This clinical trial studies the experiences and needs of women who have received pelvic radiation for gynecologic, anal, rectal or bladder cancer. Pelvic radiation, which is a critical component in the treatment of many gynecologic, bladder, rectal and anal cancers, often results in devastating and long-lasting sexual side effects. Pelvic radiation-related sexual problems are often undertreated, resulting in poor symptom management and reduced quality of life. Pelvic health physical therapy interventions and coping skills training may increase women’s engagement in important rehabilitation exercises and improve sexual functional outcomes following pelvic radiation.
Additional locations may be listed on ClinicalTrials.gov for NCT04544735.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Rebecca Shelby
Phone: 919-416-3410
PRIMARY OBJECTIVES:
I. Use an iterative model to develop and refine the physical therapy (PT) intervention based on qualitative data from interviews with cancer survivors, oncology providers, and pelvic health physical therapists.
II. Pilot test the developed intervention to examine its feasibility and acceptability.
III. Examine the patterns of change and relationships among outcome variables including vaginal changes, pelvic floor function, sexual function and satisfaction, and adherence to rehabilitation exercises.
OUTLINE:
Phase 1: Intervention Development: Participants participate in an interview with oncology providers and pelvic health physical therapists over 60-90 minutes.
Phase 2: Intervention Pilot Testing: Patients receive pelvic health physical therapy interventions.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDuke University Medical Center
Principal InvestigatorRebecca Shelby