Brief Behavioral Intervention for Insomnia During Chemotherapy

化疗期间失眠的简短行为干预

• 批准号: 9276643
• 负责人: Oxana G Palesh
• 金额: $ 59.97万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9276643
• 关键词: Acute; Address; Adjuvant; Adverse effects; Affect; Age; Anxiety; Attention; Attitude; Behavior; Behavior Control; Behavior Therapy; Behavioral; Behavioral Mechanisms; Belief; Breast Cancer Patient; Cancer Patient; Cancer Survivor; Chronic Insomnia; Circadian Dysregulation; Circadian Rhythms; Cognitive; Cognitive Therapy; Collection; Control Groups; Data; Development; Diagnosis; Disease Progression; Education; Equipment and supply inventories; Etiology; Fatigue; Female Breast Carcinoma; Functional disorder; Funding; Health; Health Status; Healthy Eating; Hot flushes; Hydrocortisone; Intervention; K-Series Research Career Programs; Lead; Link; Malignant Neoplasms; Measurement; Measures; Mediating; Mediator of activation protein; Mental Depression; Mental disorders; Modeling; Morbidity - disease rate; Neoadjuvant Therapy; Neuropsychological Tests; Outcome; Patients; Phase; Phonation; Physiological; Prognostic Factor; Quality of life; Questionnaires; Radiation therapy; Randomized; Randomized Clinical Trials; Recruitment Activity; Reporting; Research; Research Methodology; Salivary; Schedule; Secondary to; Severities; Sinus Arrhythmia; Sleep; Sleep Disorders; Sleep Wake Cycle; Sleep disturbances; Sleeplessness; Specific qualifier value; Stimulus; Symptoms; Telephone; Testing; Woman; Work; actigraphy; arm; attentional control; attenuation; cancer diagnosis; cancer survival; cancer therapy; chemotherapy; design; diaries; efficacy study; experience; falls; follow-up; hazard; heart rate variability; improved; interest; intervention effect; malignant breast neoplasm; mortality; novel; post intervention; public health relevance; respiratory; response; secondary outcome; survivorship; tumor progression

DESCRIPTION (provided by applicant): Sleep disturbance, particularly insomnia, is prevalent in cancer patients undergoing chemotherapy. Our preliminary data show that our novel intervention, Brief Behavioral Therapy for Insomnia (BBT-I), significantly reduces insomnia in breast cancer patients receiving chemotherapy. BBT-I is modeled on standard cognitive behavioral therapy for insomnia (CBT-I), including both stimulus control and sleep scheduling, and has been successfully modified to make it more suitable for breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy with recently developed insomnia symptoms. Our preliminary research suggests that BBT-I is an acceptable and feasible intervention for insomnia in breast cancer patients that might also lead to improvement in fatigue and cognitive difficulties. Methods: This research is designed to determine the efficacy of the BBT-I in comparison with the attention-matched behavioral control in reducing insomnia, fatigue, and cognitive difficulties in breast cancer patients. In addition, this study will examine the potential involvement of moderators (age, depression, anxiety, and hot flashes), specific behavioral mechanisms (maladaptive sleep behaviors, dysfunctional beliefs and attitudes), and physiological mechanisms (dysregulated circadian rhythms, disrupted wake-sleep cycles, and autonomic tone) as potential mediators of intervention-related changes in insomnia and the secondary outcomes of fatigue and cognitive difficulties. To address these aims, 180 breast cancer patients with acute insomnia during chemotherapy treatment will be recruited and randomized to receive either BBT-I or a behavioral control focused on Healthy Eating Education. Each intervention condition will consist of 2 face-to-face sessions + 4 phone calls, delivered over a period of six weeks. Assessments will include sleep diary, questionnaires, neuropsychological testing, actigraphy, heart rate variability measurement, and salivary cortisol collection at baseline, post-intervention, and 6- and 12 months follow ups. By offering this intervention during chemotherapy when patients are just beginning to develop insomnia, we hope to alleviate and avoid the development of chronic insomnia in the survivorship phase.

描述（由申请人提供）：睡眠障碍，特别是失眠，在接受化疗的癌症患者中很普遍。我们的初步数据显示，我们的新干预措施，失眠的简短行为疗法（BBT-I），显着减少接受化疗的乳腺癌患者的失眠。BBT-I以失眠症的标准认知行为疗法（CBT-I）为模型，包括刺激控制和睡眠时间安排，并已成功地进行了修改，使其更适合于最近出现失眠症状的接受辅助或新辅助化疗的乳腺癌患者。我们的初步研究表明，BBT-I是一种可接受的和可行的乳腺癌患者失眠的干预措施，也可能导致疲劳和认知困难的改善。研究方法：这项研究旨在确定BBT-I与注意力匹配行为控制相比在减少乳腺癌患者失眠，疲劳和认知困难方面的疗效。此外，本研究还将探讨主持人的潜在参与（年龄、抑郁、焦虑和潮热）、特定的行为机制（适应不良的睡眠行为、功能失调的信念和态度）和生理机制（昼夜节律失调、觉醒-睡眠周期紊乱和自主神经张力）作为失眠干预相关变化的潜在介质以及疲劳和认知困难的次要结局。为了实现这些目标，将招募180名在化疗期间患有急性失眠的乳腺癌患者，并随机接受BBT-I或专注于健康饮食教育的行为控制。每种干预条件将包括2次面对面会议+ 4次电话会议，为期六周。评估将包括睡眠日记、问卷调查、神经心理学测试、活动记录仪、心率变异性测量和基线、干预后以及6个月和12个月随访时的唾液皮质醇收集。通过在化疗期间提供这种干预，当患者刚刚开始出现失眠时，我们希望减轻和避免生存期慢性失眠的发展。