cervix is normal), 
which may lead to unnecessary interventions and anxiety; 

false negative test results (a normal screening test in women with cervical 
abnormalities); 

identification of other illnesses, for which treatment may not be available. 
Following the recommendations in this Guide will, in general, help to minimize these 
undesirable outcomes. 

Target groups and frequency of screening 

Decisions on the target age group and frequency of screening are usually made at the 

national level, on the basis of local prevalence and incidence of cervical cancer, related 

factors such as HIV prevalence, and availability of resources and infrastructure. < 

All existing data on recommended ages and frequency of screening are derived from 

experience in cytology programmes. To date, there are no comparable data from = 

programmes using HPV-based and visual screening methods. ^ 

When deciding on target age group and screening frequency, planners should take into 
account the following: 

HPV infection is very common in young women, but most infections are transient. 

Only a small percentage of all HPV infections will lead to invasive cancer. 

Cervical cancer usually develops slowly, taking 1 0-20 years from early precancer to 
invasive cancer. 

Cervical cancer is rare before the age of 30 years. Screening younger women will 
detect many lesions that will never develop into cancer, will lead to considerable 
overtreatment, and is not cost-effective. 

Screening every three years is nearly as effective as yearly screening. If resources 
are limited, screening every 5-10 years - or even just once between the ages of 35 
and 45 years - will significantly reduce deaths from cervical cancer. 



o 



5? 

3 

CD 



O 
CD 

o' 






Chapter 4: Screening for Cervical Cancer 



RECOMMENDED TARGET AGES AND FREQUENCY OF CERVICAL 
CANCER SCREENING 

New programmes should start by screening women aged 30 years or more, 
and include younger women only when the higher-risk group has been covered. 
Existing organized programmes should not include women less than 25 years of 
age in their target populations. 

If a woman can be screened only once in her lifetime, the best age is between 35 
and 45 years. 

For women over 50 years, a five-year screening interval is appropriate. 

In the age group 25-49 years, a three-year interval can be considered if resources 
are available. 

Annual screening is not recommended at any age. 

Screening is not necessary for women over 65 years, provided the last two 
previous smears were negative. 



Special considerations 

Before embarking on a widespread screening programme, national planners should 
ensure that the services needed to manage newly identified cancer cases are in place. 
To treat invasive cancer effectively, specialized facilities are needed; these must be in 
place before a screening programme is put into effect (see Chapter 6). 

If a population has not previously been screened, many cases of pre-existing cancer in 
different stages will be detected in a new screening programme. Women whose disease 
is very advanced, or for whom treatment is impossible for any reason, should receive 
palliative care (see Chapter 7). 



Screening in settings with high HIV prevalence 

In settings with high HIV prevalence, screening for cervical cancer is particularly 
important. HIV-positive women have more persistent HPV infections, and a higher 
incidence of cervical precancer and, in some settings, invasive cervical cancer. Where 
HIV is endemic, screening results may be positive in up to 1 5-20% of the target 
population. Cytology screening is equally effective in HIV-positive and HIV-negative 
women. Although HIV-infected women are at greater risk of precancer and cancer, 
screening, follow-up and treatment may not be a priority for the women themselves, 
who have competing health or social needs. All women, regardless of their HIV status, 




Chapter 4: Screening for Cervical Cancer 87 



should be encouraged to be screened for cervical cancer, provided that they have 
access to affordable services. Care should be taken not to link a positive cervical 
cancer screening test to HIV testing. However, a woman with precancer may benefit 
from knowing her HIV status, especially if antiretroviral treatment (ART) is available. 
Screening criteria for women with known HIV infection should be developed at the 
national level with these issues in mind. 



RECOMMENDATION 

Women should be offered the same cervical cancer screening options irrespective 
of their HIV status. 



Screening of pregnant women 

Not screening for cervical cancer during pregnancy is sometimes seen as a missed 
opportunity. Visits for antenatal care may be a good occasion for screening. However, 
integrating screening into routine antenatal care is not the best option for the following 
reasons: 

Most pregnant women are younger than the target group. 

In some cultures, pregnant women may be reluctant to undergo a gynaecological 
examination. 

During pregnancy, interpretation of screening tests, such as cytological tests, is more 
difficult. 

Regression of CIN during pregnancy is minimal, but there is a significant rate of 
spontaneous regression postpartum. 

A biopsy for diagnosis should be taken from a pregnant woman only if invasive 
cancer cannot be ruled out. 

Treatment of preinvasive disease is contraindicated during pregnancy. 

Women in the target age group who attend antenatal services should be advised to 
return for screening 12 weeks after giving birth. However, if a cervical abnormality is 
noted on speculum examination, or if the provider feels there is a risk that the woman 
will not return, she should be offered screening during the visit. In addition, the provider 
can suggest that the woman should encourage other women in the target age group in 
her extended family to be screened. 



o 



88 Chapter 4: Screening for Cervical Cancer 



Screening family planning clients 

Opportunistic cervical cancer screening is often integrated into family planning services. 
p Family planning counselling provides a good opportunity to discuss the benefits of cervical 

cancer screening and a gynaecological examination is often more easily accepted during 
g" a reproductive health consultation. Screening should be encouraged and performed on 

H clients of family planning services within the target age group. Contraceptive users do not 

Z need to be screened more often than other women, regardless of the method they use. 



=> Screening women with a reproductive tract or sexually transmitted infection (RTI/STI) 

3' 

^ Women in the target age group who present to health facilities with complaints suggestive 

^ of RTI/STI should be examined. They should be screened for cervical cancer only if there is 

2j no visible acute infection. If the speculum examination reveals evidence of acute infection, 

g appropriate treatment should be given and cervical cancer screening should be deferred 

o until after the infection has resolved. 

13 

CD Health education and counselling on RTI/STI should include information on HPV infection, 

its relation to cervical cancer, and the protection offered by safer sex behaviours, including 
condom use. Male partners too should be treated, and counselled on cervical cancer 
prevention. STI services aimed primarily at men should include information on HPV and 
cervical cancer prevention. 

Other opportunities for cervical cancer screening 

Women at the end of their reproductive years are at greatest risk of cervical cancer, 
particularly if they have never been screened. They tend to use reproductive health 
services less often than younger women, but may use other health services, e.g. for 
management of hypertension, heart disease, diabetes or infectious diseases. In addition, 
women in the target age group may come to a health facility with a child or relative who 
needs services. All women in the target age group who visit a facility for any reason 
should receive information and be encouraged to come for screening (see also Chapter 
3). General medical services at primary, secondary and tertiary levels can provide cervical 
cancer screening for such women, using on-site, trained providers. If this is not possible, 
women should be given health education and referred to a convenient screening clinic. 

No missed opportunities 

Cervical cancer screening programmes should also try to reach all women in the 
target age group who have contact with the health system for any reason. 



Chapter 4: Screening for Cervical Cancer 

Choice of screening test to be used 

The choice of screening test or tests to be used is usually made at the national or -^ 

regional level. Nevertheless, providers should have some basic knowledge of all the - %) 

available screening tests. 

Decisions on the test or tests to be used may be based on: -o 

the organization of the health system; i 

the funds available; q* 

the number and type of health workers; 

the availability of laboratory services and transport; < 

the availability and cost of the various screening tests. ^ 

The test used may also be determined based on the physical proximity of services to i. 

women; for example, it might be decided to use the Pap smear (which requires women ? 

to return for their test results) in urban areas and visual inspection with acetic acid (VIA) g 

(for which results are immediately available) in more inaccessible rural areas in the 
same country. 

The most extensive and long-term experience in cervical cancer screening is with 
cytology, which has been used in numerous countries since the 1950s. Cytology-based 
screening and treatment programmes have reduced cervical cancer incidence and 
mortality by as much as 80% in Canada, the USA and some Nordic countries, and by 
50-60% in other European countries. 

It has been difficult to replicate this success in low-resource settings, because of the 
inherent requirements of a cytology- based programme. These include highly trained 
personnel, well equipped laboratories, transport of specimens, and an effective system 
for collecting information and following up patients. In addition, the demands of other 
competing health needs often result in a lack of resources or political will to make 
cervical cancer screening a priority. 

Because of the problems of implementing quality cytology-based screening, alternative 
methods, such as visual inspection, have been developed. These methods have shown 
promise in controlled research settings but have not yet been widely implemented. 
Their ultimate impact on cervical cancer incidence and mortality will not be known until 
large ongoing population-based studies are completed. HPV-based tests are now also 
commercially available, but have disadvantages, including the need for sophisticated 
laboratory facilities and high cost. 



90 Chapter 4: Screening for Cervical Cancer 



Ethical issues 

^^ Decisions on how best to use scarce resources have to weigh the extent of disability 

and death caused by different diseases, and the efficacy, cost and impact of diagnosing 

and treating them. While decisions about priorities are usually made at national level, 

S providers should understand the reasons for the decisions, so that they are motivated to 

It implement them and can explain them to their patients (see Chapter 1 ). If well planned 

^ and integrated into other sexual and reproductive health activities, screening for 

q* cervical cancer has the potential to both strengthen the health care system and improve 

g> the health of women, particularly women over childbearing age, whose health is often 

( =' relatively neglected. 

Before a screening programme is implemented, the following elements should be 
g? considered to ensure an ethical and equitable approach: 

S Screening should be accessible to all women in the target group, including the 

o poorest, most vulnerable, and hardest to reach. 

S> Patients, providers and communities should receive health education to ensure 

informed decision-making on screening and treatment. 

Patient record systems should ensure confidentiality. 

Diagnostic tests, follow-up, and treatment should be available and accessible. 

Providers should have clear guidelines on follow-up and management of women 
with positive screening results. 

A referral system should be in place for other health problems, including 
gynaecological disorders, discovered during the screening process. 

Informed choice and Informed consent 7 

Informed choice and informed consent are based on the ethical principles of autonomy 
and respect for the individual. In many cultures, the notion of consent may be a 
collective decision-making process involving others, such as partner, 
family, and village leaders. Accurate information provided through health 
education and counselling can ensure that women and their extended 
families understand the facts about cervical cancer, who is at risk, how 
screening can reduce risk, and any potential harm related to screening. 
Before consenting to screening, women should be given information on the specific 
test to be used, the meaning and consequences of a positive test, and the availability 
of treatment. In addition, when results are not available immediately (as they are with 




Note: informed consent is not equivalent to informed choice. Consent refers to the explicit 
permission given by a person for a procedure or test, once she (or he) has received sufficient 
information to make a rational personal (informed) choice. 




Chapter 4: Screening for Cervical Cancer 91 



visual screening methods), informed consent should include explicit permission to be 
contacted at home or at work. Respect for autonomy requires that the choice to be 
screened is voluntary and free of coercion. 

Client assessment 

All clients attending for screening should have a basic assessment 
before proceeding to the screening test. This assessment should include 
information and counselling, informed consent, a social and clinical counselling 

history, and a physical examination. 

The history can provide useful information for guiding decisions about management 
or additional examinations or tests that might benefit the patient. Because of the 
stigma associated with genital problems, women are often reluctant to talk about 
their concerns or symptoms and signs. To establish and maintain trust and respect, 
confidentiality and privacy must be explicitly guaranteed to each woman who presents 
for screening before she is asked about her history. 

For cervical cancer screening, the essential components of the pelvic 

examination are visual inspection of the external genitals and a 

speculum examination. Providers should explain what is being done at 

each step during the examination; if an abnormality is noted, the provider Pelvic exam 

should inform the woman without alarming her. Having female providers 

perform the physical examination, if possible, can greatly reduce reluctance to be 

examined and can play a major role in making screening acceptable. When the provider 

is a man, the woman may request that a female companion or clinic attendant is in the 

room. 

Sexual and reproductive health problems detected during history-taking 
and examination 

An integrated approach to management of sexual and reproductive health problems 
during screening can help improve the health of women, especially older women. 
The provider should pay particular attention to signs and symptoms suggestive of 
cancer, STI, or other diseases detected during history-taking and pelvic examination. In 
addition, women should be offered an opportunity to raise personal concerns regarding 
sexual and reproductive health issues. Women with abnormal findings can be treated or 
referred for further investigation, as appropriate. 

Infection prevention in cervical cancer screening 

In screening, as in all clinical activities, scrupulous attention should be given to infection 
prevention. Pathogens, including HIV, can be transmitted if guidelines on handwashing, 
handling of instruments, and disposal of used supplies, including gloves, are neglected. 





92 Chapter 4: Screening for Cervical Cancer 



Universal precautions (see Annex 1) against spreading infection should 

be used with all patients, whether they appear sick or well, and whether j nex ^ 

their HIV or other infection status is known or not. In this way, providers 

protect both their patients and themselves. Providers should use only infection prevention 

uncontaminated instruments, and should wear latex gloves on both 

hands when performing speculum or bimanual examinations and taking specimens, 

and when performing procedures such as cryotherapy. 

SCREENING TESTS 

A good screening test should be: 

accurate; 

reproducible; 

inexpensive; 

easy to perform and easy to follow up; 

acceptable; 

safe. 

The following tests meet the above criteria to a greater or lesser extent: 

cytology: conventional (Pap smear) and liquid-based; 

HPV DMA test; 

visual inspection: with acetic acid (VIA) or Lugol's iodine (VILI). 

The performance of each test is described below. The strengths and limitations of 
the different tests are summarized in Table 4.1 . Measurement and interpretation of 
performance characteristics are outlined in Annex 3. 





Cytology 

Test s performance 
Conventional Pap smear 

In the Pap smear test, a sample of cells is taken from the transformation 

zone of the cervix using an extended-tip wooden spatula or brush; using 

a cotton swab is no longer recommended. The entire transformation pg 

zone should be sampled since this is where almost all high-grade 

lesions develop. The sample is then smeared onto a glass slide and 

immediately fixed with a solution to preserve the cells. The slide is 

sent to a cytology laboratory where it is stained and examined using 

a microscope to determine whether the cells are normal (Figure 4.1) Bethesda system 

and to classify them appropriately, using the Bethesda classification 

(see Annex 2). The results of the Pap smear are then reported to the clinic where the 




Chapter 4: Screening for Cervical Cancer 



93 



specimen was taken. Health workers are responsible for ensuring that the woman is 

informed of her result and that she receives appropriate follow-up as outlined in Annex 

4a. The Pap test takes less than 5 minutes to perform, is not painful, 

and can be done in an outpatient examination room. It is advisable to 

postpone taking a Pap smear if the woman is menstruating actively, has 

a clinically evident acute inflammation, or is pregnant. A satisfactory 

smear requires adequate numbers of well preserved squamous 

epithelial cells and an adequate endocervical/transformation zone 

component. Each smear should be legibly labelled. 

Figure 4.1 Graphic representation of normal and abnormal epithelial cells 




Annex 4a 



Normal squamous 
cell 



High grade 
lesion 




The accuracy of cytological testing depends on the quality of the services, including 
sampling practices (taking and fixing the smears), and preparation and interpretation of 
smears in the laboratory. Under the best conditions in developed countries or research 
settings, conventional cytology can detect up to 84% of precancer and cancer. However, 
under poor conditions its sensitivity can be as low as 38%. The specificity of the test is 
usually over 90%. 



Liquid-based cytology (LBC) 

This refinement of conventional cytology was introduced in the mid-1990s and is 
increasingly used in high-resource settings. Instead of smearing cervical cells on a 
slide, the provider transfers the specimen from a brush to a preservative solution. The 
specimen is sent to a laboratory where the slide is prepared. LBC is more expensive 
than conventional cytology and laboratory staff need to be specially trained. However, it 
appears to have a number of advantages over conventional methods. 

The specimens obtained are more representative of the areas sampled with fewer 
false negatives. 

There are fewer unsatisfactory specimens. 

Each specimen requires a shorter interpretation time, leading to increased efficiency 
and cost-effectiveness. 

The material collected can also be tested for HPV DMA. 



94 Chapter 4: Screening for Cervical Cancer 



Although, as yet, no randomized controlled trial comparing LBC with conventional Pap 
smear has been published, several studies have shown that LBC is more sensitive than 
Pap smear and has almost the same specificity. 

Providers 

After a short training course, any provider who knows how to do a speculum 
examination (nurse, auxiliary or assistant nurse, midwife, clinical officer, medical doctor) 
can take a Pap smear. 

Indications 

The following groups of women should be offered screening: 

Any woman between the ages of 25 and 65 years, who has never had a Pap smear 
before or who had one 3 or more years ago (or according to national guidelines). 

Women whose previous Pap smear was reported as inadequate or showed a mild 
abnormality. 

Women who have abnormal bleeding, bleeding after intercourse or after the 
menopause, or other abnormal symptoms. 

Women who have been found to have abnormalities on their cervix. 

Interpretation of smears 

Smears are read in a laboratory by trained cytotechnicians, under the supervision of a 
pathologist, who has final responsibility for the reported results. Correct interpretation 
of slides is crucial to a successful programme. To maintain proficiency and avoid 
fatigue, cytotechnicians should spend a maximum of 5 hours a day at the microscope 
and should review a minimum of 3000 slides per year. Quality assurance is crucial 
and should be established in all cytology laboratories. The two most commonly used 
methods are rapid review of all negative slides, and full rescreening of a 1 0% random 
sample of slides originally reported as negative. In both methods, the review is done 
by another cytotechnician, with confirmation of abnormal smears by the supervising 
pathologist. Current evidence shows that, of the two methods, rapid review of all 
negative smears is more effective and more cost-effective. Laboratories should be 
equipped to read a minimum of 1 5 000 smears annually. 8 Therefore, cytology services 
should not be decentralized to primary health care clinics or to small laboratories. 
Reliable transport of slides and test results to and from the laboratory is essential. 



Detailed information on cytology laboratories is beyond the scope of this Guide. Further information 
can be found in the references listed under "Additional resources" at the end of this chapter. 



Chapter 4: Screening for Cervical Cancer 95 



The speed with which results are sent to the health facility is an important ele- 
ment of the quality of the laboratory service and the quality of care, and greatly 
affects women's satisfaction with the service. 



RECOMMENDATION 

Cytology is recommended for large-scale cervical cancer screening programmes, 
if sufficient resources exist. 




HPV DNA-based screening methods 

New screening procedures are based on the detection of high-risk HPV 
DMA in vaginal or cervical smears. A sample of cells is collected from 
the cervix or vagina using a swab or small brush, and placed in a small Hpv fest 
container with a preservative solution. The specimen can be collected 
by a health care provider or by the woman herself, inserting a swab deep into the 
vagina. Studies comparing the two collection methods have shown that self-collection 
is less sensitive than provider-collection. In either case, the specimen containers are 
transported to a laboratory where they are processed. HPV DNA-based tests currently 
require sophisticated and expensive laboratory equipment, although work is under way 
to develop a more affordable and less complicated test that can be carried out in lower- 
level settings. Detection of high-risk HPV does not necessarily mean that precancer 
or cancer is present; it indicates simply that there is an HPV infection. As mentioned 
earlier, HPV infections are extremely common in women under 35 years, and most of 
them resolve spontaneously. When detection of HPV is used as a primary screening test, 
the sensitivity for detection of precancer and cancer varies from 50% to 95%, with most 
studies reporting high sensitivity of 85% or more. The specificity ranges from 50% to 
95%, with an average of 84%. In women aged 35 years or older, HPV DNA tests perform 
better because in these women a positive test is more likely to be due to a persistent 
infection than in younger women. The average sensitivity and specificity in this group 
are 89% and 90%, respectively. The combination of cytology and HPV testing has very 
high sensitivity and negative predictive values approaching 100% (see Annex 3). It 
might therefore be possible to increase the interval between screenings 
for women who are negative on both tests. However, performing the 
two tests together is expensive. The high cost, and the need for both a 
molecular laboratory and reliable methods of transport, present major Apnex 3 

challenges, and the feasibility of HPV testing has not been demonstrated 
in low-resource settings. A new, faster, highly sensitive and less costly 
test for HPV is under development but is not yet available. 




96 Chapter 4: Screening for Cervical Cancer 



Providers 

HPV DMA testing can be done by trained providers at any level of the health care 
Q system, provided that there is an appropriate laboratory within a reasonable distance, 

and that reliable transport is available for specimens. Clinic needs for HPV testing are 
|f the same as for Pap smears and visual methods. 

1 

^ Indications 

C/3 

HPV is not generally used on its own as the primary screening test. It is mainly used in 

=. combination with cytology to improve the sensitivity of the screening or as a triage tool 

<Q to assess which women with borderline Pap results need to be referred for colposcopy. 

The main indication is a Pap result of "atypical cells of undetermined significance" 

g? (ASC-US). Of the women with this lesion, only those who test positive for high-risk HPV 

o will need to be referred for colposcopy and biopsy, significantly reducing the number of 

^ colposcopies. 

CD 

Laboratory facilities 

The HPV laboratory requires a special clean room to avoid contamination, and highly 
trained technicians. It also requires equipment and reagents as specified by the 
manufacturers of the test. 



RECOMMENDATION 

HPV DMA tests as primary screening methods, at this time, are recommended for 
use only in pilot projects or other closely monitored settings. They can be used in 
conjunction with cytological or other screening tests, where sufficient resources 
exist. HPV DNA-based screening should not begin before 30 years of age. 



Visual methods 

Two visual methods are available: 

visual inspection with acetic acid (VIA); 

visual inspection with Lugol's iodine (VILI). 

Abnormalities are identified by inspection of the cervix without magnification, after 
application of dilute acetic acid (vinegar) (in VIA) or Lugol's iodine (in VILI). When vinegar 
is applied to abnormal cervical tissue, it temporarily turns white (acetowhite) allowing 
the provider to make an immediate assessment of a positive (abnormal) or negative 




Chapter 4: Screening for Cervical Cancer 97 



(normal) result. If iodine is applied to the cervix, precancerous and cancerous lesions 
appear well-defined, thick, and mustard or saffron-yellow in colour, while squamous 
epithelium stains brown or black, and columnar epithelium retains its normal pink 
colour. 

Because they do not rely on laboratory services, VIA and VILI are promising alternatives 
to cytology where resources are limited. They are currently being tested in large, 
cross-sectional, randomized controlled trials in developing countries. Until data from 
these studies are available, VIA and VILI are recommended by WHO only for use in 
pilot settings, because the impact on cervical cancer incidence and mortality is still 
unproven. In research settings, VIA has been shown to have an average sensitivity for 
detection of precancer and cancer of almost 77%, and a range of 56% to 94%. 
The specificity ranges from 74% to 94% with an average of 86%. Low-level 
magnification does not improve the performance of VIA over and above that of naked 
eye visualization. One study has shown that VILI can detect 92% of women with 
precancer or cancer, a sensitivity considerably higher than that of either VIA or cytology. 
Its ability to identify women without disease is similar to that of VIA (85%), and lower 
than that of Pap smears. One study showed that VILI had a higher reproducibility than 
VIA. VIA and VILI can be performed in clinics and other outpatient facilities. They are 
both short procedures and cause no pain. Assessment is immediate, and no specimen 
is required. 

Advantages 

VIA and VIL! are relatively simple and can be taught to nurses, nurse-midwives and 
other health workers. 

Assessment is immediate and no transport, or laboratory equipment or personnel, is 
needed. 

The tests are likely to be less costly than other approaches in routine use. 

Results are available immediately, eliminating the need for multiple visits in most 
cases, and reducing loss to follow-up. 

They could potentially be used in an approach based on screening and treating 
women in a single visit (see Chapter 5). 

Disadvantages 

Because of the low positive predictive value of the test (see Annex 
3), a considerable number of women who test positive do not 
have disease, resulting in excessive diagnosis and treatment, and 
unnecessary anxiety. 

Visual tests cannot be relied on in postmenopausal women, because the 
transformation zone of these women is often inside the cervical canal. 




98 



Chapter 4: Screening for Cervical Cancer 






CD 

3 
Zj' 
CO 



o 

CD 



There is no permanent record of the test that can be reviewed later. 

VIA has mostly been evaluated as a once-in-a-lifetime screening test, and its 
performance in periodic screening has not been assessed. 

Providers 

Trained nurses, nurse-midwives, nurse assistants, physicians and other health workers 
with adequate and ongoing support and supervision can perform VIA. Training takes 
5-10 daysusing a competency-based approach. To maintain quality services, it is 
important that an experienced provider conducts regular assessments. Studies show 
that immediately after training, providers have more false positive results. These 
decrease in a few months as the providers gain experience. 

Indications 

If adopted by a programme as a screening method, VIA and VILI are indicated for all 
women in the target age group specified in national guidelines, provided that: 

They are premenopausal. Visual methods are not recommended for postmenopausal 
women, because the transition zone in these women is most often inside the 
endocervical canal and not visible on speculum inspection. 

Both squamocolumnar junctions (i.e. the entire transformation zone) are visible. 

If the patient does not meet the above indications and no alternative screening method 
is available in the particular clinical setting, she should be referred for a Pap smear. 






RECOMMENDATION 

Visual screening methods (VIA and VILI), at this time, are recommended for use only 
in pilot projects or other closely monitored settings. These methods should not be 
recommended for postmenopausal women. 



Chapter 4: Screening for Cervical Cancer 



99 



Table 4.1 Summary of characteristics of screening methods for cervical cancer 



Test 


Procedure 


Strengths 


Limitations 


Status 


Conventional 


Sample of 


History of long use 


Results not 


Available 


cytology 


cervical cells 


Widely accepted 


immediately 


in many 


(Pap smear) 


taken by provider 
and examined 


Permanent record 
of test 


available 
Systems needed 


countries 
since the 




by trained 


Training and 


to ensure timely 


1950s 




cytotechnicians in 


mechanisms for 


communication 


Cytology- 




a laboratory 


quality control 


of test results 


based 






established 


and follow-up of 


programmes 






Modest 


women 


have reduced 






investments in 


Transport required 


cancer 






existing 


for specimen to 


mortality in 






programmes can 


laboratory and for 


developed 






improve services 


results to clinic 


countries 






High specificity 


Requires laboratory 










quality assurance 










Moderate 










sensitivity 




Liquid-based 


Sample of cervical 


Fewer inadequate 


Results not 


Selected as 


cytology (LBC) 


cells is obtained 


or unsatisfactory 


immediately 


screening 




with a small brush, 


samples requiring 


available 


method in some 




immersed in 


patient call-back 


Supplies and 


developed 




special liquid and 


and rescreening 


laboratory 


countries 




sent to laboratory 


Once 


facilities more 


(e.g. United 




for processing and 


cytotechnicians 


expensive than 


Kingdom) 




screening 


are proficient, LBC 


for conventional 








samples take less 


cytology 








time to review 


No controlled 








Samples can be 


studies, to date, 








used for molecular 


comparing 








testing (such as 


sensitivity and 








for HPV) 


specificity with 










conventional 










cytology 





continued next page 



100 



Chapter 4: Screening for Cervical Cancer 



Continued from page 99 

Table 4.1 Summary of characteristics of screening methods for cervical cancer 



o 









i 

O 



Test 


Procedure 


Strengths 


Limitations 


Status 


HPV DNA 


Molecular 


Collection of 


Results not 


Commercially 


testing 


testing for 


specimen simple 


immediately 


available and used 




HPV -swab 


Automated 


available 


in some developed 




taken by 


processing 


High unit cost 


countries in 




provider 


Can be combined 


Complex laboratory 


addition to cytology 




or woman 


with Pap smear 


requirements and 


Lower-cost tests in 




herself 


to increase the 


specimen transport 


development 




and sent to 


sensitivity, but this 


Low specificity 






laboratory 


increases also the 


in young women 








cost 


leading to 








A negative test 


overtreatment 








means no HPV and 


Storage of reagents 








related morbidity 


problematic 








is present 










The assay result 










is a permanent 










record 










High specificity 










in women over 










age 35 






Visual 


Trained 


Relatively simple 


High provider 


Limited evidence 


methods 


provider 


and inexpensive 


variability 


available 


(VIA and 


examines 
cervix after 


Results available 
immediately 


Lower specificity 
resulting in high 


Only recommended 
at this time for use 


VILI) 


staining with 


Can be performed 


referral rate and 


in demonstration 




vinegar (in 


by wide range of 


overtreatment 


projects 




VIA) and 


personnel after 


No permanent 


Large randomized 




with Lugol's 


short training 


record of test 


controlled trials 




iodine (in 


Low level of 


Not appropriate for 


under way to 




VILI) 


infrastructure 


postmenopausal 


determine effect on 






required 


women 


cancer incidence 






Can be combined 


Lack of 


and mortality 






with offer of 


standardization 








immediate 


Frequent retraining 








treatment in 


needed 








single-visit 










approach 








Chapter 4: Screening for Cervical Cancer 1 01 



FOLLOW-UP 

Follow-up and management of women with an abnormal (positive) test 

Screening by itself will not prevent a single case of cervical cancer. An effective system 
for follow-up and treatment of women who test positive is perhaps the most important 
component of a successful cervical cancer prevention programme. 

Ideally, all women should receive the results of their test, whether negative or positive. 

In practice, resources will sometimes be too limited to allow this. 

At the very least, women whose test result is positive or abnormal 

must be informed of the result and of what follow-up is needed. 

Follow-up should be in line with national protocols or based on the Flowchart screening 

recommendations found in Annex 4. 

Follow-up is essential for the woman's welfare and for the success of the programme 
and every effort should be made to contact women with positive test results. 

The following actions will help ensure that women with an abnormal screening test can 
be reached for follow-up: 

The woman's address, or other information on how she can be reached, should be 
noted at the time of screening (with her consent). 

During counselling and after screening, providers need to emphasize the importance 
of coming back for results and follow-up care. 

Every clinic should have a directory of all women with abnormal test results, with an 
indication of whether they have received the results and been followed up. Clinics 
should designate someone to ensure that follow-up is done. 

For women who do not return spontaneously as advised, providers can: 

send a letter by mail; 

telephone women at home or at work; 

ask community health workers to contact women directly at home. 

Health care managers and providers can develop other locally appropriate approaches 
to reach women with abnormal screening tests. 

Health facilities need to make every effort to find women with abnormal results if 
they do not return for scheduled appointments. 



1 02 Chapter 4: Screening for Cervical Cancer 



Record-keeping 

Records should be compatible throughout a country, so that all the data collected by the 
cervical cancer control programme can be compared. The information system should 
include every woman's clinical record, appointments scheduled, and those kept or 
5f missed. This can be a simple paper record or can be computer-based. A logbook can be 

CD used to register women screened and record their test results. If women need to return 

later for their results, a system must be in place to ensure that those 
with abnormal results are notified and that women who are hard to 
locate are traced. Sample forms for follow-up can be found in Annex 7. 

