Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Vulvar Neoplasms

Lichen Planus

Lichen Sclerosus et Atrophicus

Vulvar Lichen Sclerosus

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lichenoid Eruptions

Exanthema

Skin Diseases

Skin Diseases, Papulosquamous

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lichen Sclerosus

Vulvar Cancer

Participants will be shown how to perform vulval self-examination in a face-to-face intervention and provided with an information leaflet. They will be sent reminders to self-examine each month.

Face-to-face training in vulval self-examination Supplemented with use of aids ( hand mirror, mobile phone with selfie-stick), patient information leaflet, reminders to self-examine

Training in Vulval Self-Examination

Vanitha Sivalingam, PhD

Vulval cancer, while rare, has increased in incidence by 17% since the 1990s. It is strongly associated with age, thus this increasing trend is likely to continue with extended life expectancy. Vulval cancer is highly treatable when detected early. Women with chronic vulval conditions including lichen sclerosus, lichen planus and vulval intraepithelial neoplasia are at increased risk of developing vulval cancer. Most patients are in hospital follow-up, however regular vulval self-examination can pick up lesions earlier. There are no formalised methods of teaching self-examination and no evidence that it is acceptable to women.

The main objective of this study is to pilot an intervention to promote and support vulval self-examination for women at increased risk of vulval cancer including those with lichen sclerosus, lichen planus and vulval intraepithelial neoplasia.

Findings from this feasibility study will inform the design of a randomised trial comparing the interventions versus control with an embedded cost-effectiveness analysis.

Vulval cancer is a rare gynaecological cancer, with an increasing incidence rate. IThis trend is expected to risk in years to come because of an aging populating and the increasing rate of human-papillomavirus-related vulval squamous cell carcinoma (VSCC) in young women.

Vulval cancer has a profound effect on the quality of life of women diagnosed with the disease. It carries both disease-related mortality risk and significant morbidity including lower limb lymphoedema, sexual dysfunction and groin discomfort.

Early detection of vulval cancer leads to improved survival and allows for conservative surgical treatment, lower morbidity and improved cosmesis. It is widely agreed that there is no role for screening the general population for vulval cancer; there are no systematic screening programmes nor are there reliable screening methods for identifying malignant precursors . The identification of vulval premalignant and malignant disease, therefore relies on the recognition and reporting of vulval symptoms by the patient and the knowledge and clinical acumen of the health care professional.

There is however, a population of women with chronic vulval conditions who are more likely to develop vulval cancer. Lichen sclerosus (LS), lichen planus (LP) and VIN are recognised precursors of vulval cancer. Regular follow-up in a specialist vulval clinic allows for evaluation of symptom control and treatment compliance and identification of early malignant change; however, regular vulval self-examination may prompt early diagnosis. The interval between noticing a symptom and seeking help could potentially be reduced by providing clear information on signs and symptoms of vulval cancer and guidance on monitoring skin-changes.

Secondary follow-up is not necessary for all women, and women with stable lichen sclerosis are often managed in primary care. Recent guidance from the British Association of Dermatology recommends that women with vulval LS who have responded to treatment be discharged to the care of their general practitioner after a twelve month follow-up period .However, as a majority of women discharged from UK vulval clinics are not subsequently followed up in primary care appropriately, it is important that women are able to self-examine and are confident in recognising and reporting suspicious symptoms. There is, however, no formalised method of teaching vulval self-examination and many women continue with secondary care input.

Self-management focusses on actions that people undertake for themselves to manage their health and illness. In order to self-manage, self-management support is needed (e.g. actions by healthcare professionals). Self-management has been shown to be effective in improving health outcomes such as quality of life. Skin self-examination can reduce mortality in melanoma. A meta-analysis of 18 trials of skin self-examination concluded that interventions including personalised phone counselling, whole body photographs and reminders to perform skin self-examination increased the number of events of patients examining themselves for skin cancer.

