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Vaginal Dilator Therapy After Pelvic Radiation

NCT07216456 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-10-15

No results posted yet for this study

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 this study, 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.

Conditions

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

Interventions

BEHAVIORAL

Improving 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Juliann Stalls, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-08-01
Primary Completion
2030-04-30
Completion
2030-04-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT07216456 on ClinicalTrials.gov