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
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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 0 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 0 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
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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. 0
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
0
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 0 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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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
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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.
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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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Normal CIN1 CIN2 CIN3 '^nr'X6
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 0 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
0 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
STORY3
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.
0
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
0 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.
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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.
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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. 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
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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:
3J1
- 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
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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
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• 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.
STORY5
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. 0
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
0 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 £jnex ^
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. §"•
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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
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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?
S1
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
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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
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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
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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 acid12 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
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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
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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
0
o
3
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(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
undertreatment13
• 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
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CO
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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 Precancer
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 LEEP18
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 0
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 0 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
0 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 0
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 mm3) 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 0
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
0
>
In the community
CD
O
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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:
0
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 0 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
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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
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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
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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 0
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.
0 • 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 mana9ement
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;
>37°C
(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
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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 0 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
PREVENTION24
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 instruments25
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 0 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
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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 28
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
&
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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/m2
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
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8
I
§
I
3
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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 DOCUMENTS29
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
doxycyclinea100mg
orally twice a day for
7 days
ofloxacin a-b>c 300 mg
orally twice a day for
7 days, or
tetracycline3 500 mg
orally 4 times a day for
7 days, or
erythromycin 500 mg
orally 4 times a day for
7 days
erythromycind 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
ciprofloxacin3 500 mg orally as a single dose, or
spectinomycin 2 g by intramuscular injection
Chlamydia
doxycyclineb 100 mg orally twice a day for 14 days, or
tetracyclineb 500 mg orally 4 times a day for 14 days
Anaerobes
metronidazoleb 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 0 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
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