CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors

 描述(申请人提供)：失眠是癌症治疗最常见的不良后果之一。虽然失眠最初在较大的癌症背景下可能看起来是一个轻微的症状，但它往往会发展成一种令人衰弱的慢性疾病。事实上，多达27%的癌症幸存者甚至在治疗完成10年后也会经历临床上严重的失眠，许多人将睡眠不良的后果描述为“比癌症治疗的效果更令人无法抗拒”。在一般人群中，慢性失眠与一系列负面的身体和心理社会健康后果有关。鉴于失眠对幸存者健康的重大影响，美国国家癌症研究所强调了将睡眠作为生存护理的一部分的重要性；然而，研究一直表明，在癌症人群中，失眠仍然“得不到充分认识和治疗”。多项随机对照试验已经证明，认知行为疗法(CBT)是治疗失眠的有效方法，发表的指南支持这种方法为首选的“一线”治疗方法。不幸的是，这种经验性验证的治疗方法在很大程度上无法为需要它的不断增长的癌症幸存者提供。此外，即使有了它，它也往往无法解决导致幸存者失眠的癌症相关症状。癌症幸存者的行为失眠治疗的可用性和有效性受到三个因素的阻碍：1)治疗时间较长--通常是6至8个单独疗程；2)接受过CBT治疗失眠培训的提供者相当短缺；3)目前的CBT治疗没有针对导致幸存者睡眠中断的癌症相关症状。为了解决这些障碍，我们专门为癌症幸存者开发了一种新的短暂失眠干预措施-CBT-癌症幸存者失眠治疗(CBTI-CS)。基于我们中心使用CBTI-CS干预的成功试点数据32，我们现在建议将CBTI-CS干预进一步细化为标准化的3次会议心理教育计划，并在对照试验中测试其有效性。在研究的第一阶段(现正进行中)，我们将从先前完成的CBTI-CS先导研究中，与12名参与者进行焦点小组研究，以进一步完善干预措施。在第二阶段，一项对50名癌症幸存者进行的随机对照试验将比较CBTI-CS与普通护理对照组的疗效。在第三阶段，将对10名癌症幸存者进行一项试点研究，通过基于小组的视频会议提供CBTI-CS治疗。尽管经验证据表明，认知行为干预是治疗失眠的最佳方法，但仍有200多万受影响的幸存者无法获得这种干预。我们的新型CBTI-CS干预针对患有失眠的癌症幸存者的特定需求，并通过整合干预内容和纳入新的交付方法来减少治疗障碍。CBTI-CS干预计划有可能为幸存者提供广泛的失眠治疗，并显著改善数百万癌症幸存者的健康和生活质量 慢性失眠。

 DESCRIPTION (provided by applicant): Insomnia is one of the most frequent unwanted consequences of cancer treatment. While insomnia may initially appear to be a minor symptom in the larger cancer context, it often develops into a debilitating chronic medical condition. In fact, as many as 27% of cancer survivors experience clinically significant insomnia even 10 years after treatment completion and many describe the consequences of poor sleep as "more overwhelming than the effects of cancer treatment." In the general population, chronic insomnia is associated with an extensive list of negative physical and psychosocial health outcomes. Given the significant health implications of insomnia for survivors, the National Cancer Institute emphasizes the importance of addressing sleep as part of survivorship care; yet research consistently shows insomnia remains "under-recognized and undertreated" in cancer populations. Multiple randomized-controlled trials have demonstrated that cognitive- behavioral treatment (CBT) is an effective treatment for insomnia, and published guidelines endorse this approach as the preferred "front-line" treatment approach. Unfortunately, this empirically validated treatment is largely unavailable to the growing population of cancer survivors who need it. Moreover, even when it is available it often fails to address cancer-related symptoms contributing to survivors' insomnia. The availability and efficacy of behavioral insomnia treatments for cancer survivors is impeded by three factors; 1) Treatment is lengthy-typically 6 to 8 individual sessions; 2) There is a considerable shortage of providers trained in CBT for insomnia; and 3) Current CBT treatments do not target the cancer-related symptoms that contribute to survivors' disrupted sleep. To address these impediments, we have developed a new brief insomnia intervention specifically for cancer survivors-CBT-Insomnia Treatment for Cancer Survivors (CBTI- CS). Based on successful pilot data using the CBTI-CS intervention at our center32 we now propose to further refine the CBTI-CS intervention into a standardized 3-session psychoeducational program, and test its efficacy in a controlled trial. In Phase 1 of the study (now underway), we will conduct focus groups with 12 participants from previously completed CBTI-CS pilot studies to further refine the intervention. In Phase 2, a randomized controlled trial of 50 cancer survivors will compare the efficacy of CBTI-CS to a usual care control group. In Phase 3, a pilot study delivering the CBTI-CS treatment via group-based videoconference will be conducted with 10 cancer survivors. Despite empirical evidence that cognitive-behavioral interventions are the best treatment for insomnia, it remains unavailable to the more than 2 million affected survivors. Our novel CBTI-CS intervention targets the specific needs of cancer survivors with insomnia, and reduces barriers to treatment by consolidating intervention content and incorporating novel delivery methods. The CBTI-CS intervention program has the potential to make insomnia treatment widely available for survivors, and to significantly improve the health and quality of life for the millions of cancer survivors suffering from chronic insomnia.