Multicenter Randomized Controlled Trial of Brief Behavioral Therapy for Cancer Related Insomnia

短期行为疗法治疗癌症相关失眠的多中心随机对照试验

• 批准号: 10591478
• 负责人: Oxana G Palesh
• 金额: $ 59.76万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10591478
• 关键词: Acute; Affect; Age; American; Attention; Autonomic nervous system; Behavior Control; Behavior Therapy; Behavioral Paradigm; Benchmarking; Breast Cancer Patient; Cancer Center; Cancer Patient; Cancer Survivor; Chronic; Circadian Dysregulation; Circadian Rhythms; Clinic; Clinical; Clinical Oncology; Clinical Research; Cognitive Therapy; Communities; Community Clinical Oncology Program; Country; Development; Diagnosis; Disease; Education; Effectiveness; Effectiveness of Interventions; Exclusion; Fatigue; Functional disorder; Future; Gender; Health; Health Services Accessibility; Healthy Eating; Hydrocortisone; Infusion procedures; Intervention; Learning; Link; Malignant Neoplasms; Measures; Mediator; Medical; Melatonin; Mental disorders; Metastatic breast cancer; Methods; Modeling; Morbidity - disease rate; Nurses; Nursing Research; Outcome; Pathway interactions; Patient Outcomes Assessments; Patients; Phase; Physical activity; Physiological; Private Practice; Prognostic Factor; Psychophysiology; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Research Assistant; Severities; Sinus Arrhythmia; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Stimulus; Survivors; Symptoms; Telephone; Testing; Time; Training; Treatment-Related Cancer; Universities; Woman; Work; acceptability and feasibility; actigraphy; adherence rate; attenuation; cancer care; cancer survival; cancer therapy; cancer type; chemotherapy; circadian; clinical care; community clinic; community setting; design; efficacy evaluation; efficacy testing; experience; heart rate variability; hypothalamic-pituitary-adrenal axis; improved; improvement on sleep; indexing; innovation; interest; intervention effect; malignant breast neoplasm; meetings; mortality; novel; novel strategies; phase II trial; poor sleep; programs; recruit; respiratory; response; side effect; sleep regulation; treatment response

Abstract Background: Sleep disturbances, particularly insomnia, are prevalent in cancer patients undergoing chemotherapy. Our clinically based Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) is a new approach for treating insomnia symptoms during cancer care and can serve as a model for other behavioral interventions during medical treatment. Our design allows us to capture patients just as they are developing insomnia symptoms, but before their problems become chronic and require more intensive intervention. Our behavioral intervention is innovative because we can deliver it in tandem with patients’ biomedical treatments, at the bedside, which significantly reduces patient burden. BBT-CI is a brief (2 face-to-face meetings, four 15-minute phone calls), feasible and acceptable intervention that has shown promise in reducing insomnia and other cancer-related side effects and in improving circadian rhythms at four community oncology clinic sites. Methods: The proposed project will test the efficacy of a novel BBT-CI in multiple private practice clinical oncology settings (n=20) across the country through the University of Rochester Cancer Center NCI Community Oncology Research Program (NCORP). We propose to randomize 400 cancer patients receiving chemotherapy to either BBT-CI or Healthy EAting Education Learning for healthy sleep (HEAL). Our HEAL control condition has been tested in our preliminary trial and is matched to BBT-CI for time and attention while excluding active components of the BBT-CI intervention (i.e., stimulus control, physical activity, circadian entrainment). The proposed innovative study will: 1) test the efficacy of a novel BBT-CI intervention in a community setting (NCORP network), 2) train nurses and clinical assistants to deliver the intervention in the infusion clinic, making it easier to disseminate in the future, and 3) elucidate the psychophysiology of insomnia and treatment response by collecting physiological circadian and autonomic nervous system markers. The proposed study aims to change the paradigm of how behavioral treatments can be delivered by creating and delivering the intervention in tandem with acute cancer care.

摘要 背景：睡眠障碍，尤其是失眠，在癌症患者中很普遍。 正在接受化疗。我们基于临床的癌症相关短期行为疗法 失眠(BBT-CI)是治疗癌症护理期间失眠症状的一种新方法。 可以作为医疗期间其他行为干预的典范。我们的设计 使我们能够在患者出现失眠症状时捕获他们，但在他们出现失眠症状之前 问题变得长期存在，需要更密集的干预。我们的行为干预 是创新的，因为我们可以在患者的生物医学治疗的同时提供它，在 床边，大大减轻了患者的负担。BBT-CI是一个简短的(2次面对面的会议， 4个15分钟的电话)，可行且可接受的干预措施已在 减少失眠和其他与癌症相关的副作用，并改善昼夜节律 四个社区肿瘤科诊所。 方法：建议的项目将测试一种新的BBT-CI在多个私人 通过罗切斯特大学在全国各地实践临床肿瘤学(n=20) 癌症中心NCI社区肿瘤研究计划(NCORP)。我们建议 将400名接受化疗的癌症患者随机分为BBT-CI组或健康饮食组 教育学习健康睡眠(Heavy)。我们的治愈控制条件已经在 我们的初步试验，在时间和注意力方面与BBT-CI匹配，但不包括Active BBT-CI干预的组成部分(即刺激控制、体力活动、昼夜节律 夹带)。拟议的创新研究将：1)测试一种新型BBT-CI的有效性 社区环境干预(NCORP网络)，2)培训护士和临床助理以 在输液诊所提供干预，使其更容易在未来传播，以及3) 收集生理学资料阐明失眠的心理生理学及治疗反应 昼夜节律和自主神经系统标记物。拟议的研究旨在改变 如何通过创建和交付 在急性癌症护理的同时进行干预。