Session: PD11: Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy I
PD11-01: Acceptant and Commitment Therapy to increase compliance to sexual dysfunction treatments in men with prostate cancer: 6- and 12-month data from a randomized controlled trial
Introduction: For many men with prostate cancer, difficulty with sexual dysfunction, in particular erectile dysfunction (ED), can trigger a psychological process which leads to avoidance of utilizing sexual dysfunction treatments. This study tests a novel psychological intervention based on Acceptance and Commitment Therapy (ACT) concepts to help men utilize these treatments. Methods: This ongoing study recruited men with prostate cancer starting intracavernosal injection therapy (ICIT) for the treatment of ED. The recruitment goal is N=220. Subjects are randomized to ICIT + ACT (ACT), which focuses on reducing avoidance, or ICIT + Enhanced Monitoring and Education (EME), which includes enhanced follow-up. Both groups receive ICIT plus 3 sessions (30-45 min) and 10 booster sessions (10 min). The interventions are delivered over the course of a year. Subjects are assessed at entry and every 6 months (m) for two years. The primary outcomes are the number of penile injections/week (verified by syringe count), and compliance (defined as =2 injections/week). Secondary outcomes assess psychosexual variables. Preliminary 6m and 12m data is presented. Since these are preliminary analyses, effect sizes (d) are reported for secondary variables (d=0.2, small effect; d=0.5, medium effect; d=0.8, large effect). Results: To date, 191 subjects have been randomized; 112 have completed the 6m assessment (ACT n=57, EME n=55) and 97 completed the 12m assessment (ACT n=48, EME n=49). Mean age at baseline was 60±7 years. At 6m and 12m, the ACT group utilized more injections/week vs. the EME group (6m: median 1.8 vs. 1.2, p=0.01; 12m: median 2.0 vs. 1.4, p=0.01) and were more compliant with ICI vs. the EME group (6m: 65% vs. 35%, p=0.01, RR=1.86; 12m: 79% vs. 41%, p=0.01, RR=1.93). At 6m and 12m, the ACT group reported greater: satisfaction with ED treatment (d=0.6) and overall sexual relationship (d=0.2). The ACT group also reported lower: sexual bother (d=0.2), prostate cancer treatment regret (d=0.3), negative psychological impact of cancer (d=0.3), and depressive symptoms (d=0.4). Conclusions: Preliminary analysis suggests ACT significantly increases ICI use. Data also indicate that ACT helps increase men’s satisfaction with injections and sexual relationship, while reducing sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. SOURCE OF Funding: National Institutes of Health: R01 CA 190636
