Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04952961
Study type Interventional
Source University of Manchester
Contact
Status Completed
Phase N/A
Start date November 4, 2021
Completion date March 6, 2023

See also
  Status Clinical Trial Phase
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A
Completed NCT01986725 - The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence Phase 2
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Completed NCT05372016 - Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3
Recruiting NCT05743517 - Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment) N/A
Recruiting NCT05914974 - Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Recruiting NCT05979610 - Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies Phase 2
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Active, not recruiting NCT04357873 - Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Phase 2
Completed NCT00551187 - A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Phase 2
Completed NCT00520598 - Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Phase 2
Terminated NCT00669422 - ChemoFx® PRO - A Post-Market Data Collection Study N/A
Completed NCT03676101 - Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 1
Not yet recruiting NCT06039111 - Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma Phase 2
Recruiting NCT06127836 - Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer N/A
Completed NCT01806350 - Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors N/A
Completed NCT00019110 - Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Phase 1
Recruiting NCT04141449 - A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Phase 2
Recruiting NCT04122235 - The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study N/A