Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors

项目总结/摘要 三分之一的普通人群会出现失眠症状，10-15%的人符合失眠标准 睡眠障碍，以慢性睡眠障碍为特征，对健康、功能和健康造成破坏性影响， 存在。癌症和癌症治疗的症状和副作用使癌症幸存者的风险增加 治疗失眠症据估计，40%的癌症幸存者在几年后报告了睡眠障碍。 完成治疗。到目前为止，很少有研究存在的战略，以有效地减少失眠的癌症 幸存者，特别是在应用认知行为疗法失眠（CBT-I）在床边， 护士在非癌症人群中的研究表明，CBTI是安全，有效和持久的。然而，CBTI 由于缺乏训练有素的专业人员和治疗费用高昂，因此， 是CBTI的替代品，由护士提供，经过严格测试，成本低，耐用， 并且具有高的治疗保真度。因此，目前的目标是确定一种药物的有效性和持久性。 简化的护士提供的CBTI版本，特别是短暂行为治疗（BBTI），使用 癌症幸存者的大量异质样本。本研究提出了一种多层次的翻译方法， 解决癌症幸存者的失眠问题。目标1将确定手动BBTI治疗的疗效 与该团队先前开发的注意力控制相比，癌症幸存者的注意力控制协议。目标2 研究将确定BBTI疗效的预测因素，以告知未来的传播合格标准， 实施研究。目标3将评估BBTI的实施，重点是表征 患者和提供者层面的促进者和障碍。158名癌症幸存者将被随机分组 或者注意力控制。睡眠、情绪、功能状态和生活质量将在1- 干预后3个月、3个月、12个月。主要结果将是自我报告的失眠 使用1个月时的Insufficiency严重度指数评估严重度，而将在3个月时检查干预的持久性。 治疗后3个月和12个月。这一提议首次提供了一个检验 自我管理行为干预对癌症幸存者失眠的有效性和持久性 减少疾病负担和残疾，改善福祉，加强自决和参与 保健，预防疾病和并发症。因此，快速转化为临床应用， 在临床方面很有吸引力，但在个体患者水平上也有很大的希望。

Project Summary/Abstract Insomnia symptoms occur in one-third of the general population and 10-15% meet criteria for insomnia disorder, marked by chronic sleep disturbances that cause devastating effects on health, function and well- being. Symptoms and side effects of cancer and cancer treatments render cancer survivors at increased risk for insomnia disorder. An estimated 40% of cancer survivors report sleep disturbances years after completing treatment. To date, little research exists on strategies to effectively reduce insomnia in cancer survivors, especially in the application of cognitive behavioral therapy for insomnia (CBT-I) at the bedside by nurses. Research in non-cancer populations revealed that CBTI is safe, efficacious, and durable. However, CBTI is not widely available due to a lack of trained professionals and the high cost of treatment. Thus, a major gap in the field of oncology is an alternative to CBTI that is nurse-delivered, rigorously tested, low cost, durable, and having high treatment fidelity. As such, the current objective is to determine efficacy and durability of a streamlined nurse-delivered version of CBTI, specifically Brief Behavioral Therapy for Insomnia (BBTI), using a large heterogeneous sample of cancer survivors. This study proposes a multi-tiered, translational approach to address insomnia in cancer survivors. Aim 1 will determine the efficacy of a manualized BBTI treatment protocol in cancer survivors compared to an attention control previously developed by this team. Aim 2 of the study will determine predictors for efficacy of BBTI to inform future eligibility criteria in dissemination and implementation research. Aim 3 will evaluate BBTI implementation with a focus on characterization of the patient- and provider-level facilitators and barriers. One hundred fifty-eight cancer survivors will be randomized to either BBTI or attention control. Sleep, mood, functional status and quality of life will be evaluated before, 1- month, 3-months and 12-months after the interventions. The primary outcome will be self-reported insomnia severity using the Insomnia Severity Index at 1-month while durability of the intervention will be examined at 3- months and 12-months post treatment. This proposal provides an opportunity for the first time to test the efficacy and durability of a self-management behavioral intervention for cancer survivors with insomnia in order to reduce disease burden and disability, improve well-being, strengthen self-determination and participation in health care, and prevent illness and complications. Thus, the rapid translation to clinical application makes this appealing on the clinical front but has significant promise at the individual patient level as well.