RecruitingNot ApplicableNCT07216456

Vaginal Dilator Therapy After Pelvic Radiation

Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial


Sponsor

Duke University

Enrollment

130 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed. In Phase I of the study, individual qualitative interviews with patients in the target sample (N=20) and medical providers (N=10) will be used to inform the behavioral program development. In Phase II, the program will be refined through user testing interviews (N=12). In Phase III, 88 participants will be randomly assigned to one of two groups: * One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use. * The other group will receive written educational materials (enhanced usual care). The study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins. The goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation for people with anorectal cancer, gynecologic cancers, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALImproving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

The intervention includes coping strategies from cognitive behavioral therapy (e.g., progressive muscle relaxation) and acceptance and commitment therapy (e.g., mindfulness), as well as psychoeducation (e.g., how to use dilators), to enhance engagement with vaginal dilator therapy.


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT07216456


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