Brief Behavioral Intervention for Insomnia During Chemotherapy

化疗期间失眠的简短行为干预

基本信息

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
项目类别：
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

项目摘要

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，尤其是失眠，在接受化学疗法的癌症患者中普遍存在。我们的初步数据表明，我们的新型干预措施，简短的失眠行为疗法（BBT-I）大大减少了接受化学疗法的乳腺癌患者的失眠。 BBT-I是基于失眠（CBT-I）的标准认知行为疗法建模的，包括刺激控制和睡眠计划，并已成功修饰，以使其更适合于最近出现的辅助性化学疗法的乳腺癌患者，并具有最近发育为失眠症症状的乳腺癌患者。我们的初步研究表明，BBT-I是乳腺癌患者失眠的一种可接受且可行的干预措施，这也可能导致疲劳和认知困难的改善。方法：本研究旨在确定BBT-I与注意力匹配的行为控制在减少乳腺癌患者中失眠，疲劳和认知困难相比的功效。此外，这项研究将研究主持人（年龄，抑郁，焦虑和潮热），特定的行为机制（不良适应性睡眠行为，功能障碍的信念和态度）的潜在参与以及生理机制（失调的生理机制）（昼夜节律的失调，均匀的节奏和潜在的唤醒式训练学的变化）疲劳和认知困难的结果。为了解决这些目的，将招募180名急性失眠的乳腺癌患者，并随机分配以接受BBT-I或专注于健康饮食教育的行为控制。每个干预条件将包括2个面对面的会话 + 4个电话，在六个星期内发送。评估将包括睡眠日记，问卷调查，神经心理学测试，动作法，心率变异性测量以及基线，干预后以及6个月和12个月的随访时的唾液皮质醇收集。通过在患者刚刚开始患失眠时进行化学疗法期间提供这种干预措施，我们希望减轻并避免在生存阶段发展慢性失眠。