Documents 







o 

03 



Chapter 4: Screening for Cervical Cancer 



103 



SCREENING ACTIVITIES AT DIFFERENT LEVELS OF THE HEALTH SYSTEM 



In the community 




At the health centre 



Health C 



At the district hospital 

IT 




At the central hospital 




Educate and inform the community, promote the screening 
programme, and encourage women to attend. 

Refer appropriate women for screening. 
Assist women to attend screening clinics. 

Assist in follow-up of women with a positive screening to ensure 
that they return to the clinic for management. 

Screen, using methods specified by national guidelines and 
integrating screening into other services. 

Train, support and supervise CHWs. 

Work with CHWs to educate women, and recruit them for 
screening. 

Participate in campaigns to bring women at high risk for testing. 

Provide counselling and health education in the clinic and 
community. 

Inform and counsel women with positive screening test results, 
and advise them on needed follow-up, diagnosis and treatment. 
Implement an accurate patient information system, to allow 
proper tracking and follow-up of women after treatment. 

Carry out screening activities as per national programme. 
Inform and counsel women with positive screening test results, 
and advise them on needed follow-up, diagnosis and treatment 
Train, support and supervise providers at health centre level. 

Manage referral systems with lower and higher levels of the 
health system. 

Carry out screening in outpatient clinics where women are seen. 

Maintain central cytology, pathology, and molecular laboratories, 
as feasible. 

Interpret screening and histopathology results and ensure that 
results reach the screening site. 

Train medical personnel, and support and supervise providers in 
lower-level health facilities. 

Manage referral and links with lower levels of the health system. 



1 04 Chapter 4: Screening for Cervical Cancer 



Counselling messages 



Women who have just had a screening test need to be told: 
5 if anything abnormal was noted; 

when the results will be available; 
^ the date of the next appointment. 

| Women returning for test results should be counselled on: 

< the result of the test and what it means; 

^ if normal, when they need to return for repeat screening; 

< if inadequate or not normal, what follow-up is needed; 

o" 

where and when to go for follow-up. 

I 

CD 



Chapter 4: Screening for Cervical Cancer 1 05 



ADDITIONAL RESOURCES 

ACCR Planning and implementing cervical cancer prevention programs: a manual for 
managers. Seattle WA, Alliance for Cervical Cancer Prevention, 2004. Q 

Arbyn M . A technical guideline: collection of adequate Pap smears of the uterine o 
cervix. Brussels, Scientific Institute of Public Health, 2001 . ." 

Cervical cancer prevention: guidelines for low-resource settings. Baltimore, MD, 

JHPIEGO Corporation, 2001. 

CHIP. Implementing cervical screening in South Africa. Volume I. A guide for o> 
programme managers. New York, Cervical Health Implementation Project, South 

Africa, University of Cape Town, University of the Witwatersrand, EngenderHealth, <2, 

2004. ^ 

IARC. A practical manual on visual screening for cervical neoplasia. Lyon, lARCPress, 

2003. 8 

IARC. Cervix cancer screening. Lyon, IARC Press, 2005 (IARC Handbooks of Cancer * 
Prevention, Volume 1 0). S 

Infection prevention: a reference booklet for health care professionals. New York, 
EngenderHealth, 2001. 

Infection prevention curriculum: a training course for health care providers and other 
staff at hospitals and clinics. New York, EngenderHealth, 1999. 

Miller AB. Cervical cancer screening programmes, managerial guidelines. Geneva, 
WHO, 1992. 

PATH. Planning appropriate cervical cancer prevention programs. Seattle, WA, 
Program for Appropriate Technology in Health, 2000. 

PATH VIA/VILI curriculum. Course in visual methods for cervical cancer screening. In: 
Tsu V et al., Western Kenya Cervical Cancer Prevention Project Final Report. Seattle, 
WA, Program for Appropriate Technology in Health, 2004 (Annex 10). 

Salas Diehl I, Prado Buzeta R, Munoz Magna R. Manual de Procedimientos de 
Laboratorio de Citologfa. Washington, DC, Organization Panamericana de la Salud, 
2002. 

WHO. Cervical cancer screening in developing countries. Report of a WHO 
Consultation. Geneva, 2002. 



106 



PS 6: Obtaining Informed Consent 107 

PRACTICE SHEET 6: OBTAINING INFORMED CONSENT 

PS 6 

WHAT IS INFORMED CONSENT? 

Women must give informed consent before being screened for cervical cancer. This -o 

means that she should understand what is to take place, including the potential risks 
and complications of both proceeding and not proceeding, and has given permission 
for the procedure. It should be made clear to the woman that there will be no punitive 
action if she refuses the procedure. 

<? 
When asking for informed consent: 

Give the woman all essential information on what you are about to do and request 
her consent before starting any examination or procedure. It is unethical to ask for 
informed consent retroactively. 

If there is a possibility that she might need to be contacted at home or at work 
(e.g. to give test results or remind her to return for an appointment), obtain 
consent for doing so. 

Family members should be included in the discussion only if the woman has given 
explicit permission. 

Keep medical terminology to a minimum. Explain any technical words that have no 
local equivalent. 

You may find it helpful to draw or use pictures to illustrate your explanations. 

Be clear and direct; do not use words the patient will not understand, or which are 
vague, such as "growth" or "neoplasm". 

Do not confuse the woman by saying too much, but cover all the important issues. 

Allow some time for the woman to take in what you have said. Then let her ask 
questions. When all the questions have been addressed, ask the woman for her 
formal consent. 

It might be culturally important to include others, such as the woman's partner, 
in the decision-making process; however, you should ensure that the woman's 
wishes are respected. 

EXPLAINING PRACTICES AND PROCEDURES 

You will find explanations for patients included in each chapter of this Guide and 
in the practice sheets. You may adapt these to individual situations to help explain 
procedures in terms the patient and her family understand. 




108 PS 6: Obtaining Informed Consent 



STEPS FOR OBTAINING INFORMED CONSENT 
Preparation 

1 . Ensure privacy and explain that confidentiality is always respected 
in your facility. 

2. Follow your facility's regulations on obtaining informed consent. 

Counselling 

3. Apply general rules on counselling and good communication. Listen 

carefully .and address the woman's concerns; give her the time she needs to 
understand and to make a decision. 

4. Ask her if she would like to have family members present or if she would like to 
discuss the decision with family members at home. Do not pressure her to make a 
decision before she is ready. 

Process 

5. Give all the necessary information on the test, procedure or treatment you are 
recommending and any available alternatives. Use the explanations for patients 
included in this Guide, adapted to your facility and the individual situation, to help 
explain procedures such as cryotherapy, surgery, and radiotherapy. Include the 
following information: 

purpose of the procedure; 

possible benefits; 

risks of doing what you suggest and of not doing it; 

need for anaesthesia or hospitalization; 

potential side-effects and complications and what to do if any of them occur; 

recovery time; 

cost; 

chance of success or failure. 

6. Ask the woman if she has any questions, and answer them. 

7. Check that the patient has understood. You can do this by asking her to repeat 
points that may be difficult or important, or by using other words to reiterate the 
most important issues, such as: "Did you understand that you should not have 
intercourse for 4 weeks after this procedure? How do you think your husband will 
feel about that?" 

8. Correct any misunderstanding. 

9. Keep a written record, either on a consent form or in the medical record 
(according to your facility's guidelines), that: 

you confirmed her understanding of the information; 

her decision to undergo a test or treatment (or to refuse it) was voluntary. 



PS 7: Taking a History and Performing a Pelvic Examination 1 09 



PRACTICE SHEET 7: TAKING A HISTORY AND PERFORMING 

A PELVIC EXAMINATION 9 PS 7 

Cervical cancer screening includes taking a history, to assess if the woman has ^ 

specific risk factors or suggestive symptoms. Most screening tests involve a 

speculum examination. " 

CD 

The following equipment and supplies should be available: w 

clinical chart and pencil; 

sj 

drawings of pelvic organs, if possible; 

tf 

soap and water for washing hands; 

light source to examine the cervix; 

examination table covered by clean paper or cloth; 

disposable or high-level disinfected examination gloves; , 

specula of different sizes, high-level disinfected (need not to be sterile); 

o. 

small container of warm water to lubricate and warm the speculum; 

0.5% chlorine solution for decontaminating instruments and gloves. 

HISTORY 

Ask the patient about: 

her age, education, number of pregnancies, births and living children, last 
menstrual period, menstrual pattern, previous and present contraception; 

previous cervical cancer screening tests, their dates and results; 

medical history including any medications or drug allergies; 

social history, including factors that may increase her risk of cervical cancer; 

sexual history including age of sexual initiation and of first pregnancy, number of 
partners, previous STIs, and any behaviours that may suggest an increased risk of 
cervical cancer; 

any symptoms and signs of cervical cancer and other illnesses. 



Adapted from: Burns A et al. Where women have no doctor. Berkeley, CA, Hesperian 
Foundation, 1 997; and WHO. Sexually transmitted and other reproductive tract infections: a 
guide to essential practice. Geneva, 2005. 



110 PS 7: Taking a History and Performing a Pelvic Examination 

PERFORMING A PELVIC EXAMINATION 

After taking a history, perform a pelvic examination. There are three components to 
the female genital examination: 

an external genital examination; 

a speculum examination; 

a bimanual examination. 

Before the examination 

1 . Have all necessary equipment and supplies ready. Ensure the speculum used is 
at a comfortable temperature. 

2. If tests or interventions are planned (e.g. a Pap smear), tell the woman what they 
are, what they are for, and when you expect to have the results. 

3. Ask the woman if she has any questions, and answer them truthfully. 

4. Explain what the pelvic examination consists of and show the woman a 
speculum. 

5. Ask the woman to empty her bladder (urinate) and have her undress from the 
waist down. Be particularly sensitive to her sense of modesty about uncovering 
normally clothed areas, or if the examination is perceived to be invasive. 

6. Position the woman on the examination table. 

Examination of the external genital area 

7. Using a gloved hand to gently touch the woman, look for redness, lumps, 
swelling, unusual discharge, sores, tears and scars around the genitals and in 
between the skin folds of the vulva. These can be signs of a sexually transmitted 
infection. 



PS 7: Taking a History and Performing a Pelvic Examination 



111 



The speculum examination 

8. Hold the speculum blades together 
sideways and slip them into the 
vagina. Be careful not to press on the 
urethra or clitoris because these areas 
are very sensitive. When the speculum 
is halfway in, turn it so the handle is 
down. Gently open the blades and look 
for the cervix. Move the speculum 
slowly and gently until you can see 
the entire cervix. Tighten the screw 
(or otherwise lock the speculum in the 
open position) so it will stay in place. 



cervix 




PS 7 



9. Check the cervix, which should look pink, round and smooth. There may be small 
yellowish cysts, areas of redness around the opening (cervical os) or a clear 
mucoid discharge; these are normal findings. 

1 0. Look for any abnormalities, such as: 

a. Vaginal discharge and redness of the vaginal walls, which are common signs 
of vaginitis. If the discharge is white and curd-like, there is probably a yeast 
infection. 

b. Ulcers, sores or blisters. Genital ulcers may be caused by syphilis, chancroid, 
herpes virus or, in some cases, cancer. Sores and blisters are usually caused by 
herpes virus. 

c. Easy bleeding when the cervix is touched with a swab, or a mucopurulent 
discharge, which are signs of a cervical infection. 

d. An abnormal growth or tumour, which might be cervical cancer. 

1 1 . Gently pull the speculum towards you until the blades are clear of the cervix, close 
the blades and remove the speculum. 



112 



PS 7: Taking a History and Performing a Pelvic Examination 



The bimanual examination 

^ ' The bimanual examination allows you to feel the reproductive organs inside the 
abdomen. 







1 2. Test for cervical motion tenderness. Put the pointing and the middle finger of 
your gloved hand in the woman's vagina. Turn the palm of your hand up. Feel 
the cervix to see if it is firm and round. Then put one finger on either side of the 
cervix and move the cervix gently while watching the woman's facial expression. 
If this causes pain (you may see the woman grimace), this indicates cervical 
motion tenderness, and she may have an infection of the womb, tubes or 
ovaries (pelvic inflammatory disease or PID). If her cervix feels soft, she may be 
pregnant. 

1 3. Feel the womb by gently pushing on her lower abdomen with your other hand. 
This moves the womb, tubes and ovaries closer to the fingers inside her vagina. 
The womb may be tipped forwards or backwards. When you find the womb, feel 
for its size and shape. It should feel firm, smooth and smaller than a lemon. 

If the womb feels soft and large, the woman is probably pregnant. 

If it feels lumpy and hard, she may have a fibroid or other growth. 

If it hurts her when you touch it, she may have an infection. 

If it does not move freely, she may have scars from an old infection. 



PS 7: Taking a History and Performing a Pelvic Examination 1 1 3 



1 4. Feel the tubes and ovaries. If these are normal, they will be hard to feel. If you feel 
any lumps that are bigger than an almond or that cause severe pain, she may have 
an infection or other condition needing urgent treatment. If she has a painful lump, 
and her period is late, she may have an ectopic pregnancy; in this case, she needs 
medical help right away. 

1 5. Move your finger to feel the inside of the vagina. Make sure there are no unusual 
lumps, tears or sores. 

16. Ask the woman to cough or push down as if she were passing stool. Look to see 
if something bulges out of the vagina. If it does, she may have a fallen womb or 
fallen bladder (prolapse). 

After the examination 

17. Place used equipment and gloves in decontamination solution. 

1 8. Wash your hands with soap and water. 

19. Record all findings on the woman's chart. 

20. Tell the woman if her examination was normal or if you noted anything unusual or 
abnormal, and explain what any abnormality you noted might mean. 

21 . If you noted any signs that might indicate a sexually transmitted infection, treat the 
woman and her partner immediately, according to national or WHO guidelines. 10 
Provide condoms and teach them how to use them. If you found an acute cervical 
infection or PID, provide treatment as outlined in Annex 8. 

Annex 

22. If you found something that needs urgent treatment or that cannot 
be handled at your centre (e.g. ectopic pregnancy, prolapse, 
cervical tumour), refer the woman to a higher level of care. 

23. Give her a date to return for follow-up if necessary. 




WHO. Sexually transmitted and other reproductive tract infections: a guide to essential practice. 
Geneva, 2005. 



114 



PS 7: Taking a History and Performing a Pelvic Examination 



PS 8: Taking a Pap Smear 1 1 5 



PRACTICE SHEET 8: TAKING A PAP SMEAR 

In a Pap smear test, a sample of cells is taken from the uterine cervix using a spatula 
or brush (see figure PS8.1), smeared onto a slide, and examined under a microscope 
for abnormal cells (precancer or cancer). When a Pap smear shows abnormal 
epithelial cells, it is reported as positive. Most women with a positive Pap smear need 
more tests to confirm the diagnosis and to determine whether treatment is needed. 11 

The following materials and equipment are needed for taking a conventional Pap 
smear: 

soap and water for washing hands; 

a light source to examine the cervix; 

an examination table covered by clean paper or cloth; 

a speculum, high-level disinfected (it need not be sterile); 

disposable or high-level disinfected examination gloves; 

an extended-tip wooden or plastic spatula (or another device for sampling); 

a glass slide with frosted edge and pencil for labelling; 

fixative solution; 

recording form; 

small container of warm water to lubricate and warm the speculum; 

0.5% chlorine solution for decontaminating instruments and gloves. 




PS 8 



00 



CO 



CO 

CD 
CO 



Figure PS8.1 Devices for Pap smear sampling 



(a) Wooden spatula 

(b) Endocervical brush 

(c) Plastic brush / broom 



When the Pap smear reports ASC-US or LSIL, only persistent lesions (reported on two Pap 
smears within 6 months to 1 year) should be investigated further. 



116 



PS 8: Taking a Pap Smear 



TAKING A PAP SMEAR 

Note the following: 

It is best not to take a smear from women who are actively menstruating or have 
symptoms of an acute infection. Slight bleeding is acceptable. 

Pregnancy is not an ideal time for a Pap smear, because it can give misleading 
results. However, if the woman is in the target age group and it is likely that she 
will not return after giving birth, proceed with the smear. 

Use Practice Sheet 4 to give counselling before doing any examination, 
test or procedure. Counselling steps specific to taking smears are 
included in the steps below. 

Counselling 




Preparation 

1 . Explain the procedure, what the test results mean, and why 
it is important to return for the test results and act on them 
appropriately. Ensure that the woman has understood and obtain 
informed consent. 

2. Do a speculum examination as described in Practice Sheet 7. 




Informed consent 




PS7 Pelvic exam 



Taking the smear with a wooden spatula 

3. Insert the long tip of the spatula into the os, and rotate it through a full circle 
(360 degrees). 

Figure PS8.2 Taking a sample of cervical cells with a wooden spatula 




cervix vagina 



4. Smear both sides of the spatula onto the glass slide with one or two careful 
swipes. If you see any abnormalities outside the area sampled, take a separate 
specimen and smear it on another slide. 



PS 8: Taking a Pap Smear 



117 



5. Immediately fix each slide. Either use spray fixative, at a right angle to, and a 
distance of 20 cm from, the slide, or immerse the slide in a container of 95% 
ethanol for at least 5 minutes. 

Figure PS8.3 Fixing a conventional Pap smear 



IJjF 




If the slide is not fixed immediately, the cells will dry and become misshapen; it will 
then not be possible to read the slide accurately in the laboratory. 

6. Gently close and remove the speculum. 

7. Place all used instruments in decontamination solution. 



PS 8 



9? 
S 1 



S 



After taking the smear 

8. Label the frosted edge of each slide carefully with the woman's name and clinic 
record number, and the date. 

9. On the patient record, note and illustrate any features you have noted: visibility 
of the transformation zone, inflammation, ulcers or other lesions, abnormal 
discharge. Note whether other samples were taken, for example Pap smear of 
other areas, any STI tests and, if the woman has been referred elsewhere, to 
whom and when. 

1 0. Ask the woman if she has any questions. 

1 1 . Tell her when and how she will receive the test results and stress the importance 
of returning for her results. Ideally, results should be sent to the clinic within 2 or 
3 weeks. It is not acceptable for the laboratory to take more than 1 month before 
reporting back. 



118 



PS 8: Taking a Pap Smear 



PS 8 



C/5 

00 



1 2. If you saw something for which you wish to refer the woman to a higher level, 
explain why, where and when she must go, and whom to see; stress the 
importance of keeping this appointment. 

1 3. Suggest to the woman that she encourage family members and friends in the 
target age group to come in for a Pap smear. 



0) 
C/9 

i 



Follow-up 

14. When~the woman returns, give her the test results, explain what they mean, and 
advise what needs to be done. 

If the test is negative (normal), tell her to have another test within 3 years (or 
as per national guidelines). 

In the other cases, use the flowchart in Annex 4a to advise the woman on 
how she should be followed up. 

Flowchart PAP 





1 5. If the woman does not return, and her smear was abnormal or 
inadequate, try to contact her. A sample letter to send to such 
patients is given in Annex 7. Other strategies to ensure return are 
described in Chapter 4. Documents 

Your task is not completed until each woman has been told her test results, 
or at least those women with abnormal test results. 



PS 9: Collecting Samples for HPV DNA Testing 1 1 9 



PRACTICE SHEET 9: COLLECTING SAMPLES FOR HPV DNA 
TESTING 

For HPV DNA testing, secretions are collected from the cervix or vagina using a swab 

or small brush, and placed in a special liquid to be sent to the laboratory. There they 3 

can be tested for HPV infection, which can stimulate changes in the cells covering the 

cervix. The test does not diagnose cervical precancer or cancer. JJ, 

The following materials and supplies are needed to collect samples for HPV testing: 

soap and water for washing hands; 

a light source to examine the cervix; 

an examination table covered by clean paper or cloth; <g 

a speculum, high-level disinfected (it need not be sterile); 

disposable or high-level disinfected examination gloves; 

small brush or soft swab; 

o 

small container with preservative solution; 

recording form; 

small container of warm water to lubricate and warm the speculum; 

0.5% chlorine solution for decontaminating instruments and gloves. 

CO 



TAKING A SAMPLE FOR HPV TESTING 

Note the following: 

It is best not to take a sample from women who are actively menstruating. Slight 
bleeding is acceptable. 

HPV testing, if available, is most useful when done in conjunction with a 
cytological test, in women aged 35 years or older. 

Use Practice Sheet 4 to give counselling before doing any examination, 
test or procedure. Counselling steps specific to the HPV test are included 

in the steps below. 

Counselling 




1 20 PS 9: Collecting Samples for HPV DMA Testing 

Preparation 

1 . Explain what an HPV test is and what a positive test means. Ensure that the 
woman has understood and obtain informed consent. 

2. Do a speculum examination as described in Practice Sheet 7. 




Taking the sample 

3. Take a "smear from the top of the vagina and the cervical os using a brush or 
swab. 

4. Place the brush or swab in a special container with preservative solution. 

5. Gently close and remove the speculum. 

6. Place all used instruments in decontamination solution. 

7. Label the container with the woman's name and clinic record number, and the 
date. 

After taking the specimen 

8. Tell the patient about anything unusual you noted. 

9. Record your observations and the taking of the sample on the patient chart. 

1 0. Tell the woman when she should return for the test results. 

1 1 . If you saw something for which you wish to refer the woman to a higher level, 
explain why, where and when she must go, and whom to see; stress the 
importance of keeping this appointment. 

Alternative method: self-collection 

1 . Explain to the woman how to collect her own specimen, as per instructions of 
the manufacturer of the test kit. 

2. Provide her with swabs and a vessel with preservative solution. 

3. She can collect the specimen in the clinic, if there is a private area, or at home. 

4. If she collects the specimen at home, she should bring it to the clinic as soon as 
possible, and in any case within the time specified by the manufacturer of the 
test kit. 

5. Send the specimen to the special laboratory for examination. 



PS 9: Collecting Samples for HPV DNA Testing 



121 



Follow-up 

1 2. When the woman returns, whether the specimen was collected by herself or by the 
provider, give her the test result, explain what it means, and if necessary advise 
her on any additional tests or treatment needed. 

1 3. If the test was used as a primary screening tool, women with a positive test should 
be referred for colposcopy. If the test was done in conjunction with a Pap smear, 
whose result was ASC-US, only women positive for high-risk HPV need to be 
referred for colposcopy and biopsy. 

1 4. Be prepared to respond to questions concerning the implications of 
a positive HPV test. 

V 

FAQs 





8 

CO 



o 

o 



s? 

5. 

$ 


i 



I 



122 



PS 9: Collecting Samples for HPV DNA Testing 



PS 9 



PS 10: Visual Screening Methods 



123 



PRACTICE SHEET 10: VISUAL SCREENING METHODS 

In a visual test, the provider applies acetic acid (in VIA) or Lugol's iodine solution (in 
VILI) to the cervix, and then looks to see if there is any staining. A VIA test is positive^ 
if there are raised and thickened white plaques or acetowhite epithelium; a VILI test 
is positive if there are mustard or saffron-yellow coloured areas, usually near the 
SCJ. Either test is suspicious for cancer if a cauliflower-like fungating mass or ulcer 
is noted on the cervix. Visual screening results are negative if the cervical lining is 
smooth, uniform and featureless; it should be pink with acetic acid and dark brown or 
black with Lugol's iodine. 

The following materials and equipment are needed for visual methods: 

soap and water for washing hands; 

a bright light source to examine the cervix; 

a speculum, high-level disinfected (it need not be sterile); 

disposable or high-level disinfected examination gloves (need not be sterile); 

examination table covered by clean paper or cloth; 

cotton-tipped swabs; 

dilute acetic acid solution (3-5%) or white vinegar; 

Lugol's iodine solution; 

0.5% chlorine solution for decontaminating instruments and gloves; 

recording form. 



PERFORMING VISUAL SCREENING TESTS 

Note the following: 

Visual methods are not recommended for use in postmenopausal women, because 
their transition zone is most often inside the endocervical canal and not visible on 
speculum inspection. 



Preparation 

1 . Explain the procedure, how it is done, and what a positive test 
means. Ensure that the woman has understood and obtain 
informed consent. 

2. Do a speculum examination as described in Practice Sheet 7. 




PS7 Pelvic exam 




PS10 



5? 

I 

SL 

S? 
I 



124 



PS 10: Visual Screening Methods 



Performing the test 

3. Adjust the light source in order to get the best view of the cervix. 

Use a cotton swab to remove any discharge, blood or mucus from the cervix. 
Identify the SCJ, and the area around it. 



Apply acetic acid or Lugol's iodine to the cervix; wait a minute or two to allow colou 
changes to develop. Observe any changes in the appearance of the cervix. Give spe 
attention to abnormalities close to the transformation zone. 

7. Inspect the SCJ carefully and be sure you can see all of it. Report if the cervix bleed 
easily. Look for any raised and thickened white plaques or acetowhite epithelium if ] 
used acetic acid or saffron-yellow coloured areas after application of Lugol's iodine. 
Remove any blood or debris appearing during the inspection. 

8. Use a fresh swab to remove any remaining acetic acid or iodine solution from the ce 
and vagina. 

9. Gently remove the speculum. 

After screening 

1 0. Record your observations and test result. Draw a map of any abnormal findings 
on the record form. 



Figure PS10.1 VIA results recorded on labelled drawing 




O Outline of squamocolumnar junction (SCJ) 
White epithelium 
O Actual cervical os 



1 1 . Discuss the results of the screening test with the patient. If the test is negative, 
tell her that she should have another test in three years. If the test 
is positive or cancer is suspected, tell her what the recommended 
next steps are (see Annex 4a for standard approach and Annex 4b 
for the screen-and-treat approach). If she needs to be referred for 
further testing or treatment, make arrangements and provide her 
with all necessary forms and instructions before she leaves. If you 
can make the appointment immediately, do so. 




Annex 4a&4b 




CHAPTER 5: DIAGNOSIS AND MANAGEMENT 
OF PRECANCER 



Chapter 5: Diagnosis and Management of Precancer 1 27 



CHAPTER 5: DIAGNOSIS AND MANAGEMENT 
OF PRECANCER 



Key points 



Further investigations are needed in all women with a positive or abnormal 
screening test, in order to make a definitive diagnosis. 

The standard method for diagnosis of cervical precancerous lesions is 
histopathological examination of tissue obtained through biopsy guided by 
colposcopy. 

The "screen-and-treat" approach involves providing treatment on the basis of a 
positive screen test, without further diagnostic testing. This is a new approach and 
the long-term impact on cancer incidence has yet to be evaluated. 

It is essential that precancerous lesions graded CIN 2 or 3 are treated. GIN 1 lesions 
are more likely to resolve spontaneously, but should be treated if it is likely that the 
woman will not return for follow-up, and in other special circumstances. 

Outpatient treatments, such as cryotherapy and loop electrosurgical excision 
procedure (LEEP), are preferable to more invasive treatments (such as cold knife 
conization), which require anaesthesia and often hospitalization, and have more 
complications. 

Cold knife conization is appropriate when the eligibility criteria for cryotherapy and 
LEEP are not met. 

Hysterectomy should not be used to treat precancer, unless there are other 
compelling reasons to remove the uterus. A desire for surgical sterilization is not an 
acceptable reason. 

ABOUT THIS CHAPTER 

This chapter describes diagnostic and treatment procedures for precancer - colposcopy 
and biopsy, cryotherapy, loop electrosurgical excision procedure and cold knife 
conization - and discusses their indications, advantages and disadvantages. It also 
outlines the "screen-and-treat" approach. 

ROLE OF THE PROVIDER 

The health care provider is responsible for ensuring that all women with abnormal 
screening tests receive the follow-up and treatment they need. They should explain 
to women with a positive screening test what follow-up is indicated, managing cases 



128 



Chapter 5: Diagnosis and Management of Precancer 



locally where possible, or referring them to a higher-level facility. They also need to 
counsel women who undergo diagnostic and treatment procedures on the importance 
of abstaining from sexual intercourse, or using condoms correctly and consistently, for 
some time afterwards. 




STORY 

Maria Is a 60-year-old Nicaraguan mother with 
12 children, who has been married to the same 
man for 45 years. The teacher at her literacy class 
told her about a clinic to be held in her village to 
test women for cervical cancer, and advised her to 
attend. At the clinic, she had a Pap smear. When she 
returned for her test results, she was told she had a 
HSIL, a condition that needed to be treated because 
otherwise it could get worse and become cancer. She was referred to the 
district hospital, where a doctor looked inside her vagina with a colpo- 
scope and took a biopsy from the abnormal area. The biopsy confirmed 
that she had a precancerous lesion and she was treated with cryotherapy. 
The doctor explained the importance of regular examinations after treat- 
ment, as sometimes a few abnormal cells remain and continue to progress 
towards cancer. But Maria was leaving the country and did not return for 
many months. When she came back, she was told that the health worker 
had come to visit her and had left a message that it was very important for 
her to attend the follow-up visit. She finally attended the clinic 1 8 months 
after treatment. The doctor in the hospital repeated the colposcopy, which 
revealed that there was again a suspicious lesion. The biopsy confirmed a 
CIN 3 lesion, needing further treatment. Maria was admitted to the hospital 
for a cold knife conization under anaesthesia; she was operated on early 
in the morning and discharged the same day. The entire abnormal area 
was removed, and she has had normal follow-up tests since then. 



Chapter 5: Diagnosis and Management of Precancer 1 29 



MANAGEMENT OPTIONS FOR PRECANCER 

Standard practice for diagnosis: colposcopy and biopsy 

Biopsy performed with the aid of a colposcope is the standard method for diagnosis of 
cervical precancer and preclinical invasive cancer. For satisfactory biopsy, the entire 
transformation zone must be visible to allow the degree of abnormality to be assessed 
and to identify areas for biopsy. If the SCJ or the transformation zone is partially or 
entirely inside the cervical canal, an endocervical speculum examination should be 
done to visualize any lesions in their entirety, and an endocervical curettage (ECC) 
done to obtain a sample for histopathological examination. If precancer is diagnosed, it 
should be treated using cryotherapy, LEEP or cold knife conization. 

Barriers to colposcopy and biopsy services 

Ideally, colposcopy and biopsy should be used to manage women with a positive 
screening test, but there are frequently barriers to the establishment of these services: 

Colposcopes are sophisticated, relatively expensive instruments. 

Specialized training and experience are required to maintain proficiency. 

Biopsy samples need to be transported to a histopathology service, which may be 
difficult in low-resource settings. 

