Early Detection of vulval CAncer Through self-Examination (EDuCATE)
Research type
Research Study
Full title
Early Detection of vulval CAncer Through self-Examination (EDuCATE): A mixed methods analysis on improving early detection of vulval cancer in women at increased risk through self-examination
IRAS ID
251758
Contact name
Vanitha Sivalingam
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
G68496, MFT R&D
Duration of Study in the UK
1 years, 3 months, 31 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 the study is to assess the current practice, acceptability and barriers to self-examination in patients and clinicians using questionnaires. The secondary objectives are to develop the feasibility of aids to support self-examination. Aids will include nurse-led self-examination teaching clinics, face-to-face self-examination teaching, a patient education video and aids for self-examination (information leaflet, magnified mirror, selfie stick and MySkinSelfie smartphone App). In a follow-on study, the acceptability and feasibility of these aids will be assessed using focus groups and a pilot study over three months. Findings from both studies will inform the design of a randomised trial comparing the interventions with an embedded cost-effectiveness analysis; standard hospital follow-up versus self-examination clinics with patient-directed follow-up.This is a questionnaire-based study which will recruit patients primarily from the Greater Manchester Area. The patient and clinician questionnaires will also be available online and publicised through the British Society for the Study of Vulval Disease (BSSVD). A funding application is in place with the BSSVD.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0091
Date of REC Opinion
25 Mar 2019
REC opinion
Further Information Favourable Opinion