STEP-YA: An Online Self-Management Intervention for Young Adult Cancer Survivors with Insomnia

项目摘要 年轻的成年癌症幸存者(YAC)特别容易受到癌症治疗的晚期影响，包括 失眠：每4个YACS中有1-8个在完成治疗数年后仍报告有严重失眠。5-7，9慢性 失眠与严重的健康问题(如心脏病、肥胖症、高血压、糖尿病、 抑郁和焦虑)。10-19因为YAC很容易受到这些相同条件的影响，为他们提供了 有效的失眠治疗对他们的健康和发育至关重要。 失眠治疗(CBTI)是一种久经考验的治疗失眠的方法。多重 随机试验已经证明了它在普通人群和癌症幸存者中的有效性，23-25 26 专业指南认可CBTI是治疗失眠的“一线治疗”。 令人信服的证据是，这种经验性验证的治疗方法很大程度上无法用于不断增长的 28，29障碍包括缺乏训练有素的提供者，30传统CBTI的高负担，以及缺乏 针对他们的特定需求的CBTI治疗方案。要解决这些障碍，并提供有效的失眠 YACS的治疗，经验支持的针对成人癌症幸存者的CBTI干预被用于 制定针对青年癌症幸存者的睡眠治疗教育计划(STEP-YA)作为简介 CBTI在线干预。在讲师Step-YA的指导下，在90分钟的同步1：1课程中讲授 解释失眠的原因，介绍CBTI的原则和方法，并解决发展，社会， 以及特别影响YACS睡眠的健康因素。使用症状自我管理方法，Step-YA 通过指导行为，支持幸存者将计划建议落实到他们的日常生活中 计划。遵循关于开发和早期测试行为干预措施的建议，31和 建议进行优化试验，以评价STEP-YA改善YACS患者失眠的疗效。在这场审判中，94人- 治疗YACS(年龄20-39岁)将随机(1：1)接受STEP-YA干预，1)单独 (非指导条件)，或2)增加2个远程指导会话(指导条件)。全 学习活动将远程完成。具体目标是：1)检验STEP-YA假设 改善失眠症状(主要结果)和情绪(次要结果)，以及2)比较 与非教练条件相比，教练条件下的这些结果有所改善。次要目标将探索 与干预的临床显著反应相关的参与者因素。STEP-YA地址 YACS幸存者失眠治疗的障碍，因为它是简单、低成本、低负担的，并针对他们的 特定的需求。STEP-YA是第一个专门为YACS开发的简短CBTI干预措施。评估 在这项试验中，Step-YA的有效性和个性化指导的效用是优化下一步的关键 干预，计划未来的大规模试验，并最终确保STEP-YA有效和广泛 可用于改善慢性失眠症患者的健康和生活质量。

Project Summary Young adult cancer survivors (YACS) are particularly vulnerable to late-effects of cancer therapy including insomnia:1-8 1 in 4 YACS reports significant insomnia even years after completing treatment.5-7, 9 Chronic insomnia is associated with significant health problems (e.g., heart disease, obesity, hypertension, diabetes, depression, and anxiety).10-19 As YACS are vulnerable to many of these same conditions, providing them with effective insomnia treatment is critically important to their health and development.20-22 Cognitive-behavioral therapy for insomnia (CBTI) is a well-established, empirically supported treatment for insomnia. Multiple randomized trials have demonstrated its effectiveness in the general population and in cancer survivors,23-25 26 and professional guidelines endorse CBTI as “front-line treatment” for insomnia.27 Unfortunately, despite compelling evidence, this empirically validated treatment is largely unavailable to the growing population of YACS who need it.28, 29 Barriers include lack of trained providers,30 high burden of conventional CBTI, and lack of CBTI treatments targeting their specific needs. To address these barriers and deliver effective insomnia treatment to YACS, empirically supported CBTI interventions for survivors of adult cancers were used to develop the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA) as a brief online CBTI intervention. Delivered in a 90-minute, synchronous 1:1 session led by an instructor, STEP-YA explains causes of insomnia, introduces CBTI principles and methods, and addresses developmental, social, and health factors specifically affecting YACS's sleep. Using a symptom self-management approach, STEP-YA supports survivors in implementing program recommendations into their daily lives with guided behavioral planning. Following recommendations for development and early testing of behavioral interventions,31 an optimization trial is proposed to evaluate efficacy of STEP-YA to improve insomnia in YACS. In this trial, 94 off- treatment YACS (ages 20-39) will be randomized (1:1) to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). All study activities will be completed remotely. Specific aims are: 1) To test the hypothesis that STEP-YA improves insomnia symptoms (primary outcome) and mood (secondary outcome), and 2) To compare the improvement in these outcomes in the coaching versus non-coaching conditions. A secondary aim will explore participant factors associated with clinically significant response to the intervention. STEP-YA addresses barriers to insomnia treatment for YACS survivors because it is brief, low cost, low burden, and targets their specific needs. STEP-YA is the first brief CBTI intervention develop specifically for YACS. Evaluating the efficacy of STEP-YA and the utility of individualized coaching in this trial are critical next steps for optimizing the intervention, planning future large scale trials, and ultimately insuring that STEP-YA is effective and widely available to improve the health and quality-of-life of YACS suffering from chronic insomnia.