Clinical trial · Interventional
Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study
Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study A Feasibility Study of Interventions to Promote Vulval Self-examination in Women at Increased Risk of Vulval Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lichen Planus | — | UNRESOLVED | — |
| Self-Examination | — | UNRESOLVED | — |
| Vulval Cancer | — | UNRESOLVED | — |
| Vulval Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | ALIAS | 0.90 |
| Vulval Intraepithelial Neoplasia With Lichen Sclerosus | — | UNRESOLVED | — |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Lichen Sclerosus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Training in Vulval Self-Examination | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm Intervention
- description
- Participants will be shown how to perform vulval self-examination in a face-to-face intervention and provided with an information leaflet. They will be sent reminders to self-examine each month.
- interventionNames
- Behavioral: Training in Vulval Self-Examination
Primary outcomes (1)
- measure
- Change in number of self-reported vulval self-examination events
- timeFrame
- 6 months
- description
- Change in number of self-reported vulval self-examination events over one month before and after the intervention. Patients are asked to record self-examination events in the patient diary
Secondary outcomes (4)
- measure
- Change in Perceived Vulval Cancer Risk Score
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prior diagnosis of a vulval condition with increased risk of malignancy ( lichen sclerosus, lichen planus or vulval intraepithelial neoplasia) * New diagnosis of a vulval condition with increased risk of malignancy ( lichen sclerosus, lichen planus or vulval intraepithelial neoplasia) * Must be able to provide informed consent Exclusion Criteria: * Inability to consent or complete questionnaires due to cognitive or language issues * Inability of perform a vulval self-examination due to physical or visual impairments Note: Those with physical or visual impairments can participate if a dyad is willing to learn how to perform a vulval examination
References
Publications (0)
Data not yet available