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（YACS）特别容易受到癌症治疗的晚期影响，包括 失眠：1-8 1/4的YACS患者在完成治疗数年后仍报告严重失眠。5 -7，9慢性 失眠与严重的健康问题有关（例如，心脏病、肥胖症、高血压、糖尿病， 10 -19由于YACS易受许多相同条件的影响，因此为他们提供 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）是一种成熟的、经验支持的失眠治疗。多 随机试验已经证明了它在一般人群和癌症幸存者中的有效性，23-25 26 和专业指南认可CBTI作为失眠症的“一线治疗”。 令人信服的证据，这种经验验证的治疗方法在很大程度上不适用于不断增长的人口， 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 CBTI治疗针对他们的特定需求。为了解决这些障碍，并提供有效的失眠 治疗YACS，经验支持CBTI干预成人癌症幸存者， 制定年轻成年癌症幸存者睡眠治疗教育计划（STEP-YA）， 在线CBTI干预。在90分钟的同步1：1课程中进行，由讲师STEP-YA带领 解释失眠的原因，介绍CBTI的原则和方法，并解决发展，社会， 以及影响YACS睡眠的健康因素。使用症状自我管理方法，STEP-YA 支持幸存者在日常生活中实施计划建议， 规划根据关于发展和早期测试行为干预措施的建议， 本研究拟通过优化试验评价STEP-YA改善YACS患者失眠的疗效。在这次审判中，94个- 治疗YACS（年龄20-39岁）将随机（1：1）接受STEP-YA干预，1）单独 （非辅导条件），或2）增加2个远程辅导会话（辅导条件）。所有 研究活动将远程完成。具体目的是：1）检验STEP-YA 改善失眠症状（主要结局）和情绪（次要结局），和2）比较 在这些结果的改善，在教练与非教练的条件。第二个目标是探索 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，因为它是短暂的，低成本，低负担，并针对他们的目标， 具体需求。STEP-YA是第一个专门为YACS开发的简短CBTI干预。评价 STEP-YA的有效性和本试验中个性化指导的实用性是优化的关键下一步 干预，规划未来的大规模试验，并最终确保STEP-YA是有效和广泛的， 可用于改善患有慢性失眠症的YACS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.