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

NCT04952961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-06-22

No results posted yet for this study

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.

Conditions

  • Self-Examination
  • Vulvar Cancer
  • Vulvar Lichen Sclerosus
  • Vulval Intraepithelial Neoplasia
  • Vulval Cancer
  • Vulval Intraepithelial Neoplasia With Lichen Sclerosus
  • Lichen Planus

Interventions

BEHAVIORAL

Training in Vulval Self-Examination

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

Sponsors & Collaborators

  • British Society for the Study of Vulval Disease

    collaborator UNKNOWN

  • University of Manchester

    lead OTHER

Principal Investigators

  • Vanitha Sivalingam, PhD · University of Manchester

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2022-07-30
Completion
2023-03-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04952961 on ClinicalTrials.gov