Alternative approaches to diagnosis and treatment 

"Screen-and-treat" approach 

In this approach, treatment decisions are based on the results of the 

screening test, without a prior diagnostic test. Most screen-positive 

women can be treated with cryotherapy at primary health care level Screen and treat 

at the time of screening; this could reduce loss to follow-up and have 

an impact on cervical cancer control. However, tissue will not be available for later 

examination. This approach is discussed in more detail in Annex 4b. 

Colposcopy-based "see-and-treat" approach 

To address the issue of potential overtreatment with the screen-and-treat approach, an 
intermediate approach can be used. Patients with a positive screen (on Pap smear, VIA, 
VILI, or HPV) can be examined with a colposcope. If a precancerous lesion is detected, 
it can be treated immediately. If cryotherapy is the chosen treatment, colposcopically- 
directed biopsies can be taken before treatment to confirm the diagnosis following the 
procedure. If LEEP is used, tissue will be available as a result of the procedure. This 
approach is contingent on the availability of equipment and trained and experienced 
providers. 




OJ 
(O 



1 30 Chapter 5: Diagnosis and Management of Precancer 



DIAGNOSIS 

Colposcopy, biopsy and endocervical curettage 

Colposcopy 

Colposcopy is the examination of the cervix, vagina and vulva with a colposcope, 
which provides illumination and magnification, allowing the cellular patterns in 
the epithelial layer and surrounding blood vessels to be examined. Application 
of dilute acetic acid 12 will highlight abnormal areas, which can then be biopsied. 
Used as a diagnostic tool on patients with a positive screen test, colposcopy has 
a high sensitivity (around 85%) and a specificity of about 70% for the detection of 
precancer and cancer. 

Colposcopy is used to: 

visually evaluate precancerous and cancerous lesions; 

help define the extent of lesions; 

guide biopsies of areas that appear abnormal; 

assist treatment with cryotherapy or LEER 
Colposcopy should not be used as a screening tool. 





RECOMMENDATION 

Colposcopy is recommended only as a diagnostic tool and should be performed by 
properly trained and skilled providers. 



Biopsy 

Biopsy is the removal of small areas of the cervix for histopathological diagnosis. 
It should be done only with colposcopic assistance. With a punch biopsy forceps 
(Figure 5.1), one or more small pieces of tissue (1-3 mm across) are removed from the 
abnormal areas of the cervix identified by colposcopy. Bleeding is usually minimal. The 
samples are placed in a preservative, such as formalin, and the container labelled. This 
is then sent to a laboratory for precise histopathological diagnosis of the abnormalities, 
whether they are precancer or cancer, and their severity and extent, so that treatment 
can be tailored to each case. 



12 Staining with Lugol's iodine, although still used, is not recommended for routine use because it can 
potentially produce artefacts in the biopsy specimen. 



Chapter 5: Diagnosis and Management of Precancer 



131 



Figure 5.1 Cervical punch biopsy forceps 




Endocervical curettage 

If a woman has a positive Pap test, but no abnormal areas are observed with 
colposcopy, there may be a lesion in the cervical canal. In this case, the endocervix 
can be examined with a special speculum and a sample of cells can be obtained with 
an endocervical curette for microscopic diagnosis. Endocervical curettage is a simple 
procedure, in which some of the surface cells are gently scraped from the cervical 
canal. The cells are then sent to a laboratory for examination. The procedure takes only 
a few minutes. 

Colposcopy, biopsy and endocervical curettage are almost painless (although they may 
cause brief cramping) and do not require anaesthesia. After a biopsy or endocervical 
curettage, the woman should abstain from sexual intercourse until she has no more 
discharge or bleeding; this usually means a couple of days. If this is not possible, she 
should use condoms. 



Providers 

If a colposcope, biopsy forceps and a endocervical curette are available, colposcopy, 
biopsy and endocervical curettage can be performed at primary care level by trained 
and skilled physicians, nurses and other health care providers. More commonly, they 
are performed as outpatient procedures at secondary level (district hospital). 

Indications for colposcopy and biopsy 

Colposcopy and biopsy should be performed: 

on women with an abnormal screening test; 

if suspicious lesions are seen on the cervix on speculum examination; 

to map abnormalities before cryotherapy or LEER 



1 32 Chapter 5: Diagnosis and Management of Precancer 



Indications for endocervical curettage 

Endocervical curettage should be performed in the following circumstances: 

The patient has a positive Pap smear, but no abnormality is seen with colposcopy. 
There may be a precancer or cancer hidden inside the cervical canal, which can be 
detected by examining tissue obtained by curettage. 

The Pap smear revealed a glandular lesion. These usually arise from the columnar 
epithelium inside the canal. In this case, endocervical curettage must be performed 
regardless of the colposcopy findings. 

Colposcopy was unsatisfactory because the transformation zone was not seen in its 
entirety. 

Special considerations 

The entire transformation zone is not visible. In this case, the colposcopy is 
unsatisfactory and an endocervical curettage should be done. If this is not possible, 
women should be referred for LEEP or cold knife conization. This is especially 
important if the screening test revealed a high-grade lesion. 

The woman is pregnant. As discussed in Chapter 4, pregnancy is not the ideal time 
to perform a screening test. However, if a test is done and is abnormal, or if a lesion 
is noted on speculum examination, the patient should be referred for colposcopy. 
Taking biopsies during pregnancy can be associated with significant bleeding. 
Therefore, if there is no colposcopic indication of invasive cancer, the patient 

can be given an appointment to return at 12 weeks postpartum for colposcopic 
re-evaluation and possible biopsy. If cancer is suspected, she should be referred 
immediately to a specialist. 

The woman is postmenopausal. In many postmenopausal women, the entire 
transformation zone is not visible. If an adequate endocervical curettage is not 
possible, a cold knife conization should be done. 

The woman is HIV-positive. Management of abnormalities, including colposcopy 
and biopsy, should not be modified on the basis of a woman's HIV status. During the 
healing process after any procedure, seropositive women might have increased virus 
shedding and, if re-exposed, might be more likely to acquire an additional virus load. 
Abstinence from intercourse until healing has occurred is most important. 



Chapter 5: Diagnosis and Management of Precancer 1 33 



Follow-up 

The patient should be asked to return in 2-3 weeks for the results of the biopsy. 
Treatment options, according to the severity and extent of the abnormality, should then 
be discussed with her. Women who do not return as requested should be contacted, 
given their results and advised about what treatment they need (see Chapter 4 for 
strategies to ensure that women receive the information they need). 

TREATMENT OF PRECANCER 

Patient management depends on the results of the colposcopy, biopsy and endocervical 
curettage, and should be in line with national guidelines. The 
flowchart in Annex 5 indicates management options. 




Flowchart precancer 

Principles of treatment 

In most cases, precancerous lesions can be treated on an outpatient basis using 
relatively non-invasive procedures, such as cryotherapy or LEER For lesions that 
cannot be treated in this way, inpatient methods such as cold knife conization can be 
used. Hysterectomy, a highly invasive procedure with a risk of complications, such 
as infection, haemorrhage and injury to adjacent organs, should not be used to treat 
precancer, unless there are other reasons to remove the uterus. Desire for permanent 
contraception on the part of the patient is not an acceptable concurrent reason for 
hysterectomy. 



RECOMMENDATION 

Precancer should be treated on an outpatient basis whenever possible. Both 
cryotherapy and LEEP may be suitable for this purpose, depending on eligibility 
criteria and available resources. 



1 34 Chapter 5: Diagnosis and Management of Precancer 



Indications for treatment 

All biopsy-confirmed GIN 2 and 3 lesions should be treated, because the majority of 
them persist and may eventually progress to invasive cancer. CIN 1 is more likely to 
resolve spontaneously; these patients can be followed up with colposcopy and cytology 
every 6 months until the lesion regresses to normal, or there is evidence of progression 
of the abnormality. If progression is noted, or in cases where follow-up is problematic, 
as well as in older women in whom spontaneous regression is less likely, immediate 
treatment should be considered. 

Special considerations 

Pregnancy. Women known or suspected to be pregnant should not be treated 
for precancer; they should be advised to return at 1 2 weeks postpartum for 
further evaluation. If invasive cancer is suspected, the patient should be referred 
immediately to a specialist (see Chapter 6). 

The woman is menstruating. Women who present for treatment during 
menstruation can be treated if the bleeding is slight. It is advisable to delay the 
procedure if menstruation is heavy and interferes with visualization of the extent of 
the lesion. 

The woman has a cervical infection or pelvic inflammatory disease (PID). 

- A cervical infection with no evidence of PID (diagnosed clinically during speculum 
examination or with laboratory tests) can be treated with antibiotics concurrently 
with cryotherapy. If LEEP or cold knife conization is to be used, the infection must 
be treated before the procedure. 

- If PID is suspected, a full course of appropriate antibiotic treatment should be 
completed prior to any treatment. 

- Whenever a woman is treated for a cervical infection, with or without PID, her 
partner also needs to be fully treated to prevent reinfection. Until both have been 
fully treated, they should be advised to abstain from sexual intercourse or use 
condoms. Condoms and instructions on their use need to be provided to all such 
patients. 

The woman is HIV-infected. HIV-positive women should be managed in the same 
manner as uninfected women. However, HIV-positive women are known to have 
higher rates of persistence, progression and recurrence of disease after treatment. 
Women with HIV infection should therefore be monitored every 6 months after 
treatment, and promptly re-treated if persistent, progressive or recurrent high-grade 
lesions are detected. 



Chapter 5: Diagnosis and Management of Precancer 1 35 



At present there is no clear evidence on whether treatment with highly active 
antiretroviral drugs modifies regression or progression of cervical precancer and cancer. 
Before any treatment, HIV-positive women should receive counselling to ensure that 
they understand the need for close follow-up, and the possibility of need for repeat 
treatments, as well as the potential for increased transmission and acquisition of STIs 
and HIV during healing. Abstinence from sexual intercourse is the best protection 
following treatment; if this is not feasible, condoms should be used consistently and 
correctly. 



RECOMMENDATION 

Women should be offered the same treatment options irrespective of their HIV 



status. 



Treatment methods 

Treatment methods may be ablative (destroying abnormal tissues by heating or 
freezing) or excisional (surgically removing abnormal tissues). The main disadvantage 
of ablative methods is that, unless a biopsy is taken before treatment, there is no tissue 
specimen for histological examination and confirmation of the lesion. 

The choice of treatment will depend on: 

the training and experience of the provider; 

the cost; 

the advantages and disadvantages of each method; 

the location and extent of the lesion. 

Cryotherapy and LEEP are the recommended outpatient treatment options. Cryotherapy 
is the easiest and least costly treatment method for precancer. However, LEEP is the 
treatment of choice when the lesion is too large for the cryoprobe or involves the 
endocervical canal, or when a histological specimen is needed. The two methods have 
comparable effectiveness (see Table 5.1). Cold knife conization should be done when 
the eligibility criteria for outpatient methods are not fulfilled, or when such methods are 
not available. 

Regardless of the treatment method to be used, the patient must 
receive full information on what will be done. Informed consent must be 
obtained before the procedure is undertaken. 

Informed consent 




136 



Chapter 5: Diagnosis and Management of Precancer 




Cryotherapy 

Cryotherapy eliminates precancerous areas on the cervix by freezing them. This 
relatively simple procedure takes about 1 5 minutes and can be performed on 
an outpatient basis. It involves applying a highly cooled metal disc 
(cryoprobe) to the cervix, and freezing its surface using carbon dioxide 
(C02) or nitrous oxide (N20) gas. The cryoprobe is applied to the cervix 
twice, for three minutes each time, with a 5-minute thaw in between 
(double-freeze technique). A continuous supply of carbon dioxide or 
nitrous oxide is required. The more expensive, bone-dry medical grade of gas is 
preferred, but industrial-grade gas can be used if that is what is locally available 
and affordable. Cryotherapy is highly effective for the treatment of small lesions, but 
for larger lesions the cure rate is below 80%. Because the area of the cervix that is 
frozen has very few nerve endings, cryosurgery is generally associated only with some 
cramping or mild pain. It can, therefore, be done without anaesthesia. 



Cryotherapy 



Providers 

Cryotherapy can be performed at all levels of the health care system by a variety of 
trained providers (doctors, nurses, midwives) skilled in pelvic examination, and trained 
in cryotherapy as an outpatient procedure. 



Indications and exclusion criteria 



Eligibility criteria 



Exclusion criteria 



Positive screening test for cervical 
precancer 

Lesion small enough to be covered by 
the cryoprobe with no more than 
2 mm beyond its edges 

The lesion and all edges fully visible 
with no extension into the endocervix 
or onto the vaginal wall 



Evidence or suspicion of invasive 
disease or glandular dysplasia 

The lesion extends more than 2 mm 
beyond the cryoprobe edge 

Pregnancy 

PID (until treated) 

Active menstruation 



Chapter 5: Diagnosis and Management of Precancer 



137 




Loop electrosurgical excision procedure (LEEP) 

LEER also called large loop excision of the transformation zone (LLETZ), is the 

removal of abnormal areas from the cervix using a thin heated wire. It requires an 

electrosurgical unit that produces a constant low voltage and transmits 

it to a wire loop device, which is used to remove the abnormal tissue. 

The loops are of very fine stainless steel or tungsten wire and come 

in different sizes and shapes. The loop cuts and coagulates at the 

same time. LEEP aims to remove both the lesion and the entire 

transformation zone. The tissue removed can be sent for examination 

to the histopathology laboratory, allowing the extent of the lesion to be assessed. Thus, 

LEEP serves a double purpose: it treats the lesion, and at the same time, produces a 

specimen for pathological examination. The procedure also has the advantage that it 

can be performed under local anaesthesia on an outpatient basis. It is successful in 

eradicating precancer in more than 90% of cases. Treatment failure (i.e. persistent 

lesions at 6 or 12 months follow-up) is seen in less than 10% of women. 



LEEP 



en 
O 



Providers 

LEEP is a relatively simple surgical procedure, but it should be performed only by a well 
trained provider with demonstrated competence in the procedure and in recognizing 
and managing intraoperative and postoperative complications, such as haemorrhage. 
LEEP is best carried out in facilities where back-up is available for management of 
potential problems. In most resource-poor countries, this will limit LEEP to second-level 
(district hospital) facilities. 



Indications and exclusion criteria 



Eligibility criteria 



Exclusion criteria 



A positive diagnostic test for 
precancer 

Lesion extending less than 
1 cm into the endocervical 
canal 



Suspicion of invasive cancer or glandular 
dysplasia 

Lesion extending more than 1 cm into the 
endocervical canal, or whose distal or upper 
extent is not visible (these lesions are treated by 
cold knife conization) 

Cervical infection or PID (until treated or 
resolved) 

Pregnancy or delivery within the last 1 2 weeks 
Bleeding disorders 



138 



Chapter 5: Diagnosis and Management of Precancer 



CO 
CD 

CD 




Conization 



Cold knife conization 

Cold knife conization is the removal of a cone-shaped area from the cervix, including 

portions of the outer (ectocervix) and inner cervix (endocervix) (Figure 5.2). Conization is 

recommended for the treatment of dysplasia when outpatient treatment 

is not feasible or not accessible, and to rule out invasive cervical cancer. 

It is a rather extensive operation, involving removal of a large area of 

the cervix with a scalpel, and is usually done under general or regional 

(spinal or epldural) anaesthesia. It takes less than one hour. The patient 

may be discharged from hospital the same or the next day. Because of 

possible side-effects, cold knife conization should be reserved for cases that cannot be 

resolved with cryotherapy or LEEP excision. The extent of the conization will depend on 

the size of the lesion and the likelihood of finding invasive cancer. The woman's desire 

to have more children also has to be taken into account, as conization may result in 

cervical stenosis or incompetence in a few women. The tissue removed is sent to the 

pathology laboratory for histological diagnosis and to ensure that the abnormal tissue 

has been completely removed. 






Fig 5.2 Area of the cervix removed in conization 



Cone biopsy 




Providers 

Cold knife conization should be performed only by providers with surgical skills, in an 
equipped surgical facility. Providers are usually gynaecologists or surgeons trained to 
perform the procedure and to recognize and manage complications. 



Chapter 5: Diagnosis and Management of Precancer 



139 



Indications and exclusion criteria 



Eligibility criteria 



Exclusion criteria 



Screen or diagnostic test 
suspicious for microinvasive cancer 

Endocervical glandular neoplasia 
Abnormal endocervical curettage 

Positive screen showing need for 

excisional procedure and outpatient 

procedures, such as LEEP, are not 

feasible 

No contraindications to anaesthesia 



Untreated cervicitis or PID 

Pregnancy or childbirth within the past 
1 2 weeks 

Obvious invasive cancer 



Management of complications 

After cold knife conization, bleeding is the most common complication; it can occur 
immediately (primary bleeding) or up to 14 days after the procedure 
(secondary bleeding). In either case, the patient needs to return to the 
surgical facility. Secondary haemorrhage is usually related to local 
infection and, along with measures to stop the bleeding, treatment 
with antibiotics should be prescribed. 




Infection treatment 



140 



Chapter 5: Diagnosis and Management of Precancer 



Table: 5.1 Comparison of cryotherapy, LEEP and cold knife conization 







o 

3 
I 



CO 
(Q 

1 

C/D 





Cryotherapy 


LEEP 


Cold Knife Conization 


Advantages 


High cure rate (86-95%) 


High cure rate 


Highly effective (cure 




for small lesions 


(91-98%) 


rate 90-94%) 




Equipment simple and 


Reliable histology 


A single surgical 




relatively inexpensive 


specimen obtained, 


specimen, without 




Can be performed by 


which allows invasive 


"burnt" edges, is 




trained and competent 


disease to be ruled out 


removed, which 




physicians and non- 


Few complications 


facilitates the 




physicians. Training 


Can be performed on 


evaluation of the 




takes a few days 


an outpatient basis at 


margins for complete 




Can be performed as an 


a secondary level 


excision of the 




outpatient procedure in a 


Fast (5-1 Omin) and 


diseased area 




primary care setting 


technically simple to 






Fast (about 15 minutes 


perform 






for double-freeze 


In a see-and-treat 






method) 


approach, diagnosis 






Anaesthesia not required 


and treatment can be 






Electricity not required 


offered at the same 






Complications and side- 


time, maximizing 






effects rare 


treatment coverage 




Disadvantages 


Less effective for larger 


Requires intensive 


Requires 




lesions (cure rates 


training 


hospitalization and an 




< 80% at one year) 


Postoperative bleeding 


operating theatre 




No tissue sample 


in less than 2% of 


Requires spinal or 




available for histological 


treated women 


general anaesthesia 




examination 


More sophisticated 


Requires highly skilled 




Needs continuous supply 


equipment needed 


personnel 




of carbon dioxide or 


Requires electricity 


Complications may 




nitrous oxide 


Requires local 


occur, including 




Causes prolonged and 


anaesthesia 


bleeding, infection, 




profuse watery discharge 




stenosis and cervical 








incompetence with 








possible decreased 








fertility 



The "screen-and-treat" approach 

If there is no capacity for tissue diagnosis with colposcopy and histology, treatment 
based on screening alone may be appropriate, especially in limited-resource settings. 
Screening tests for the screen-and-treat approach can include visual tests, HPV or 



Chapter 5: Diagnosis and Management of Precancer 



141 



cytological tests. With screening tests that provide immediate results, such as VIA and 
VILI, screening and treatment can be provided during a single hospital visit. However, a 
second visit might be needed in the following circumstances: 

The patient is menstruating heavily, is pregnant or needs treatment for PID. 

The therapy available is not appropriate for the lesion. 

Treatment is not available at the same site and the patient needs to be referred to 
another facility. 

The client prefers to discuss the treatment with her partner before proceeding. 

The client needs further evaluation. 



Studies and pilot projects using the screen-and-treat approach have mainly focused 
on the use of visual tests for screening and cryotherapy for treatment, because of the 
advantages of a single-visit approach that can be decentralized to primary care level. 
A flowchart for this approach is given in Annex 4b. It is important to 
note that the impact of the screen-and-treat approach on the incidence Annex 
and mortality of invasive cervical cancer is not yet known. Therefore, 
if this approach is implemented in countries, careful monitoring and 
evaluation must be carried out. 




4b 



Screen and treat 



CD 

a 



Advantages and limitations of the screen-and-treat approach 



Advantages 



Limitations 



Infrastructure and equipment are 
simpler and less costly, and provider 
level lower 

Single-visit approach reduces loss 
to follow-up and treatment, resulting 
in a reduced burden of tracking and 
contacting women 

Lowers burden for women by 
reducing the number of visits 

Highly acceptable to women and 
providers 



Impact on cervical cancer incidence 
and mortality not yet known 

Important ethical and resource use 
concerns, including overtreatment and 
undertreatment 13 

No specimen available for later 
evaluation, unless biopsy taken before 
treatment 



13 



Overtreatment is treatment of women who do not have disease. If specificity of VIA is 85%, about 
1 5% of women screened would be treated on the basis of false positive results, wasting resources 
and increasing exposure to potential risks and side-effects. Undertreatment occurs if women with 
invasive disease or disease within the endocervical canal are treated with cryotherapy. 



1 42 Chapter 5: Diagnosis and Management of Precancer 



FOLLOW-UP AFTER TREATMENT 

Women should return for a follow-up visit 2-6 weeks after treatment. The visit should 
include the following: 

o gynaecological examination to ensure the cervix is healing well; 

counselling to emphasize the need for regular follow-up; 

^ discussion of results of histopathology (in the case of LEEP and conization). 

o 

co - 

< If the entirelesion was removed, the patient should return for further follow-up visits at 

i. 6 and 1 2 months. In cases of positive margins (for precancer) after LEEP or cold knife 

conization, the patient should be advised that she will need close follow-up and might 
^ need further treatment. 

CO 

Z3 
CO 

^ Follow-up visits after 6 and 1 2 months should include the following: 

A screening test and, if possible, colposcopy and directed biopsy of any persistent 

lesions. 

S If no abnormalities are seen on the first two follow-up visits, patients treated for 

CIN 1 or CIN 2 can be referred back to the screening programme. 

g> Patients treated for CIN 3 should be rescreened every year for 5 

years, and then referred back to the screening programme 
(see Annex 5). Flowchart precancer 

If the lesion progresses or persists, re-treatment is needed. 




Chapter 5: Diagnosis and Management of Precancer 



143 



DIAGNOSIS AND TREATMENT ACTIVITIES AT DIFFERENT LEVELS 



In the community 




At the health centre 




Support women who have been treated, by encouraging- 
abstinence from intercourse or condom use, helping with 
removal of vaginal packing, enquiring about and acting on 
symptoms of complications. 

Provide condoms to all women. Train them in consistent and 
correct use. 

Contact the health centre if the patient has questions that you 
cannot answer, or if you are concerned about her status. 

Keep records and visit women to remind them when they have 
to return to the health centre for follow-up. 

Track women who do not return for follow-up, on request of 
providers at the health centre. 

Perform colposcopy, biopsy and cryotherapy (if providers have 
necessary training and equipment). 

Refer women who need further care to the district hospital. 

Provide routine and emergency follow-up care for women 
treated in the health centre and district hospital. 

Maintain communication with the district hospital and with 
CHWs. 

Train, supervise, and support CHWs doing home visits, and 
provide supplies. 

With CHWs, track women who do not return to the centre in a 
timely manner. 



o 



CO 
CO 

1 
CO 
CO 

E. 



CO 
(O 
CD 



At the district hospital 




At the central hospital 




Manage women referred by the health centre (for diagnosis 
and treatment) and advise women on follow-up. 

Refer women with invasive disease and complications 
requiring higher expertise to the central hospital. 

Assist in the training and supervision of CHWs and health 
centre staff. 

Maintain two-way communication with health centre staff. 

Maintain quality services in the histopathology laboratory. 
Manage women who are referred by the lower levels. 
Train and supervise workers at lower levels. 

Maintain communication with lower levels about referred 
women, their management and follow-up. 



1 44 Chapter 5: Diagnosis and Management of Precancer 



Counselling messages 



For women who will be managed at your level: 
g Explain management options. 

Explain procedures that they are likely to need and where they take place. 

en Obtain informed consent. 

Explain what follow-up is needed. 

CO 

For women who are referred to a different level for diagnosis, treatment or 
complications: 

IF Explain why you are referring her, and when and where she must go. 

CQ Tell her that she can come to see you if she has questions and concerns. 

CD 

Educate her about self-care, and symptoms of complications, and advise her 

what to do if she experiences any symptoms. 

i 

Advise all women to use condoms, train women (and their partners) in how to use 
them, and provide them with condoms. 



Chapter 5: Diagnosis and Management of Precancer 1 45 



ADDITIONAL RESOURCES 

ACCP. Effectiveness, safety, and acceptability of cryotherapy. A systematic literature 
review. Seattle, WA, Alliance for Cervical Cancer Prevention, 2003 (Cervical Cancer 
Prevention Issues in Depth, No.1). 

Mclntosh N, Blumenthal P, Blouse A, eds. Cervical cancer prevention: guidelines for 
low-resource settings. Baltimore, MD, JHPIEGO, 2001 . 

Sellers JW, Sankaranarayanan R. Colposcopy and treatment of cervical intraepithelial 
neoplasia: a beginners' manual. Lyon, lARCPress, 2003. 

WHO . Sexually transmitted and other reproductive tract infections. A guide to 
essential practice. Geneva, 2005. 

Wright TC, Richart RM, Ferenczy, A. Electrosurgery for HPV-related diseases of 
the lower genital tract. A practical handbook for diagnosis and treatment by loop 
electrosurgical excision and fulguration procedures. Quebec, Arthur Vision Inc., 1 992. 



146 



PS 1 1 : Colposcopy, Punch Biopsy and Endocervical Curettage 



147 



PRACTICE SHEET 11: COLPOSCOPY, PUNCH BIOPSY 

AND ENDOCERVICAL CURETTAGE PS 1 1 

WHAT ARE COLPOSCOPY AND BIOPSY? ^ 

Colposcopy is the use of a colposcope (Figure PS1 1 .1) - an instrument that provides 

magnification and a strong light - to look at the cervix. Biopsy involves taking a small 

tissue sample from the abnormal areas of the cervix using a biopsy forceps. Biopsy c/5 

may cause mild discomfort or cramping. An endocervical curettage (ECC) can also be 

performed to obtain a sample of cells from inside the cervical canal. This can cause 

cramping, but not severe pain, and occasionally may trigger a vasovagal reaction. 14 



The following equipment and supplies are needed for colposcopy, biopsy and ECC: 



vaginal speculum, high-level disinfected, 
and sterile endocervical speculum; 

normal saline solution; 

3-5% acetic acid; 

colposcope; 

Monsel's paste; 

punch biopsy forceps; 

endocervical curette; 

ring forceps; 

cotton swabs; 

specimen bottles with 10% formalin; 

pencil and labels. 



For basic equipment to perform a pelvic 
examination refer to PS7. 



Figure PS1 1.1 Colposcope 




I 
s 



14 



Occasionally, when an ECC is being performed, the patient may experience a vasovagal 
reaction, which is usually self-limiting. If it persists, elevate the patient's legs and lower her 
head. 



148 PS 1 1 : Colposcopy, Punch Biopsy and Endocervical Curettage 



PERFORMING COLPOSCOPY, BIOPSY AND ECC 
PS 1 Preparation 

1 . Explain the procedure, what the tests may show, and why it is important to 
^ return for further management as requested. Ensure that the patient has 

understood and obtain informed consent. 
o' 
2. Show the patient the colposcope and explain how you will use it to examine her. 

3. Prepare the patient for a gynaecological examination, and do a speculum 
examination (see Practice Sheet 7). 

4. Make sure the posterior fornix (vaginal space surrounding the ectocervix) is dry. 

o 

i 

Procedure 

s< 

jp 5. Tell the patient what you will do at every step, and warn her before you do 

anything that might cause cramps or pain. 

=r 

6. Inspect the cervix at low-power magnification (5x to 1 0x), looking for any 
obvious areas of abnormality (e.g. leukoplakia, condylomata). Identify the 
transformation zone and the original and new squamocolumnar junctions. 
If advisable, or if the entire SCJ is not visible, you can inspect the cervical 
canal using an endocervical speculum. If the entire SCJ is still not visible, 
the colposcopic procedure is termed inadequate or unsatisfactory and an 
endocervical curettage should be done (see Step 12). 

o 

7. Apply saline to the cervix. Inspect the cervix with a green filter and 1 5x 
magnification, noting any abnormal vascular patterns. 

8. After telling the patient that she might feel a mild stinging sensation, apply 
acetic acid. 15 Wait one or two minutes to allow colour changes to develop. 
Observe any changes in the appearance of the cervix. Give special attention to 
abnormalities close to the SCJ. 

9. Integrate the findings of the saline test and the acetic acid test to make a 
colposocpic assessment. 

1 0. Tell the woman that you will take a biopsy of her cervix, which may cause some 
cramping. 



Sometimes Lugol's iodine is applied after the acetic acid, to help in identifying the lesion. 
However, it is not always possible in resource-poor settings. Moreover, the routine use of Lugol's 
iodine is not recommended because high concentrations can cause histological artefacts in the 
biopsy specimen. 



PS 1 1 : Colposcopy, Punch Biopsy and Endocervical Curettage 



149 



1 1 . Take cervical biopsies of the most abnormal areas, and place tissues in separate 
labelled bottles containing formalin. 

12. If necessary, perform an endocervical curettage. Hold the curette like a pen and" 
scrape the endocervical canal in short firm strokes until it is completely sampled. 
Keep the curette inside the canal during the entire procedure. At the end, remove 
the curette, place the curettings on gauze or brown paper, and immediately immerse 
in 10% formalin. 

13. If active bleeding is noted, apply Monsel's paste to the bleeding 

Annex 

areas. 9 



1 4. Withdraw the colposcope and gently remove the speculum. 




PS11 



Monsel's paste 




Condom use 



After the procedure 

1 5. Explain what you saw and, if you took biopsies and endocervical curettings, what 
these may reveal. 

1 6. Advise the woman how to take care of herself when she goes home: 

a. She should abstain from sexual intercourse until she has no more 
discharge or bleeding. If this is not possible, she should use condoms. 

b. She should not insert anything in the vagina for 3 or 4 days. 

c. Tell her the signs and symptoms of complications: active 
bleeding, serious cramping or lower abdominal pain, pus-like 
discharge, fever. If she experiences any of these, she needs to 
return to the centre or go to hospital. 

1 7. Provide condoms and teach her how to use them. 

1 8. Give a specific date for the return visit. Laboratory reports should be available within 
2-3 weeks, so a follow-up visit should be planned 2-3 weeks after the colposcopy. 

