EDuCATE Intervention Study
Research type
Research Study
Full title
Early Detection of vulval CAncer Through self-Examination ( EDuCATE): Intervention Study
IRAS ID
295615
Contact name
Vanitha Sivalingam
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research 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 despite national guidelines recommending discharge to the community with regular self-examination in stable lichen sclerosus.
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. This includes women with lichen sclerosus (LS), lichen planus (LP) and vulval intraepithelial neoplasia (VIN). The intervention is face-to-face training in vulval self-examination and provision of a choice of aids to support self-examination. Aids will include a magnified mirror, a selfie-stick to allow mobile phone images and the option to use an NHS-developed mobile phone app called "SkinSelfie" to examine and monitor the vulval skin.
Findings from this feasibility study will inform the design of a randomised trial comparing the interventions versus control with an embedded cost-effectiveness analysis. This study aims to use a structured approach to vulval self-examination to improve early detection of vulval cancer and empower patients in the follow-up of chronic vulval conditions. This research study is designed to accompany their normal medical treatment over a period of one year.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
21/NW/0229
Date of REC Opinion
24 Aug 2021
REC opinion
Further Information Favourable Opinion