Vaginal Dilator Therapy After Pelvic Radiation

Duke University

Status: Begins enrollment in a year or more

Conditions: Pelvic Radiotherapy; Pelvic Cancer; Urologic Cancer; Anorectal Cancer; Vaginal Stenosis; Gynecologic Cancers

Treatments: Behavioral: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07216456

Pro00118002

1K08CA304375 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This study is testing a new behavioral program to help women who have had pelvic radiation therapy use vaginal dilators more regularly. Vaginal dilators are important tools that help prevent or treat vaginal stenosis-a condition where the vagina becomes shorter or narrower after radiation. This can make medical exams and sexual activity painful or difficult. Although dilators are commonly recommended, many women struggle to use them consistently.

The new program is designed to support women in overcoming common challenges to using dilators, such as pain, emotional distress, and lack of information. It includes strategies from cognitive behavioral therapy and acceptance and commitment therapy, and is based on the Health Belief Model, which helps people understand how their beliefs affect their health behaviors.

The study will include 88 participants who will be randomly assigned to one of two groups:

• One group will receive the new behavioral program.
• The other group will receive written educational materials (enhanced usual care).

Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months. They will also complete short monthly check-ins to report how often and how long they use their dilators.

The main goals of the study are to:

• See if the program is easy to use and acceptable to participants.
• Track how often participants use their dilators.
• Measure changes in symptoms, emotional distress, and knowledge about dilator therapy.

This pilot study will help researchers prepare for a larger study in the future and improve support for women recovering from pelvic radiation.

Enrollment: 88 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

88 participants in 2 patient groups

Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Experimental group

Description:

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.

Treatment:

Behavioral: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Enhanced Usual Care

No Intervention group

Description:

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