1 9. Explain when the results will be available, and the importance of returning to the 
clinic for them. 

20. Document the findings. Use appropriate forms to record the colposcopic assessment. 

21 . Send labelled biopsies and curetted tissue to the laboratory. 

22. If you noted something you cannot handle, refer the woman immediately to a higher 
level for further examinations or tests. 



0) 

I? 



PS11 



QJ 

i. 



1 50 PS 1 1 : Colposcopy, Punch Biopsy and Endocervical Curettage 

Follow-up (2-3 weeks after the colposcopy) 



23. Explain what is in the laboratory report. 

24. Advise the patient what follow-up she needs, on the basis of the results. Use 
national guidelines or, if not available, the flowchart in Annex 

5, to advise the woman of her diagnosis and recommended 7nnex 
treatment plan. 

C/> 

25. Do^a pelvic examination and check for healing. Flowchart P recancer 

26. Refer her for needed therapy or make an appointment for the next visit. 
o 

Your job is not done until you have reviewed the histopathological report with 
the patient and have a treatment plan in place. 




PS 12: Cryotherapy 



151 



PRACTICE SHEET 12: CRYOTHERAPY 

Cryotherapy is the freezing of the abnormal areas of the cervix by the application^ 

a very cold disc to them. It takes only a few minutes and usually only causes some 

cramping. 

The following materials and equipment are needed for cryotherapy: 

speculum, high-level disinfected (it need not be sterile); 

disposable or high-level disinfected examination gloves (need not be sterile); 

cotton swabs for wiping the cervix; 

normal saline solution; 

colposcope, if used in the particular venue; 

cryosurgery unit with adequate gas supply (Figure PS1 2.1 ). 

For basic equipment to perform a pelvic examination refer to PS7. 




PS12 



Figure PS12.1 Cryotherapy equipment components 




1. Probe 

2. Trigger 

3. Handle grip (fibreglass) 

4. Yoke 

5. Inlet of gas from cylinder 

6. Tightening knob 

7. Pressure gauge showing cylinder pressure 

8. Silencer (outlet) 

9. Gas-conveying tube 

10. Probe tip 



Source: Sellers JW, Sankaranarayanan R. Colposcopy and treatment of cervical intraepitheilal 
neoplasia: a beginners' manual. Lyon, IARC Press, 2002. 



512 

l 




152 PS12:Cryotherapy 



PERFORMING CRYOTHERAPY 
Before the procedure 

1 . Explain the procedure, and why it is important to return for 
further management as requested. Ensure that the woman has 

understood and obtain informed consent. 

PS6 Informed consent 

2. Show her the cryotherapy equipment and explain how you will PS7 Pelvic exam 
use it to freeze the abnormal areas on the cervix. 

3. Prepare the patient for a gynaecological examination, and perform a speculum 
examination (see Practice Sheet 7). 

4. If there is no evidence of infection, proceed with cryotherapy. 

5. If there is a cervical infection, provide treatment as described in Annex 8. You 
may proceed with the cryotherapy, or you may give the patient an appointment 
to return once the infection is cured. 



Procedure 

6. Wipe the cervix with a saline-soaked cotton swab and wait a few minutes. 

7. Apply acetic acid to outline the abnormality and wait a further few minutes. 

8. Tell the woman she might feel some discomfort or cramping while you are 
freezing the cervix. 16 

9. Wipe the cryoprobe surface with saline to ensure optimum effectiveness. 

1 0. Apply the cryoprobe tip in the centre of the os and make sure the probe 
adequately covers the lesion (Figure PS12.2). If the lesion extends more than 2 
mm beyond the probe, discontinue the procedure. Explain to the woman why you 
are doing this and what needs to be done for her as an alternative. 

1 1 . Ensure that the vaginal wall is not in contact with the cryoprobe or you may 
cause a freezing injury to the vagina. 

1 2. Set the timer and release the gas trigger to cool the probe. 

1 3. You will observe the ice forming on the tip of the cryoprobe and on the cervix 
(Figure PS1 2.2). When the frozen area extends 4-5 mm beyond the edge of the 
cryoprobe, freezing is adequate. 



In some cases, the patient may have a vasovagal reaction, with fainting and plummeting blood 
pressure. If this happens, stop the treatment immediately and raise the patient's legs as much as 
possible. 



PS 12: Cryotherapy 



153 



Figure PS12.2 Position of cryoprobe on the cervix and ice forming 




PS12 



14. Allow two cycles of freezing and thawing: 3 minutes freezing, followed by 5 
minutes thawing, followed by a further 3 minutes freezing. 

1 5. Once the second freezing is complete, allow time for thawing before attempting 
to remove the probe from the cervix. Removing it before it is fully thawed will 
pull tissue off the cervix. 

16. Gently rotate the probe on the cervix to remove it. The area you have frozen will 
appear white. 

17. Examine the cervix for bleeding. If bleeding is noted, apply 
Monsel's paste. 

18. Do not pack the vagina. 

19. Remove the speculum. 




After the procedure 

20. Provide a sanitary pad. 

21 . Instruct the woman to abstain from intercourse and not to use vaginal tampons 
for 4 weeks, until the discharge stops completely. This to avoid infection. 

22. Provide condoms for use if she cannot abstain from intercourse 
as instructed. Teach her how to use them. 

23. Invite her to return in 2-6 weeks to be checked for healing, 
and again in 6 months for a repeat Pap smear and possible 
colposcopy. 




Condom use 



154 PS 12:Cryotherapy 

24. Inform her of possible complications and ask her to return immediately if she notes: 

a. fever with temperature higher than 38 C or shaking chills; 

b. severe lower abdominal pain; 

c. foul-smelling or pus-like discharge; 

d. bleeding for more than two days or bleeding with clots. 

25. Clean and disinfect the cryoprobe and decontaminate the cryogun, tubing, pressure 
gauge and gas tank: 17 

a. Decontaminate the cryotherapy unit, hose and regulator by wiping them with 
alcohol. 

b. Wash the cryotip and the plastic sleeve with soap and water until visibly clean. 

c. Rinse the cryotip and plastic sleeve thoroughly with clean water. 

d. High-level disinfect (HLD) the cryotip and plastic sleeve by one of the following 
methods: 

boil in water for 20 minutes; or 

steam for 20 minutes; or 

soak in chemical disinfectant (0.1% chlorine solution or 2-4% glutaral) for 
20 minutes and then rinse with boiled water. 

e. It is critical that the hollow part of the cryotip is completely dry when next used, 
otherwise the water will freeze and the probe could crack or the treatment not 
work. 

f. Either use a rubber cap to seal off the hollow part of the cryoprobe during 
processing, or thoroughly dry the cryoprobe before it is reused. 

g. If none of the high-level disinfection options are available, the cryotip and sleeve 
may be disinfected by soaking in 70-90% ethanol or isopropanol for 20 minutes. 
Allow to air-dry and then reassemble. 

Follow-up 

26. Perform a pelvic examination to check for healing 2-6 weeks 
after the cryotherapy. 

27. At 6 and 1 2 months, do a Pap test and a colposcopy and take a Flowchart precancer 
biopsy if necessary. Follow up as described in Annex 5. 




7 Some cryoguns get blocked by ice. This can be avoided by pushing the defrost button every 20 
seconds to clean the tube. Alternatively, use the cryotherapy gas conditioner developed by PATH. 



PS 13: Loop Electrosurgical Excision Procedure (LEEP) 



155 



PRACTICE SHEET 13: LOOP ELECTROSURGICAL EXCISION 
PROCEDURE (LEEP) 

LEEP is the removal of abnormal areas from the cervix, using a thin wire heated with 
electricity. It is successful in curing precancer in 9 out of 10 women. 

The following equipment and supplies are needed for LEEP: 

reliable power supply; 

electrosurgical generator and electrode handle; 

colposcope; 

non-conducting speculum, preferably with side retractors; 

return electrode; 

wire electrodes of several sizes (Figure PS1 3.1 ); 

coagulating/ball electrode; 

smoke evacuator; 

forceps; 

local anaesthetic: 1 % or 2% lidocaine, with or without 1 :1 00 000 
epinephrine; 

5-ml syringes with long 27-gauge needle; 

bottles with normal saline and with 5% acetic acid; 

Monsel's paste; 

large swabs; 

needles and suture material; 

specimen containers with 1 0% formalin. 

For basic equipment to perform a pelvic examination refer to PS7. 



PS13 



Figure PS1 3.1 Different types and sizes of electrodes 

(a) Ball electrode 

(b) Square loop electrode 

(c) Semicircular loop electrode 



156 PS 13: Loop Electrosurgical Excision Procedure (LEEP) 



PERFORMING LEEP 
Before the procedure 

1 . Explain the procedure and why it is important to return for further management as 
requested. Ensure that the woman has understood and obtain informed consent. 

2. Prepare the patient for a gynaecological examination. 

3. Attach a return electrode to the inner thigh. 

4. Insert a non-conducting speculum with an electrically insulating coating, or a 
speculum covered with a latex condom. 

5. Look at the cervix, and note any abnormalities, such as discharge from the os, 
inflammation, bleeding or lesions. Record the findings. 

6. If there is no evidence of infection, proceed. If you note signs of infection, suspend 
the procedure and treat the patient and her partner completely before making a 
second attempt. 

During LEEP 18 

7. Before each step, tell the woman what you will do and what she may feel. 

8. Wipe the cervix with a saline-soaked cotton swab. 

9. Apply 5% acetic acid and examine with the colposcope to determine the location 
and extent of the lesion. 

1 0. Inject 3-5 ml of local anaesthetic (1 % or 2% lidocaine with 1 :1 00 0000 
epinephrine (to control bleeding)), using a long 27-gauge needle, just beneath 
the cervical epithelium at the 1 2 o'clock, 3 o'clock, 6 o'clock and 9 o'clock 
positions (in patients with cardiac problems, use lidocaine without epinephrine). 

1 1 . Select the appropriate electrode to remove the entire abnormal area in a single 
pass: for small low-grade lesions in nulliparous women, use an electrode 1 .5 cm 
wide by 0.5 cm deep; for larger lesions and multiparous women, use one 2.0 cm 
wide by 0.8 cm deep. 

12. Turn the vacuum suction on and activate the generator. 

1 3. Excise the lesion: push the electrode perpendicularly into the tissue to a depth 
of 4-5 mm and draw it laterally across the cervix to the other side, producing 
a dome-shaped circle of tissue with the canal in the centre. Do not insert the 
electrode deeper than 5 mm at the 3 o'clock and 9 o'clock positions, because 
this can damage the uterine arteries. 



18 

In some cases, the patient may have a vasovagal reaction, with fainting and plummeting 
blood pressure. If this happens, stop the treatment immediately and raise the patient's legs as 
much as possible. 



PS 13: Loop Electrosurgical Excision Procedure (LEEP) 



157 



Figure PS13.2 LEEP of an ectocervical lesion with one pass: excision of the lesion 
with wire electrode and fulguration with ball electrode 




14. Additional passes with the loop can be made to excise residual tissue. 

1 5. Pick up all excised tissues with the forceps, and place in a labelled bottle with 
formalin to send to the histopathology laboratory. 

16. Perform an endocervical curettage and place the tissue in a separate bottle with 
formalin. 

17. Fulgurate any bleeding tissue in the crater base using a ball electrode and 
coagulation current. 

1 8. Apply Monsel's paste to the crater base to prevent further bleeding and remove 
the speculum. 



After the procedure 

19. Provide a sanitary pad. 




Monsel's paste 



20. Instruct the patient to abstain from sexual intercourse for a minimum of 4 
weeks, and until the bleeding stops completely. This to avoid infection and heavy 
bleeding. 

21 . Provide condoms for use if she cannot abstain as instructed. Teach her how to 
use them. 





158 PS 13: Loop Electrosurgical Excision Procedure (LEEP) 



22. Tell her she may have some mild to moderate pain for a couple of days; she can 
PS 1 3 take ibuprofen or paracetamol. 

23. Explain that she may have very light bleeding and that she will notice blood-tinged 
discharge for one month or more. She can use sanitary pads but not tampons for 
this. 

24. Advise her how to take care of herself when she goes home: 

a. She should rest and avoid heavy work for several days. 

b. She should not put anything in the vagina. 

25. Inform her of possible complications and ask her to return immediately if she 
"^ notes: 

a. fever with temperature higher than 38 C or shaking chills; 

b. severe lower abdominal pain; 

c. foul-smelling or pus-like discharge; 

d. heavy bleeding or bleeding with clots. 

o 

26. Answer her questions. 
o 

-o 27. Recommend that she should return to the health centre in 2-6 weeks to be 

checked for healing and to receive the laboratory report. 

CD 

28. Agree a follow-up date with her. 

CD 



PS 13: Loop Electrosurgical Excision Procedure (LEEP) 



159 



Management of complications of LEEP 



Problem 



Treatment 



Bleeding during the 
procedure: can be diffuse 
or arterial 



For diffuse bleeding: use a combination of pressure and 
coagulation with ball electrode. 
For arterial bleeding: place ball electrode in firm contact with 
the source and use coagulation current. 



Bleeding after the 
procedure (happens in 
less than 2% of cases) 



Remove blood clot, clean with 5% acetic acid, identify 
bleeding area, anaesthetize with lidocaine and epinephrine. 
If bleeding is not heavy, apply Monsel's paste. If bleeding 
is heavy, fulgurate using either a 5-mm ball electrode or a 
macroneedle electrode and the coagulation current. 



Infection after the 
procedure: pus-like 
discharge, pain, fever 



Treat with antibiotics: for example, 

cefixime 400 mg, orally, single dose, plus 

doxycyclin 1 00 mg orally twice a day for 1 4 days, plus 

metronidazole 400-500 mg, orally, twice daily for 1 4 days 






At the first follow-up visit (2-6 weeks) 

29. Ask how she is feeling and if she has had any unexpected problems since the 
LEEP. 

30. Review the pathology report and advise next steps based on it. 

31 . Examine her to check healing. 

32. Make an appointment for the next visit. 



At 6 months and 12 months 

33. Do a Pap test and a colposcopy, and take a biopsy if necessary. Follow up as 
described in Annex 5. 




Flowchart precancer 



160 



PS 13: Loop Electrosurgical Excision Procedure (LEEP) 



PS13 



i. 

5? 

O 



o' 

3 

-o 
3 

o 

CD 



PS 1 4: Cold Knife Conization 1 61 

PRACTICE SHEET 14: COLD KNIFE CONIZATION 

PS K 

Cold knife conization is the surgical removal of a cone-shaped area of the cervix, 
It should be done by a specialist, and the patient should be given anaesthesia or 
sedation. This Practice Sheet is included to allow a first- or second-level health care 
provider to explain to a patient, before she goes to hospital, how the procedure will be 
performed, and to help her recover once she returns home. 

EXPLAINING THE PROCEDURE 

Give the woman as much information as you can on the procedure, the anaesthesia, 

and the possible side-effects and complications of surgery. The description below will s 

help you answer any questions she may have. 



Before the woman goes to hospital 

1 . The hospital staff will give her instructions for preparation: what clothing to take 

with her and any medicines she needs to take beforehand. She will be told not to 
eat or drink anything in the 8 hours before surgery, and to bathe before going to 
hospital. 

The operation 

2. General or regional anaesthesia will be used for the operation. 

3. The surgeon will insert a speculum to visualize the cervix. 

4. An iodine solution will be applied to highlight the abnormal areas, and the cervix 
will be examined with a colposcope. 

5. A substance to reduce risk of heavy bleeding will be injected into the cervix. Or 
the surgeon may suture the small arteries supplying the area to be removed. 



162 



PS 14: Cold Knife Conization 



6. A cone-shaped area of the cervix, including the endocervical canal, will be 
removed using a special knife (Figure PS14.1). The removed tissue will be placed 
in a jar with formalin and sent to the laboratory, with the findings recorded on the 
appropriate histology form. 



Figure PS14.1 Removal of a cone-shaped area of the cervix 





7. After the cone is removed, the base of the crater (the area of the cervix after 
excision) will be cauterized using ball cautery. 

8. Any active bleeding will be stemmed by applying pressure using cotton balls, 
and by applying Monsel's paste or by cauterizing using ball cautery. 

9. A gauze pack may be placed in the vagina to apply pressure and 
control the bleeding, but this will not be done if Monsel's paste 

has been used. 

Monsel's paste 

Just after the operation 

1 0. After the operation, the patient will be monitored by the hospital staff in the 
recovery room. Once she wakes up, she will be moved to a regular bed to 
recover fully. 

1 1 . If she feels well, has no significant bleeding, and lives near the hospital, she will 
be discharged after a few hours. If she is not able to go home the same day, she 
will be discharged the next day, provided there are no complications. 

12. The woman and her partner will be instructed to abstain from sexual intercourse 
for 6 weeks after the operation, so that the raw area of the cervix has a chance 
to heal. 



PS 1 4: Cold Knife Conization 1 63 

At the first follow-up visit (2-6 weeks) 

1 3. A speculum examination will be done to determine if the wound has fully healed. 

14. The laboratory results will be discussed and the next steps planned. 

1 5. The patient will be advised to return in 6 months and 1 2 months for assessment. 

CD 

At 6 months and 12 months 

8 

1 6. A Pap test and colposcopy will be done, and a biopsy if necessary. The patient will 

then be followed up as described in Annex 5. 




Flowchart precancer 
FOLLOW-UP AT HOME 

Before she leaves hospital, the woman will be given counselling on how to take care of 
herself, and what symptoms of complications to look for. You can help her by reinforcing 
this advice. 

1 . If gauze packing was left in the vagina, it must be removed within 6-1 2 hours to 
avoid infection. If there is a local health care provider who knows how to do this, 
he or she can assist the woman. 

2. Relative rest for a few days is recommended. The patient should avoid heavy work 
for the first three weeks. Normal daily activities can be performed, such as light 
housework, bathing, showering, and eating. 

3. If the patient has discomfort (not severe pain), she may take paracetamol. 

4. She will have a hidden wound in the vagina, which needs at least 4-6 weeks to 
heal. To prevent infection and allow proper healing, she should not put anything 
into the vagina for that time, including fingers or tampons, and she should not 
douche or have sexual intercourse (although she can be intimate in other ways). If 
she is unable to abstain from intercourse, provide condoms and teach her (and her 
partner) how to use them. 

5. Make sure she knows the symptoms of complications (see next page) and instruct 
her to go to the health centre or hospital immediately if any of them occur. 

6. She should have been given an appointment for a check-up in 2-6 weeks to 
discuss the results of the tissue examination and to be examined by the surgeon. 
Encourage her to keep this appointment. 




PS14 



a 
8 



5 
j? 

o 

o 

I 



164 



PS 14: Cold Knife Conization 



Complication 


Symptoms 


Treatment 


Infection 


Pain in the lower 
abdomen 


Provide treatment for PID 




Foul-smelling yellow 
discharge from vagina 




Haemorrhage 


Heavy vaginal bleeding 


Speculum examination, 
remove blood clot, 
identify bleeding areas 




- 


Fulgurate/cauterize 
bleeding area using ball 
electrode 






Apply Monsel's paste or 
pack with ribbon gauze 




Infection treatmen 







CHAPTER 6: MANAGEMENT OF INVASIVE CANCER 



Chapter 6: Management of Invasive Cancer 1 67 

CHAPTER 6: MANAGEMENT OF INVASIVE CANCER 



Key points 



Health care providers at all levels should know the common symptoms and signs 
of cervical cancer. If a woman presents with such symptoms, her cervix should be 
examined visually to determine whether further testing is needed. 

The stage of the cancer is a measure of how far it has advanced. This determines 
how it can be treated, and the likely outcome. 

Invasive cervical cancer should be treated by specialists at central-level facilities. 

Treatment is by surgery or radiation therapy, with or without chemotherapy. 

Access to treatment greatly improves prognosis and survival rates. 

Curative treatment is possible for all except the most advanced disease. 

The availability of a basic radiotherapy unit (teletherapy and brachytherapy) can 
permit effective treatment and palliation in all cases of invasive cancer. 

Specialists who diagnose or treat women with cervical cancer should write clear 
referral letters back to the provider closest to the home of the patient. 

Patients should be made aware that they will need long-term follow-up and contact 
with the cancer unit where they have received treatment. Providers should facilitate 
this. 

ABOUT THIS CHAPTER 

It is important for the welfare and survival of women with invasive cancer that they are 
managed by specialists at tertiary-level facilities. This chapter describes how cancers 
are staged (to determine the extent of the disease) and gives the recommended specific 
management for each stage of disease. It also describes the roles of the specialists 
involved in care of the patient. 

THE ROLE OF THE PROVIDER 

The provider at first or second health care levels may have diagnosed invasive cancer 
in the patient and referred her to a tertiary-level facility. This provider is responsible for 
making a link between the tertiary care level (where the patient undergoes staging and 
treatment for invasive cancer) and the patient herself, her family and her community. 
This chapter is not primarily intended to be used by tertiary-level providers, but rather 
to help first- and second-level providers to understand how cervical cancer is managed, 
to explain it to the patient and her family, and to communicate with carers at tertiary 
and community levels. In addition, the providers will be responsible for identifying and 
managing side-effects and complications of treatment, and referring the patient back to 
the treatment facility when necessary. 



168 



Chapter 6: Management of Invasive Cancer 




STORY 

Betty, aged 42, has 5 children. For the past 3 months, 
she has had vaginal spotting and copious bleeding 
after intercourse. She and her partner were told by 
the community worker that they should go to the 
gynaecology department of a specialist hospital as 
soon as possible. At the hospital, the intern examined 
her and noted a large fungating mass at the top of the 
vagina, from which he took a biopsy; he also ordered a 
haemoglobin test. Because cancer was a high probability, 
Betty was kept in for the combined assessment clinic 
the next day, when she was again examined by a number of doctors, 
who explained that there was a tumour on the cervix. After examining 
her, they agreed that the tumour had spread beyond the cervix but that 
she could be cured. They asked about urinary symptoms, but she had 
none. An ultrasound scan of the kidneys and ureters was done to see if 
there was obstruction of urine outflow and these tests were normal, so 
she was told the cancer was in stage IIB. They offered her treatment with 
radiotherapy and reassured her that she had a good chance of being cured. 
However, her periods would stop, she would develop hot flushes and she 
would not be able to become pregnant again. She and her partner were 
also informed that women who are treated with radiation may develop 
discomfort on sexual intercourse, but they would be able to give her advice 
if it happened. They also explained clearly how the treatment would be 
applied. Because her blood tests showed that she was anaemic, she first 
received a blood transfusion. She then received 5 weeks of daily treatment 
by teletherapy and, from the third week on, treatment by high-dose-rate 
brachytherapy until 4 applications had been given. The treatment was 
given on an outpatient basis, so that she could continue to care for her 
children. However, near the end of the treatment, she felt very tired, so she 
was admitted to the hospital for a few days. Her partner and older children 
helped with household duties, not only when she was in the hospital, but 
also in the weeks after, until she recovered. 



Chapter 6: Management of Invasive Cancer 



169 



DIAGNOSIS 

Symptoms and signs of invasive cancer 

Microinvasive cancers may be asymptomatic, and may be detected only on 
investigation of an abnormal Pap smear. On the other hand, most cases of frankly 
invasive cervical cancer come to the attention of providers and are diagnosed once 
they become symptomatic (see Table 6.1). If the woman is not sexually active, the 
disease may remain asymptomatic until it is well advanced. The clinical presentation 
is determined by the patterns of growth and spread as explained in Chapter 2. 
Eliciting patients' symptoms is important for optimal patient management and for 
pain control. 

Early detection of cervical cancer 

Women may present with one or more of the following complaints: irregular 

bleeding, postcoital bleeding, postmenopausal bleeding, persistent vaginal 

discharge (especially when unresponsive to STI syndromic management). They 

should have a speculum examination to visualize the cervix, and any visible 

lesions should be biopsied. If the woman is pregnant, she should be referred to 

a specialist for biopsy and follow-up. 

Table 6.1 . Symptoms of invasive cancer 



Early 



Vaginal discharge, sometimes foul-smelling 

Irregular bleeding (of any pattern) in women of reproductive age 

Postcoital spotting or bleeding in women of any age, even young 
women 

Postmenopausal spotting or bleeding 

In the case of abnormal perimenopausal bleeding, cervical cancer 
should always be considered, particularly if the bleeding fails to respond 
to appropriate treatment 



Late 



Urinary frequency and urgency 

Backache 

Lower abdominal pain 



if-..-- |_4_ 

very late 



Severe back pain 

Weight loss 

Decreased urine output (from obstruction of the ureters, or renal failure) 

Leakage of urine or faeces through the vagina (due to fistulae) 

Swelling of the lower limbs 

Breath lessness (due to anaemia or, rarely, lung metastases or effusion) 



The definitive diagnosis of cancer is confirmed by histopathological examination of a tissue 
specimen taken from the lesion and is mandatory before any therapy, or even extensive 
investigations, are started. 



170 



Chapter 6: Management of Invasive Cancer 



CERVICAL CANCER STAGING 
The purpose of staging 

Once a histological diagnosis of cervical cancer has been made, the next step is to 
formulate the most effective therapy for the individual concerned. In order to manage a 
cervical cancer patient properly, it is essential to understand the extent or "stage" of her 
disease at the time of diagnosis. Although staging systems are to some extent artificial, 
they guide the clinician in both tailoring treatment and assessing prognosis. 

Cancer staging systems 

A number of staging systems are used for cancer. The classification of the International 
Federation of Gynecology and Obstetrics (FIGO), which is based on tumour size and 
the extent of spread of disease in the pelvis and distant organs, is recommended 
for staging invasive cervical cancer. The extent of growth of the cancer is assessed 
clinically, 19 supplemented by a limited number of relatively unsophisticated 
investigations (see Table 6.2). An exception to the above is staging of microinvasive 
cervical cancers, which are staged according to pathological criteria of the depth and 
width of the invasive lesion in relation to the epithelium of origin (which may be either 
squamous or glandular epithelium). 



Table 6.2 Investigations for staging and treatment for cervical cancer according to FIGO 



Mandatory 
for staging 


Supplementary for 
staging 


Optional, to inform additional 
treatment, not for staging 


Speculum, vaginal and 


Cystoscopy 


Blood tests for HIV and 


rectal examination 


Proctoscopy 


syphilis, and haemogram 


Intravenous pyelogram 
(IVP) or 


Cone biopsy 
Endocervical 


Computerized tomographic 
(CT) scan of abdomen and 
pelvis 


Abdominal ultrasound 


curettage or smear 
Chest X-ray 


Magnetic resonance imaging 
(MRI) of pelvis 




Skeletal X-ray or bone 






scan (if bone pain) 





19 



Note: Occasionally a hysterectomy is performed for a reason unrelated to cervical disease 
and there is an incidental finding of cervical cancer. These cases cannot be clinically staged, but 
should be treated according to the characteristics reported by the pathologist. 



Chapter 6: Management of Invasive Cancer 1 71 



In many low-resource settings, speculum, vaginal and rectal examinations are the only 

feasible approaches to staging; these will often provide sufficient information when 

performed by experienced clinicians, who pay particular attention to the size ofthe" 

tumour and possible involvement of the vaginal fornices, the parametria (transverse 

cervical and uterosacral ligaments), the pelvic walls, the bladder and the rectum. This 

assessment can be done under general anaesthesia, if there is any doubt about the H 

diagnosis or if the patient is too tense or in pain. Other imaging modalities, such as J 

computerized tomographic (CT) scan and magnetic resonance imaging (MRI) of the ^ 

abdomen and pelvis, are optional and not needed for diagnostic and staging purposes. 

If easily available, they may be used to acquire more detailed information on the extent < 

of the disease and its prognosis, and to inform the choice of treatment. All investigations i 

for the purpose of staging and their results should be carefully documented in the case 

record. A descriptive diagram should be included whenever an invasive cervical cancer 

is assessed. o5 

C/5 

i 

s? 



172 



Chapter 6: Management of Invasive Cancer 



o 



Overview of FIGO stages related to management and prognosis 

Stage 0: Carcinoma in situ, cervical intraepithelial neoplasia Grade III. 

This is not considered invasive cancer, since the lesion has not gone beyond the 
basement membrane. 



CD 
O 



Stage I: Carcinoma confined to the cervix. Extension to the uterus is disregarded. 

IA: Microinvasive carcinoma, strictly confined to the cervix. Can only be diagnosed 
by microscopy; it is not clinically visible. 

- Stage IA1 : Stromal invasion no greater than 3.0 mm in depth and not more than 
7.0 mm in horizontal spread. 

5-year survival with optimal treatment: -98%. 

- Stage IA2: Stromal invasion of more than 3.0 mm but not more than 5.0 mm in 

depth and with horizontal spread of 7.0 mm or less. 
5-year survival with optimal treatment: -95%. 

IB: Carcinoma strictly confined to the cervix and clinically visible; or a microscopic 
lesion greater than IA2 (Figure 6.1). 

- IB1 : Clinically visible lesion 4.0 cm or less in greatest dimension. 
5-year survival with optimal treatment: -85%. 

- IB2: Clinically visible lesion more than 4.0 cm in greatest dimension. 
5-year survival with optimal treatment: -75%. 



Figure 6.1 Cervical cancer stage IB 



fallopian tube 



ectocervix 



ovary 




lateral 
pelvic wall 



Chapter 6: Management of Invasive Cancer 



173 



Stage II: Carcinoma confined to the cervix. Extension to the uterus is disregarded. 

HA: Spread beyond the cervix, including upper two-thirds of the vagina, but not to 
tissues around the uterus (parametria) (Figure 6.2). 
5-year survival with optimal treatment: -75%. 

Figure 6.2 Cervical cancer stage HA 



fallopian tube 



ovary 




lateral 
pelvic wall 



ectocervix 



(Q 
CD 



MB: Spread beyond the cervix, with parametrial invasion, but not as far as the pelvic 
wall or the lower third of the vagina (Figure 6.3). 
5-year survival with optimal treatment: -65%. 

Figure 6.3 Cervical cancer stage IIB 



fallopian tube 



ovary 




lateral 
pelvic wall 



ectocervix 



174 



Chapter 6: Management of Invasive Cancer 



8 



Stage III: Tumour extends to pelvic wall or involves lower third of the vagina, or 
causes hydronephrosis or non-functioning kidney. 

IMA: Invasion of the lower third of the vagina, with no extension to the pelvic wall 
(Figure 6.4). 
5-year survival with optimal treatment: -30%. 

