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

CBTI-CS：一种治疗癌症幸存者失眠的新型认知行为疗法

基本信息

批准号：
9190366
负责人：
Christopher John Recklitis
金额：
$ 8.75万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-02-01 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9190366
关键词：
Address Adult Affect Aftercare Behavior Therapy Behavioral Cancer Center Cancer Patient Cancer Survivor Caring Chronic Chronic Insomnia Clinical Cognitive Therapy Control Groups Data Development Evidence based treatment Fatigue Feasibility Studies Feedback Focus Groups General Population Guidelines Health Hot flushes Individual Instruction Intervention Intervention Studies Late Effects Length Malignant Neoplasms Medical Methods Minor Modality National Cancer Institute Outcome Participant Patients Pharmacotherapy Phase Pilot Projects Population Provider Publishing Quality of life Randomized Controlled Trials Relapse Research Sleep Sleeplessness Standardization Survivors Symptoms Testing Training Travel United States Videoconferences Work alternative treatment base cancer survival cancer therapy clinically significant cognitive training comparative efficacy control trial design effective therapy experience group intervention high risk improved innovation intervention program novel phase 1 study programs psychoeducation psychoeducational psychologic psychosocial public health relevance routine care survivorship telehealth treatment as usual treatment effect

项目摘要

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.

描述（由适用提供）：失眠是癌症治疗中最常见的后果之一。尽管在较大的癌症情况下，失眠最初可能似乎是一个较小的症状，但它通常会发展为令人衰弱的慢性病病。实际上，即使在治疗完成10年后，癌症生存经验中有多达27％的临床失眠体验，许多人将睡眠不良的后果描述为“比癌症治疗的影响更大”。在一般人群中，慢性失眠与广泛的负面身体和社会心理健康成果有关。鉴于失眠对生存的重大健康影响，国家癌症研究所强调了作为生存护理的一部分解决睡眠的重要性。然而，研究始终表明失眠症在癌症种群中仍然“识别不足和缺乏”。多次随机控制的试验表明，认知行为治疗（CBT）是一种有效的失眠治疗方法，并且发布的指南将这种方法称为首选的“前线”治疗方法。不幸的是，这种紧急验证的治疗在不断增长的需要它的癌症幸存者中无法获得。此外，即使可以使用，它通常无法解决导致生存失眠的癌症相关症状。行为失眠治疗癌症存活的可用性和有效性受到三个因素的阻碍。 1）治疗是长度典型的6至8个单独的课程； 2）考虑到在CBT中培训失眠的提供者缺乏； 3）当前的CBT处理并不针对有助于生存的睡眠中断的癌症相关符号。为了解决这些障碍，我们开发了针对癌症幸存者（CBTI-CS）的癌症生存-CBT-Insomnia治疗的新简短失眠干预措施（CBTI-CS）。基于使用CBTI-CS干预措施在我们的Center32上的成功试验数据32，我们现在建议将CBTI-CS干预进一步完善为标准化的3-Session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（现在正在进行）中，我们将与来自先前完成的CBTI-CS初步研究的12名参与者进行焦点小组，以进一步完善干预措施。在第2阶段，一项50个癌症存活的随机对照试验将比较CBTI-CS与通常的护理对照组的有效性。在第3阶段，通过基于组的视频会议进行CBTI-CS治疗的试点研究将使用10个癌症存活。尽管经验证据表明，认知行为干预是对失眠症的最佳治疗方法，但它仍然是我们新颖的CBTI-CS干预措施，目标是失眠症患者的特定需求，并通过巩固干预含量和增加新颖的递送方法来减少治疗的障碍。 CBTI-CS干预计划有可能使失眠治疗可广泛用于生存，并显着改善数百万癌症生存的健康和生活质量来自慢性失眠。