Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation: A Pilot Randomized Controlled Trial - Survivors of gynecologic, anorectal, and urologic cancers often complete pelvic radiation therapy, resulting in many survivors (38-80%) developing shortening or narrowing of the vagina (i.e., vaginal stenosis). Vaginal stenosis may cause patients to avoid or be unable to complete pelvic exams for cancer surveillance due to pain or vaginal obstruction. Vaginal stenosis may also cause painful sexual intercourse. Dilator therapy is the primary treatment for preventing and treating vaginal stenosis. However, engagement with dilator therapy is poor. There are modifiable biopsychosocial barriers to dilator therapy engagement (symptom burden [e.g., pain, vaginal dryness], emotional distress, dilator knowledge), but few interventions have addressed modifiable barriers and improved engagement with dilator therapy. If engagement remains poor, survivors are at risk for missing critical cancer surveillance, emotional distress, impaired sexual and relational functioning, and poor quality of life. Grounded in the NIH stage model, this study aims to develop, refine, and pilot test a novel behavioral intervention, informed by the Health Belief Model, to enhance engagement with dilator therapy among female cancer survivors who underwent pelvic radiation. In Phase I, individual qualitative interviews with patients in the target sample (N=20) and medical providers (N=10) will be used to inform intervention development. It is anticipated that the intervention will employ strategies from cognitive behavioral therapy and acceptance and commitment therapy. In Phase II, the intervention will be refined through user testing interviews (N=12). In Phase III, feasibility and acceptability of the intervention will be examined, 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. Participants (N=88) will be randomized to the intervention or enhanced usual care and complete 4 primary assessments (baseline and 3, 6, and 9 months post-baseline) plus a brief monthly survey evaluating dilator use. In line with the NCI’s priority area of cancer survivorship, the overall goal of the award is Dr. Stalls’ becoming an independent clinical scientist with expertise in developing, evaluating, and disseminating behavioral interventions to improve sexual health among cancer survivors. To do so requires a unique combination of knowledge and skills: 1) Sexual Health among Cancer Survivors, 2) Sexual Health Research and Advanced Qualitative and Quantitative Research Methods, 3) Randomized Controlled Trials Design and Conduct, and 4) Leadership and Professional Development. Dr. Stalls will accomplish these career development goals through training with expert mentors, collaborators, and consultants as well as capitalizing on the resources and training opportunities at Duke University and Duke Cancer Institute. Completion of this award would strengthen the cancer research workforce, a direct mission and priority area of the NCI; Dr. Stalls’ developed expertise would help address a national gap in clinician scientists working at the intersection of behavioral oncology and sexual health.
