Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04952961 |
| Other study ID # |
295615 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 4, 2021 |
| Est. completion date |
March 6, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
University of Manchester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
