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.
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
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
Duke University
Lead sponsor
National Cancer Institute (NCI)
Collaborator