University of Virginia School of Medicine, Charlottesville, VA, United States.
Fox Chase Cancer Center, Philadelphia, PA, United States.
JMIR Res Protoc. 2024 Aug 19;13:e57781. doi: 10.2196/57781.
Although most survivors of breast cancer report substantial sexual concerns following treatment, few receive support for these concerns. Delivering sexual health care to survivors of breast cancer via the internet could overcome many of the barriers to in-person treatment. Even when delivered remotely, survivor time constraints remain a leading barrier to sexual health intervention uptake.
Guided by the multiphase optimization strategy methodological framework, the primary objective of this study is to identify the most efficient internet-delivered sexual health intervention package that is expected to provide survivors of breast cancer the greatest benefit with the fewest (and least-intensive) intervention components. This study aims to determine how intervention components work (mediators) and for whom they work best (moderators).
Partnered, posttreatment adult female survivors of breast cancer (N=320) experiencing at least 1 bothersome sexual symptom (ie, pain with sex, vaginal dryness, low sexual desire, and difficulty with orgasm) related to their breast cancer treatment will be enrolled. Clinic-based recruitment will be conducted via the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Participants will be randomly assigned to 1 of 16 combinations of four intervention components with two levels each in this factorial trial: (1) psychoeducation about cancer-related sexual morbidity (receive either enhanced vs standard versions); (2) communication skills training for discussing concerns with health care providers (received vs not received); (3) communication skills training for discussing concerns with a partner (received vs not received); and (4) intimacy promotion skills training (received vs not received). Cores will be fully automated and implemented using a robust internet intervention platform with highly engaging elements such as animation, video, and automated email prompts. Survivors will complete web-based assessments at baseline (prerandomization time point) and again at 12 and 24 weeks later. The primary study aim will be achieved through a decision-making process based on systematically evaluating the main and interaction effects of components on sexual distress (Female Sexual Distress Scale-Desire, Arousal, Orgasm) and sexual functioning (Female Sexual Function Index) using a generalized linear model approach to ANOVA with effect coding. Mediation analyses will be conducted through a structural equation modeling approach, and moderation analyses will be conducted by extending the generalized linear model to include interaction effects.
This protocol has been reviewed and approved by the National Cancer Institute Central Institutional Review Board. Data collection is planned to begin in March 2024 and conclude in 2027.
By identifying the combination of the fewest and least-intensive intervention components likely to provide survivors of breast cancer the greatest sexual health benefit, this study will result in the first internet intervention that is optimized for maximum impact on the undertreated, prevalent, and distressing problem of breast cancer-related sexual morbidity.
ClinicalTrials.gov NCT06216574; https://clinicaltrials.gov/study/NCT06216574.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/57781.
尽管大多数乳腺癌幸存者在治疗后都报告存在大量的性问题，但很少有人得到这些问题的支持。通过互联网为乳腺癌幸存者提供性健康护理，可以克服许多当面治疗的障碍。即使是远程提供服务，幸存者的时间限制仍然是接受性健康干预的主要障碍。
本研究以多阶段优化策略方法学框架为指导，主要目的是确定最有效的互联网性健康干预方案，该方案有望使乳腺癌幸存者受益最大，所需的干预措施最少（且最少强化）。本研究旨在确定干预措施的工作原理（中介）以及对谁最有效（调节）。
将招募 320 名有伴侣、接受过治疗的成年女性乳腺癌幸存者，她们至少有 1 种与乳腺癌治疗相关的烦扰性性症状（即性疼痛、阴道干燥、性欲低下和性高潮困难），将她们纳入研究。将通过维克森林国家癌症研究所社区肿瘤学研究计划（NCORP）研究基地进行基于诊所的招募。参与者将在这个析因试验中被随机分配到 16 种 4 种干预措施的 16 种组合中的 1 种，每种干预措施都有两种水平：（1）关于癌症相关的性发病率的心理教育（接受增强版或标准版）；（2）与医疗保健提供者讨论问题的沟通技巧培训（接受或不接受）；（3）与伴侣讨论问题的沟通技巧培训（接受或不接受）；（4）促进亲密关系的技巧培训（接受或不接受）。核心内容将完全自动化，并使用具有高吸引力元素的强大互联网干预平台来实施，例如动画、视频和自动电子邮件提示。幸存者将在基线（随机分组前时间点）和 12 周和 24 周后再次完成基于网络的评估。主要研究目标将通过基于系统评估组件对性困扰（女性性困扰量表-欲望、唤起、高潮）和性功能（女性性功能指数）的主要和交互效应的决策过程来实现，使用广义线性模型方法进行方差分析，采用效果编码。通过结构方程模型方法进行中介分析，并通过扩展广义线性模型来包括交互效应，进行调节分析。
该方案已由国家癌症研究所中央机构审查委员会审查和批准。数据收集计划于 2024 年 3 月开始，并于 2027 年结束。
通过确定提供乳腺癌幸存者最大性健康益处的最少和最不强化的干预措施组合，本研究将产生第一个针对治疗不足、普遍存在和困扰性的乳腺癌相关性发病率的问题进行优化的互联网干预措施。
ClinicalTrials.gov NCT06216574；https://clinicaltrials.gov/study/NCT06216574。
国际注册报告标识符（IRRID）：PRR1-10.2196/57781。
