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，特别是失眠，在接受化疗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——失眠简短行为疗法（BBT-I）可显着减少接受化疗的乳腺癌患者的失眠。 BBT-I以标准失眠认知行为疗法（CBT-I）为蓝本，包括刺激控制和睡眠安排，并已成功进行修改，使其更适合接受辅助或新辅助化疗且最近出现失眠症状的乳腺癌患者。我们的初步研究表明，BBT-I 是治疗乳腺癌患者失眠的可接受且可行的干预措施，还可能改善疲劳和认知困难。方法：本研究旨在确定 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功效。此外，本研究还将探讨调节因素（年龄、抑郁、焦虑和潮热）、特定行为机制（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、觉醒睡眠中断）的潜在参与。周期和自主神经张力）作为干预相关的失眠变化以及疲劳和认知困难的次要结果的潜在中介因素。为了实现这些目标，将招募 180 名在化疗期间出现急性失眠的乳腺癌患者，并随机接受 BBT-I 或以健康饮食教育为重点的行为控制。每个干预条件将包括 2 次面对面会议 + 4 次电话，为期六周。评估将包括睡眠日记、问卷、神经心理学测试、体动记录仪、心率变异性测量以及基线、干预后以及 6 个月和 12 个月随访时的唾液皮质醇收集。通过在化疗期间当患者刚刚开始出现失眠时提供这种干预，我们希望减轻和避免在生存阶段出现慢性失眠。