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: 10642316
• 负责人: Oxana G Palesh
• 金额: --
• 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/10642316
• 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; Fatigue; Functional disorder; Future; Gender; Gold; Health; Health Services Accessibility; Healthy Eating; Hydrocortisone; Infusion procedures; Intervention; Learning; Link; Malignant Neoplasms; Measures; Mediator of activation protein; 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; base; 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; 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.

抽象的 背景：睡眠障碍，特别是失眠，在癌症患者中普遍存在 正在接受我们基于临床的癌症相关短期行为疗法。 失眠（BBT-CI）是一种治疗癌症护理和治疗期间失眠症状的新方法。 可以作为我们的设计中其他行为干预的模型。 使我们能够在患者出现失眠症状时、但在他们出现之前捕捉到他们的信息 问题变得长期存在，需要我们进行更深入的行为干预。 之所以具有创新性，是因为我们可以将其与患者的生物医学治疗同时进行 床边，这显着减轻了患者的负担 BBT-CI 是一个简短的（2 次面对面会议， 四次 15 分钟的电话），可行且可接受的干预措施已显示出希望 减少失眠和其他与癌症相关的副作用，并改善昼夜节律 四个社区肿瘤诊所。 方法：拟议的项目将测试新型 BBT-CI 在多个私人中的功效 通过罗切斯特大学在全国各地开展临床肿瘤学实践（n=20） 我们建议 NCI 癌症中心社区肿瘤学研究计划 (NCORP)。 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 健康睡眠教育学习 (HEAL) 我们的 HEAL 控制条件已经过测试。 我们的初步试验，与 BBT-CI 的时间和注意力相匹配，同时排除活跃的 BBT-CI 干预的组成部分（即刺激控制、身体活动、昼夜节律） 拟议的创新研究将：1）测试新型 BBT-CI 的功效。 社区环境干预（NCORP 网络），2) 培训护士和临床助理 在输液诊所提供干预措施，以便将来更容易传播，以及 3) 通过收集生理学来阐明失眠的心理生理学和治疗反应 拟议的研究旨在改变昼夜节律和自主神经系统标记。 如何通过创建和提供行为治疗来提供的范式 与急性癌症护理同时进行干预。