Figure 6.4 Cervical cancer stage IIIA 



fallopian tube 



ovary 




ectocervix 



lateral 
pelvic wall 



IIIB: Extension to the pelvic wall, or hydronephrosis or nonfunctioning kidney 

(Figure 6.5). 

5-year survival with optimal treatment: -30%. 



Figure 6.5 Cervical cancer stage IIIB 



fallopian tube 



ovary 




lateral 
pelvic wall 



ectocervix 



endocervix 
vagina 



Chapter 6: Management of Invasive Cancer 



175 



Stage IV: Tumour has spread 

IVA: Spread to involve the mucosa of the bladder or rectum (Figure 6.6). 
5-year survival with optimal treatment: -10%. 

Figure 6.6 Cervical cancer stage IVA 




uterus 

urinary 
bladder 



vagina 



IVB: Spread to distant organs, such as extrapelvic lymph nodes, kidneys, bones, 

lungs, liver and brain (Figure 6.7). 

5-year survival with optimal treatment: <5%. 

Figure 6.7 Cervical cancer stage IVB 




lateral 
pelvic wall 



ectocervix 




RECOMMENDATII 

Histological confirmation of cervical cancer and FIGO stagir 
completed before embarking on further investigations and treatment. 




1 76 Chapter 6: Management of Invasive Cancer 



PRINCIPLES OF TREATMENT 

Treatment must be tailored to the best interests of the patient. While the guidelines on 
Ep optimal clinical management protocols given in Annex 6 should generally be adhered to, 

overall assessment of the patient, and differences in availability and 
g" quality of surgery, radiotherapy and medical oncology services, may 

H affect the treatment offered. Invasive cancer should be treated at 

o> tertiary referral centres, where the necessary expertise and equipment Management cancer 

s are available. Additional tests, including those to determine the patient's 

suitability to undergo anaesthesia or major surgery, may be required and may affect 
treatment selection. In HIV-positive women, the CD4 count may also influence the choice 

3 of treatment. Testing for syphilis, and blood tests for haemoglobin and liver and kidney 

o function, must also be done before management can be planned. 

1 

Survival rates 

Q The survival rate is expressed as the proportion of women surviving 5 years after receiving 

treatment. It is determined by both disease stage and treatment given. In countries where 
therapy is either unavailable or inadequate, survival rates are significantly lower than the 
optimum. 

The following factors influence prognosis: 

the clinical stage of disease at presentation: this is the single most important predictor 
of long-term survival, along with access to treatment; 

age: survival declines with advancing age; 

lymph node status; 

general health, nutritional status, presence of anaemia; 

degree of immunosuppression. 

Primary therapy 

Primary therapy may be surgery or radiotherapy, or occasionally a combination of both. 
Chemotherapy is not used for primary therapy, but may be given concurrently with 
radiotherapy. Curative surgery in cervical cancer aims to remove the primary tumour, with 
all extensions, in a single operation. The operation undertaken will depend on the clinical 
stage of the tumour and the findings of the surgeon when the operation is in progress. 



RECOMMENDA 




Surgery and radiotherapy are the only recommended primary treatmer 
modalities for cervical cancer. 




Chapter 6: Management of Invasive Cancer 1 77 



Explaining procedures and obtaining informed consent for treatment 

The provider should adapt the explanations found in this chapter and in the practice 
sheets to individual situations, in order to explain procedures, such as surgery and r 
radiotherapy, in terms the patient and her family can understand. The 
general rules for counselling given in Practice Sheet 4 also apply to 
communication of complex information about treatment. It may be 
helpful to draw or use pictures to illustrate difficult points. The provider counselling 
should keep medical terminology to a minimum and explain any 
technical words that have no local translation. 

Women should be given all the information they need about a procedure before it 
is performed. This should include the possible benefits, risks, potential side-effects 
and what to do if one or more occur, recovery time, cost, and chance of success. If a 
woman would like family members to help her make a decision on care, they should 
be included in the discussion. Providers should follow local and national regulations on 
obtaining informed consent, as well as hospital regulations regarding the need for a 
signature or thumbprint on a consent form. At the very least, what was said, who was 
present, and the woman's understanding and consent, if given, should be documented 
in her medical record. 

Treatment by stage 

Of all cervical cancer patients presenting at multidisciplinary gynaecological 
assessment clinics in tertiary hospitals in developing countries, only about 5% have 
microinvasive or early invasive cancer (tumours up to stage IB1/IIA <4 cm in diameter). 

These cases are preferably treated with surgery because: 

The surgical procedure and recovery in hospital takes less than 2 weeks. 

The extension of the tumour and completeness of removal can be assessed 
immediately. 

Ovarian function is retained, which is particularly important for premenopausal 
patients. 

The patient keeps a functional, elastic, and lubricated vagina. 

Most complications are seen within a few days of the procedure. 

Surgery should also be favoured for patients with pelvic inflammatory disease, 
especially when there is an abscess in or near the uterus (pyometra). Radiotherapy, 
while having the same high 5-year survival rates as surgery, takes about 6 weeks to 



1 78 Chapter 6: Management of Invasive Cancer 



administer, and the total extent of the tumour cannot be evaluated. Sequelae, such as 
loss of vaginal elasticity (fibrosis), shortening and narrowing (stenosis) and dryness 
f^ of the vagina, may occur months to years after radiation and may make intercourse 

painful, 
g 
|T About 80% of all cases are in stage IB2 to stage IIIB, with cervical tumours and 

CD parametrial involvement extending towards or up to the pelvic side walls, with or 

& without obstruction of the ureters. These bulky tumours, which may measure 1 

IF cm across; have a cure rate ranging from 30% to 75% when treated with radical 

< radiotherapy. Large stage IIA tumours ( 4 cm or more in diameter) are treated as stage 

IB2 tumours. 

CD 

Stage IV tumours are less commonly seen. Stage IVA, with rectal or, less commonly, 
bladder invasion, accounts for about 1 0% of cases. Only about 1 0% of these can be 
| cured, and fistulae between the involved organs and the vagina are frequent. Stage IVB 

<' (5% of cases), with distant haematogenous metastases, is incurable by any currently 

Q known means. However, effective palliative care can be given in these cases. 

If the cancer recurs, it is usually in the two years following treatment. The treatment of 

recurrent cancer is determined by the extent of disease at recurrence, the disease-free 
interval, the general condition of the patient, and the primary treatment given. 



Chapter 6: Management of Invasive Cancer 1 79 



TREATMENT MODALITIES 
Surgery 

_ ftm 

Curative surgery in cervical cancer aims to remove the primary tumour, with all its %8l 

extensions, in a single operation. The operation undertaken will depend on the clinical o 

stage of the tumour and the findings of the surgeon when the operation is in progress. g 
Palliative surgery is usually used to relieve distressing symptoms when radiotherapy 

has failed or caused complications, such as rectovaginal or vesicovaginal fistulae. & 

I 
B 

Surgical procedures < 

The main surgical procedures are radical hysterectomy and pelvic lymphadenectomy, 
although simple hysterectomy and trachelectomy are indicated in specific cases. 
After surgery, the patient is usually discharged from the hospital after 7-1 days, but it = 

may take from 6 to 1 2 weeks for full recovery. > 

I 

o 
Trachelectomy 

Trachelectomy is the removal of the cervix. Radical trachelectomy includes removal of 
the parametria and upper vagina in addition to the cervix (Figure 6.8). 



Figure 6.8 Tissue removed by radical trachelectomy 

Radical trachelectomy 




1 80 Chapter 6: Management of Invasive Cancer 



Simple hysterectomy 

Simple hysterectomy is the surgical removal of the entire uterus, including the cervix, 
either through an incision in the lower abdomen, or through the vagina (Figure 6.9). The 
tubes and ovaries are not routinely removed, but they may be, if they appear abnormal. 



Figure 6.9 Removal of the uterus by simple hysterectomy 

^^^_^_ 

Simple hysterectomy 




Radical hysterectomy 

Radical hysterectomy is the surgical removal of the uterus, cervix, and surrounding 
tissues (parametria), including 2 cm of the upper vagina (Figure 6.10). The removal 
of as much cancer-free tissue from around the tumour as possible is associated with 
a much better cure rate. Ovaries are not routinely removed because cervical cancer 
rarely spreads to the ovaries. In a modified radical hysterectomy, less parametrium is 
removed than in standard radical hysterectomy (Figure 6.10). 

Recovery time is slightly longer than after simple hysterectomy. 

Figure 6.10 Radical and modified radical hysterectomy 



I 



Radical hysterectomy 




Modified 

radical hysterectomy 

Radical \ \ 
hysterectomy^ 






Chapter 6: Management of Invasive Cancer 1 81 



It is important to note that, even once the surgery has started, the surgeon may 

abandon the procedure. This happens when, before incising the peritoneum, the 

surgeon notices that there is extensive involvement of pelvic nodes. In this case, 

patient should be treated with radiotherapy. The peritoneum needs 

to remain intact, because incising the peritoneum when lymph nodes 

are involved increases the rate of complications associated with ^^^gM "S- 

radiotherapy. The procedure for, and complications of, simple and radical Hysterectomy 

hysterectomy are detailed in Practice Sheet 15. 

Bilateral pelvic lymphadenectomy or nodal dissection 

This operation involves the removal of the three groups of lymph nodes in the pelvis, 
which are often involved in invasive cervical cancer, even in early stages (IA2 onwards). 
These nodes are located close to the large blood vessels of the pelvis. 

Indications 

The specific surgical treatment will depend on the extent of the disease. 

Trachelectomy\s not a standard procedure, but can be offered to women with 
microinvasive cancer, who wish to have children in the future. There is increasing 
evidence that a radical trachelectomy with pelvic lymphadenectomy is a valid procedure 
for treatment of stage IA2. 

Simple hysterectomy \s indicated for women with microinvasive cervical cancer of 
stage IA1 and sometimes IA2. Stage IA2 can be treated with a simple hysterectomy 
and lymph node dissection, but a modified radical hysterectomy with lymph node 
dissection is preferred. Hysterectomy is not usually indicated for treatment of high- 
grade precancerous lesions and carcinoma in situ, which can be treated with simpler 
outpatient methods, but may be appropriate when there are also other gynaecological 
problems, such as abnormal uterine bleeding. A desire for sterilization on the part of the 
patient should not be a reason for hysterectomy. 

Radical hysterectomy is performed on women who have invasive cervical cancer, with 
tumours of up to 4 cm in diameter confined to the cervix, or with very early extension to 
the vaginal fornices (stages IB1 and IIA). Stage IB1 may not be visible (occult IB1). 



O 



1 82 Chapter 6: Management of Invasive Cancer 



Type of provider and level of service 

Simple hysterectomy can be performed in a regional or central hospital, by a general or 
gynaecological surgeon specialized in the treatment of cervical cancer. The operation is 
performed with general anaesthesia and takes about 2 hours. 




Radical hysterectomy Is usually performed in a central hospital by a gynaecological 
surgeon specialized in the treatment of cervical cancer, using general anaesthesia; it 
^ takes about 3 hours. 

CD 

ZJ 

B 

CO 
CD 

I RECOMMENDATION 

o 

Surgery for treatment of cervical cancer should be performed only by surg 

c with focused training in gynaecological cancer surgery. 

S 
B 
Radiotherapy 

Radiotherapy plays a central role in the treatment of most invasive cervical cancers. 
It is mainly used for cases with bulkier tumours (stages IB and IIA through to IVB) and 
those with extensive involvement of the lymph nodes seen on laparotomy (without 
hysterectomy). It is also used to manage cancers in patients who are unable to 
tolerate general anaesthesia. In addition to its curative role, radiation can also alleviate 
symptoms, especially bone pain and vaginal bleeding. 

How radiotherapy works 

Notwithstanding its long history of use, radiotherapy is still often poorly understood 
by the general public. In radiotherapy, the tumour is treated with ionizing radiation. 
Radiation is like a ray of light with higher energy, which is released as the ray 
penetrates the body, damaging and destroying cancer cells. It also has a smaller effect 
on rapidly dividing normal cells in the skin, bladder and large bowel, which causes 
some of the reversible symptoms noted during and immediately after treatment. The 
person receiving radiotherapy feels no pain at the time it is being given. 



Chapter 6: Management of Invasive Cancer 



183 




Types of radiotherapy 

There are two broad groups of radiation treatment, which differ in terms of position of 
the source of radiation relative to the patient: 

teletherapy, in which the source of radiation is distant from the patient; 

brachytherapy, in which small radioactive sources are placed in cavities within the 
body. 

Curative treatments are based on a combination of pelvic teletherapy 
and intravaginal brachytherapy. The procedures and possible 

complications are described in Practice Sheets 16 and 17. 

PS1 6 Teletherapy 
PS 1 7 Brachytherapy 

Teletherapy 

Teletherapy is also called external beam radiation therapy (EBRT). The origin of 
the radiation is a shielded head, which has a small opening through which a beam 
of radiation can pass (Figure 6.1 1). The beam is aimed at the area of the cervix 
with cancer and the sites at risk of disease spread. Care must be taken to avoid 
the bladder and rectum, to protect their function. The treatment is administered in 
a specialist hospital, and takes place in an enclosed space (therapy bunker). No 
anaesthesia is needed because the patient feels no pain. Radiation machines weigh 
many tonnes, and the head can rotate around the treatment table where the patient 
lies. The head may contain radioactive material, such as cobalt 60, or be a linear 
accelerator, which accelerates electrons to immense speeds until they hit a target and 
release their energy as radiation - the same process as a diagnostic X-ray machine.ln 
cervical cancer, the radiation is delivered evenly to the entire pelvic contents, in daily 
sessions of a few minutes each. Usually four beams are used to deliver the total daily 
dose. Sessions are given on five days a week for about five weeks. In preparation 
for this treatment, an image of the pelvis is taken by simulation or computerized 
tomographic scanning. A computer is then used to plan the treatment. The direction 
of the beams is verified during the treatment using X-rays. 

Figure 6.11 Application of teletherapy 
movable support system radiation beam source 



o 
3 

f 

cr> 




patient support couch 



184 



Chapter 6: Management of Invasive Cancer 



O 



o 



1 

0) 



CO 
CO 
CD 



g? 



Brachytherapy 

In brachytherapy, the radiation source is in close contact with the tumour. The radiation 
sources are placed inside an applicator in the uterus and vaginal vault (intracavitary 
brachytherapy, Figure 6.12). 

Fig 6.12 Application of intracavitary brachytherapy 



Intracavity therapy 




radioactive, 
sources 



The radiation is directed to the cancer on the cervix, uterus, upper vagina and tissue 
surrounding the cervix (parametria). Care is needed to avoid exposing the bladder 
and rectum to the radiation, in order to preserve their function as much as possible. 
The treatment is given by a team of a radiation oncologist, a medical physicist and 
a radiation technician in a specialist hospital with the appropriate equipment. The 
radiation is highest within the applicator and decreases rapidly over a few centimetres 
distance. The dose rate is the speed of delivery of a radiation dose at a specified point. 
Intracavitary brachytherapy can be administered with a low dose rate (LDR), pulsed 
dose rate (PDR), medium dose rate (MDR) or high dose rate (HDR). The rate used 
determines the time the patient will be kept in isolation, as well as the total dose to be 
used, and the number of sessions the patient will have. 

The most commonly available brachytherapy devices are LDR and HDR, which have 
similar effectiveness. Usually, only one of these forms is available in any institution. 
The two devices are very different in terms of the need for anaesthesia, time spent in 
hospital, and number of insertions (Table 6.4). It would be advisable for health workers 
who will be counselling patients on brachytherapy to attend a treatment session at the 
referral hospital to understand the sequence of events. 



Chapter 6: Management of Invasive Cancer 



185 



Table 6.4: Differences between low-dose-rate and high-dose-rate brachytherapy 





Low dose rate 


High dose rate 


Commencement 


At completion of teletherapy 


From the third week of 
teletherapy 


Hospitalization 


Inpatient: 2-3 days 


Outpatient: 1/2 to 2 hours 


Anaesthesia used 
at placement 


General anaesthesia 


Mild sedation 


Applications 


Usually once only 


From 2 to 8: usually 4 



Indications 

Teletherapy is indicated when the entire area affected by the cancer cannot be removed 
by simple or radical hysterectomy. This means that most women with invasive cervical 
cancer without distant metastases (stages IB to IVA) should be treated with teletherapy. 
Brachytherapy is usually used in addition to teletherapy. Its use is mandatory if the 
intent is to cure cervical cancer. For stages IB1 or lower, if surgery is not possible, 
brachytherapy can be used as the exclusive treatment. 

Provider 

Radiotherapy is conducted by a radiation oncologist and a radiotherapy technician with 
standard radiotherapy training. 




RECOMMENDATION 

Brachytherapy is a mandatory component of curative radiotherapy of cervical 
cancer. 



1 86 Chapter 6: Management of Invasive Cancer 

Chemotherapy 

^^ Chemotherapy is not a primary mode of treatment for cervical cancer, but it may 

^f be used concurrently with surgery or radiation to treat bulky tumours. Cisplatin is 

the most commonly used drug and is included in WHO'S Model List of Essential 

sf Medicines. The benefits of adding cisplatin to radiotherapy in developing country 

CD settings has not been proven. Cisplatin increases the toxicity of radiotherapy and may 

q> not be well tolerated by patients with poor nutrition, anaemia, impaired renal function 

^ or more advanced cancers. Radiotherapy alone is an acceptable option. 
S 

PATIENT FOLLOW-UP 

CD 

Women who have been treated for cervical cancer should be followed up at the 
treatment centre, if this is at all possible. The discharge from hospital and follow-up 
3 should be discussed at a meeting of all those who have been involved in the patient's 

g' care, and should include input from the woman herself and her family. If follow-up 

> needs to be done at a distance from the treatment centre, a primary care physician 

(preferably a gynaecologist) should receive a comprehensive report detailing 
the stage, treatment administered, prognosis and common problems expected. 
The report should include contact information (phone, fax, email, address) of the 
treatment centre and request regular feedback. The primary care physician should be 
encouraged to seek advice if the patient presents with unexpected symptoms. Mobile 
telephones are increasingly available to maintain contact between treating physicians 
and the patient or family. 

Follow-up for women treated with surgery alone 

Women who have been treated with surgery alone should have three-monthly 
follow-up consultations for a period of 2 years, with careful recording of symptoms, 
particularly bleeding, discharge or pelvic pain. 

During the consultations, the following examinations should be performed: 

speculum examination and visualization of the vaginal vault; 

cytological smear of the vaginal vault and of any abnormality noted on 
examination; 

bimanual vaginal and rectal examination to palpate for recurrence of disease; 

other investigations depending on the clinical findings and resources available. 
Recurrent disease in these women can be treated with radiation. 



Chapter 6: Management of Invasive Cancer 1 87 



Follow-up for women treated with radiation 

For women who have been treated primarily with radiation, follow-up should be the_ ^^ 
same as for those who have had surgery, but the role of vaginal cytology is less clear 

and clinical evaluation is more difficult because of radiation-induced fibrosis. One of 

the reasons for regular follow-up is to look for sequelae of radiotherapy, which may be 3 

mistaken for recurrence of cancer. Treatment options for women with recurrence after ~& 

primary radiation are somewhat limited, as no further radiation can be given. Salvage 9? 

hysterectomy may be considered where surgical expertise and facilities exist; this !? 

approach is unlikely to alter the survival rate, but is associated with a longer disease- ^ 
free interval and possibly a better quality of life. Chemotherapy is also an option in case 
of recurrence after radiation. Finally, radiation can be used to treat non-pelvic or distant 

metastases, e.g. in the bones, lung or other organs. 3, 

SPECIAL SITUATIONS | 

Pregnancy g? 

Although rare, cancer of the cervix is sometimes diagnosed in a pregnant woman. This 

can pose a serious dilemma for the woman, especially if she is early in her pregnancy. 

Each case should be treated individually, taking into account the concerns and health 

of the mother and the impact of possible treatments on the viability of the fetus. The 

management of cervical cancer in pregnancy is stage-related, as for non-pregnant 

patients. It is also related to the stage of the pregnancy. A diagnosis of cancer in 

pregnancy, particularly if it will require termination of the pregnancy, might be difficult 

for the woman to accept. Skilled counselling will be needed to help the woman and 

her family come to terms with the diagnosis and arrive at a decision about care. If 

radiotherapy is used, the treatment begins with pelvic irradiation, which will cause 

fetal death and abortion. An ultrasound scan must be done to verify that the fetus is no 

longer viable. After the uterus is evacuated, treatment continues in the usual way. In the 

third trimester, definitive treatment is usually delayed until the fetus is mature. Then, the 

baby is delivered by Caesarean section, followed immediately by surgery or radiation as 

determined by the tumour stage. If radiation is the management of choice, 

it must be done after involution of the uterus. The overall guidelines for 

management of invasive cancer in pregnancy are given in Annex 6E. 

^ 

Annex 6E 
HIV/AIDS 

A special group of women are those who suffer immunosuppression secondary to 
infection with HIV. Women with low CD4 counts (<200 mm 3 ) are at particular risk of 
complications when treated by any means. Surgery is preferable when appropriate, and 
treatment with radiation or chemotherapy must be tailored to the individual. 




1 88 Chapter 6: Management of Invasive Cancer 



TALKING TO PATIENTS WHO HAVE INVASIVE DISEASE AND 
TO THEIR FAMILIES 
^ Disclosure of information 

g In giving information to women and their families about cervical cancer, it should 

H initially be emphasized that cervical cancer is a treatable disease. A diagnosis of 

cancer is generally not expected by the woman and her family, and receiving bad 
^ news (especially if the cancer is advanced) is never easy. The provider should give 

such information to the patient, and to her family if the woman wishes, and away 
CQ from other patients. Some guidelines for disclosure and discussion with families are 

| as follows. 

2" Respect the culture, norms and customs of the patient; it may or may not be 

acceptable, for example, to give difficult news directly to her. 

Be clear and direct in meaning and words; do not use words the patient will not 

understand, or which are vague, such as "growth" or "neoplasm". 

!D Do not confuse the patient by saying too much, but do not leave important issues 

untouched. 

Allow some time for those present to take in the impact of what you have said; 
then give them time to ask questions. 

As people are often shocked when they receive sudden bad news, they may not 
fully hear or understand what has been said. Try to talk to the patient and her 
family (if she agrees) again the next day. 

After the initial diagnosis the patient may go through different stages of denial, 
anger, and resignation, which require understanding and support. 

When further treatment is not feasible 

When it becomes obvious that no further anticancer treatment can be given, it is 
best to counsel the patient and family in a sensitive but truthful manner. Try to avoid 
saying "nothing more can be done," because carers can help by relieving symptoms, 
supplying medication, arranging lower-level care, or just being available. For a patient 
who has been in hospital and is going home, this is the time to ensure that contact is 
made with local carers who can provide palliative care services. Questions about how 
much time is left should be answered honestly, i.e. that one does not know but it may 
be a question of a few days/weeks/months. This will give an indication to the patient 
and family of what to expect, so that they can make appropriate arrangements. 




Pain management 



Chapter 6: Management of Invasive Cancer 1 89 



Ensuring pain control 

When a patient with late-stage cancer goes home, the treating physicians 

(radiotherapist, oncologist, or gynaecologist) should make sure that she has 

prescriptions for appropriate pain medications, and that a supply will be available once 

she leaves the hospital. Most cancer patients, particularly in developing countries, if 

suffer unnecessarily with severe pain without adequate relief, because of restricted 53" 

availability of opiates at peripheral or lower levels; hospital-based providers, however, 9? 

may be able to secure and supply the necessary medicines for their patients. There is f? 

no substitute for oral morphine for severe pain, though palliative radiotherapy can be ^ 

a valuable adjunct to morphine for pain relief (see also Chapter 7 and 

Practice Sheet 1 8). psi8\- = 



8 



190 



Chapter 6: Management of Invasive Cancer 



MANAGEMENT OF INVASIVE CANCER: ACTIVITIES AT DIFFERENT LEVELS 







> 



In the community 




CD 
O 



CD 

O 



Maintain regular direct communication with the patient and her 
family. 

Maintain regular telephone or personal communication about 
the patient's condition with health centre staff. 

Detect new distressing symptoms of the disease or side- 
effects of treatment and inform health centre staff about these 
findings. 

Provide palliative care as specified in national guidelines and 
prescribed by specialists and other health care providers. 

Establish links between the patient and her family and 
faith-based or other assistance agencies, which may provide 
additional non-medical support. 

Aid the patient and family during the terminal stages as much 
as possible. 



At the health centre 



Maintain oversight of the patient's condition and 
communication with community-based health workers and 
with district and tertiary health care staff. 

Provide follow-up, as advised by treating facility, if appropriate 
at this level or if patient is unable to go to higher-level facilities. 

Prescribe and administer treatment for side-effects of 
treatments received or symptoms of disease in consultation 
with the treating centre. 

If feasible, do home visits for severely ill and terminal patients 
who cannot come to the centre. 

Collaborate in training of community workers and staff newly 
integrated into care team. 



At the district hospital 




and 
At the central hospital 




Provide treatment. 

If it is not possible to manage the patient directly, inform 
lower-care levels of needed follow-up and medical care to be 
provided, including prescription of medicines for pain relief. 

Maintain communication with patient's family and carers by 
telephone, mail, etc. 

Collaborate in training of lower-level providers in care of 
cancer patients. 



Chapter 6: Management of Invasive Cancer 1 91 



Counselling messages 



Make sure you address the following issues with the patient and family: 







the stage of her cancer; g 

the treatment she received before discharge; 

what possible side-effects she may note and how to deal with them; CT> 

the symptoms of complications and where she needs to go if she experiences any 

of them; 

CO 

needed follow-up: when, where, who to see; | 

your willingness to be supportive in any way possible. 



ADDITIONAL RESOURCES o 

Benedet JL, Bender H, Jones H III, Ngan HY, Pecorelli S. FIGO staging classifications 
and clinical practice guidelines in the management of gynaecologic cancers. FIGO 
Committee on Gynecologic Oncology. International Journal of Gynecology and 

Obstetrics, 2000, 70(2): 209-262. 

Chao KSC, Perez CA, Brady LW, eds. Radiation oncology: management decisions, 2nd 
ed. Philadelphia, PA, Lippincott, Williams & Wilkins, 2001 . 

Fletcher GH, ed. Textbook of radiotherapy, 3rd ed. Philadelphia, PA, Lea and Febiger, 
1980. 



192 






PS 15: Hysterectomy 193 



PRACTICE SHEET 15: HYSTERECTOMY 

Kbit 

Hysterectomy is the removal of the uterus. In simple hysterectomy, the entire uterus, 

including the cervix is removed. The tubes and ovaries may or may not be removed. ^ 

In radical hysterectomy, the uterus plus tissues around it and part of the upper vagina 

are removed. The overall procedures are essentially identical. This Practice Sheet is 

included to allow a first- or second-level health care provider to explain to a patient, 

before she goes to hospital, how the procedure will be performed, and to help her 

recover once she returns home. 

C7I 

EXPLAINING THE PROCEDURE 

Give the woman as much information as you can on the procedure, the anaesthesia, 
and the possible side-effects and complications of surgery. The description below will 
help you answer any questions she may have. 

Before the woman goes to hospital 

1 . The hospital staff will give her instructions for preparation: what clothing to take 
with her and any medicines she needs to take beforehand. She will be told not to 
eat or drink anything in the 8 hours before surgery, and to bathe before going to 
hospital. 

In the hospital, preparation for surgery 

2. The details of the operation will be explained and informed consent obtained. 

3. To help prevent infection, the woman's genital and abdominal areas will be 
cleaned with soap, water and iodine; her genital hair may be clipped. 

4. General anaesthesia will be given intravenously or by inhalation. 

5. A plastic tube (catheter) will be placed into her bladder and her urine will be 
collected in a bag. 

6. A gauze pack will be placed in her vagina to make it easier for the surgeon to 
remove tissues around the cervix. 



194 PS 15: Hysterectomy 



The operation 

7. A cut will be made in the lower abdomen, vertically or horizontally. 

8. In simple hysterectomy, the uterus is cut away from where it is attached to the 
fallopian tubes and the vagina. In radical hysterectomy, the surgeon removes the 

8. uterus, parametria, cervix and the top two centimetres of the vagina. After the 

uterus and parametria are removed, the surgeon will remove three sets of lymph 
nodes from the fatty tissue around the large blood vessels of the pelvis. 

9. All the tissues removed will be placed in a preservative solution and sent to 
the laboratory, where a pathologist will examine them to determine if the entire 
cancer has been removed. 

1 0. At the end of the operation, a drain may be left in the pelvis; this is a plastic tube 
placed in the abdomen to drain blood and fluid into a bag. It may be left in place 
for 24-48 hours. 

1 1 . Most surgeons will also put a tube (known as a suprapubic catheter) from the 
outside of the abdomen into the bladder, to drain urine. It will be left in place for 
5-7 days in case the nerves to the bladder have been damaged. 

1 2. The abdomen will then be sewn closed and wiped clean, and the wound 
bandaged. 

Just after the operation 

1 3. After the operation, the patient will be cared for by hospital staff in a special 
recovery room. Once she wakes up, she will be moved to a regular bed to 
recover. 

14. When the patient wakes up, she will have drips and tubes coming out of her 
body; she will also have nausea, which will last for a few hours. For the first few 
days, she will have pain in the abdomen where the operation was done. The 
hospital staff will give her medicines to relieve the pain and nausea for as long 
as she needs them. 



Recovery in the hospital 

1 5. In the hospital, the staff will make sure that the patient regularly coughs and 
breathes deeply, sits up, moves her muscles, and walks as soon as she is able. 
This helps to prevent complications. 



PS 15: Hysterectomy 195 



16. All the moving around of tissues and organs in the pelvis during the operation 
can damage some of the nerves that supply the bladder and the rectum. As a 
result, both organs may become "lazy" afterwards, i.e. they empty less efficiently 
than before the operation. Passing urine or stool will be difficult. The suprapubic 
catheter will be left in place for a few days, until she can urinate normally again. 
In most cases the bladder and rectum will have partially recovered before the 
patient is discharged from the hospital, and they will return completely to normal 
within 3-6 months of the operation. 

1 7. Most hospitals will allow the patient to return home after 7-1 days, depending 
on how fast she recovers and what care is available at home. Complete recovery 
from a radical hysterectomy takes 6-1 2 weeks. 

Follow-up (6 weeks after surgery) 

18. The woman will be given the results of the microscopic examination of the tissue 
removed. The surgeon will examine her thoroughly to make sure that she is 
recovering normally. Any problems detected will be managed. 

