The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

治疗失眠对乳腺癌幸存者行为减肥结果的影响

• 批准号: 10680737
• 负责人: Michael T Smith
• 金额: $ 67.96万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10680737
• 关键词: Address; Adult; Behavior; Behavioral; Biological; Body Composition; Body Weight; Body Weight decreased; Body fat; Breast Cancer Risk Factor; Breast Cancer Treatment; Breast Cancer survivor; Breast Cancer survivorship; Caloric Restriction; Calories; Cancer Relapse; Cessation of life; Chronic Insomnia; Clinical; Clinical Trials; Cognitive Therapy; Complex; Consumption; Data; Diet; Education; Energy Intake; Fatty acid glycerol esters; Female; Food; General Population; Healthcare; Impairment; Incidence; Individual; International Agency for Research on Cancer; Intervention; Knowledge; Link; Long Term Survivorship; Malignant Neoplasms; Mediating; Medical; Metabolic syndrome; Morbidity - disease rate; Obesity; Outcome; Outcome Measure; Overweight; Participant; Pathway interactions; Patients; Physical activity; Practice Guidelines; Prevalence; Randomized; Randomized Controlled Clinical Trials; Recommendation; Recording of previous events; Recurrence; Recurrent Malignant Neoplasm; Research; Risk; Sleep; Sleep Deprivation; Sleep Disorders; Sleep disturbances; Sleeplessness; Survivors; Technology; Testing; Time; Treatment Efficacy; Treatment outcome; United States; Weight; Weight Gain; Woman; breast cancer diagnosis; breast cancer survival; cancer recurrence; cancer survival; cancer therapy; clinically significant; comorbidity; comparison intervention; dietary; disorder risk; effective intervention; evidence base; improved; improvement on sleep; innovation; malignant breast neoplasm; mortality; multidisciplinary; novel; novel strategies; obesity treatment; poor sleep; prevent; prospective; sleep quality; standard care; telehealth; translational clinical trial; treatment group; treatment guidelines; weight loss intervention; weight maintenance

Overweight and obesity are highly prevalent in the U.S. and are associated with increased breast cancer risk, reduced treatment efficacy, and increased risk of recurrence, medical comorbidity and mortality. Breast cancer survivorship is increasing, and is associated with weight gain, increased fat mass, insomnia, and disease risk, making breast cancer survivorship a major healthcare priority. Weight loss is a standard treatment guideline for individuals with breast cancer with overweight/obesity; however, achieving clinically significant and sustained weight loss is challenging in general, and particularly for those who have undergone breast cancer treatment. While several trials have tested the effects of behavioral weight loss (BWL) in breast cancer survivors, a significant percentage of patients do not achieve clinically significant weight loss. Insomnia disorder is also highly prevalent in individuals with breast cancer and, like obesity, predicts breast cancer risk, progression and death. Research demonstrates that inadequate sleep may directly contribute to obesity and impair weight loss efforts via many behavioral and biological pathways. Several studies demonstrate that cognitive-behavioral therapy for insomnia (CBT-I) is efficacious in treating breast cancer survivors. One approach that has yet to be tested in a large scale study, however, is adding an intervention to improve sleep quality before a BWL intervention. Our preliminary data suggest that CBT-I may enhance weight loss outcomes in women with early stage breast cancer (ESBC). Although the complex, inter-related mechanisms linking sleep, obesity and dietary/physical activity behaviors are only beginning to be explored, we hypothesize that improving insomnia will catalyze weight loss efforts and enhance the effects of BWL on dietary and physical activity behaviors. We propose a randomized controlled clinical trial to test whether a 6-session CBT-I intervention delivered over 8-weeks combined with a one-year BWL intervention (CBT-I+BWL) delivered via telehealth (audio-video) is superior to a sleep education control condition (EDU) combined with BWL (EDU+BWL) among 250 adult female survivors of ESBC who are overweight or obese and have insomnia. Assessments will be conducted at randomization, after CBT-I/EDU, and at 3-, 6-, and 12-months of BWL. We have the following aims: Aim 1: Evaluate the short (3 mo), intermediate (6 mo), and long-term (12-mo) effects of CBT-I+BWL compared to EDU+BWL on weight loss (% TWL 12-months, primary) and body composition (secondary). Aim 2: Evaluate the extent to which 12-month weight loss is mediated by pre to post sleep treatment changes in sleep parameters (Sleep Efficiency, SE; Total Sleep Time, TST). Exploratory Aim 3: Determine whether CBT-I+BWL alters caloric intake, diet quality and/or physical activity relative to EDU+BWL and evaluate the extent to which these factors are associated with sleep continuity and weight loss at 3, 6 and 12-months. This novel approach to addressing sleep disturbances in weight loss treatment has the potential to substantially impact the treatment of obesity and to advance the management of survivors of ESBC.

超重和肥胖在美国非常普遍，并与乳腺癌风险增加有关， 治疗效果降低，复发风险增加，医疗合并症和死亡率增加。乳腺癌 存活率正在增加，并与体重增加、脂肪量增加、失眠和疾病风险有关， 使乳腺癌的生存成为主要的医疗保健优先事项。减肥是一项标准的治疗指南 患有超重/肥胖的乳腺癌患者；然而，在临床上显著和持续的 总的来说，减肥是具有挑战性的，尤其是对那些接受过乳腺癌治疗的人来说。 虽然有几项试验已经测试了行为减肥(BWL)对乳腺癌幸存者的影响，但一项 有很大比例的患者没有达到临床上显著的体重减轻。失眠障碍的发病率也很高 在乳腺癌患者中很常见，和肥胖一样，它可以预测乳腺癌的风险、进展和死亡。 研究表明，睡眠不足可能直接导致肥胖并损害减肥效果 通过许多行为和生物途径。多项研究表明，认知行为疗法对 失眠(CBT-I)是治疗乳腺癌幸存者的有效方法。其中一种方法尚未在 然而，大规模研究在BWL干预之前增加了一项改善睡眠质量的干预措施。我们的 初步数据显示，CBT-I可能会增强早期乳腺癌患者的减肥效果 (ESBC)。尽管将睡眠、肥胖和饮食/体力活动联系起来的复杂、相互关联的机制 行为的探索才刚刚开始，我们假设改善失眠会促进减肥。 努力并增强BWL对饮食和体力活动行为的影响。我们提出了一个随机化的 一项对照临床试验，以测试6次CBT-I干预是否在8周内与 通过远程健康(音频-视频)提供的为期一年的BWL干预(CBT-I+BWL)优于睡眠教育 控制条件(EDU)联合体重指数(EDU+BWL)对250名成年女性ESBC幸存者的影响 超重或肥胖，并有失眠。评估将在CBT-I/EDU之后以随机方式进行， 出生后3个月、6个月和12个月时。我们有以下目标：目标1：评估短(3个月)、中 (6个月)，与EDU+BWL相比，CBT-I+BWL的长期(12个月)减肥效果(%TWL 12个月， 主要)和身体成分(次要)。目标2：评估12个月体重减轻的程度 通过睡眠治疗前后睡眠参数的变化(睡眠效率，SE；总睡眠时间， TST)。探索目标3：确定CBT-I+BWL是否改变卡路里摄入量、饮食质量和/或体力活动 相对于EDU+BWL，并评估这些因素与睡眠连续性和 在3、6和12个月时体重减轻。在减肥治疗中解决睡眠障碍的新方法 有可能对肥胖症的治疗产生重大影响，并促进幸存者的管理 ESBC的。