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

基本信息

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
项目类别：
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

项目摘要

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：癌症患者普遍存在睡眠障碍，尤其是失眠症接受化学疗法。我们基于临床的简短行为疗法与癌症有关失眠（BBT-CI）是治疗癌症护理和治疗失眠症状的新方法可以作为医疗期间其他行为干预措施的模型。我们的设计允许我们捕获患者，就像他们正在出现失眠症状一样，但之前问题变得慢性，需要更深入的干预。我们的行为干预之所以创新，是因为我们可以与患者的生物医学治疗一起交付床边，大大减少了伯恩患者。 BBT-CI是简短的（2次面对面的会议，四个15分钟的电话），可行且可接受的干预措施，已显示出承诺减少失眠和其他与癌症相关的副作用以及改善昼夜节律四个社区肿瘤学诊所网站。方法：拟议的项目将测试多个私有的新型BBT-CI的效率通过罗切斯特大学在全国范围内实践临床肿瘤学环境（n = 20）癌症中心NCI社区肿瘤研究计划（NCORP）。我们建议随机接受400例接受化疗的癌症患者或健康饮食健康睡眠的教育学习（治愈）。我们的治疗控制状况已在我们的初步试验，并与BBT-CI相匹配，以获取时间和注意力 BBT-CI干预的组成部分（即刺激控制，体育锻炼，昼夜节律享受）。拟议的创新研究将：1）测试新型BBT-CI的效率在社区环境中进行干预（NCORP网络），2）培训护士和临床助理在输液诊所进行干预，使将来更容易传播，3）通过收集生理学来阐明失眠和治疗反应的心理生理学昼夜节律和自主神经系统标记。拟议的研究旨在改变通过创建和交付行为治疗如何提供行为治疗的范式与急性癌症护理串联干预。