Improving sleep in gynecologic cancer survivors

项目总结 睡眠障碍是妇科癌症幸存者的主要主诉之一，超过80%的 幸存者报告睡眠困难。睡眠障碍也会导致与健康相关的质量恶化 生活质量(HRQOL)和增加的症状负担。尽管对睡眠的非药物干预 已经在癌症人群中探索了干扰，高达50%的幸存者不坚持治疗 建议，可能是由于其行为劳动密集型的性质。因此，有必要 寻找更有效和更可接受的方法来改善癌症患者的睡眠结果。此应用程序建议 职业发展计划，支持Rina Fox博士建立一个独立的研究计划，专注于 关于研究提高癌症幸存者的HRQOL和减轻症状负担的策略， 特别要考虑睡眠和昼夜节律在整体疾病体验中的作用。她 职业发展将得到一个多学科研究小组的支持。她的导师，王博士，里尼， 和Zee是行为睡眠医学、癌症控制和生存以及昼夜节律方面的公认学者 节奏和生物学。他们在联邦资助、多学科合作方面有着悠久的历史 合作，以及对继续实现独立的受训者的成功指导。福克斯博士的训练将 由专家顾问加强，他们将在临床妇科肿瘤学方面提供指导(坦纳医生)， 生物统计学和最优化方法(西迪克博士)、定性研究方法(凯瑟博士)、昼夜节律 癌症幸存者的活动节律和以睡眠为重点的研究执行情况(安科利-以色列博士)，以及 干预效果的生物行为学机制与心理社会干预的发展 在妇科癌症幸存者中(佩内多医生)。此应用程序的目标是优化行为 减少睡眠障碍的干预(主要结果)，改善HRQOL和减轻症状 妇科癌症幸存者的负担(继发结果)。在第一阶段，15名参与者将 同时接收已知可减少睡眠干扰(即，睡眠)的三个候选干预成分 限制、刺激控制和强光)，随后将完成半结构化个体 面谈，以提供关于遵守干预措施的障碍和促进者的反馈。在第二阶段，80 参与者将在23个完全析因试验设计内随机评估这些干预成分， 在多阶段优化策略(MOST)框架的指导下，确定 候选干预组件，增强以促进依从性，最好地影响研究的主要和 次要结果。睡眠障碍和昼夜节律标记物也将被评估为潜在的机制 潜在的候选干预成分对研究结果的影响。这一创新成果 研究将直接导致R01的应用，以及一条独立的、程序化的研究路线。 福克斯专注于癌症幸存者的HRQOL、症状负担以及睡眠和昼夜节律紊乱。

PROJECT SUMMARY Sleep disturbance is one of the primary complaints of gynecologic cancer survivors, with more than 80% of survivors reporting sleep difficulties. Sleep disturbance also contributes to worsened health-related quality of life (HRQOL) and increased symptom burden. Although non-pharmacological interventions for sleep disturbance have been explored among cancer populations, up to 50% of survivors do not adhere to treatment recommendations, possibly due to the behaviorally labor-intensive nature thereof. Therefore, there is a need for more effective and acceptable approaches to improve sleep outcomes in cancer. This application proposes a career development plan to support Dr. Rina Fox in establishing an independent research program focused on examining strategies to improve HRQOL and reduce symptom burden among cancer survivors, with particular consideration for the role of sleep and circadian rhythms in the overall disease experience. Her career development will be supported by a multidisciplinary group of researchers. Her mentors, Drs. Ong, Rini, and Zee, are recognized scholars in behavioral sleep medicine, cancer control and survivorship, and circadian rhythms and biology, respectively. They have lengthy histories of federal funding, multidisciplinary collaboration, and successful mentorship of trainees who go on to achieve independence. Dr. Fox’s training will be enhanced by expert consultants who will provide guidance in clinical gynecologic oncology (Dr. Tanner), biostatistics and optimization methodology (Dr. Siddique), qualitative research methods (Dr. Kaiser), circadian activity rhythms and execution of sleep-focused research among cancer survivors (Dr. Ancoli-Israel), and biobehavioral mechanisms of intervention efficacy and psychosocial intervention development specifically among gynecologic cancer survivors (Dr. Penedo). The aim of this application is to optimize a behavioral intervention to decrease sleep disturbance (primary outcome), and improve HRQOL and reduce symptom burden (secondary outcomes) among gynecologic cancer survivors. In Phase I, 15 participants will simultaneously receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, and bright light), and will subsequently complete semi-structured individual interviews to provide feedback regarding barriers and facilitators to intervention adherence. In Phase II, 80 participants will be randomized to evaluate these intervention components within a 23 full factorial trial design, as guided by the Multiphase Optimization Strategy (MOST) framework, to identify the optimal combination of candidate intervention components, enhanced to promote adherence, that best affect the study’s primary and secondary outcomes. Sleep disturbance and circadian markers will also be evaluated as potential mechanisms underlying the candidate intervention components’ effects on study outcomes. Results of this innovative research will directly lead to an R01 application and an independent and programmatic line of research for Dr. Fox focused on HRQOL, symptom burden, and sleep and circadian disturbance among cancer survivors.