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

项目摘要 失眠是与癌症治疗相关的最常见的问题之一；多达四分之一的人长期失眠 幸存者报告慢性失眠，即使在治疗完成数年后也是如此。1，2未经治疗的失眠与 NCI强调，由于健康问题的广泛清单(例如，心脏病、高血压、糖尿病)，3-12 解决幸存者睡眠问题的重要性，13但失眠仍然“未得到充分认识和治疗”14 在生存护理方面。失眠的认知行为疗法(CBTI)是一种成熟的、经验性的疗法 支持失眠的治疗。多项随机试验已经证明了它在 在普通人群和癌症幸存者中，15-22岁和专业指南支持CBTI为“一线” 23然而，尽管有令人信服的证据，CBTI在很大程度上无法用于不断增长的人口 24向幸存者提供CBTI的障碍包括 传统的CBTI导致遵从性低，访问受限。25、26应对这些挑战并提供 为了有效治疗癌症幸存者的失眠，我们制定了睡眠治疗教育计划-1 (步骤1)，通过提炼在NIH资助的试验中发现成功的简短失眠干预措施(R03CA201459)。 STEP-1是一项自我管理的CBTI干预措施，作为单一在线教育课程提供。交付日期为 讲师进行了75分钟的一对一培训，Step-1向幸存者介绍失眠的原因。 并向他们介绍了CBTI的原则和方法。使用症状自我管理方法， Step-1支持幸存者将计划建议落实到他们的日常生活中 行为规划和带回家的材料。STEP-1代表CBTI治疗的重大创新 并解决了癌症幸存者接受治疗的障碍，因为它简单、成本低、负担轻 比目前可用的CBTI治疗方法更好。基于单臂试验结果显示STEP-1显著 为了减少幸存者的失眠，我们建议对70名癌症幸存者进行随机对照试验(RCT)，评估 与增强的日常护理控制条件相比，STEP-1改善失眠的有效性。同意 未接受治疗6个月的幸存者将被安排参加个人视频会议，在会议中他们将 在随机化之前使用Qualtrics基于网络的平台完成基线测量27(1：1)和 通过现场视频会议接收分配给他们的干预。在干预后4周和8周，参与者 将跟踪数据直接输入Qualtrics，并根据需要在研究人员的帮助下获得25美元的礼物 每一次后续评估的卡片。我们假设失眠症状(主要结果)和情绪 (次要结果)与对照参与者(主要结果)相比，第一步参与者将显著改善 目标)。次要目标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，评估对照干预的可接受性，并探索 为参与者提供个性化的指导，而不会对第一步干预做出重大反应。

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.