Sleep Treatment Education Program-1 (STEP-1): A Randomized Trial of a Self-Management Insomnia Intervention for Cancer Survivors

项目摘要 炎症是与癌症治疗相关的最常见问题之一;多达四分之一的长期 幸存者甚至在治疗完成后数年仍报告慢性失眠。1，2由于未经治疗的失眠与 具有广泛的健康问题列表（例如，心脏病，高血压，糖尿病），3 -12，NCI强调， 解决幸存者睡眠问题的重要性，13但失眠仍然“认识不足，治疗不足“14 幸存者护理失眠症的认知行为疗法（CBTI）是一种成熟的，经验丰富的 支持治疗失眠。多项随机试验已证明其在 一般人群和癌症幸存者，15-22和专业指南认可CBTI为“一线” 然而，尽管有令人信服的证据，CBTI在很大程度上不适用于不断增长的人口 24向幸存者提供CBTI的障碍包括： 常规CBTI导致低依从性和有限的访问。25、26为了应对这些挑战， 有效的失眠治疗癌症幸存者，我们制定了睡眠治疗教育计划-1 （STEP-1），通过改进在NIH资助的试验（R 03 CA 201459）中发现成功的简短失眠干预措施。 STEP-1是一种自我管理CBTI干预，作为单一的在线教育课程提供。交付的 一个75分钟，1对1的会议由教练，步骤1教育幸存者有关失眠的原因后， 并向他们介绍CBTI的原则和方法。使用症状自我管理方法， STEP-1支持幸存者在日常生活中实施计划建议， 行为规划和带回家的材料。STEP-1代表了CBTI治疗的重大创新 并解决了癌症幸存者的治疗障碍，因为它简短，成本低，负担轻 比目前可用的CBTI治疗更有效。基于单组试验结果显示STEP-1显著 减少幸存者的失眠，我们提出了一个随机对照试验（RCT）的70名癌症幸存者评估 STEP-1改善失眠的功效与增强的常规护理控制条件相比。同意 将安排停药≥ 6个月的幸存者参加单独的视频会议， 在随机化（1：1）前使用Qualtrics网络平台27完成基线测量，以及 通过实时视频会议接受指定的干预。在干预后4周和8周，参与者 将在研究工作人员的协助下，将随访数据直接输入Qualtrics，并获得25美元的礼品 每一个后续评估的卡片。我们假设失眠症状（主要结果）和情绪 STEP-1受试者（次要结局）相对于对照受试者（主要结局） aim）。次要目的包括确定与临床相关的参与者和干预因素。 对STEP-1的显著反应，评估控制干预的可接受性，并探索 为对STEP-1干预没有显著反应的参与者提供个性化辅导。

Project Summary Insomnia is one of the most common problems associated with cancer therapy; as many as 1 in 4 long-term survivors report chronic insomnia even years after therapy completion.1, 2 As untreated insomnia is associated with an extensive list of health problems (e.g., heart disease, hypertension, diabetes),3-12 the NCI emphasizes the importance of addressing sleep in survivors,13 yet insomnia remains “under-recognized and undertreated”14 in survivorship care. Cognitive-behavioral therapy for insomnia (CBTI) is a well-established and empirically supported treatment for insomnia. Multiple randomized trials have demonstrated its effectiveness in the general population and in cancer survivors,15-22 and professional guidelines endorse CBTI as “front-line” insomnia treatment.23 Yet, despite compelling evidence, CBTI is largely unavailable to the growing population of cancer survivors who need it.24 Barriers to delivering CBTI to survivors include the significant burdens of conventional CBTI leading to low adherence, and limited access. 25, 26 To address these challenges and deliver effective insomnia treatment to cancer survivors, we developed the Sleep Treatment Education Program-1 (STEP-1), by refining brief insomnia interventions found successful in an NIH-funded trial (R03CA201459). STEP-1 is a self-management CBTI intervention delivered as a single online educational session. Delivered in a 75-minute, 1 on 1 session by an instructor, STEP-1 educates survivors about causes of insomnia after cancer and introduces them to CBTI principles and methods. Using a symptom self-management approach, STEP-1 supports survivors in implementing program recommendations into their daily lives with guided behavioral planning and take-home materials. STEP-1 represents a significant innovation in CBTI treatment and addresses barriers to treatment for cancer survivors because it is brief, low cost, and less burdensome than currently available CBTI treatments. Based on single-arm trial results showing STEP-1 significantly reduces survivors' insomnia, we propose a randomized controlled trial (RCT) of 70 cancer survivors evaluating efficacy of STEP-1 to improve insomnia compared to an enhanced usual care control condition. Consenting survivors ≥ 6 months off-therapy will be scheduled for an individual videoconference session in which they will complete baseline measures using the Qualtrics web-based platform27 before being randomized (1:1) and receiving their assigned intervention via live videoconference. At 4- & 8-weeks post-intervention, participants will enter follow-up data directly into Qualtrics, with study staff assistance as needed, and receive a $25 gift card for each follow-up assessment. We hypothesize insomnia symptoms (primary outcome) and mood (secondary outcome) will improve significantly in STEP-1 participants relative to control participants (primary aim). Secondary aims include identifying participant and intervention factors associated with clinically significant response to STEP-1, evaluating acceptability of the control intervention, and exploring feasibility of providing individualized coaching for participants without a significant response to the STEP-1 intervention.