A recent mixed-method study by the investigators has demonstrated that only 9% of women have been taught to self-examine, yet up to 86% self-examine regularly. Despite being motivated, 50% reported a lack of confidence in recognition of vulval pathology and a high level of worry about their vulval condition. Both clinicians and patients agreed that face to face teaching was the best intervention for teaching vulval self-examination (unpublished).

The overarching aim of the intervention is to support vulval self-examination in women at high risk of developing vulval cancer. The aims, processes and outcomes were agreed at the focus groups of both women with vulval conditions and clinicians.

The structured intervention will include face-to-face training on vulval self-examination(VSE), supplemented with the use of aids including a hand-mirror or a selfie-stick. Women will be supported with reminders to self-examine, access to a telephone helpline and a leaflet on self-examination.

Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study

Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study A Feasibility Study of Interventions to Promote Vulval Self-examination in Women at Increased Risk of Vulval Cancer

Change in number of self-reported vulval self-examination events over one month before and after the intervention. Patients are asked to record self-examination events in the patient diary

Change in the perceived vulval cancer risk score before and after the intervention. Min 0, Maximum 3. Higher scores indicate higher perceived risk of cancer

This score assesses worry about developing vulval cancer. Change in the score will be assessed before and after the intervention. It has been adapted from the melanoma worry scale. Minimum is 5, Maximum is 19. Higher scores indicate higher worry.

This is a validated scale to measure anxiety and depression in hospital patients. Change will be assessed before and after the intervention. Anxiety and depression can be scored for separately. Minimum score is 0 and Maximum score is 21. Higher scores indicate higher rates of anxiety and depression

This is a validated measure to assess quality of life in women with vulval disease. Change in the vulval quality of life will be assessed before and after the intervention. Higher scores indicate higher impact of vulval conditions of quality of life. Minimum is 0 and maximum is 45

British Society for the Study of Vulval Disease

University of Manchester

Academic Clinical Lecturer in Gynaecological Oncology

Blood and Lymph Conditions

Gland and Hormone Related Diseases

Uterine Cervical Neoplasms

Lymphedema

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Lymphatic Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina

Patients without malignant gynaecological cancers

Andreas Obermair, MD FRANZCOG CGO

This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.

Pathological swelling of the lower limbs (lymphoedema) is widely accepted to be a common consequence of treatment for gynaecological cancer. It is both a serious and debilitating complication, associated with significant morbidity, which impacts physically and emotionally on otherwise healthy women. Lymphoedema can also affect patients' ability to earn an income, especially if their work requires prolonged periods of standing or walking.

The causes of lymphoedema are largely unknown with clinical data scarce regarding its onset time and incidence after gynaecological cancer treatment.

The following hypotheses will be tested to address the aims of the project:

1. At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
2. Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.
3. Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual \& financial well-being, compared to those who do not develop lymphoedema.
4. There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.

Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

The University of Queensland

Royal Brisbane and Women's Hospital

Mater

Mater Private Hospital

Queensland Institute of Medical Research

Queensland University of Technology

Australia New Zealand Gynaecological Oncology Group

Cancer Australia

Queensland Centre for Gynaecological Cancer

Behaviors and Mental Disorders

Vaginal Neoplasms

Sexual Dysfunctions, Psychological

Vaginal Diseases

Mental Disorders

Psychotic Disorders

Vaginal Cancer

All Drugs and Chemicals

Estrogens

3 level intervention: level 1:Self help booklet level 2: CNS delivered intervention level 3: psychologist delivered intervention

level 1 intervention: self help booklet Non study trained CNS will offer assessment, advice, vaginal dilator training where appropriate, arrange topical oestrogens or other creams

Behavioral: SAFFRON stepped care Stepped care (Improving Access to Psychological Therapies, 2012; Richards et al., 2012) adapted for the gynaecological cancer setting to produce a 3-step model including a clinical assessment and treatment algorithm.

Assessment Algorithm FSFI Interventions

Level 1:

Best available self-help literature on psychosexual difficulties after cancer as judged by the project team and two patient advocates.

