Vaginal Dilator Therapy After Pelvic Radiation

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.

• Change in Dilator Therapy Use [Срок оценки: From baseline to end of study enrollment at 9 months]
• Completion of cancer screening [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in symptoms, as measured by the Edmonton Symptom Assessment System [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in depressive symptoms, as measured by the PROMIS Depression Short Form [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in psychological flexibility, as measured by the Acceptance and Action Questionnaire II [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in understanding of psychosocial changes as measured by the modified Knowledge Scale [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in self-efficacy, as measured by the modified Generalized Self-Efficacy Scale [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in perceived susceptibility to developing vaginal stenosis, benefits and barriers to engaging in dilator therapy, as measured by the modified susceptibility, Benefits and Barriers Scale [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in cues that prompt health-promoting behaviors, as measured by the modified Cues to Health Action Questionnaire [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in sexual feelings and responses, as measured by the Female Sexual Function Index [Срок оценки: From baseline to end of study enrollment at 9 months]
• Change in anxiety symptoms, as measured by the PROMIS Anxiety Short-Form [Срок оценки: From baseline to end of study enrollment at 9 months]