Vaginal Dilator Therapy After Pelvic Radiation

NCT07216456 | Not Yet Recruiting DMC

• 2 other identifiers: Pro001180021K08CA304375
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vaginal dilator therapy; pelvic radiation

Outcome Measures

Primary Outcomes (2)

• Feasibility, as Measured by Session Completion and Attrition

  Feasibility will be determined by 1) greater than or equal to 80% of sessions completed and 2) attrition rate of less than or equal to 20%.

  3 months post-baseline

• Acceptability, as Measured by the Treatment Acceptability Questionnaire

  Acceptability will be determined by average score of 5 or greater on the Treatment Acceptability Questionnaire (TAQ). The TAQ is a six-item measure assessing perceptions of an interventions acceptability, ethics, and effectiveness. Items are rated on a 7-point Likert scale, from "very unacceptable" to "very acceptable".

  3 months post-baseline

Secondary Outcomes (11)

• Change in Dilator Therapy Use

  From baseline to end of study enrollment at 9 months

• Completion of cancer screening

  From baseline to end of study enrollment at 9 months

• Change in symptoms, as measured by the Edmonton Symptom Assessment System

  From baseline to end of study enrollment at 9 months

• Change in depressive symptoms, as measured by the PROMIS Depression Short Form

  From baseline to end of study enrollment at 9 months

• Change in psychological flexibility, as measured by the Acceptance and Action Questionnaire II

  From baseline to end of study enrollment at 9 months

Study Arms (2)

Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

EXPERIMENTAL

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.

Behavioral: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Enhanced Usual Care

NO INTERVENTION

Written materials will highlight the purpose of dilator therapy and how to use dilators (including frequency and duration).

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.

Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Eligibility Criteria

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

You may qualify if:

• female sex
• adults aged 18 years or older
• diagnosed with cancer of the anus, anal canal, anorectum, cervix, uterus, vagina, vulva, and/or bladder
• completed pelvic radiation therapy in the past year
• dilator therapy recommended by medical provider and standardized dilator received from provider
• able to speak/read English

You may not qualify if:

• aged less than 17 years
• under the care of a pelvic floor physical therapist at the time of study enrollment
• have a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider
• inability to provide consent

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pelvic Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Officials

• Juliann Stalls, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smrithi Divakaran, MPH

CONTACT

919-681-7695; smrithi.divakaran@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be shared either at the time of publication or at the end of the performance period, whichever comes first. All data deposited with the Duke Research Data Repository will be retained for a minimum of 25 years according to their stated Retention Policy.

Locations

US (1)