Optimizing psychosocial intervention for breast cancer-related sexual morbidity: A factorial trial using the National Cancer Institute Community Oncology Research Program (NCORP) network

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PROJECT SUMMARY/ABSTRACT Approximately three-quarters of the 3.8 million breast cancer survivors in the U.S. experience clinically significant sexual distress and dysfunction. This cancer-related sexual morbidity can be addressed by Internet interventions that include multiple therapeutic techniques to target the overlapping biopsychosocial aspects of the problem; however, the full potential impact of these interventions has yet to be realized due to high refusal rates from time burden and high attrition rates. A more efficient sexual morbidity intervention that retains efficacy while lowering participant burden would have greater public health impact. Therefore, the goal of this proposal is to determine an Internet intervention that is optimized for greatest impact on breast cancer-related sexual morbidity, to evaluate mediators and moderators of intervention component efficacy, and examine survivors’ engagement with the intervention components. Specifically, we will test four research-tested and fully-automated Internet intervention components for breast cancer survivors – psychoeducation about cancer-related sexual morbidity, training for communication with their clinicians, training for communication with their partners, and physical intimacy enhancement – using the Multiphase Optimization Strategy (MOST) research framework. We will recruit 320 intimately partnered women who have completed primary breast cancer treatment and report sexual morbidity through the NCI Community Oncology Research Program (NCORP). In the highly-efficient optimization trial, participants will be randomized to receive a combination of the four intervention components and will complete online assessments at baseline (pre-randomization), 3-month post-assessment, and 6-month post- assessment. For Aim 1, we determine the optimal breast cancer-related sexual morbidity intervention package by following a systematic data-driven approach that tests intervention component effects both independently and synergistically on sexual distress (primary outcome) and sexual functioning (secondary outcome). For Aim 2, we will evaluate mediators (sexual functioning knowledge; sexual communication self-efficacy with providers and with partners; relationship intimacy) and moderators (menopausal status at diagnosis; adjuvant endocrine therapy use; metastatic disease; psychological distress; relationship duration and dissatisfaction) of intervention component efficacy on sexual morbidity. Last, for Aim 3, we will examine survivors’ engagement and satisfaction with the intervention components. As the first MOST study of cancer-related sexual morbidity, this study is directly responsive to NOSI NOT-OD-20-106 and to calls from leaders in cancer control to advance intervention science through systematically testing intervention components and their mechanisms. By identifying the combination of sexual morbidity intervention components likely to provide breast cancer survivors the greatest benefit for the least burden, this study will result in the first Internet intervention optimized for maximum impact for the undertreated, prevalent, and devastating problem of breast cancer-related sexual morbidity.