Pilot Study to Support Vaginal Dilator Use in Women After Pelvic Radiation for Gynecologic and Pelvic Cancers

What this Trial Is About

Researchers are evaluating a new behavioral program designed to help women who have undergone pelvic radiation therapy use vaginal dilators more regularly. Vaginal dilators are important for preventing or treating vaginal stenosis, a condition where the vagina becomes shorter or narrower after radiation, which can cause pain or difficulty during medical exams and sexual activity. Although dilator use is recommended, many women struggle to use them consistently, which this study aims to address. The study is conducted in three phases. Phase I involves interviews with patients and medical providers to help develop the behavioral program. Phase II consists of user testing interviews to refine the program. In Phase III, 88 participants will be randomly assigned to one of two groups one group will receive the new behavioral program delivered remotely in six 45-minute sessions using strategies from cognitive behavioral therapy, acceptance and commitment therapy, and psychoeducation the other group will receive written educational materials about dilator therapy enhanced usual care. Participants will complete surveys at the start of the study and again at 3, 6, and 9 months, along with brief monthly check-ins to report dilator use. Researchers will measure the programs feasibility and acceptability, track changes in dilator use, symptoms, emotional distress, psychological flexibility, knowledge, self-efficacy, and sexual function. This pilot study aims to prepare for a larger future trial and improve support for women recovering from pelvic radiation.

Vaginal Dilator Therapy After Pelvic Radiation