Vaginal Dilator Therapy After Pelvic Radiation
Purpose
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
- Urologic Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
Durham, North Carolina 27710
More Details
- Status
- Recruiting
- Sponsor
- Duke University
Detailed 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. In Phase I, individual qualitative interviews with patients in the target sample (N=20) and medical providers (N=10) will be used to inform behavioral program development. It is anticipated that the program will employ strategies from cognitive behavioral therapy and acceptance and commitment therapy. 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. - 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.