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

项目摘要/摘要 在美国380万乳腺癌幸存者中，约有四分之三的人经历了具有临床意义的经历 性困扰和性功能障碍。这种与癌症相关的性发病率可以通过互联网干预来解决 这包括针对问题重叠的生物、心理和社会方面的多种治疗技术； 然而，由于有时拒绝率很高，这些干预措施的全部潜在影响尚未实现。 负担和高流失率。一种更有效的性发病率干预措施，在降低发病率的同时保持疗效 参与者的负担将对公共卫生产生更大的影响。因此，这项提案的目标是确定 为最大限度地降低乳腺癌相关的性发病率而优化的互联网干预 评估干预成分有效性的调解人和调解人，并检查幸存者的敬业度 具有干预组件。具体地说，我们将测试四个经过研究测试的全自动互联网 针对乳腺癌幸存者的干预内容--关于癌症相关的性发病率的心理教育， 培训他们与临床医生的沟通，培训他们与伴侣的沟通，以及体检 亲密度增强-使用多阶段优化策略(MOST)研究框架。我们将招募 320名已完成初次乳腺癌治疗并报告有性行为的亲密伴侣女性 NCI社区肿瘤学研究计划(NCORP)的发病率。在高效的优化中 试验中，参与者将被随机接受四种干预成分的组合，并将 在基线(随机化前)、3个月后评估和6个月后完成在线评估 评估。对于目标1，我们确定了与乳腺癌相关的最佳性发病率干预方案 通过遵循系统的数据驱动的方法，独立地和 性困扰(主要结果)和性功能(次要结果)的协同作用。对于目标2，我们 将评估调解人(性功能知识；与提供者的性交流自我效能；以及 与伴侣；关系亲密)和调节因素(确诊时的绝经状态；辅助内分泌 治疗使用；转移性疾病；心理困扰；关系持续时间和不满意)干预 组份对性发病率的疗效。最后，对于目标3，我们将检查幸存者的参与度和满意度 具有干预组件。作为与癌症相关的性发病率的第一个最多的研究，这项研究是 直接响应NOSI NOT-OD-20-106和癌症控制领导对推进干预的呼吁 通过系统地测试干预组件及其机制来进行科学研究。通过识别 性发病率干预成分的结合可能为乳腺癌幸存者提供最大 以最小的负担受益，这项研究将导致第一次针对最大影响进行优化的互联网干预 针对乳腺癌相关的性发病率这一未得到充分治疗、普遍存在且具有破坏性的问题。

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.