Level 2:

A 3-5 session manualised psycho-educational intervention delivered fortnightly by study trained CNSs with taping and supervision for adherence to protocol and manual.

Level 3:

16 weekly session manualised brief psychotherapy adaptation of InterPersonal Therapy, IPT (Interpersonal Psychotherapy for Sexual Adjustment post Gynaecological Cancer, IPT-APGyC)

SAFFRON stepped care

Susan F Gessler, PhD

Anne Lanceley, PhD

Women affected by gynaecologic cancers are often not aware of sexual consequences of cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the impact on their sexuality may be profound. Despite this several potential therapies can be effective in helping recovery. A major challenge is informing and involving the patients in an appropriate and sensitive manner, and a further issue is the delivery of such therapies in busy and medically driven gynaecologic oncology clinics. It will use and adapt existing evidence based therapies for improving sexual function after cancer treatment and develop a model for delivering these in the NHS (United Kingdom National Health Service) setting. The model of 'stepped care' is adapted from that used nationally and successfully in the Increasing Access to Psychological Therapies (IAPT) programme. Assessment allows for 'stepping up and down', i.e. calibrating the type of help a woman receives according to need and her response to treatment already given.This study will develop and evaluate a 'stepped' system of interventions using elements of best available evidence, adapting existing interventions to help women recover their sexual feelings and activity, starting with simple methods, moving on to new talking treatments for more complex cases. The investigators address all gynaecologic cancers on the principle that sexual difficulty is the problem the investigators are treating, not the cancer of origin. Ongoing clinical assessment will be vital for the success of the stepped care model. The investigators will deliver training and supervision to enhance the skills needed by the Clinical Nursing Specialist (CNS). An important part of this study will be characterising the range of women and their willingness to participate in psychosexual help. One-to-one follow up interviews will inform the level of input required for any subsequent Randomised Control Trial (RCT). The investigators will use internationally recognised rating scales for rating sexual function, assess how illness and treatment affect mood and self esteem. The investigators will also measure the overall cost-effectiveness to the public sector of providing this treatment, compared to costs of subsequent use of health and social services. This pilot study will assess the feasibility of conducting a full scale investigation of a stepped therapy and indicate the potential benefits to the patients, their partners, and to the NHS generally.

