Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT07216456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-15
First Post:
2025-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaginal Dilator Therapy After Pelvic Radiation
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K08CA304375 | NIH | None | https://reporter.nih.gov/quic… | View |