RCT for Mechanisms and Management of Sleep Utilizing Multicenter Clinical Oncology Network

利用多中心临床肿瘤学网络进行睡眠机制和管理的随机对照试验

• 批准号: 8831046
• 负责人: KAREN M. MUSTIAN
• 金额: $ 21.04万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2016-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8831046
• 关键词: Acute; Adverse effects; Affect; Attention; Autonomic Dysfunction; Behavior Control; Behavior Therapy; Behavioral Research; Biological; Breast Cancer Patient; Cancer Center; Cancer Patient; Chronic; Circadian Rhythms; Clinic; Clinical; Clinical Oncology; Clinical Research; Cognitive; Communities; Community Clinical Oncology Program; Controlled Clinical Trials; Country; Data; Development; Diagnosis; Disease Progression; Eating; Education; Etiology; Fatigue; Female; Female Breast Carcinoma; Functional disorder; Funding; Health; Heart Rate; Hour; Individual; Intervention; K-Series Research Career Programs; Learning; Link; Malignant Neoplasms; Measures; Medical; Metastatic breast cancer; Methods; Modeling; Moods; Morbidity - disease rate; Multicenter Studies; Nurses; Outcome; Patients; Peer Review; Phase; Prevalence; Private Practice; Prognostic Factor; Protocols documentation; Psychologist; Quality of life; Randomized; Reporting; Research; Resources; Severities; Sinus Arrhythmia; Site; Sleep; Sleep Disorders; Sleep Wake Cycle; Sleep disturbances; Sleeplessness; Specific qualifier value; Survivors; Symptoms; Telephone; Testing; Time; Training; Universities; Woman; Work; actigraphy; arm; attenuation; base; cancer care; cancer diagnosis; cancer therapy; chemotherapy; cost; design; experience; falls; follow-up; hazard; heart rate variability; improved; indexing; innovation; instrument; malignant breast neoplasm; mortality; novel; novel strategies; public health relevance; respiratory; response

 DESCRIPTION (provided by applicant): Background: Sleep disturbance, particularly insomnia, is prevalent in cancer patients undergoing chemotherapy. Our clinically-based Brief Behavioral Therapy for Insomnia (BBT) is a new approach for treating symptoms during cancer care and can be used 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. The innovation of our behavioral intervention is that we can deliver it in tandem with patients' biomedical treatments, by their bedside, which is a focal point of translational behavioral research, significantly minimizing patient burden. BBT is a brief (3 hrs over 6 weeks), feasible and acceptable intervention that has shown promise in reducing insomnia and cancer-related side effects and in improving circadian rhythms at a single site (Stanford Cancer Center). The development and feasibility of BBT was supported through a K award by the NCI. The proposed Phase II RCT is designed to test the feasibility and efficacy of administering BBT in a multicenter community clinical oncology program (CCOP) network. Methods: The proposed study will gather preliminary efficacy data on conducting BBT in 70 breast cancer patients undergoing chemotherapy in 5 community clinics via CCOP network where the intervention will be conducted by trained clinical staff (e.g., clinical research assistants, nurses) rather than clinical psychologists using our manualized intervention. We will examine the impact of BBT primarily on insomnia and secondarily on mood and quality of life. In addition, we would like to examine underlying biological mechanisms: circadian rhythm disruption, autonomic dysfunction and sleep-wake cycles. This project has already received peer review at the NCI and has been approved as a concept and protocol for a multicenter study. This R21 is needed to support the costs for this project that are not already covered under the University of Rochester Cancer Center CCOP Research Base and the individual CCOPs. Given the recent NCI approval, funding via R21 can leverage the existing CCOP resources by providing funds for examination of the potential involvement of dysregulated circadian rhythms (actigraphy) and autonomic tone (heart rate variability) as biological potential mechanisms for any changes in insomnia noted during the intervention.

 描述（由申请人提供）：背景：睡眠障碍，特别是失眠，在接受化疗的癌症患者中很普遍。我们的基于临床的短暂行为治疗（BBT）是一种治疗癌症护理期间症状的新方法，可用作医疗期间其他行为干预的模式。我们的设计使我们能够在患者出现失眠症状时捕捉他们，但在他们的问题变成慢性病并需要更密集的干预之前。我们行为干预的创新之处在于，我们可以在患者的床边与患者的生物医学治疗同时进行，这是转化行为研究的焦点，大大减少了患者的负担。BBT是一种简短（6周3小时），可行且可接受的干预措施，已显示出减少失眠和癌症相关副作用以及改善单一部位（斯坦福大学癌症中心）昼夜节律的前景。BBT的开发和可行性得到了NCI的K奖的支持。拟定的II期RCT旨在测试在多中心社区临床肿瘤学项目（CCOP）网络中给予BBT的可行性和有效性。 研究方法：拟议的研究将通过CCOP网络收集在5个社区诊所接受化疗的70名乳腺癌患者中进行BBT的初步疗效数据，干预将由经过培训的临床工作人员进行（例如，临床研究助理，护士），而不是临床心理学家使用我们的手动干预。我们将主要研究BBT对失眠的影响，其次是对情绪和生活质量的影响。此外，我们想研究潜在的生物学机制：昼夜节律紊乱，自主神经功能障碍和睡眠-觉醒周期。该项目已经在NCI接受了同行评审，并已被批准为多中心研究的概念和方案。需要该R21来支持本项目的费用，这些费用尚未由罗切斯特大学癌症中心CCOP研究基地和各个CCOP支付。考虑到最近NCI的批准，通过R21的资金可以通过提供资金来检查昼夜节律失调（体动记录）和自主神经张力（心率变异性）的潜在参与，从而利用现有的CCOP资源，作为干预期间注意到的失眠任何变化的生物学潜在机制。