Many cancer patients have sexual difficulties , gynaecologic cancer (Gyn-Onc) patients are particularly vulnerable to changes in sexual activity and lack of sexual desire with sexual difficulty rates estimated between 40 and 100% . Women undergo a range of treatments for ovarian, cervix, womb and vulval cancer with different combinations of surgery, chemotherapy, and radiation. Some treatments have a deleterious effect on women's internal and external sex organs, surrounding tissues and nerves, and render some menopausal. Following such treatments women report a wide range of difficulties including loss of libido, dyspareunia, vaginal dryness, and orgasmic difficulty. In addition, the symptom burden of gynaecologic cancers is heavy with many women reporting pain, fatigue, changes in bowel function, urinary symptoms including leakage, and depression and anxiety which interact with menopausal and sexual difficulties. The major impact of physical well-being on sexual function has been noted, as well as the lack of relationship between extent of treatment and formal scores of sexual function. Unsurprisingly, women treated for gynaecologic cancer are at high risk of emotional distress. One prevalence study found 23% satisfying criteria for major depressive disorder and another found greater depressive symptoms in gyn-onc patients than in breast, urology or gastro intestinal cancers. It is suggested that some of the depressive symptoms are related to the very high levels of sexual difficulty experienced after treatment. Some suggest that sexual self schema is an important moderator of response, finding positive sexual self schema associated with more frequent sexual activity, better sexual responsiveness, and higher global sexual satisfaction across all disease sites and confounders, suggesting it makes women more resilient to the adverse sexual impacts of gynaecologic cancer. Despite their sexual difficulties, many gynaecologic cancer survivors resume intercourse. Frequency of intercourse in one sample was comparable to available norms for similarly aged women, but these and other longitudinal data have shown sexual satisfaction and responsiveness significantly impaired following treatment. Patients report sexuality rarely addressed by physicians. It has been found that conversation with physicians about sexual effects of cancer is associated with significantly lower likelihood of complex sexual morbidity among very long-term survivors; but 62% of 221 participants reported their physician had never initiated a discussion about sexuality after cancer. Examining sexuality in palliative care, it has been found that patients consider it important to talk about sexuality and to face it with an experienced professional even though life expectancy is short. Patients in that study had not had this opportunity. Moreover, some patients were still able to maintain a sufficient sexual activity, in terms of quality and quantity.Nursing researchers found that cancer nurses were more likely to focus on the technical aspects of sexual recovery post treatment, for example vaginal dilation, and offered minimal advice or opportunities for disclosure for sexual dysfunctions, dissatisfaction with partner relationships or mood and other psychological difficulties. Clinical Nurse Specialists (CNSs) in gynaecologic cancer acknowledge that they have an important role in this aspect of care but do not always feel confident or competent to assess or manage patients psycho-sexual needs, and appropriate referral is then problematic . A recent review of specific complaints of all cancer patient referrals to the Sexual Health Program of the Memorial Sloan Kettering Cancer Center found that most sought help for painful intercourse (65%), vaginal dryness (63%), low sexual desire (46%), and orgasmic disorder (7%). The first two of these are partially managed through current best treatment, i.e. topical estrogen, vaginal dilators and lubricants. Prevalence reports by cancer site include a comparison of crude prevalence (66.67%) with age-standardized prevalence (55%) in cervical cancer. Many other studies report ranges from 83% sexual difficulties, to 66% significant and 46% moderate difficulties. In early stage cervix cancer treated with radical hysterectomy, 65.8% were reported to have sexual difficulties. In contrast with most sexual therapy interventions where anxiety reduction is often key, management of low sexual desire in the context of gynaecologic cancer requires an intervention which additionally addresses the wider range of mediating factors, including loss, life-threat, trauma, change of body image, pre-existing psychological outlook, mood, depression and anxiety symptoms as well as the relationship within which the woman finds herself. A wide range of non-controlled trials of sexual therapy interventions are reported in reviews across a range of interventions. All show small effect sizes, but are accompanied by patient satisfaction. A Cochrane Review of RCTs for psycho-sexual dysfunction in women treated for gynaecologic cancer concluded, 'there is insufficient evidence to support or refute the use of any interventions for psychosexual dysfunction after gynaecologic cancer.' Further, they suggested that future trials required multi-center RCTs with outcome measures validated in gynaecologic cancer patients. 'When considering interventions to trial, the investigators would suggest that investigators should focus on interventions that can be delivered by existing members of the multidisciplinary team treating women with gynaecologic cancers. It is more likely that such measures, if found effective, will be affordable and capable of being integrated into standard care. An international consensus on outcome measures would greatly facilitate the comparison of interventions in the future.' This study attempts to address this for the NHS by using the existing multi-disciplinary team to deliver a stepped care approach. This involves CNS delivered interventions at step 1 and step 2 as the major treatment delivery, and only a small minority of more complex psychological issues being treated at step 3 by a level 4 practitioner to whom patients should have access according to peer review.From the evidence above, it is often the case that women affected by gynaecologic cancer are not aware of basic information about the sexual consequences of their gynaecologic cancer and its treatment, and do not receive appropriate advice or help to recover sexual function, and adapt to their changed body and relationships. It is generally recognized by two Cochrane reviews that new interventions are needed for sexual dysfunction in gynaecological cancer and these need to be examined in multi-center RCTs with agreed outcome measures. There is a sizable population with these problems to be addressed as there are currently 1.8 million people in England living with and beyond cancer, and 2 million across the UK as a whole. This number is likely to grow by over 3% per year, reflecting the increasing incidence of cancer and better survival rates. By 2030 there are likely to be around 3 million cancer survivors in England. Since the investigators have the ability to develop suitable treatments, the investigators have a duty to explore them. The current acceptance of the worth of well-being, and conversely the cost of depression, anxiety or unwillingness to engage with the healthcare system - all potential long term effects for the patient group concerned - are drivers for this research. Better awareness of mental health issues and depression in general and in cancer patients plus greater acceptance that these symptoms have causes which can be treated or addressed is relevant too. In addition the work is planned at a time when there is more awareness of sexual health, and evidence from cancer user groups, policy makers) and research of more openness to discuss these matters as a medical need. The potential of CNSs to deliver interventions to help with the consequences of cancer treatment has been recognized by the UK Department of Health yet little is known about CNS's training or supervisory needs to provide interventions for psycho-sexual dysfunction to work alongside psychologists. If care pathways exist for addressing sexual dysfunction in cancer they are currently unique to individual units; providing the evidence for pathways which better meet the requirements of the population will facilitate clinical application of more appropriate and consistent practice. What is needed is a study to develop interventions and test them to facilitate best practice in treatment of sexual dysfunction for all relevant women in gynaecologic cancer centres.

