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

优化乳腺癌相关性发病率的心理社会干预：使用国家癌症研究所社区肿瘤学研究计划 (NCORP) 网络进行的析因试验

• 批准号: 10579737
• 负责人: Kelly McLean Shaffer
• 金额: $ 70.51万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-19 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10579737
• 关键词: Address; Affect; Behavioral; Breast Cancer Treatment; Breast Cancer survivor; Cancer Control; Cancer Survivor; Caring; Communication; Community Clinical Oncology Program; Data; Development; Diagnosis; Disease; Distress; Dropout; Education; Electronic Mail; Emotional; Exercise; Functional disorder; Goals; Guidelines; Health Benefit; Healthcare; Individual; Internet; Intervention; Intervention Studies; Knowledge; Learning; Malignant Neoplasms; Mediation; Mediator; Menopausal Status; Methodology; Mission; Morbidity - disease rate; National Cancer Institute; Outcome; Participant; Population; Privacy; Provider; Public Health; Qualitative Research; Randomized; Reporting; Research; Resources; Science; Self Efficacy; Sex Functioning; Sexual Health; Site; Survivors; Techniques; Testing; Therapeutic; Time; Training; Woman; Work; adjuvant endocrine therapy; animation; biopsychosocial; cancer care; clinically significant; experience; improved; innovation; intimate behavior; malignant breast neoplasm; multiphase optimization strategy; novel; preference; primary outcome; programs; psychoeducation; psychoeducational; psychologic; psychological distress; psychosocial; recruit; satisfaction; secondary outcome; sexual health intervention; skills; social stigma; survivorship; usability

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.

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临床显著的 性困扰和性功能障碍。这种与癌症有关的性发病率可以通过互联网干预来解决 包括多种治疗技术，针对问题的重叠生物心理社会方面; 然而，由于拒绝率较高，这些干预措施的全部潜在影响尚未实现 负担和高损耗率。一种更有效的性发病率干预措施，既保持疗效，又降低 参与者的负担将对公共卫生产生更大的影响。因此，本提案的目标是确定 一种优化的互联网干预措施，对乳腺癌相关性发病率产生最大影响， 评估干预成分有效性的中介者和调节者，并检查幸存者的参与度 与干预的组成部分。具体来说，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措施-关于癌症相关性疾病的心理教育， 培训与他们的临床医生沟通，培训与他们的合作伙伴，和身体 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名亲密伴侣的女性完成了原发性乳腺癌治疗，并报告了性行为 通过NCI社区肿瘤学研究计划（NCORP）。在高效优化中 试验，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）、评估后3个月和评估后6个月完成在线评估 考核对于目标1，我们确定了最佳的乳腺癌相关性发病干预方案 通过遵循系统的数据驱动方法，独立测试干预成分的影响， 协同作用于性困扰（主要结果）和性功能（次要结果）。对于目标2， 将评估中介（性功能知识;与提供者的性沟通自我效能， 与伴侣;关系亲密度）和调节因素（诊断时的更年期状态;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度） 成分对性发病率的功效。最后，对于目标3，我们将考察幸存者的参与度和满意度 与干预的组成部分。作为第一个MOST研究癌症相关性发病率，这项研究是 直接响应NOSI NOT-OD-20-106和癌症控制领导人的呼吁，以推进干预 通过系统地测试干预成分及其机制，通过识别 性发病率干预成分的组合可能为乳腺癌幸存者提供最大的 这项研究将导致第一次互联网干预优化最大的影响， 治疗不足，流行，和毁灭性的乳腺癌相关性疾病的问题。