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

NCT04952961 | Completed

• 1 other identifier: 295615
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in number of self-reported vulval self-examination events

  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

  6 months

Secondary Outcomes (4)

• Change in Perceived Vulval Cancer Risk Score

  6 months

• Change in Vulval Cancer Worry Scale

  6 months

• Change in the Hospital anxiety and depression scale

  6 months

• Vulval quality of life index

  6 months

Study Arms (1)

Single Arm Intervention

EXPERIMENTAL

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.

Behavioral: Training in Vulval Self-Examination

Interventions

Training in Vulval Self-Examination BEHAVIORAL

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

Single Arm Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• British Society for the Study of Vulval Disease: collaborator

Study Sites (1)

St Mary's Hospital, Manchester University Hospitals Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Self-Examination; Vulvar Neoplasms; Vulvar Lichen Sclerosus; Lichen Planus

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vanitha Sivalingam, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Clinical Lecturer in Gynaecological Oncology

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 7, 2021
• Study Start: November 4, 2021
• Primary Completion: July 30, 2022
• Study Completion: March 6, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)