19. She will be examined with a speculum to make sure the wound in the vagina has 
healed. 

20. The information from the laboratory will allow the surgeon to discuss with her 
how far the cancer had spread, what other treatment might be needed, and the 
chances of the cancer returning. 

FOLLOW-UP AT HOME 

Before she leaves hospital, the woman will be given counselling on how to take 
care of herself, and what symptoms of complications to look for. You can help her by 
reinforcing this advice. 

1 . To help the patient to recover from the operation, other members of the family 
should take over her normal household tasks for the first 3-6 weeks, until she 
regains her strength. During these weeks, the woman should avoid doing heavy 
housework, walking long distances, carrying heavy objects, or performing other 
physically taxing tasks. She can perform normal daily activities, such as bathing, 
showering, and eating normally. She should take short walks a couple of times a 
day, as she gradually regains strength and returns to normal. 

2. The family should encourage the patient to rest when she seems tired, and make 
sure she eats well. 



196 



PS 15: Hysterectomy 



3. The woman will have a hidden wound in the vagina, which needs at least 6 
weeks to heal. To prevent infection and allow proper healing, she should not 
put anything into the vagina for that time, including fingers or tampons, and she 
should not use vaginal douching or have sexual intercourse (although she can be 
intimate in other ways). Her partner's support in this will be important. 

4. The chart below lists some symptoms that may occur in the few weeks after 
surgery, and what the woman should do if they occur. 



If she feels 


Cause 


What she should do 


Depression - feeling 
sad after a major 
operation is common 


Pain, fatigue, worry 


Wait; this should not last 
more than 2 weeks or so 


Abdominal discomfort 
- this is normal 


Soreness from the cutting 
that was done 


Eat food high in fibre, drink 
plenty of liquids, take stool 
softeners (bisacodyl); this 
should disappear within 6 
months 


Difficult and slow 
urination; bladder not 
emptying properly 


Nerve damage during 
surgery, "lazy" bladder 


"Double void": pass urine 
normally then get up, walk 
around for a few minutes 
and pass urine again. If this 
does not work, she may 
have to put a tube in herself. 
The hospital will show her 
how to do this and give her 
the materials. The problem 
should disappear within 3- 6 
months 


Tiredness -this is 
normal 


The body is healing itself 
and needs extra rest 


Lie down to rest during the 
day as often as she needs 



PS 15: Hysterectomy 



197 



5. Make sure that the patient and her family know the signs and symptoms of 
complications (see below) and instruct her to go to the health centre or hospital 
if any of them occur. 



Complication 


Signs and symptoms 


Infection of the abdominal 
wound 


Pain, redness and pus in the cut area on the 
abdomen 


Infection in the pelvis 


Pain (not just discomfort) in lower abdomen, 
often with fever, foul-smelling vaginal discharge 
or bleeding 


Lymphocyst - caused by 
collection of lymph fluid after 
removal of lymph glands 


Swelling or pain in the lower abdomen 2-3 
months after surgery 


Bladder infection 


Burning sensation on urination; frequent urination 


Blood clot in the leg 
(thrombosis) 


Redness, pain and swelling in one leg 



Supplies needed at home: these can be obtained from the hospital or a prescription 
written for later if needed: 

paracetamol for mild pain (if needed); 

stool softener (e.g. bisacodyl); 

urinary catheters; 

gauze bandage and disinfectant for wound. 



198 



PS15 




8 



CJl 



I 

i 



PS 15: Hysterectomy 



PS 16: Pelvic Teletherapy 



199 



PRACTICE SHEET 16: PELVIC TELETHERAPY 



Pelvic teletherapy is radiation given to the pelvic area from a distance, using a special 
machine (Figure PS16.1). 




Figure PS16.1 Machine for teletherapy 



This Practice Sheet is included to allow a first-or second-level health care provider to 
explain to a patient, before she goes to hospital, how the procedure will be performed, 
and to help her recover once she returns home. 

EXPLAINING THE PROCEDURE 

Give the woman as much information as you can on the procedure, and the possible 
side-effects. Tell her what the treatment will consist of and who will be in charge of 
it at the hospital. Tell her that she will be alone during treatment, but that it will not 
take long and that it does not hurt. The description below will help you answer any 
questions she may have. 



Before the therapy starts 

1 . The hospital staff will give her instructions for preparation: what clothing to take 
with her and any medicines she needs to take beforehand. 

2. The details of the treatment, its possible complications and options will 
be explained and informed consent requested. The woman will receive an 
appointment for pelvic imaging (with X-rays) on a simulator or computerized 
tomographic (CT) scanner. 



200 



PS 16: Pelvic Teletherapy 



Preparation for treatment 

3. On the first day at the hospital, she will be asked to undress and to lie on a special 
table. She may have a pelvic examination, and X-rays will be taken. With the 
information obtained from the X-rays, her abdomen and pelvis will be marked with 
an indelible pen. This is to help the operator limit the radiation to the tumour; she 
must not rub these marks off. 

4. She will be told the schedule for the therapy, and when to return for the first 
treatment. 

5. The patient will be given the following information and counselling concerning the 
entire period of the therapy: 

To avoid potential chafing of the skin, she should wear loose clothing and avoid 
wearing trousers. 

She can shower with warm water, but should not soak in a bath, and should 
avoid sponging, rubbing the skin and using harsh soaps. 

She should not put anything into the vagina during the entire therapy (such as 
tampons), or have sexual intercourse (although she can be intimate in other 
ways). 

She should avoid commercially available skin creams, as they may contain 
harmful heavy metals. If she needs to use cream, she should ask the staff at 
the health centre to prescribe it for her. 

She should cut down on heavy work and work performed in a hot, sweaty 
environment. 

She can continue with her usual housework or light office work. 

She may experience some tiredness or depression near the end of the course of 
treatment, and she should limit her activities accordingly. 

The repetitive daily treatments will become boring. She should keep in mind 
that the chance of cure is diminished if she misses appointments or breaks her 
schedule, thus delaying completion of therapy. 



Treatment 

6. On the first day of treatment, the radiotherapy technician will reconfirm the 
patient's identity, therapy plan and informed consent. The technician will explain 
the procedure and show her the therapy machine inside the bunker. 



PS 16: Pelvic Teletherapy 



201 



7. The patient will be placed on the therapy table and told to remain in position. All 
personnel will leave the room. 

8. She will be alone inside the treatment room, but she will have closed circuit 
television and audio links for communication. 

9. During treatment, the therapy machine will be moved several times automatically, 
or the technician will enter the room to move it. 

1 0. The patient will not feel anything during the therapy, which lasts only a few 
minutes. 

1 1 . Usually, 25 such treatments will take place over a period of 5 weeks. 



Repeat treatments 

1 2. The daily treatments will be as described above. The patient will be encouraged 
to report any problems to the technician. If it is felt she needs a more specialized 
response, she will be referred to the radiation oncologist. 



CT> 



S' 



& 



Side-effect 


Signs and symptoms 


What to do 


Skin response to 
radiation 


Redness starting after about 
3 weeks and increasing 
with treatment. Possibly dry 
then moist peeling of the 
skin, especially in the fold 
between the buttocks. 


Only gentle occasional washing of 
the area. Avoid scrubbing. If painful, 
take mild analgesia. If the reaction is 
severe (usually because of excessive 
washing) the radiation oncologist may 
delay the completion of treatment (this 
can compromise the cure rate). 


Bowel effects 


The rectum and terminal 
colon, which reabsorb water 
from the bowel contents, 
are in the pelvic region. 
Radiation may impair water 
reabsorption, resulting in 
loose stools or diarrhoea. 


The radiation oncologist will prescribe 
medication if required. Usual 
household remedies should not be 
used. 


Bladder effects 


Urinary frequency and 
urgency. There may be 
a burning sensation on 
passing urine. Rarely there 
may be evidence of blood in 
the urine. 


Patient should return to the hospital for 
examination and treatment. 



202 PS 16: Pelvic Teletherapy 



1 3. The radiation oncologist will see the patient once a week for a "treatment 
PS 1 6 check", and will ask about any signs or symptoms and assess how well the 

patient is tolerating treatment. 

-o 1 4. The woman will be informed about common acute side-effects of radiotherapy 

(see below) and what to do if they occur. These side-effects will resolve 
spontaneously once the treatment is finished. 

i 

Follow-up 

1 5. The patient will be given an appointment to return 6 weeks after completion of 
the teletherapy. The doctor will examine her and check the vagina to determine if 
it has healed. 

o 

16. The oncology team (radiation oncologist and gynaecologist) is best placed to 
assess any symptoms related to the pelvic area - in the vagina, bowel and 
bladder. They should be told about any symptoms or signs that appear to be 

3 unusual or severe. 

WHAT YOU CAN DO DURING AND AFTER THE THERAPY 

1 . Help the woman to keep a positive attitude. 

2. Counsel her and her husband that she should not have sexual intercourse during 
the treatment period. After this period, it is recommended that the woman 
remains sexually active. 

3. Inform her that she does not need to use contraception. Pregnancy is impossible 
during and after teletherapy to the pelvis. 

4. Ask her to keep the regular follow-up appointments with the team of radiation 
oncologist and gynaecologist. If she has unusual or severe symptoms, she 
should make an earlier appointment than scheduled. 

5. Tell the family that they should help the woman to recover from the therapy by 
doing her normal household tasks for her, until she regains her strength. 

6. Encourage her to lie down during the day if she feels tired; make sure she eats 
well. 



PS 16: Pelvic Teletherapy 



203 



7. Inform the woman about late complications: 

The radiation will cause a premenopausal woman to enter the menopause,-with 
its typical symptoms of lack of menstruation, hot flushes, and vaginal dryness. 

The vaginal symptoms of menopause are made worse by vaginal fibrosis and 
narrowing of the vaginal tube, making intercourse uncomfortable or impossible. 
Vaginal lubricants and dilators should be prescribed to keep the vagina free of 
adhesions. It is important to keep the vagina open to allow inspection of the 
cervix. Continued sexual activity should be encouraged. 

Starting 6 months after treatment, the skin exposed to radiation may show 
areas of pigmentation, depigmentation or stiffening. 

Long-term narrowing of the rectum, and a passage (fistula) between the vagina 
and the rectum may develop. These are very disabling complications, which 
may need further surgery or even a colostomy. 

The bladder may become stiff and reduced in size, causing the woman 
to urinate frequently, and predisposing her to urinary infections. Rarely, a 
vesicovaginal passage or fistula develops, resulting in incontinence. This may 
require surgical repair. 

Very rarely (one patient in a thousand), the radiation may stimulate the 
development of a new cancer. 



PS16 



s 

CO 



I 

a' 

2 

I 

CD 

3 




204 



PS16 



PS 16: Pelvic Teletherapy 



CD 



PS17:Brachytherapy 205 



PRACTICE SHEET 17: BRACHYTHERAPY 

Brachytherapy is radiation therapy delivered from a source of radiation placed close 
to the tumour, i.e. inside the uterus and in the vaginal vault. This Practice Sheet is 
included to allow a first- or second-level health care provider to explain to a patient, 
before she goes to hospital, how the procedure will be performed, and to help her 
recover once she returns home. 

EXPLAINING THE PROCEDURE 

Give the woman as much information as you can on the procedure, the anaesthesia, 
and the possible side-effects and complications of the therapy. The description below 

will help you answer any questions she may have. %< 

3 

CD 

Low-dose-rate (LDR) brachytherapy 

Preparation 

1 . The hospital staff will give her instructions for preparation: what clothing to take 
with her and any medicines she needs to take beforehand. 

2. The details of the treatment and its possible complications will be explained, 
and informed consent requested. The patient will receive an appointment for 
admission to hospital. 

Procedure 

3. On the day of the procedure, the patient will be taken to the operating room and 
given a general anaesthetic. 

4. She will have a tube placed in her bladder. 

5. A pelvic examination will be performed. 

6. Through a speculum in the vagina, special metal devices will be placed into the 
cervical canal and around it in the vagina. These devices will hold the radioactive 
sources. 

7. Their position will be checked with X-rays. 

8. When she wakes up, she will be taken to an isolation ward (shielded room). 

9. She will be instructed to remain on her back in bed for the duration of the 
treatment (about 2 days). 

10. The urinary catheter will remain in place and will be attached to a bag to collect 
urine. 



206 PS17:Brachytherapy 



11. The hospital staff will leave the room and the radioactive sources will be loaded 
PS 1 7 under computer control into the metal devices previously inserted close to the 

tumour. 



o 1 2. The patient will not feel any pain at all while she is receiving the treatment. 

1 3. During the entire procedure, the door of the room will remain closed. She 
will need to use a bedpan to empty her bowel. The patient will be able to 
communicate with the nursing staff by audio link, and all meals will be served in 
bed. She can spend the time reading, listening to radio, or watching television. 
But she must remain in bed for the entire time! Very limited visiting will be 

w permitted. 

B0 

1 4. When the time for the procedure has been completed, she will be given a mild 
sedative and the devices containing the radiation sources will be removed. 

<D 

15. Once she has recovered from the sedation, she will be discharged from the 
hospital. 

In some hospitals, two such treatments are given with a one-week interval between 
them. 



High-dose-rate (HDR) brachytherapy 

The procedure is similar to that for LDR brachytherapy, with the following differences: 

1 . Treatment will usually start in the third week after starting teletherapy. 

2. Each treatment lasts only one hour, and is given on an outpatient basis. It. can be 
performed under mild analgesia; anaesthesia is seldom used. 

3. After catheterization, repeat manual and speculum vaginal examinations will be 
performed and vaginal retractors and speculum inserted. 

4. A metal brachytherapy catheter is inserted into the uterus, and attached to the 
remote afterloading HDR brachytherapy unit that contains the radioactive source. 

5. The patient will be told to remain in position while the personnel leave the room. 
She must remain in the same position for the whole time that she is receiving 
radiation, which takes several minutes. 

6. She can be discharged when the procedure is over. 

7. The number of treatments varies from 2 to 8, but is usually 4. The interval 
between treatments may vary from one day to a week. 

8. After the first treatment, the patient will be given a series of appointments for the 
rest of the treatments. 



PS 17: Brachytherapy 



207 



Possible side-effects and complications of gynaecological brachytherapy 

The side-effects of brachytherapy are the same as those of pelvic teletherapy (see 

Practice Sheet 16). The information and counselling to be provided to the patient are 

also similar. Inform the patient about the anaesthesia or sedation she 

will receive to make her feel more comfortable.Brachytherapy makes 

a major contribution to vaginal symptoms of local fibrosis, mucosal 

atrophy and formation of petechiae, which predisposes to local 

bleeding. It also contributes to late rectal and bladder complications. 




PS17 




Pelvic teletherapy 



208 



PS17 



CD 

a 



CO 

3 
o 



PS 17: Brachytherapy 



o 



CHAPTER 7: PALLIATIVE CARE 



Chapter 7: Palliative Care 211 

CHAPTER 7: PALLIATIVE CARE 



Key points 



Palliative care is an essential element of cervical cancer control. 

The goal of palliative care is to avoid unnecessary suffering and improve the quality 
of life of women with advanced cervical cancer and their families, through emotional 
support, symptom control, end-of-life care and bereavement care. It addresses the 
physical, psychosocial, and spiritual needs of patients and their families. 

Palliative care should begin as soon as cervical cancer is diagnosed, so that needs 
can be anticipated, and preventive and treatment measures planned and put into 
effect. 

Palliative care can help people with advanced disease to have dignity and peace 
during difficult and final phases of life. 

Freedom from pain can be considered as a human right, yet pain control 
remains vastly underutilized. The mechanisms for its implementation need to be 
strengthened. 

Using a broad combination of medical and non-medical methods, pain can be 
effectively controlled in 90% of cases. 

Patients and their caregivers need training, ongoing support, and supplies for 
palliative care, including for symptom management at home. 

ABOUT THIS CHAPTER 

This chapter deals with one of the most important and often neglected components of 
a comprehensive cervical cancer control programme. It focuses on the importance of 
having a team of trained, home-based and clinical providers, who can make the end 
of life of a cancer patient more comfortable and satisfying, and it provides advice on 
symptom management. The patient's family is considered part of the care team. Most of 
the issues treated in this chapter are also relevant to patients who need palliative care 
for other non-curable diseases. Practice Sheets 18-20 provide detailed 
instructions for management of pain, vaginal symptoms and other 
common problems encountered in seriously ill patients. 

PS 18, 19, 20 




212 



Chapter 7: Palliative Care 



o 






THE ROLE OF THE HEALTH CARE PROVIDER 

The health care provider has an essential role in improving the quality of life of the 
patient with a life-threatening illness and her family. 20 Providers at all levels of the 
health system need to work as a team, to provide treatment, comfort and care, and to 
transmit accurate information and skills to the patient, her family and the community. 
To be able to do this, providers need special focused training in management of 
both physical and emotional problems, and must have skills in communication and 
understanding. 




STORY 

Amelia is a 57-year-old woman from Angola, with 6 chil- 
dren and many grandchildren. She was taken to the near- 
est district hospital, 95 kilometres away 
from her home, by her eldest daughter, 
after she developed a vaginal discharge 
with a very bad odour, which persisted 
for many months. The doctor who exam- 
ined her did some tests, and explained 
that she had advanced cervical cancer 
which had spread from her cervix to her 
vagina and bladder and the walls of her pelvis. The bad 
odour was caused by urine leaking from her bladder into 
her vagina and mixing with discharge from the tumour. 
The doctor said that unfortunately, at this stage, there was no treatment or 
cure for her cancer, but that she could be cared for and made comfortable 
at home. She added that she worked with community health workers near 
Amelia's village, who provided home-based care for people who were very 
sick with AIDS, cancer, or other illnesses. Then she wrote a referral note 
to the woman in charge of the home-based care organization, explaining 
Amelia's condition and asking her to visit her at home. The doctor said 
she would work from a distance with the health worker, to make sure that 
Amelia would have the medicines she needed, including medicine for pain, 
which might get worse as the cancer progressed, (continued next page) 




20 In this context, "family" includes anyone that the patient considers to be significant to her. 



Chapter 7: Palliative Care 21 3 




Although Amelia and her daughter were shocked and saddened by the 
news, the doctor's kindness and concern reassured them. Her promise^ 
to watch over her care with the local health worker made them both feel 
more confident and hopeful about the future. 

The health worker came as promised; she showed Amelia 
and her daughter how to deal with some of the problems; 
how to prepare pads from old, clean cloths to absorb the 
vaginal discharge, how often to change them and how to 
wash them, to apply petroleum jelly to the vaginal area as 
the skin was beginning to get irritated from the constant 
moisture, to gently wash the area daily with soap and 
water, and to have sitting baths. With Amelia's permission, 
she spoke to the family about supporting Amelia and each 
other during her illness, and emphasized the importance of sharing the 
work as Amelia's condition got worse. There would be more laundry, as 
bedding and underwear would need to be washed often; the bed should 
be protected from discharge and urine with a plastic sheet; medicines 
for pain could be bought at low cost from the local mission hospital, and 
someone would need to fetch them regularly; other help at home was 
available through Amelia's church. Amelia's family was poor, but the health 
worker helped to organize support from the community, the church and 
the local mission so that the needed supplies were usually there. 

She helped the family to understand the importance of keeping Amelia 
involved in their daily lives, and the life of the community. The family 
arranged for friends to visit when Amelia felt well enough; they took turns 
preparing food and, when she became too weak to leave her bed, they 
made sure that someone was always there for her. Amelia felt that she 
was not cast aside because of her illness. Even as she approached death, 
conversation and good spirit kept the house full of life and Amelia felt 
loved and needed until the end of her life. 



21 4 Chapter 7: Palliative Care 



A COMPREHENSIVE APPROACH TO PALLIATIVE CARE 

^ Palliative care aims to improve the quality of life of patients and their families facing 

p problems associated with life-threatening illness. Palliative care is not only end-of-life 
care, but also includes management of all distressing symptoms, including pain. The 

g" patient's future needs should be considered at the time she is diagnosed with advanced 

H cancer, so that problems can be anticipated, and prevented or managed (Figure 7.1 ). 

r^j Palliative care can be provided by people in the family, community, health centres and 

g hospitals^ 

I 

S Figure 7.1 Continuum of care 



bereavment 
care 




diagnosis illness death 



Why is palliative care necessary? 

Even with the best prevention and screening programmes, some women are diagnosed 
with advanced disease or will develop such disease, and will need clinical and 
emotional support and pain control. In many low-resource countries, women are not 
reached by organized screening programmes and many are diagnosed as having 
cervical cancer only when they develop symptoms, usually in late stages of disease 
(see Chapter 6). In addition, facilities for the treatment of cervical cancer may not exist 
or may not be accessible to many women; as a result, some women with relatively 
early cancers will not receive the most effective treatment. In these settings, palliative 
care is particularly important, as many of these women will need relief from pain and 
other distressing symptoms. Adequate resources have to be made available to care for 
those who cannot be cured, particularly in rural areas with few health services, where 
many women will die at home in difficult conditions. 

Patients with other chronic severe diseases, such as AIDS, also need special care, 
and efforts should be made to create a team of health providers at all levels of the 
health care system with knowledge and skills in palliative care. If appropriate, patients' 
families should be enrolled into palliative care teams. 



Chapter 7: Palliative Care 215 



RECOMMENDATION 

The needs of women with incurable disease should be addressed by using 
existing palliative care services or establishing new ones. Providers at all levels 
need to be trained and to have the resources necessary to manage the most 
common physical and psychosocial problems, with special attention to pain 
control. 

I 






Principles of palliative care 

Palliative care: 

provides relief from pain and other distressing symptoms; 

affirms life and regards dying as a normal process; 

is intended neither to hasten nor to postpone death; 

integrates the clinical, psychological and spiritual aspects of care; 

gives the patient and her family as much control and decision-making power as they 
desire and are able to accept; 

offers a support system to help patients live as actively as possible until death; 

offers a support system to help the family cope during the patient's illness and in 
their own bereavement; 

uses a team approach; 

will enhance quality of life, and may also positively influence the course of illness; 

is applicable early in the course of illness, in conjunction with other therapies that 
are intended to prolong life, such as surgery and radiotherapy. 

Essential components of palliative care 

Prevention and management of symptoms: this may include palliative radiation to 
reduce the size of the tumour, as well as treatment for vaginal discharge, fistulae, 
vaginal bleeding, nutritional problems, bedsores, fever, and contractures. Families 
should be taught how to prevent problems, where possible, as well as how to 
support the patient in her daily activities, such as bathing, going to the toilet, and 
moving around. 

Pain relief: effective pain control can be achieved in 90% of cases, using the 
medical management described in this chapter, together with ancillary non-medical 
methods. 



216 



Chapter 7: Palliative Care 



o 

Z3- 
JD 



I 
g 

I 

8 

3 



Psychosocial and spiritual support: this is an important component of palliative care 
and requires trained providers with good communication skills. 

Involving the family: the health worker can ensure that the patient and her family 
understand the nature and prognosis of the disease and recommended treatment. 
The palliative care worker must also be able to help the patient make decisions 
about her care. The patient and her family should have sense of being in control, 
with full support from the health care team, whose task is to provide appropriate 
information and advice and support informed decisions. 

Palliative care requires systematic and continuous application of the five steps (five 
"A"s), described below. Like other aspects of cervical cancer care, this approach 
requires teamwork and adequate resources. 



The five As of palliative care: Assess, Advise, Agree, Assist and Arrange. 



Assess the patient's status and identify the treatments needed; 
assess the patient's and carers' knowledge, concerns and skills 
related to the illness and the treatment. 



Advise: 



Explain how to prevent and manage symptoms, and teach needed 
skills, a few at the time, by demonstration and observed practice. 



Agree: 



After giving information and teaching skills, make sure that the 
patient knows what to do and that she wants to do it. Empower 
her to stay in charge. Support patient self-management and 
family care. 



Assist: 



Make sure the patient and her family have enough supplies to 
cope with difficult situations and give required care. Give written 
instructions as a reminder of what has to be done, with pictures if 
needed for those who cannot read. 



Arrange: 



Schedule a time for the next visit. Make sure the patient, her 
family and other carers know where to go if they have questions 
or concerns. 



Make sure the family knows when and who to call for help. 



Chapter 7: Palliative Care 217 



The role of the family in palliative care 

Palliative care should be available wherever patients are - at home, in hospitals, 

in hospices, etc. In developing countries, most patients die at home, and the family" 

plays an important role in palliative care. If the patient agrees, and if appropriate, the 

patient's family should be involved and empowered in joint decision-making, should |f 

be constantly kept informed of medical decisions, including changes in carers and 11 

treatment, and should be trained in best practices of palliative care.The patient's r^ 

family and other carers can be taught to give home-based care. Clinical care should be g 

provided by health workers trained to use recommended medicines within the national 

legal framework. Providers of palliative or home-based care should have continual 

back-up from first-level health workers (physician, clinical officer, or nurse) who should 

be available for consultation or referral when needed. 

Accessing local resources for care at home 

When a woman is no longer able to work or care for her family, meagre resources 
may become further stretched. Money for food, supplies and medicines for her 
care or the supplies themselves are sometimes available through local, regional or 
national nongovernmental organizations, faith-based organizations, women's groups 
and community-based organizations. A palliative care or home-based care (HBC) 
programme should have links with these organizations where possible, and provide 
referrals for women and their families. 

MANAGING COMMON SYMPTOMS OF EXTENSIVE CANCER 

Women with advanced cancer can suffer a constellation of physical, psychological and 
emotional problems. Pain is almost always part of the constellation, and its relief should 
always be part of palliative care. 

Pain management 

Pain relief for cancer patients: 

is vastly underutilized and, as a result, many patients suffer needlessly; 

is achievable and inexpensive; 

needs cooperation and two-way communication between home-carers and clinical 
providers at all levels of the health care system. 

Home-carers are most in touch with the patient's needs, while clinical 
providers can offer support and medications. 




Pain management 



218 Chapter 7: Palliative Care 



The following are the major barriers to effective pain relief: 

^^ lack of awareness, on the part of health care providers and the general public, that 
^p pain relief is achievable and inexpensive. 

lack of availability of pain medications as a result of restrictive regulatory policies. 

_" Even when controlled pain medications (opiates and oral morphine) are available 

gf in principle, providers - including physicians - may be restricted by national drug 

^ control policies from prescribing or dispensing them. 

~& 

= providers' unrealistic fears of promoting drug dependence in patients, and of 

=? contravening drug enforcement laws. 

o National rules and regulations must be followed. They should be carefully checked to 

see whether they allow pain relief to be administered by non-medical people under the 
supervision of doctors or nurses. If not, medical and non-medical people need to join 
forces to advocate for patients' right to freedom from pain. 

In the context of palliative care in national cancer control programmes, restrictive drug 
regulations need to be modified to allow access to pain control. Although changing 
policy and law is not the role of the care team, providers should advocate for, and 
demand, policy change, to remove barriers to access to pain relief, including opioids. 



RECOMMENDATION 

A comprehensive cervical cancer control programme should ensure that 
opioid, non-opioid and adjuvant analgesics, particularly morphine for oral 
administration, are available. 



WHO'S analgesic ladder 

WHO has developed an effective and relatively inexpensive method for relieving cancer 
pain in about 90% of patients. This method is called the WHO ladder for cancer pain 
relief and is described in Practice Sheet 18. It can be summarized as follows: 

by mouth: whenever possible, analgesics should be given orally in 
order to permit wide applicability of this method; 

by the clock: analgesics should be given at fixed time-intervals. The 

next dose should be given before the effect of the previous one has Pain mana 9 ement 
fully worn off, to ensure continuous pain relief; 

by the ladder: the first step is to give a non-opioid, typically paracetamol. If this does 
not relieve the pain, opioids for mild to moderate pain , such as codeine, should be 




Chapter 7: Palliative Care 



219 



given. The third step is to give opioids for severe pain, such as morphine. Additional 
drugs, called adjuvants, can be used in certain circumstances; for example, 
psychotropic drugs may be given to calm fear and anxiety; 
for the individual: there is no standard dose for opioid drugs. The right dose is the 
dose that relieves the patient's pain. 

Two rules for opiate dosage: 

There is no standard dose for opioid drugs: the right dose is the dose that relieves 

pain. There is no ceiling dose for opioid drugs: the dose will gradually need to be 

increased as patients become tolerant to the pain-relieving effects. 



o 

s 



In cervical cancer patients, pain management will depend on the body part involved. 
Table 7.1 outlines management of some commonly encountered pain syndromes. 

Table 7.1 Pain syndromes in cervical cancer and their management 



Syndrome, clinical features 


Pain probably 
caused by: 


Treatment 


Tenderness over a bone, may be 
worse on movement (severe pain or 
tenderness in weight-bearing bones 
needs urgent attention to prevent 
fractures) 


Metastases in 
bone 


Radiotherapy 
Bisphosphonates 

Surgery (e.g. pins) for weight- 
bearing bones 

NSAIDs* paracetamol (if 
no contraindications) always 
needed 






Corticosteroids, if NSAIDs are 
contraindicated 






Opioids if pain still present 


Leg calf and foot pain, possible loss 
of strength 


Involvement of 
lumbosacral 
nerve plexus 


NSAIDs paracetamol 

Steroids: dexamethasone 4 
mg for 1 or 2 days, then 2 mg 
a day 






Opioids 






Tricyclic antidepressants or 
an anticonvulsant 


Pain when leg flexed at hip (Psoas 
sign) 

Leg pain 


Infiltration of 
psoas muscle 


Same as above but diazepam 
or other antispasmodic 
essential 



"Nonsteroidal anti-inflammatory drugs. 



220 Chapter 7: Palliative Care 



Non-medical methods to assist in pain control 

Many non-medical methods, appropriate to local customs and culture, can help control 
p pain. These methods can be used together with pain medications but should never 
take the place of effective pain-relieving medicines. Non-medical pain management 
=f may include: emotional support, physical methods (touching and massage), distraction, 

" prayer, meditation and other non-harmful local traditional methods. They should be 

^i provided only with the explicit understanding and approval of the patient and her family. 

I 

Si Prevention and management of other problems of advanced disease 

o Problems to be managed at home may include: 

vaginal discharge, 




vaginal bleeding, 

PS 19 Home-based care 

nausea and VOmitmg, PS 20 Managing vaginal 

diarrhoea or constipation, 

fever, 

loss of appetite, wasting, weakness and fatigue, 

leg swelling, 

bedsores, 

shortness of breath, 

depression. 

DEATH AND DYING 
Anticipating practical issues 

To help the patient and her family bear the burden of imminent death and bereavement, 
home-care providers can encourage discussion of important issues, such as writing a 
will, financial support of the family, changing roles within the family and reconciliation 
of old quarrels. 

