This clinical trial develops and implements a behavioral intervention to improve engagement with vaginal dilator therapy in patients after pelvic radiation. A growing population of gynecologic, anorectal, and urologic cancer survivors face significant vulvovaginal and sexual health side effects of pelvic radiation therapy that negatively impact many life domains. Pelvic radiation therapy is a component of curative treatment for many who receive one of these diagnoses. Despite advancements in the use of pelvic radiation for cure, this therapy has significant acute and long-term toxicities. Vulvovaginal and sexual health are significantly impacted for women who underwent pelvic radiation; women may experience vaginal dryness, dyspareunia, sexual dissatisfaction, and vaginal stenosis. Vaginal dilator therapy is the primary treatment used to manage vaginal stenosis in cancer survivors but engagement in this critical therapy is poor. Dilator therapy involves inserting tube-shaped devices of increasing size into the vagina to stretch vaginal tissue over time. A behavioral intervention that facilitates dilator therapy engagement that incorporates cognitive behavioral therapy and acceptance and commitment therapy strategies may improve dilator therapy engagement.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07216456.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Juliann Stalls
Phone: 919-613-5550
PRIMARY OBJECTIVES:
I. Clarify intervention targets and strategies to address modifiable barriers to dilator therapy. (Phase I, Aim I)
II. Develop structured therapist and patient intervention manuals. (Phase I, Aim I)
III. Refine the intervention as well as therapist and patient intervention manuals. (Phase II, Aim II)
IV. Examine feasibility and acceptability of the intervention as well as patterns of change in primary (frequency and duration of dilator use) and secondary (symptom burden, emotional distress, and dilator therapy knowledge) outcomes of interest through a pilot randomized controlled trial (RCT). (Phase III, Aim III)
OUTLINE:
AIM I: Patients complete an interview over 60 minutes as well as a survey and providers complete an interview over 30 minutes as well a survey for intervention development on study.
AIM II: Patients participate in user testing session over 90 minutes to provide feedback on the developed intervention to inform intervention refinement on study.
AIM III: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in the behavioral intervention that involves coping strategies based in traditional cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT), in addition to educational content informed by psychoeducational interventions which improved dilator knowledge for six, 45 minute sessions over 9 months on study.
ARM II: Patients receive enhanced usual care written educational materials over 9 months on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorJuliann Stalls