Trial objectives:Aims: To establish whether women treated for gynaecologic cancer with moderate to severe sexual dysfunction are willing to participate in a randomized trial model and adhere to treatment 1)To indicate likely rates of recruitment to a future evaluation of the SAFFRON intervention2)To pilot a stepped care psycho-sexual intervention (SAFFRON) on the IAPT model3)To establish whether the SAFFRON intervention is acceptable to patients4)To establish whether SAFFRON is deliverable by a Gyn-Onc cancer center multidisciplinary team;5)To indicate the most appropriate outcome measures for use in a larger trial6)To inform estimates of the likely effect size, which will assist sample size calculations for a larger trial Research questions:To establish whether women treated for gynaecological cancer with moderate to severe sexual dysfunction are willing to participate in a randomized trial model and adhere to treatment

1. Will women agree to be randomized to a sexuality intervention?
2. Are different tumor sites, treatments, cancer stages at approach associated with different rates of uptake of therapy/intervention of recruitment to trial?
3. Is stepped care operable within the NHS system as it stands?
4. What is the likely effect of three levels of intervention on sexual function, mood and self-esteem as measured by standard measures?
5. What is the rate of attrition from each treatment modality? Purpose of Research a)Is it possible to improve sexual functioning for women treated for gynaecological cancer within the current clinical setting of NHS gynaecological cancer treatment?b)Can a suitable intervention be developed and evaluated in a feasibility trial?c)Can a suitable intervention be developed and evaluated in a feasibility trial?d)Is a stepped approach acceptable and practical?e)Can it be done within NHS settings?

Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer

Developing a Stepped Approach to Improving Sexual Function After Gynaecological Cancer- a Feasibility Study and Randomized Controlled Trial

shows whether interventions have changed sexual functioning

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study	NCT04952961	Self-Examinatio... Vulvar Cancer Vulvar Lichen S... Vulval Intraepi... Vulval Cancer Vulval Intraepi... Lichen Planus	Training in Vul...	18 Years -	University of Manchester
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer	NCT00604994	Female Genital ... Ovarian Cancer Cervical Cancer Endometrial Can... Vulval Cancer		18 Years -	Queensland Centre for Gynaecological Cancer
Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer	NCT02458001	Cervical Cancer Ovarian Cancer Uterine Cancer Vaginal Cancer Vulval Cancer Psychosexual Dy...	SAFFRON stepped...	18 Years -	University College, London
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer	NCT00604994	Female Genital ... Ovarian Cancer Cervical Cancer Endometrial Can... Vulval Cancer		18 Years -	Queensland Centre for Gynaecological Cancer
Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study	NCT04952961	Self-Examinatio... Vulvar Cancer Vulvar Lichen S... Vulval Intraepi... Vulval Cancer Vulval Intraepi... Lichen Planus	Training in Vul...	18 Years -	University of Manchester

Spots Global Cancer Trial Database for vulval cancer