Preparing for death 

Encouraging communication within the family can make a death less stressful and ease 
bereavement (see Chapter 6 for additional advice on how to talk with the incurable 
patient and her family). At times, the patient may express anger or other strong 
emotions towards her closest family members and the health care provider; such 
outbursts need to be accepted and not taken personally. 



Chapter 7: Palliative Care 221 



The trained provider can help the dying woman by doing the following: 

helping her deal with guilt or regret; 

talking about her impending death; 19 

providing comfort and care; g 

responding to grief reactions, such as denial, sadness, bargaining, yearning, anger, || 
humiliation, despair, guilt and acceptance; ^ 

keeping communications open, and giving her the chance to talk about her feelings, g 
without pressuring her if she is not ready to talk; 

offering practical support, such as helping to make a will; 

C~3 

asking her how she wishes to die (where, and with only family present or with j| 
pastoral care); 

making sure that her wishes are respected. 

When considering the possibility of transferring the patient to the hospital, carers should 
take into account her wishes and those of her family. It is probably not appropriate to 
transfer a dying patient, unless she requests it. 

Death 

At the time of death, it is essential to respect local rites and rituals, as well as the 
previously expressed personal wishes of the patient concerning care of the body, 
funeral, and other issues. 

Bereavement 

Bereavement care is support given to the family after a patient's death, to help them 
accept the loss of their loved one. Home-care workers and clinic providers involved 
in the woman's terminal care can share the family's sorrow, by encouraging them to 
talk and express their memories. Workers should not offer false comfort but should be 
supportive, take time to listen, and try to arrange practical support with neighbours and 
friends. 




222 Chapter 7: Palliative Care 

ORGANIZATION OF PALLIATIVE CARE SERVICES 

In resource-poor settings, palliative care is most often provided by untrained community 
^ health workers. 

g To be effective, these workers require: 

"2. training in clinical and psychological palliative care, which can be 

I^ given in 1-3 weeks for those with basic medical skills; 

g supportive supervision from hospice nurses or others trained in the Home-based care 

|f management of psychosocial and medical problems in severely ill 

S' patients; 

essential medicines and other supplies needed for effective palliative care, provided 
according to a national essential drug list. The primary health care facility can 
arrange for regular supplies for home-based care providers and their patients; 

a secure place to store medicines, and a separate tracking system for pain 
medications, if this is required by the drug regulatory authority; 

open communication with the formal health system, and access to more skilled 
providers for consultation and referral of patients when needed. 

A team approach to palliative care 

Providers at all levels of care, from specialists to home-care providers, should work 
together to ensure the best quality of life and outcome for the patient with advanced 
cervical cancer. In tertiary care settings, the team might include a gynaecologist, a 
radiotherapist, a radiotherapy technician, a psychologist or counsellor, a nutritionist, a 
physiotherapist, an oncology nurse, a pharmacist, a social worker and a palliative care 
nurse. In resource-poor settings it is unlikely that such a highly specialized team can 
function down to the level of the community where the woman lives. Strategies need to 
be devised for individual community providers responsible for the patient's continuing 
care, to allow them to link the patient and her family with staff at the health centre and 
district and central hospitals. 



Chapter 7: Palliative Care 



223 



PALLIATIVE CARE AT DIFFERENT LEVELS OF THE HEALTH SYSTEM 



In the community 




At the health centre 



At the district hospital 




At the central hospital 




Visit the patient's home on a regular, scheduled basis, in order 
to anticipate and follow up problems. 

Facilitate access to supplies and medicines. 

Teach care and comfort-giving procedures to the patient and 
her family and check that they are being done. 

Answer questions, provide information and keep records. 

Encourage the family to keep the patient involved in their daily 
life as much as possible. 

Supervise, support and maintain supplies for the CHWs who do 
home visits for women with cervical cancer. 

Provide emergency or routine follow-up care for problems after 
diagnosis or treatment for invasive cancer. 

Manage referrals to other facilities for palliative care. 

Maintain contact with health centre and palliative care 
providers, and follow up women referred from this level. 

Support and supervise the team at lower levels. 

Provide treatment and care. 

Refer patients to central level for acute problems that are best 
managed there, such as uncontrolled vaginal bleeding and 
intractable pain. 

Be involved in palliative care services organized at district and 
primary facility levels. Assist, train and supervise lower-level 
providers and CHWs. 

Provide certain palliative procedures, e.g. radiotherapy. 

Counsel and educate the family and patient in how to prevent 
common problems, such as contractures and bedsores. 

Participate in the development of an individualized home-based 
care plan for each patient. Refer patients back to facilities 
closer to their home, instructing the facilities and providing 
distance supervision. Be available for consultations by 
telephone or mail. 

Write prescriptions for medications such as analgesics, 
including oral morphine, and give them to the patient or her 
carers for immediate or future use. 

Visit the community from time to time to conduct training 
sessions for HBC workers or CHWs, and to learn from them 
about the conditions in which they work, and in which their 
patients live. 



224 Chapter 7: Palliative Care 



ADDITIONAL RESOURCES 

Bruera E, de Lima L, ed. Cuidados paliativos: guias para el manejo clfnico. 
^p Washington, DC, Pan American Health Organization, International Association for 

Hospice and Palliative Care, 2004 (available only in Spanish). 

g Burns AA et al. Where women have no doctor. A health guide for women. Berkeley, 

sf CA, Hesperian, 1997. 

i^ Davis E, Higginson IJ, ed. Palliative care: the solid facts. Copenhagen, WHO Regional 

1 Office for Europe, 2004. 

<" Doyle D, Hanks G, Cherney Nl. Oxford textbook of palliative medicine, 3rd ed. Oxford, 

o Oxford University Press, 2003. 

European Association for Palliative Care. A guide to the development of palliative 
nurse education in Europe, report of the EAPC task force. Milan, EAPC, 2004. 

Palliative care for women with cervical cancer: a field manual. New York, NY, Seattle 
WA, PATH, EngenderHealth, 2003. 

Palliative care for women with cervical cancer: a Kenya field manual. Washington, 
DC, PATH, 2004. 

Recommendation 24 of the Committee of Ministers to Member States on the 
organisation of palliative care and explanatory memorandum, 2003 (adopted by the 
Committee of Ministers on 12 November 2003 at the 860th Meeting of the Ministers' 
Deputies) (www.coe.int). 

WHO. Cancer pain relief, 2nd ed. Geneva, 1 996. 

WHO. Narcotic and psychotropic drugs: achieving balance in national opioids control 
policy-guidelines for assessment. Geneva, 2000. 

WHO. National cancer control programmes, 2nd ed. Geneva, 2002. 

WHO. Palliative care: symptom management and end-of-life care. Interim guidelines 
for first-level facility health workers. Geneva, 2004 (WHO/CDS/IMAI/2004.4 Rev. 1). 

WHO. Caregiver booklet: a guide for patients, family members and community 
caregivers. Geneva, 2004. 



PS 18: Pain Management 



225 



PRACTICE SHEET 18: PAIN MANAGEMENT 

This Practice Sheet details clinical actions to relieve pain. See also Table 7.1 for _ 
additional suggestions on pain management. 

Freedom from pain can be considered a human rights issue 

MANAGING PAIN 21 

1 . Assess the patient's pain. If possible, determine the cause, identify any new pain 
and any change in pre-existing pain. Ask the patient questions to determine the 
following: 

Where is the pain? What makes it better or worse? What type of pain is it? 

What is the patient taking for the pain? 

Is there a psychological or spiritual problem in addition to a physical, cancer- 
related reason for the pain? Is the patient worried, fearful, depressed or 
grieving? 

How bad is the pain? Fingers or faces can be used to grade the pain (Figure 
PS18.1). 

Figure PS18.1 Assessing pain by using fingers or faces 








01 234 5 

no hurt hurts hurts hurts hurts hurts worst 

little bit little more even more whole lot 



2. Record your findings on the patient's chart and your own record. 

3. If you find the cause of the pain, treat the cause if possible (bone pain, muscle 
spasm, gastrointestinal pain from constipation, swelling around tumour). 



21 



Adapted from: Palliative care: symptom management and end-of-life care. Interim guidelines 
for first-level facility health workers. Geneva, WHO, 2004 (WHO/CDS/IMAI/2004.4 Rev.1). 



226 



PS 18: Pain Management 



4. Use analgesics according to the recommendations below. 

5. In addition, you may use appropriate, non-medical treatment, as long as it is not 
harmful. Non-medical treatment should not replace medical management. 

6. Check frequently the patient's need for pain-relieving medication, especially if the 
pain becomes more severe. 

Teach the woman and her carers how to use pain-relieving medications. Check 
often to make sure that she is receiving the right doses of the right medicines at the 
scheduled times. 

Pain should be treated using the WHO ladder for cancer pain relief (see Figure 
PS 18.3), and the following principles: 

1 . Treatment should be provided by mouth or rectally. Injections should be avoided 
whenever possible. 

2. Medicines should be given at fixed time intervals (calculated by the clock, the 
radio or the sun). Each dose of medicine should be given before the previous dose 
wears off. Give the first dose when the patient wakes up, and the last dose just 
before she goes to sleep; do not wake a person who is sleeping comfortably to 
give medications. The bedtime dose can be doubled if needed. 

3. If pain returns before the next dose is due, immediately give a "rescue" dose (the 
same dosage as the regular dose). This is in addition to the next scheduled dose, 
not in place of it. 

4. The dose of pain medication should be calculated and adapted where necessary 
in order to control the pain while keeping the patient as alert as possible. 

5. Write out a detailed schedule for each drug, with words or in a drawing (Figure 
PS18.2). 

Figure PS18.2 Example of a drawing that can be used to show the schedule of drug 
intake 




morning noon afternoon night 

Source: Palliative care for women with cervical cancer: a field manual. PATH, EngenderHealth, 2003. 



PS 18: Pain Management 



227 



Keep in mind: There is no such thing as an established dose for all patients. Medical 
personnel and home-carers need to establish, with the patient, her need for 
medication, based on the amount of pain she has. The right dose is the dose that 
relieves pain; it will gradually need to be increased because patients become tolerant 
to the medicine's effects. 



PS18 






How to give medicines for pain 

1 . Start with a non-opioid, such as paracetamol, aspirin or ibuprofen. 

2. If the pain persists or increases, give an opioid for mild to moderate pain, e.g. 
codeine, with or without a non-opioid (paracetamol, aspirin or ibuprofen). When 
opioids are prescribed, you should systematically give a laxative to prevent 
constipation. Add an anti-emetic if necessary. 

3. If pain persists or increases, give morphine, with or without an additional non- 
opioid. 

Note: in most countries, opioids require medical prescription and supervision. 



(O 
CD 



Figure PS 18.3 WHO'S pain relief ladder 




Non-opioid 

(paracetamol or aspirin 
or ibuprofen) 



Opioid for mild 

to moderate pain 

(codeine) 



Non-opioid 
(paracetamol or aspirin 
or ibuprofen) 



Opioid for moderate 
to severe pain 
(oral morphine) 



Non-opioid 
(paracetamol or aspirin 
or ibuprofen) 



Source: Palliative care: symptom management and end-of -life care. Interim guidelines for first-level 
facility health workers. Geneva, WHO, 2004 (WHO/CDS/IMAI/2004.4 Rev.1). 



228 



PS 18: Pain Management 



In what dose and how often should medications for pain be given? 



Medication 


Starting dose 


Dose range 


Side-effects/ 
precautions 


NON-OPIOID FOR MILD PAIN 


Paracetamol 


2 tablets of 500 
mg, every 4-6 
hours 


1 tablet may 
suffice in very 
ill patients, or 
in combination 
with opioid. 
Maximum dose 
4000 mg daily 


Can cause liver toxicity 


Aspirin 


600 mg (2 tablets 
of 300 mg) every 
4 hours 




Avoid if patient has 
gastric problems or 
vaginal bleeding; stop 
if patient has stomach 
pain, indigestion, black 
stools, small bruises, 
bleeding 


Ibuprofen 


400 mg every 6 
hours 


Maximum dose 
3000 mg (7.5 
tablets of 400 
mg) daily 


Avoid if patient has 
gastric problems; give 
with food if possible 


OPIOID FOR MILD TO MODERATE PAIN 


Codeine 

(if not available, 
alternate aspirin and 
paracetamol) 


30 mg, every 
4 hours 


30-60 mg 
every 
4-8 hours 


Give laxatives from 
the beginning to avoid 
constipation 

Can be costly 


OPIOID FOR MODERATE TO SEVERE PAIN 


Morphine liquid, 5 
mg/ml or 50 mg/5 ml 
Drop into mouth from 
syringe; can be given 
rectally using syringe 
(no needle) 


2.5-5 mg every 
4 hours (if pain 
persists increase 
dose by 1 .5 or 
2 times after 24 
hours) 


According to 
patient need, 
and breathing 

There is no 
ceiling dose 


Give laxatives to avoid 
constipation 

Reduce dose if 
breathing problems 
occur 



PS 18: Pain Management 229 



NON-MEDICAL METHODS TO ASSIST IN PAIN CONTROL 

A number of methods, appropriate to local customs and culture, can be very PS 18 

important in helping the patient cope with pain. These methods may be used in 
addition to effective modern medicines, and should never take their place. 

Non-medical methods may include: 

emotional support: the care and support of family and friends are most important 
in relieving discomfort during severe illness; 

touch, such as stroking, massage, rocking and vibration; 

distractions, such as radio, music and helping the patient to imagine a calm scene 
or a happy event in her life; 

prayer and meditation, according to the patient's practice. 

B) 

Traditional practices, if not harmful, can be very beneficial. 

3 

The attitude of the health care provider is also important: 

Listen with empathy. 

Try to understand her reactions to her illness (the different stages of grief). 

Refer to a spiritual counsellor or pastoral caregiver, according to her religion and 
wishes. 

Avoid imposing your own views. 

Empower the family to continue to provide care. 



230 



PS18 



i 

8 
I 

00 



PS 18: Pain Management 



PS 19: Home-based Palliative Care 



231 



PRACTICE SHEET 19: HOME-BASED PALLIATIVE CARE 



22 



This Practice Sheet summarizes recommendations for supportive home-care for 
severely ill cervical cancer patients. 

You can adapt it to the role you play in palliative care for a patient. 

Your objective is not to cure the patient, but rather to make her life more 
comfortable by reducing the severity of symptoms and side-effects of the illness 
and the treatment. 

You can use these recommendations with people with any advanced or terminal 
illness. 

You need to be conscious of the important contribution to patient comfort provided 
by physical, emotional, spiritual and alternative measures, e.g. massage, stroking, 
distractions, such as music, prayer and meditation, and local traditional practices. 

The patient herself must decide if she or someone else will use the available 
alternatives to treat her problems. 

Particularly when medications are needed, the support of nurses and doctors is 
essential. 

Management of common symptoms of advanced disease 



Problem/ 
Symptoms 


Cause 


Prevention 


Clinical 
management 


Home-care 


Vaginal 


Tumour necrosis 


Difficult to 


Pack vagina 


Frequent sitting 


discharge, 
which may be 


Fistula 


prevent 


twice a day with 
cloths soaked in 


baths 


foul-smelling 
(see also 
Practice Sheet 
20) 


Bacterial 
overgrowth 


Palliative 
radiation or 
surgery of 
tumour 


vinegar, sodium 
bicarbonate 
(baking soda) or 
metronidazole. 


Clean, 
absorbent pads 
changed often 








Give antibiotics 


Douching 








and/or 










antifungals, if 










necessary 








2 Adapted from: Palliative care for women with cervical cancer: a field manual. PATH, 
EngenderHealth, 2003; and Palliative care: symptom management and end-of-life care. Interim 
guidelines for first-level facility health workers. Geneva, WHO, 2004. 



232 



PS 19: Home-based Palliative Care 











Problem/ 


Cause 


Prevention Clinical 


Home-care 


Symptoms 






management 














Vesicovaginal 


Tumour creates 


Difficult; a 


None 


As above 


or rectovaginal 


passage between 


common 






fistula 


bladder or rectum 


problem of 




Keep patient 


(symptoms: 


and vagina 


late invasive 




clean and 


leaking urine 




cancer 




comfortable 


or faeces 










from the 








Zinc ointment 


vagina; vulvar 








or petroleum 


irritation) (see 








jelly to protect 


also Practice 








anus and 


Sheet 20) 








vagina 










Plastic or 










newspaper 










under bedding 










for protection 


Vaginal 


Bleeding tumour 


Palliative 


Pack vagina if 


Rest; avoid 


bleeding (see 




radiotherapy 


needed 


strenuous 


also Practice 








activity 


Sheet 20) 








and sexual 










intercourse 


Nausea or 


Opioids 


Give anti- 


Metoclopramide 


Small, regular 


vomiting 


Gastrointestinal 


emetics 


or promethazine 


sips of 




infection 


when starting 


orally or rectally 


rehydration 




Severe pain 


opioids and 
as needed, 


(by injection 
only if absolutely 


drinks, ginger 
tea, ginger ale 




Fever 


to prevent 


necessary) 


or cola drinks, 




Radiation 


nausea 




as tolerated 




Chemotherapy 










Renal failure 









PS 19: Home-based Palliative Care 



233 



Problem/ 


Cause 


Prevention 


Clinical 


Home-care 


Symptoms 






management 


_______ 


Diarrhoea 


Gastrointestinal 


Good food 


Treat cause if 


Fluids, oral 




infection, 


hygiene, 


known 


rehydration 




parasites, 
radiotherapy 


handwashing; 
use clean 


Loperamide 


salts solution, 
food as 






or boiled 




desired; keep 






drinking- 




clean; prevent 






water 




skin problems 


Fever: body 


Bacterial 


Prevent 


Treat cause, using 


Remove 


temperature 


infection 


infections 


most appropriate 


blankets; 


>37C 


(lymphangitis, 


where 


antibiotics 


ventilate room; 




kidney, lung, etc.) 


possible 


Paracetamol 


sponge baths; 










paracetamol 


Constipation 


Opioids, poor 


Encourage 


Modify diet; give 


Modify diet; 




intake of fluids 


fluids, high- 


laxatives with 


give laxatives 




and solids, 


fibre diet, 


opioids 


with opioids 




immobility 


mobility, 










regular use 










of stool 










softeners and 










laxatives 






Loss of 


Illness, 


Small 


Can use 


Can use 


appetite, 


medications 


frequent 


corticosteroids 


corticosteroids 


wasting 




meals, 










desired food 










only, fresh 










foods 






Weakness, 


Illness, normal 


Good general 


Treat cause if 


Good general 


fatigue 


postoperative 


care 


possible 


care 




recovery, 










anaemia, wasting 










234 



PS 19: Home-based Palliative Care 



PS19 



Q> 

a 
8 



CD 

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CO 



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0) 

3 



Problem/ 


Cause 


Prevention 


Clinical 


Home-care 


Symptoms 






management 




Leg swelling 


Lymph blockage 




Antibiotics, 


Wrap leg 




from tumour, 




if infection is 


and elevate, 




lymphangitis, 




suspected 


massage 


- 


kidney failure 








Bedsores 


Constant 


Daily bathing, 


Wash sores with 


Daily bathing, 




pressure breaks 


turn patient 


antiseptic twice a 


frequent 




down skin 


every 2 hours, 


day, remove dead 


turning. Clean 






soft padding 


tissue, cover with 


sores gently 






underneath, 


clean bandage; if 


every day 






cushions, 


infected give oral 


with diluted 






massage 


antibiotics 


saltwater. Fill 










the bedsore 










area with pure 










honey and 










cover with 










a clean light 










dressing to 










encourage 










healing 


Cough, 


Pneumonia, 


If family 


Treat cause if 


Increase fluids, 


breathing 


bronchitis, viral 


member 


known 


home cough 


problems 


upper respiratory 


is sick, 




remedies, sit 




tract infection, 


ensure good 




patient upright, 




tuberculosis, 


ventilation in 




codeine 




heart failure 


home 






Depression, 


Illness, grief 


Family and 


Counselling or 


Continued 


anxiety 


reaction 


spiritual 


support around 


support, time 






support, pain 


cause, if any; 


spent with her 






control 


amitriptyline 


doing things 








for depression; 


she likes, 








diazepam for 


prayer 








anxiety 





PS 19: Home-based Palliative Care 235 

When to transfer a patient for care and emergency treatment of acute symptoms 

If the patient has any of the following, consider transferring her to hospital for PS 1 9 

emergency care: 

severe vaginal bleeding; 

signs of severe dehydration: 

- pulse > 100/minute, 

- fast breathing, 

- no urine for over 24 hours; 

CD 

severe diarrhoea for more than 48 hours; 

blood in stool; 

CD 

fever over 39 C for over 48 hours; 

convulsions; 

confusion; 

severe abdominal pain, gastrointestinal obstruction (swollen, very painful abdomen, 
no defecation for over 48 hours); 

CD 

severe pain, not controlled with opioids; 

multiple infected bedsores; 

acute respiratory distress; 

attempted suicide. 

The patient (if conscious) and her immediate family need to be involved in the decision 
to transfer her. If the woman is dying, she should not be transferred at the last 
minute. 




236 



PS19 



PS 19: Home-based Palliative Care 



PS 20: Managing Vaginal Discharge and Fistulae at Home 237 



PRACTICE SHEET 20: MANAGING VAGINAL DISCHARGE 
AND FISTULAE AT HOME 



This Practice Sheet explains how to provide care and comfort for women with vaginal 
problems, resulting from advanced invasive cervical cancer and complications of 
treatments. It includes management of vaginal discharge, fistulae and bleeding. 

In addition to the specific advice in this sheet, supportive, emotional and other non- 50 

medical measures can be very effective. 

i 

Managing vaginal discharge i 

Women with cervical cancer may have watery, bloody, foul-smelling vaginal 
discharge. This symptom is a result of bacterial growth in the unhealthy tissues of the 

lower genital tract. The bacteria produce gas. 

5T 
The bacteria cannot be permanently eliminated, but symptoms can be temporarily 

alleviated by doing one or more of the following. 

Absorb the discharge with clean cloths, cotton or menstrual pads, placed in the 
panties. 

Carry out periodic, careful vaginal douching (rinsing the vagina using a tube 
attached to a clean plastic bottle or syringe), using one of the following solutions: 

- one tablespoon of sodium bicarbonate (baking soda) in two cups of boiled 
warm water; or 

- one part vinegar in 4 parts water; or 

CD 

- 5-1 crushed tablets of metronidazole dissolved in 2 cups of boiled warm 
water. 

Gently pack the vagina twice a day with clean cloths soaked in one of the above 
solutions. Packs should not be left in place for more than a few hours. 23 

Broad-spectrum antibiotics may be prescribed by a physician, but they should be 
used with caution because they are, at best, only temporarily effective. In addition, 
they can cause a yeast infection in the vagina, which can make symptoms worse. 
The patient and family must be made aware of the importance of completing any 
prescribed antibiotic regimen; not completing it may worsen the problem. The 
following antibiotics can be given during a minimum of 5 days: doxycycline, 100 
mg by mouth, twice a day; or amoxicillin, 250 mg by mouth, 3 times a day; or 
metronidazole, 400 mg by mouth, twice a day. 



23 To avoid making the problem worse, whenever something is inserted into the vagina (douche 
tube, packing), the utmost gentleness must be used. 



238 PS 20: Managing Vaginal Discharge and Fistulae at Home 

Managing fistulae 

ro L\J A fistula is an abnormal passage between the vagina and urinary bladder or rectum, 

caused either by extension of the cancer into these organs or as a complication of 
-o radiotherapy. It is a psychologically and physically debilitating condition, because 

urine or faeces may pass directly to the vagina, causing a foul-smelling and irritating 
discharge. 

I 

The fistula itself cannot be repaired, but the patient can be made more comfortable 
and clean: 

She can sit in warm water to gently clean herself. 

Soft clean cloths can be placed in her panties to absorb the discharge. 

09 

Cover the bed with a plastic sheet or newspapers, which can be changed and 
cleaned frequently. 

Protect the skin around the vagina and anus by drying the areas after bathing and 
covering them with zinc oxide cream or petroleum jelly. These measures can be 
used in a preventive way, without waiting for irritation to occur. 

Ventilate the room or burn incense or herbs, if this is acceptable. 

CD 

Managing vaginal bleeding 

ex 

31 Vaginal bleeding can be alarming and is not uncommon in women with advanced 

cervical cancer. It can be triggered by sexual intercourse or strenuous activity, or it 
may occur spontaneously for no obvious reason. 

If bleeding is slight, recommend bed rest and cleanliness until it stops. 

If bleeding is moderate, it often subsides with simple bed rest. If needed, the 
vagina can be packed with a clean moistened cloth for a few hours. 

If bleeding is severe, transfer the patient to a hospital or health centre for a 
possible blood transfusion. 

Supplies for home-based management of vaginal problems 

The following supplies are needed: 

a constant supply of clean, boiled water; 

soap for washing hands and clothes; 

clean towels; 

latex gloves, if possible (need not be sterile); 

plastic sheeting or newspapers; 



PS 20: Managing Vaginal Discharge and Fistulae at Home 239 



bags for disposal of contaminated materials; 

chlorinated water (one cup of bleach to 6 cups of water) for soaking gloves, wiping PS 20 
down furniture and plastic sheeting, etc.; 

a basin for sitting baths; ^ 

a plastic bottle and tube for douching; 

plenty of clean cloths, or cotton or menstrual pads (if possible). These should be 
boiled if they are going to be used to pack the vagina; 

sodium bicarbonate (baking soda); 

vinegar; 

zinc oxide cream or petroleum jelly; 

antibiotics and other medicines prescribed by the physician (metronidazole, 

doxycycline, amoxicillin). 

S 

COUNSELLING TIPS 

Visit the patient as often as possible. 

e/ 

Always listen to the patient's and the family's complaints, and try to relieve 
symptoms. 

Maintain communication with providers in the health centre or hospital and seek 
their advice for specific problems. 

Provide comfort and security by explaining the reasons for the symptoms and 
reassuring the family that you will do all you can to keep the patient comfortable. 

Instruct the patient and family in symptom management. 

Assist them in obtaining needed supplies. 

Most importantly, try to avoid burn-out for yourself by avoiding overwork, 1 
maintaining close relationships, and seeking the support of those close to you 

(without breaching patient confidentiality). 



240 PS 20: Managing Vaginal Discharge and Fistulae at Home 



PS 20 



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Annex 1 : Universal precautions for infection prevention 241 



ANNEX 1: UNIVERSAL PRECAUTIONS FOR INFECTION 
PREVENTION 24 

Universal precautions are simple measures that help prevent the spread of infection. All 
health care providers must use universal precautions to protect patients, themselves 
and other health care workers from the spread of infectious diseases. 

The current epidemic spread of bloodborne viruses, including hepatitis B, C and D, and 
HIV, underscores the importance of paying scrupulous attention to preventing infection 
in clinical practice. Many transmissible infections are asymptomatic, and it is not always 
possible to know who is infected. Therefore, precautions against spreading infection 
should be used with all patients, whether they appear sick or well, and whether their 
HIV or other infection status is known or not. 

Quality control and supervision are essential to ensure that infections 

are prevented. A pelvic infection after a clinical procedure is an indicator 

of poor infection-prevention measures. 



Infection prevention: universal precautions 

Wear latex gloves whenever: 

you handle items or body surfaces that might be contaminated; 

you perform clinical examinations or procedures (cryotherapy, biopsy, endocervical 
curettage and LEEP), or give injections; 

you clean the area where the patient has been; 

you handle used instruments. 

Remember: 

If gloves get damaged, remove them, wash your hands thoroughly, and then put on 
new gloves. 

Gloves are not a substitute for handwashing. 

Wash your hands with soap and water for at least 30 seconds: 

before and after contact with each client or patient; 

if you touch blood or body fluids; 

immediately after you take off latex gloves. 



94. 

Adapted from: Universal precautions against infectious diseases. University of Michigan 
Health System (www.med.umich.edu/1libr/wha/wha_unipre_crs.htm); and Burns AAetal., 
Where women have no doctor. Berkeley, CA, Hesperian Foundation, 1997. 



242 Annex 1 : Universal precautions for infection prevention 



Handle contaminated disposable items and clinic surfaces as follows: 

Discard disposable items that are soiled with blood or body fluids in a tightly sealed 
^ plastic bag. 

> Disposable needles need special handling; use your health facility's protocols. 

| Wash linen and reusable cloth items. Use detergent, dry them in the sun, and iron 

them if possible. 

Clean and disinfect surfaces such as examination tables and floors. 

1 Process reusable instruments and gloves after each use, as follows: 

. All instruments that have been in contact with the vagina or cervix (e.g. specula, 

| biopsy forceps, gloves, etc.) should be decontaminated, cleaned, and sterilized or 

cf high-level disinfected. 

=* Cryoprobes should be decontaminated, cleaned, and high-level disinfected. 



The examination or procedure table must be decontaminated after each patient. 

1 Other instruments (e.g. colposcope, cryogun, torch lights) must be decontaminated 

at least once a day, and more often if visibly soiled. 

^: 


Processing instruments 25 

There are three basic steps for processing instruments used in clinical and surgical 
procedures, before they can be reused: (1) decontamination, (2) cleaning, and (3) 
sterilization or high-level disinfection (HLD). 

Decontamination 

Decontamination is the process by which used instruments and gloves are made safe 
for handling; this step inactivates hepatitis B and HIV. To decontaminate instruments 
and gloves immediately after use, immerse them in a large plastic bucket containing 
0.5% chlorine solution for 10 minutes (not longer, as the instruments may become 
corroded); remove and rinse with clean water. The chlorine solution can be prepared by 
diluting 1 part household bleach in 9 parts clean water. It must be prepared fresh daily 
and discarded as soon as it appears dirty. For surfaces in the clinic, 60-90% ethanol or 
isopropanol can be used as an alternative to chlorine solution. 

Cleaning 

Soon after decontamination, instruments should be cleaned by a person wearing 
heavy gloves and glasses or goggles. Use a brush to scrub instruments with water and 
detergent, and rinse thoroughly with boiled water. Special attention must be given to 
instruments with teeth, joints and screws. 



25 Adapted from: Sellers JW, Sankaranarayanan R, Colposcopy and treatment of cervical 
intraepithelial neoplasia: a beginners' manual. Lyon, lARCPress, 2003. 



Annex 1 : Universal precautions for infection prevention 243 



Sterilization 

Sterilization destroys all microorganisms and must be used for all instruments that 

come into contact with sterile parts of the body, e.g. that penetrate the skin or enter the ^p 

womb. 

