||5R21CA149675-02 Interpret this number
||Ohio State University
||Psychosexual Intervention for Gynecologic Cancer Patients
DESCRIPTION (provided by applicant): Worldwide, gynecologic cancer is a leading cause of death. In the U.S. more than 80,000 diagnoses are made annually, making gynecologic tumors the third most prevalent disease site for women. For the patient, diagnosis is accompanied by extreme stress, with multimodal therapies to follow. Hundreds of randomized clinical trials (RCTs) of psychological interventions for cancer patients have been conducted, but only 21 enrolled gynecologic patients. For these patients, one of the most disruptive and long-lasting sources of morbidity is sexual, second only to extremity lymphedema. Over 50% of patients have moderate-to-severe sexual disruption, as documented with 30+ years of descriptive studies. Of the previous 21 trials, only 5 of them have included a sexual functioning component (typically one session) in the intervention, and in all cases this "dose" of treatment yielded null effects or only minimal change. Thus, the proposed research addresses this gap by pilot testing a novel, theoretically driven, psychological intervention to prevent sexual morbidity. A small RCT is proposed. Recently diagnosed, post surgery gynecologic cancer patients (N=50) will be accrued and randomized to: Psychological Intervention vs. Control (Enhanced Standard Care; ESC). Patients will be assessed at intake (baseline), and 3-, 6-, and 9-months. ESC will include three elements: stress reduction (progressive muscle relaxation), information delivery regarding gynecologic cancer treatments and sexuality, and provision of survivorship care plan documents. For the intervention arm, the investigators' build on their program of basic research in sexuality by framing the core intervention elements (sex therapy, cognitive-behavior therapy, problem solving) in the theoretical context of sexual self schema enhancement. Patients will receive four weekly, four biweekly, and two monthly sessions, for a total of ten sessions spaced across five months. The Intervention will be provided in both individual and group formats to ascertain dissemination information. Primary outcome measures assess sexual behavior, responsiveness, and satisfaction, and sexual pain. Secondary outcomes include emotional distress, depressive symptoms, and fatigue. Important for later dissemination, procedures are in place to collect cost-effectiveness data. Completion of the proposed research leads an experienced, interdisciplinary, investigator team to their overarching goal: conduct of a large-scale RCT testing the efficacy of a tailored psychological intervention suited for dissemination to this underserved and burdened cancer patient group. This is a high-impact research program that, if successful, will change the trajectory of sexual morbidity and substantively improve gynecologic cancer survivorship.
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