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.

摘要 背景：睡眠障碍，尤其是失眠，在癌症患者中普遍存在 正在接受化疗我们基于临床的癌症相关的简短行为疗法 失眠（BBT-CI）是治疗癌症护理期间失眠症状的一种新方法， 可以作为医学治疗过程中其他行为干预的模型。我们的设计 使我们能够捕捉到病人，就像他们正在发展失眠症状，但在他们之前， 这些问题成为长期问题，需要更深入的干预。我们的行为干预 是创新的，因为我们可以将其与患者的生物医学治疗结合起来， 床旁，大大减轻了患者负担。BBT-CI是一个简短的（2个面对面的会议， 四个15分钟的电话），可行和可接受的干预措施， 减少失眠和其他癌症相关的副作用，并改善昼夜节律， 四个社区肿瘤诊所。 方法：该项目将测试一种新型BBT-CI在多个私人 通过罗切斯特大学在全国范围内进行临床肿瘤学实践（n=20） 癌症中心NCI社区肿瘤学研究计划（NCORP）。我们建议 将400名接受化疗的癌症患者随机分为BBT-CI组和Healthy Eating组 健康睡眠（HEAL sleep）我们的HEAL控制条件已经过测试 我们的初步试验，并匹配BBT-CI的时间和注意力，同时排除积极的 BBT-CI干预的组成部分（即，刺激控制，身体活动，昼夜节律 夹带）。拟议的创新研究将：1）测试新型BBT-CI的疗效 社区干预（NCORP网络），2）培训护士和临床助理， 在输液诊所提供干预措施，使其在未来更容易传播，以及3） 阐明失眠的心理生理和治疗反应，通过收集生理 昼夜节律和自主神经系统标记物。这项研究旨在改变 行为治疗如何通过创建和提供 干预与急性癌症护理相结合。