Sterilization can be achieved by one of the following: | 

Expose instruments to superheated steam in an autoclave: 20 minutes for ^ 
unwrapped instruments and 30 minutes for wrapped instruments. Autoclaving is the |- 
preferred method of sterilization. 

Soak instruments in either 2-4% glutaral for 8 to1 hours, or 8% formaldehyde for " 
24 hours. Then rinse thoroughly with sterile water. 

! 

High-level disinfection 

HLD destroys all organisms except bacterial spores, and is used when sterilization lr 

equipment is not available or the instrument is too delicate to be sterilized. One of the 
following processes can be used for HLD: 

Boil instruments for at least 20 minutes in plain tapwater, which is changed at least 

daily. Make sure that instruments are fully covered by the water, and start timing o 

after the water with the instruments is fully boiling. Do not add anything to the pot 
once you have started to time. 

Soak instruments in 0.1 % chlorine or 2% glutaral solution for 20 minutes, or 6% 
hydrogen peroxide for 30 minutes. Rinse thoroughly in boiled water, air-dry and store 
in a sterile cloth. These chemicals may be corrosive and can reduce the useful life of 
instruments that are repeatedly disinfected with them. 

Supplies and equipment 

The following supplies and equipment are needed for infection prevention (depending 
on the processing methods used): 

clean and boiled water; 

detergent; 

household bleach or commercial chlorine powder; 

one or more sterilizing chemicals (2-4% glutaral, 8% formaldehyde); 

one or more HLD chemicals (0.1 % chlorine, 2% glutaral, 6% hydrogen peroxide); 

60-90% ethanol or isopropanol; 

sterile cloths; 

plastic bucket; 
(continued next page) 



244 Annex 1 : Universal precautions for infection prevention 



scrubbing brush; 

large jars for storage of solutions; 

heavy gloves for cleaning; 

sterile or high-level disinfected gloves and long-handled forceps for handling 
processed instruments; 

autoclave or vessels for boiling and soaking instruments; 

closet with tight closure to prevent entrance of dust, for storage of processed 
instruments and supplies. 



Annex 2: The 2001 Bethesda system 245 



ANNEX 2: THE 2001 BETHESDA SYSTEM 2t 

SPECIMEN ADEQUACY 

Satisfactory for evaluation (note presence or absence of endocervical transformation > 
zone component). | 

Unsatisfactory for evaluation (specify reason). ro 

Specimen rejected/not processed (specify reason). g" 

Specimen processed and examined, but unsatisfactory for evaluation of epithelial g 
abnormality because of. . . .(specify reason). ^ 

GENERAL CATEGORIZATION (OPTIONAL) 

Negative for intraepithelial lesion or malignancy. 

Epithelial cell abnormality. 

Other. 

INTERPRETATION AND RESULT 

Negative for intraepithelial lesion or malignancy 

Organisms: 

Trichomonas vaginalis; 

fungal organisms morphologically consistent with Candida species; 

shift in flora suggestive of bacterial vaginosis; 

bacteria morphologically consistent with Actinomyces species; 

cellular changes consistent with herpes simplex virus. 

Other non-neoplastic findings (optional to report, list not comprehensive): 

reactive cellular changes associated with inflammation (includes typical repair); 

radiation; 

intrauterine contraceptive device; 

glandular cells status post-hysterectomy; 

atrophy. 



oc 

This categorization can be used for reporting results of Pap smears. 



246 Annex 2:The 2001 Bethesda system 

Epithelial cell abnormalities 
Squamous cells 

Atypical squamous cell (ASC): 

- of undetermined significance (ASC-US); 

Z3 

- cannot exclude high-grade lesion (ASC-H). 
|H Low-grade squamous intraepithelial lesion (LSIL). 

> High-grade squamous intraepithelial lesion (HSIL). 

o 

S Squamous cell carcinoma. 



I" Glandular cells 

^ Atypical glandular cells (AGC) (specify endocervical, endometrial, or not specified). 

Atypical glandular cells, favour neoplastic (specify endocervical or not specified). 

Endocervical adenocarcinoma in situ (AIS). 

Adenocarcinoma. 

Other (list not comprehensive) 

Endometrial cells in women 40 years of age or over. 



Annex 3: How is a test's performance measured? 



247 



ANNEX 3: HOW IS A TEST'S PERFORMANCE MEASURED? 

A test's performance is measured in terms of its reliability and accuracy in predicting 
disease. The ability to predict disease depends on two key characteristics: sensitivity ** 
and specificity. 

Reliability is the degree to which repeated measurements yield the same result, and 
can be reproduced in other settings. 

Sensitivity refers to the ability of the test to correctly identify individuals with the 
condition, in this case precancer or cancer. The higher the sensitivity, the fewer 
women with precancer or cancer will be wrongly identified as normal (false 
negative). 

Specificity refers to the ability of the test to correctly identify individuals without 
precancer or cancer. The higher the specificity, the fewer women with a normal 
cervix will be wrongly identified as having precancer or cancer (false positive). 



8 

CO 



s 

I 



An ideal screening test would have both high sensitivity and high specificity. Such a test 
does not currently exist for cervical precancer and cancer. The danger of low sensitivity 
is that some women with disease will be missed; the danger of low specificity is that 
some women without disease may be unnecessarily referred for further diagnosis or 
treatment. 

Women might also want to know the likelihood of really having the disease when they 
have a positive screening test. This is the positive predictive value (PPM) of the test. The 
negative predictive value (NPV) is the chance of not having the disease when the test is 
negative. Unlike sensitivity and specificity, which are in general intrinsic features of the 
test, the PPV and NPV depend on the prevalence of disease in the population. 



Calculation of specificity, sensitivity, PPV and NPV 





True disease state 2 8 




Result of screening test 


Positive 


Negative 




Positive 


a 


b 


a+b 


Negative 


c 


d 


c+d 




a+c 


b+d 


a+b+c+d 



Sensitivity = a/a+c; specificity = d/b+d; PPV = a/a+b; NPV = d/c+d. 



- 7 In this guide, the reported sensitivity and specificity of screening tests for cervical precancer and 
cancer are calculated using a histological result of CIN2 or higher as the threshold (see Chapter 2). 
28 The "gold standard" for true disease state in the diagnosis of cervical precancer is the histological 
result of the biopsy. 



248 



Annex 4: Flowcharts for follow-up and management of patients according to screen results 249 



ANNEX 4: FLOWCHARTS FOR FOLLOW-UP AND MANAGEMENT 
OF PATIENTS ACCORDING TO SCREEN RESULTS 

4a. STANDARD APPROACH 



Negative 



Negative 



Rescreen every 

3 years (or as per 

national policy) 



Screening test 



Positive* 



Suspicious for cancer 



Diagnosis with colposcopy and biopsy 



Precancer 



Treat for precancer 
(see Annex 5) 



Cancer 



Treat for cancer 
(see Annex 6) 



ci 

& 



Follow-up (see Annexes 5 and 6) 



* When the Pap smear reports ASC-US or LSIL, only persistent lesions (reported on two Pap 
smears within 6 months to 1 year) should be investigated further. 



250 Annex 4: Flowcharts for follow-up and management of patients according to screen results 



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Annex 4: Flowcharts for follow-up and management of patients according to screen results 251 



4b. THE "SCREEN-AND-TREAT" APPROACH, BASED ON VISUAL INSPECTION 
WITH ACETIC ACID AS SCREENING TEST 



VIA test 



Negative 



Positive 



Suspicious for 
cancer 



Suitable for 
cryotherapy 



Not suitable for 
cryotherapy* 



Treat with cryotherapy 



Refer for colposcopy and biopsy 



I I I 

precancer cancer normal 

i i 



Treat with LEEP or 
cold knife conization 



Treat for 

invasive cancer 

(Annex 6) 



Rescreen in 3 years (or 
as per national policy) 



Post-treatment follow-up 
(Annexes 5 and 6) 



*Not suitable for cryotherapy: lesion >75% of cervical surface, extends onto vaginal wall or 
more than 2 mm beyond cryoprobe, or into the cervical canal beyond the probe tip. Pregnant 
women should also be referred. 



252 



Annex 5: Standard management of cervical precancer 



253 



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254 












Annex 6: Cervical cancer treatment by stage 



255 



ANNEX 6: CERVICAL CANCER TREATMENT BY STAGE 

6a. TREATMENT OF MICROINVASIVE CARCINOMA: STAGE IA1 AND IA2 



Cancer suspected 
No gross lesion 




Stage IA1 and 
margins clear 

I 



Stage IA2 and Stage IA1 or IA2 and margins involved 
margins clear with cancer or CIN 3 



Fertility 
desired 



Fertility not 
desired 



Fertility 
desired 



I 


q 




servation 


Ra 
plu 






Simple hysterectomy 



Fertility not 
desired 



Radical trachelectomy 

plus pelvic lymph node 

dissection 



Repeat cone biopsy 

or 

Modified radical 

hysterectomy plus pelvic 

lymph node dissection 



Modified radical hysterectomy 
plus pelvic lymph node dissection 



256 



Annex 6: Cervical cancer treatment by stage 



nex 6: Cervical canc 



& 

CO 
CD 



6b. TREATMENT OF EARLY INVASIVE CANCER: STAGE IB1 
AND IIA < 4 CM 

When the tumour is more extensive but predominantly situated in the cervix, possibly 
with some vaginal involvement, surgical removal is preferred, except in the unfit patient. 



Stages IB1 and IIA < 4 cm 



Medically fit 



Radical hysterectomy, pelvic lymphadenectomy 



Negative nodes 



Positive nodes and/or 
positive margins 



Pelvic teletherapy 

brachytherapy 

chemotherapy (cisplatin, 30-40 mg/m 2 
per week) 



Medically unfit 



Treat with radiotherapy 

option as for early bulky 

disease 



Annex 6: Cervical cancer treatment by stage 



257 



6c. TREATMENT OF BULKY DISEASE: STAGE IB2-IIIB 

Treatment of early bulky disease: Stage IB2 and HA > 4cm 



Stages IB2 and 
IIA>4cm 



According to skills and resources 
I 



I 



Pelvic teletherapy plus brachytherapy 
chemotherapy 



Radical hysterectomy 

plus 
pelvic lymphadenectomy 



May be required: 

Adjuvant pelvic EBRT for positive margins, positive nodes, deep penetration 
(outer 1/3 of myometrium) 

Radiation for positive para-aortic lymph nodes 



EBRT: external beam radiotherapy 



Treatment of extensive disease: Stages IIB-IIIB 

These patients are managed by radical (curative intent) radiotherapy, comprising 

teletherapy and brachytherapy. The role of chemotherapy has not yet been proven in 

developing country settings. 



Stages IIB-IIIB 



Pelvic teletherapy plus brachytherapy 
chemotherapy 



258 



Annex 6: Cervical cancer treatment by stage 



6d. TREATMENT OF STAGE IV 
Treatment of Stage IVA 

The radiotherapy to be administered depends on the condition of the patient 



X 

O) 

8 



Pelvic teletherapy and /or brachytherapy 



Treatment of Stage IVB and recurrent disease 

Stage IVB (5% of cases) indicates the presence of distant haematogenous metastases and is 
incurable by any currently known means. 



Stage IVB or recurrent disease 



Pelvic metastasis or 
recurrence 



Extrapelvic metastasis 



I 

No prior radiotherapy 



Prior radiotherapy 




Options: 

palliative radiotherapy 

resection of isolated 
metastases 

palliative care 



Tumour in central 
pelvis 



Tumour in pelvic 
sidewall 



Options: 

pelvic exenteration* 

radical hysterectomy if<2 cm 

palliative care 



* Pelvic exenteration is infrequently used as it has major sequelae of urinary and colonic diversion, both 
of which are difficult to care for in developing countries, and are unacceptable to many patients when it 
is not possible to offer a cure. 



Annex 6: Cervical cancer treatment by stage 



259 



6e. CERVICAL CANCER MANAGEMENT DURING PREGNANCY 



Gestational 


Stages IA1 & 


Stages IB & IIA 


Stages IIB, III 


age 


IA2 




- -._ 


< 12 weeks 


Immediate 


Either: 


Pelvic radiotherapy with 




hysterectomy 


Radical hysterectomy 


spontaneous abortion 




as in non- 


with fetus in situ 


or 




pregnant 


or 


evacuation of fetus, followed 




woman 


Pelvic radiotherapy 


by brachytherapy 






at 20Gy (2 weeks), 








with spontaneous 








abortion 








or 








evacuation of 








fetus, followed by 








brachytherapy 




12-24 weeks 


Immediate 


Either: 


Pelvic radiotherapy with 




hysterectomy 
as in non- 


Radical hysterectomy 
with fetus in situ 


hysterotomy at 2 weeks, 
followed by brachytherapy 




pregnant 


or 






woman 










Pelvic radiotherapy 








with hysterotomy at 








2 weeks, followed by 








brachytherapy 





pp 

8 



continued next page 



260 



Annex 6: Cervical cancer treatment by stage 



I 

q> 

8 

I 


I 



3 

CD 






Gestational 


Stages IA1 & 


Stages IB & HA 


Stages IIB, III 


age 


IA2 






24-32 weeks 


Delay 


Delay management 


Delay management until 32 




management 


until 32 weeks; then 


weeks; then amniocentesis 




until 32 weeks; 


amniocentesis and 


and steroids for lung maturity; 




at 32 weeks: 


steroids for lung 


then as >32 weeks 




amniocentesis 


maturity; then as 






and steroids for 


>32 weeks 




** 


lung maturity 








if needed; then 








as >32 weeks 






>32 weeks 


Classical 


Classical caesarean 


Classical caesarean section 




caesarean 
section plus 


section plus radical 
hysterectomy, 


Pelvic teletherapy plus 
brachytherapy after involution 




hysterectomy 


or 


of uterus 






pelvic teletherapy 








plus brachytherapy 








after involution of 








uterus 








Annex 7: Sample documents 261 



ANNEX 7: SAMPLE DOCUMENTS 29 

7a. SAMPLE LETTER TO PATIENT WITH AN ABNORMAL PAP SMEAR WHO DID 
NOT RETURN FOR RESULTS AT EXPECTED TIME 



Date 



Dear (patient name), 



We are writing to remind you to come in to [health centre/hospital! to 

discuss the results of the screening Pap test you had on [date of Pap smear]. 

We were hoping you would come in last week but since you have not returned, we send you this 
reminder. 



Your Pap test showed some abnormal changes in your cervix (entrance of the womb) 

requiring another visit on your part for [further diagnosis/treatment]. (If Pap 

abnormality is not invasive cancer, you may add: The changes are not indicative of cancer 
but, if left untreated, they may develop into cancer in the future.) 

We request that you come as soon as possible in the next two weeks so that we can give you all 
the information, answer any questions and plan further consultations with you. 

If you have any questions, please contact us at 

Yours sincerely, 

[provider] 



Adapted from: CHIP. Implementing cervical screening in South Africa. Volume I: A guide for 
programme managers. Cervical Health Implementation Project, South Africa. University of Cape 
Town, University of the Witwatersrand, Engenderhealth, 2004. 



262 



Annex 7: Sample documents 



7b. SAMPLE CARD THAT CAN BE USED AS PART OF A SYSTEM TO TRACK 
CLIENTS WHO NEED A REPEAT PAP SMEAR 



Cervical screening 
Tracking card: patient recall for Pap 



Name: 



Date of birth: 



Patient number: 

Home address: 

Work address: 

Telephone number: 

Date Pap smear done: 

Pap smear result: 

Date when client was asked to return: 

NOTES: 



Follow-up: 

Date of repeat Pap smear: 
Action taken if she did not return: Note sent (date) 

Other action: . 
NOTES: 



Annex 7: Sample documents 



263 



7c. SAMPLE CARD THAT CAN BE USED AS PART OF A SYSTEM TO TRACK 
PATIENTS REFERRED FOR COLPOSCOPY 



Cervical screening 
Tracking card: patient referral 



Name: 



Patient number: 

Home address: 
Work address: 
Telephone number: 
Date Pap smear done: 
Pap smear result: 
Appointment for referral at _ 
Date of referral appointment 



Date of birth: 



(name of referral site) 



Tracking record: 

Date patient informed of referral appointment: 
Outcome of referral: 



SP 



264 



Annex 7: Sample documents 



7d. SAMPLE LETTER INFORMING REFERRING CLINIC OF THE OUTCOME 
OF A PATIENT'S COLPOSCOPY 



To: 



Name of patient:. 



[name of referring clinic] 



Patient number: 



From: 



[name of colposcopy clinic] 



Patient was seen in our facility on: 



[date] 



[date] 



Colposcopy and biopsy were performed on: 



Final histological diagnosis: 



Management provided: 



Recommended follow-up: 



Thank you for your referral. Please contact us should you need further 
information. 



Yours sincerely, 



Name: 



Signature: 



Date: 



Annex 8: Treatment of cervical infections and PID 



265 



ANNEX 8: TREATMENT OF CERVICAL INFECTIONS AND 
PELVIC INFLAMMATORY DISEASE (PID) 30 

8a. TREATMENT OF CERVICAL INFECTIONS 



Therapy for uncomplicated gonorrhoea PLUS therapy for chlamydia 


Coverage 


First choice 

Choose one from each 
box below (= 2 drugs) 


Effective substitutes 


If woman is pregnant, 
breastfeeding or under 
16 years old 

Choose one from each 
box below (= 2 drugs) 


Gonorrhoea 


cefixime 400 mg 

orally as a single 
dose, or 
ceftriaxone 1 25 mg 
by intramuscular 
injection 


ciprofloxacin a>b 

500 mg orally as 
a single dose, or 
spectinomycin 2 g by 
intramuscular injection 


cefixime 400 mg orally 
as a single dose, or 
ceftriaxone 1 25 mg by 

intramuscular injection 


Chlamydia 


azithromycin 1 g 

orally as a single 
dose, or 
doxycycline a 100mg 

orally twice a day for 
7 days 


ofloxacin a - b>c 300 mg 
orally twice a day for 
7 days, or 
tetracycline 3 500 mg 
orally 4 times a day for 
7 days, or 
erythromycin 500 mg 
orally 4 times a day for 
7 days 


erythromycin d 500 mg 

orally 4 times a day for 
7 days, or 
azithromycin 1 g orally 
as a single dose, or 
amoxycillin 500 mg 
orally 3 times a day for 
7 days 



X 

00 



CO 
3 
O. 



a. Doxycycline, tetracycline, ciprofloxacin, norfloxacin and ofloxacin should be avoided in pregnancy and 
when breastfeeding. 

b. The use of quinolones should take into consideration the patterns of Neisseria gonorrhoeas 

resistance, such as in the WHO South-East Asia and Western Pacific Regions. 

c. Ofloxacin, when used as indicated for chlamydial infection, also provides coverage for gonorrhoea. 

d. Erythromycin estolate is contraindicated in pregnancy because of drug-related hepatotoxicity; only 
erythromycin base or erythromycin ethylsuccinate should be used. 



In case of a cervical infection, the woman and her partner should be treated and 
counselled on condom use. 



30 From: Sexually transmitted and other reproductive tract infections. A guide for essential 
practice. Geneva, WHO, 2005. 



266 



Annex 8: Treatment of cervical infections and PID 



8b. OUTPATIENT TREATMENT FOR PID 



P? 



Single-dose therapy for gonorrhoea PLUS multidose therapy for chlamydia PLUS 
multi-dose therapy for anaerobic infections. 


Coverage 


Choose one from each box (= 3 drugs) 


Gonorrhoea 


ceftriaxone 250 mg by intramuscular injection, or 
cefixime 400 mg orally as a single dose, or 
ciprofloxacin 3 500 mg orally as a single dose, or 
spectinomycin 2 g by intramuscular injection 


Chlamydia 


doxycycline b 100 mg orally twice a day for 14 days, or 
tetracycline b 500 mg orally 4 times a day for 14 days 


Anaerobes 


metronidazole b 400-500 mg orally twice a day for 14 days 



a. The use of quinolones should take into consideration the patterns of Neisseria gonorrhoeae 

resistance, such as in the WHO South-East Asia and Western Pacific Regions. 

b. These drugs are contraindicated for pregnant or breastfeeding women. PID is uncommon in 

pregnancy. 

c. Patients taking metronidazole should be cautioned to avoid alcohol. Metronidazole should also be 

avoided during the first trimester of pregnancy. 

In case of a PID, the partner should be treated for gonorrhoea and chlamydia, and the 
couple should receive counselling on condom use. 

Note: Hospitalization of patients with acute pelvic inflammatory disease should be 
seriously considered when: 

a surgical emergency, such as appendicitis or ectopic pregnancy, cannot be 
excluded; 

a pelvic abcess is suspected; 

severe illness precludes management on an outpatient basis; 

the patient is pregnant; 

the patient is an adolescent; 

the patient is unable to follow or tolerate an outpatient regimen; 

the patient has failed to respond to outpatient therapy. 



Annex 9: How to make Monsel's paste 



267 



ANNEX 9: HOW TO MAKE MONSEL'S PASTE 

What is Monsel's paste? 

Monsel's paste is a thick, sticky, quickly acting compound that is used to cover bleeding 
areas on the cervix to stem the bleeding. It can be useful after cryotherapy, punch 
biopsy and LEER As it is a caustic product that can damage tissues if left too long, no 
vaginal packing should be used after application. 



Ingredients 


Quantity 


1 . Ferric sulfate base 


15g 


2. Ferrous sulfate powder 


a few grains 


3. Sterile water for mixing 


10ml 


4. Glycerol starch (see 
preparation on next page) 


12g 



Preparation Take care, as the reaction is exothermic (emits heat). 

1 . Add a few grains of ferrous sulfate powder to 1 ml of sterile water in a glass 
beaker. Shake. 

2. Dissolve the ferric sulfate base in the solution by stirring with a glass stick. 
The solution should become crystal clear. 

3. Weigh the glycerol starch (see preparation instructions below) in a glass mortar. 
Mix well. 

4. Slowly add the ferric sulfate solution to the glycerol starch, constantly mixing to get 
a homogeneous mixture. 

5. Place in a 25-ml brown glass bottle. 

Note: Most clinics prefer to leave the stopper of the bottle loose, to allow the mixture 
to evaporate until it has a sticky paste-like consistency and looks like mustard. This 
may take 2-3 weeks, depending on the environment. The top of the bottle can then be 
secured for storage. If necessary, sterile water can be added to the paste to thin it. 



Label: Monsel's paste 

Store in a cool place 
For external use only 
Use by: [day/month/year] (one year from date of preparation) 



268 



Annex 9: How to make Monsel's paste 



Preparation of glycerol starch 



Ingredients 


Quantity 


1. Starch 


30 g 


2. Sterile water for mixing 


30ml 


3. Glycerine 


390 g 



Preparation 

1 . In a china crucible, dissolve the starch in the sterile water. 

2. Add the glycerine. Shake well. 

3. Heat the crucible and its contents over a Bunsen burner. Mix constantly with a 
spatula until the mass takes on a thick, swelling consistency. 

Note: Do not overheat, otherwise the mixture will turn yellow. 



Label: Glycerol starch 

Store in a cool place 
For external use only 
Use by: [day/month/year] (one year from date of preparation) 



Glossary 269 



GLOSSARY 

Note: the definitions given in this glossary refer to the way words are used in this guide. 
Dictionary definitions may be more general and broader. 

acetowhite: area on cervical epithelium that turns white when acetic acid is applied 

adenocarcinoma: cancer with gland-like characteristics; for example, cancer arising 
from the columnar epithelium of the cervical canal 

adnexae: tissues and organs lateral to the uterus; include fallopian tubes, ovaries and 
ligaments 

atypical cells: cells seen on a Pap smear that suggest an abnormality but are not 
conclusive 

basement membrane: a thin layer of tissue that lies under the epithelium 

carcinoma in situ (CIS): preinvasive stage of cancer involving the entire thickness of 
the covering layer, or epithelium, of an organ (e.g. cervix) but not penetrating the 
basement membrane 

cervical intraepithelial neoplasia (GIN): a precancerous condition involving the 
covering layer (epithelium) of the cervix. It can be diagnosed using a microscope. 
The condition is graded as CIN 1 , 2 or 3, according to the thickness of the abnormal 
epithelium (1/3, 2/3 or the entire thickness) 

cofactor: a factor that contributes to or magnifies the effect of an agent that causes a 
change; usually not active on its own 

colostomy: surgical construction of an artificial excretory opening from the colon 

condyloma: a wart-like structure caused by low-risk HPV types; also seen in chronic 
syphilis 

cost-effective: describes an activity or procedure that produces an adequate beneficial 
effect on a disease or condition in relation to its cost (in money, equipment, or time) 

coverage: the proportion of all targeted persons who attend a given service in a 
specified time 

cure rate: the percentage of a group of persons with a disease or condition who are 
cured by a specific treatment 

cytology: the study of the structure of cells under the microscope. Abnormal findings 
are usually confirmed by biopsy 



270 Glossary 



cytopathologist/cytotechnician/cytologist: persons trained in the microscopic 
examination of smears for the presence or absence of abnormal cells 

effectiveness: how well a treatment works to reduce a harmful condition in a target 
population 

efficacy: the power of a given treatment to produce a desired effect 

efficiency: the effects or results achieved in relation to the effort expended, in terms of 
money, resources and time 

epithelium (plural: epithelia): a covering or lining, comprising one or more layers of 
cells; usually protective of the organ it covers 

fistula: an abnormal passage between one hollow organ and another. With cervical 
cancer, fistulae may form between the vagina and the rectum, either as a result of 
extension of the cancer or as a late complication of radiation therapy 

fulgurate: to use heat or electric current to destroy tissue. Fulguration is used in LEEP 
to control bleeding 

fungating: describes an irregular, outward, tumour growth pattern 

gold standard: a test considered to have the highest sensitivity and specificity; used as 
a measure to compare all other similar tests 

high-grade lesion: a term used in the Bethesda classification to denote cervical 
abnormalities that have a high likelihood of progressing to cancer if not treated. 
Includes CIN2 and CIN3 

high-risk HPV types: types of the human papillomavirus known to cause cervical 
cancer 

histopathology: microscopic study of thin slices of stained tissue to determine the 
presence or absence of disease 

hysterotomy: a surgical procedure to make an opening in the uterus 

immunosuppression: reduced capacity of the body to resist attack by germs and other 
foreign substances, as seen in HIV-infected people 

incidence rate: the number of new cases of a disease in a defined population in 
a specified time, e.g. if there are 500 new cervical cancer cases every year in a 
country with 5 million women, the crude (non-age-standardized) cervical cancer 
incidence rate is 100 per million per year, or 10 per 100 000 per year 

koilocytosis: a condition of certain cells characterized by the presence of vacuoles 
around the cell nucleus 



Glossary 271 

laparotomy: a surgical incision in the abdomen 

menarche: the age at which a young woman has her first menstruation 

metaplasia: a transformation of tissue from one type to another, e.g. from squamousta 
columnar epithelium 

metastasis (plural: metastases): the appearance of a tumour, very similar to the 
original or parent tumour, in a distant organ 

microinvasive cervical cancer: cancer strictly confined to the cervix, not more than 5 
mm deep and 7 mm wide; it can only be diagnosed by microscopy 

morbidity rate: the proportion of a population who suffer from a particular disease in a 
specified time, often expressed as number of cases per 100 000 population per year 

mortality rate: the proportion of a population who die from a particular disease in a 
specified time, often expressed as number of deaths per 100 000 population per 
year 

negative predictive value (of a test): the likelihood of not having the disease when the 
test is negative 

neoplasia: process of new growth or tumour formation, sometimes malignant 

opioid: a type of drug used to relieve strong pain, e.g. morphine 

pathology: the study of disease and its effect on body tissue 

peritoneum: a continuous thin sheet of tissue covering the abdominal walls and organs 

persistent: describes lesions or diseases that do not disappear over a certain time 

pilot study: a demonstration project in a limited population; it usually aims to provide 
information on performance but not necessarily on outcome (which needs to be 
tested in a large population) 

positive predictive value (of a test): the likelihood of having a disease when a test is 
positive 

preclinical stage: the early stage of an illness, when symptoms or signs have not yet 
appeared 

prevalence rate: the proportion of persons in a defined population with a condition or 
disease at a specific point in time 

primary prevention: actions to avoid exposure to the principal causes of a disease; in 
the case of cervical cancer, prevention of HPV infection 



272 Glossary 



primary treatment: treatment that is usually tried first to attempt to cure a disease or 
condition 

prognosis: the likely outcome of a disease (improvement, deterioration or death) 
radical radiotherapy: radiotherapy with a curative intent 

recurrence (of lesions, disease): the reappearance of a problem that had previously 
disappeared with treatment 

regression: the disappearance or lessening of an abnormality 

reliability or reproducibility: the extent to which a treatment or test gives the same 
results when repeated many times 

screen-negative: result of a screening procedure that shows no abnormality 
screen-positive: result of a screening procedure that shows an abnormality 

sensitivity: the proportion of people who have a condition who are identified correctly 
by a test (true positives). 

specificity: the proportion of people who do not have a condition who are correctly 
identified by a test (true negatives) 

squamous intraepithelial lesion (SIL): precancer or abnormality of the squamous 
cells of the lining of the cervix. The Bethesda classification distinguishes between 
low-grade SIL (LSIL) and high-grade SIL (HSIL). This classification should be used 
only for reporting results of cytological tests 

stenosis: an abnormal narrowing of a canal, which can cause health problems 

survival rate: the proportion of all the people with a condition who are still alive after a 
certain time 

syndromic approach: treatment of infection based on knowledge of the principal 
causes of the presenting symptoms; for example, cervical infection can be treated 
with antibiotics against both gonorrhoea and chlamydia, without first performing 
other tests to diagnose which of the two pathogens is present 

triage: selection of persons, out of all those affected, for further testing or treatment 
ulcerating: eating into tissue and causing a shallow crater; describes some cancers 



For more information, please contact: 



Department of Reproductive Health and Research 

World Health Organization, Avenue Appia 20 

CH-1 21 1 Geneva 27, Switzerland 

Fax: +41 22791 4189/4171 

E-mail: reproductivehealth@who.int 

Internet address: www.who.int/reproductive-health 

or 

Department of Chronic Diseases and Health Promotion 

World Health Organization, Avenue Appia 20 

CH-1 21 1 Geneva 27, Switzerland 

Fax: +41 22 791 4769 

E-mail: chronicdiseases@who.int 

Internet address: www.who.int/chp 




ISBN 92 4 154700 6 
ISBN 978 92 4 1547000 




789241 54700