Recruiting

Behavioral Program

Sponsor:

Duke University

Code:

NCT07216456

Conditions

Pelvic Radiotherapy

Vaginal Stenosis

Pelvic Cancer

Gynecologic Cancers

Anorectal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Study Details

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 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.

Conditions

Pelvic Radiotherapy

Vaginal Stenosis

Pelvic Cancer

Gynecologic Cancers

Anorectal Cancer

Study ID

NCT07216456

Start date

Mar 5, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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).

Interventions

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.

Primary outcome measure

  • Feasibility, as Measured by Session Completion and Attrition [ Time Frame: 3 months post-baseline ]
  • Acceptability, as Measured by the Treatment Acceptability Questionnaire [ Time Frame: 3 months post-baseline ]

Central Contacts and Locations

Central contacts

Smrithi Divakaran, MPH

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

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Smrithi Divakaran, MPH

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

Juliann Stalls, PhD

919-416-3417juliann.stalls@duke.edu

Principal Investigator:

Juliann Stalls, PhD

More Information

Sponsor

Duke University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • vaginal dilator therapy
  • pelvic radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-22.