Vaginal Dilator Therapy After Pelvic Radiation

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07216456
Status
Recruiting
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Conditions

  • Anorectal Cancer
  • Gynecologic Cancers
  • Pelvic Cancer
  • Pelvic Radiotherapy
  • Urologic Cancer
  • Vaginal Stenosis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Oct 14, 2025
Start date
Mar 5, 2026
Status verified
Jul 2026
Primary completion
May 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
    A 6-session (45 minutes each) behavioral intervention will be delivered individually and remotely via videoconferencing. The intervention will be designed to improve engagement with vaginal dilator therapy among female cancer survivors who underwent pelvic radiation therapy. 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.
  • No Intervention: Enhanced Usual Care
    Written materials will highlight the purpose of dilator therapy and how to use dilators (including frequency and duration).

Primary Outcome Measure

Feasibility, as Measured by Session Completion and Attrition [ Time Frame: 3 months post-baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Smrithi Divakaran, MPH
[email protected]
919-681-7695
Juliann Stalls, PhD
[email protected]
919-416-3417
Juliann Stalls, PhD (PRINCIPAL_INVESTIGATOR)

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