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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（由申请人提供）：炎症是癌症治疗最常见的不良后果之一。虽然失眠最初在更大的癌症背景下可能看起来是一个小症状，但它往往会发展成为一种使人衰弱的慢性疾病。事实上，多达27%的癌症幸存者在治疗完成后10年内经历了临床上显著的失眠，许多人将睡眠不良的后果描述为“比癌症治疗的影响更压倒性”。“在一般人群中，慢性失眠与一系列负面的身体和心理健康结果有关。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将睡眠作为生存护理的一部分的重要性;然而，研究一致表明，失眠在癌症人群中仍然“认识不足和治疗不足”。多项随机对照试验表明，认知行为治疗（CBT）是治疗失眠的有效方法，已发表的指南支持这种方法作为首选的“一线”治疗方法。不幸的是，这种经过经验验证的治疗方法在很大程度上无法满足日益增长的癌症幸存者的需求。此外，即使有这种治疗方法，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）治疗是快速的-通常为6至8个单独的疗程; 2）接受CBT培训的失眠提供者相当短缺; 3）目前的CBT治疗并不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简短的失眠干预-CBT-癌症幸存者的失眠治疗（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（目前正在进行），我们将与12名来自先前完成的CBTI-CS试验研究的参与者进行焦点小组，以进一步完善干预措施。在第二阶段，一项50名癌症幸存者的随机对照试验将比较CBTI-CS与常规护理对照组的疗效。在第3阶段，将对10名癌症幸存者进行一项通过基于小组的视频会议提供CBTI-CS治疗的试点研究。尽管有经验证据表明，认知行为干预是失眠的最佳治疗方法，但仍有200多万受影响的幸存者无法获得。我们的新型CBTI-CS干预措施针对患有失眠症的癌症幸存者的特定需求，并通过整合干预内容和采用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广泛提供失眠治疗，并显着改善数百万癌症幸存者的健康和生活质量慢性失眠症