Insomnia Intervention for Breast Cancer Survivors

乳腺癌幸存者的失眠干预

• 批准号: 6664948
• 负责人: Dana Robin Epstein
• 金额: $ 14.95万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6664948
• 关键词: actigraphy; antidepressants; behavioral /social science research tag; breast neoplasms; clinical research; cognitive behavior therapy; fatigue; female; human subject; human therapy evaluation; long term survivor; patient oriented research; quality of life; sleep disorders; therapy compliance; wakefulness; women's health

DESCRIPTION (provided by applicant): Insomnia is the most common sleep disorder in both the general population and persons with cancer. Many of the sleep characteristics and ineffective insomnia management strategies of patients with cancer are similar to those of persons with insomnia in the general population. Although women with breast cancer appear to have about twice the risk of developing clinically significant levels of insomnia, sleep difficulty has received minimal treatment attention other than pharmacological intervention (e.g. sedatives/hypnotics, antidepressants). There is a paucity of intervention studies addressing the feasibility and efficacy of non-pharmacological treatment for patients most at need and at risk such as breast cancer survivors (BCS). latrogenic, psychological, and developmental factors may contribute to the development of insomnia in BCS and must be considered in the construction and testing of cognitive-behavioral treatment (CBT). The purpose of the study is to pilot test the feasibility (attendance, attrition, adherence to treatment, participant evaluation of treatment) of a multicomponent CBT and the efficacy of CBT for reducing insomnia in BCS. A 2 (group) X 2 (measurement phase) factorial design will be used. Sixty-four breast cancer survivors will be blocked on their type of insomnia (primary or secondary) and randomly assigned within each type of insomnia to one of the two conditions: CBT group or a contact control group. After the screening process, subjects will be assessed at pre-treatment, treatment, and post-treatment. Sleep outcomes will be evaluated using objective (wrist actigraphy) and subjective (daily sleep diaries) measures. In addition, the impact of CBT on the sleep-associated variables of fatigue, mood, and quality of life will also be explored. Descriptive statistics, analyses of covariance, mediational analysis, and regression analysis will be used to examine the data. This feasibility pilot study will provide the basis for a larger study to evaluate efficacy and to examine the effect of the intervention on the quality of survival time and comorbidities among BCS.

描述（由申请人提供）：失眠是普通人群和癌症患者中最常见的睡眠障碍。癌症患者的许多睡眠特征和无效的失眠管理策略与普通人群中的失眠者相似。尽管患有乳腺癌的女性出现临床显着程度的失眠的风险似乎是女性的两倍，但除了药物干预（例如镇静剂/催眠药、抗抑郁药）之外，睡眠困难受到的治疗关注很少。对于乳腺癌幸存者（BCS）等最需要和高风险的患者来说，探讨非药物治疗的可行性和有效性的干预研究很少。产源、心理和发育因素可能导致 BCS 失眠的发生，在构建和测试认知行为治疗 (CBT) 时必须考虑这些因素。该研究的目的是试点测试多成分 CBT 的可行性（出勤率、减员率、治疗依从性、参与者对治疗的评估）以及 CBT 对减少 BCS 失眠的功效。将使用 2（组）X 2（测量阶段）因子设计。 64 名乳腺癌幸存者将被锁定其失眠类型（原发性或继发性），并在每种失眠类型中随机分配到以下两种情况之一：CBT 组或接触对照组。筛选过程结束后，将对受试者进行治疗前、治疗和治疗后评估。将使用客观（手腕活动记录）和主观（每日睡眠日记）测量来评估睡眠结果。此外，还将探讨 CBT 对疲劳、情绪和生活质量等睡眠相关变量的影响。将使用描述性统计、协方差分析、中介分析和回归分析来检查数据。这项可行性试点研究将为更大规模的研究提供基础，以评估疗效并检查干预措施对 BCS 生存时间质量和合并症的影响。