Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training

通过社区有氧运动训练增强乳腺癌幸存者的认知功能

• 批准号: 10691808
• 负责人: Diane Kristen Ehlers
• 金额: $ 44.34万
• 依托单位: MAYO CLINIC ARIZONA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-22 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10691808
• 关键词: Address; Adjuvant Therapy; Adoption; Aerobic Exercise; Affect; Aftercare; Age-associated memory impairment; Aging; Area; Brain; Breast Cancer survivor; Cancer Survivorship; Characteristics; Clinical; Clinical Trials; Clinical effectiveness; Cognition; Cognitive; Cognitive deficits; Communities; Consensus; Data; Dissemination and Implementation; Distress; Education; Effectiveness; Effectiveness of Interventions; Elderly; Evidence based program; Exercise; Exercise Test; Exhibits; Fatigue; Fitness Centers; Funding; Goals; Gold; Health; Health education; Hybrids; Impaired cognition; Individual; Institutionalization; Intervention; Literature; Maintenance; Malignant Neoplasms; Measurement; Measures; Mediator of activation protein; Mind; Neuropsychology; Obesity; Outcome; Participant; Pathogenesis; Pathway interactions; Patient Self-Report; Performance; Physical activity; Population; Postmenopause; Protocols documentation; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Reporting; Research; Research Personnel; Research Support; Rest; Scientist; Short-Term Memory; Site; Stress; Structure; Survivors; Testing; Translations; Treatment Protocols; United States; United States National Institutes of Health; Woman; Work; aged; arm; attentional control; base; brain health; brain morphology; brain volume; breast cancer diagnosis; cancer therapy; cancer-related cognitive impairment; cardiorespiratory fitness; care delivery; chemotherapy; clinically significant; cognitive benefits; cognitive change; cognitive enhancement; cognitive function; cognitive performance; cognitive task; effectiveness testing; effectiveness/implementation design; executive function; exercise intervention; exercise program; exercise training; experience; follow-up; implementation outcomes; improved; information gathering; intervention delivery; neuroimaging; normal aging; novel; optimal treatments; post intervention; primary outcome; secondary outcome; standard care; success; white matter

Project Summary Women aged 50+ years comprise 77% of breast cancer diagnoses and 93% of all breast cancer survivors (BCS). Unfortunately, the interaction between cancer treatment and normal aging often results in a number of health sequelae. Up to 75% of BCS suffer cognitive changes during treatment, and over 45% experience clinically significant cognitive decline pre- to post-treatment. An optimum treatment for cancer-related cognitive impairment (CRCI) is likely one integrating interventions known to improve cognition in similar populations, such as older adults. Our previous research supports the efficacy of moderate-intensity aerobic exercise training for improving cognitive function in older adults without cancer. This work suggests that cardiorespiratory fitness (i.e., peak VO2) and brain structural and functional integrity (e.g., white matter microstructure, resting state functional connectivity) may underlie exercise-induced changes in cognitive function. We recently applied an aging framework to gain preliminary information on the effects of physical activity on cognitive function in BCS. Our work in this area suggests that aerobic exercise training may similarly ameliorate cognitive decline due to cancer and that cancer-related fatigue may also represent a mechanism of exercise’s cognitive benefits in the context of cancer. Our preliminary data in aging and cancer, along with the well-documented benefits of exercise relative to proposed CRCI mechanisms (e.g., cardiorespiratory fitness, fatigue), provide a compelling argument in support of aerobic exercise training for improving cognitive function in BCS. While evidence toward efficacy in this area is growing, few large trials have been conducted and none, to our knowledge, with consideration of dissemination and implementation a priori. We propose a clinical trial in which post-menopausal BCS (3-24 months post primary adjuvant therapy) will be randomized to a community-based aerobic exercise program or attentional control. This study utilizes a Hybrid Type I effectiveness-implementation design to investigate clinical effectiveness while gathering information on implementation success associated with our novel, community- based approach. Our exercise protocol is based upon our previous studies with demonstrated efficacy in older adults, and our community-based approach is based upon our previous studies with demonstrated implementation success in BCS and post-menopausal women without cancer. The specific aims are: 1) Examine the effectiveness of a 6-month, community-based aerobic exercise program, compared to control, on indicators of cognitive function (i.e., cognitive performance, neuroimaging metrics of brain health, self-reported cognitive impairment) in post-menopausal BCS; and 2) Gather information on the intervention’s potential for scalability as defined by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, maintenance). We will also explore intervention interactions with clinical variables (e.g., moderators: chemotherapy treatment regimen, obesity status) and potential pathways by which aerobic exercise, compared to control, influences cognitive function (i.e., mediators: neuroimaging outcomes, cardiorespiratory fitness, fatigue).

项目摘要 50岁以上的女性占乳腺癌诊断的77%，占所有乳腺癌幸存者(BCS)的93%。 不幸的是，癌症治疗和正常衰老之间的相互作用往往会导致许多健康问题 后遗症。高达75%的BCS在治疗过程中发生认知变化，超过45%的患者有临床经验 治疗前后认知功能明显下降。癌症相关认知疾病的最佳治疗方法 损害(CRCI)可能是一种整合已知的干预措施，以改善相似人群的认知，如 作为年长的成年人。我们先前的研究支持中等强度有氧运动训练对 改善非癌症老年人的认知功能。这项工作表明，心肺健康(即， VO2峰值)和大脑结构和功能的完整性(例如，脑白质微结构、静息状态功能 连通性)可能是运动引起的认知功能变化的基础。我们最近进行了一次老化试验 获取有关体力活动对BCS认知功能影响的初步信息的框架。我们的 这方面的研究表明，有氧运动训练同样可以改善癌症引起的认知能力下降。 与癌症相关的疲劳也可能代表了锻炼对认知有益的机制 癌症的威胁。我们关于衰老和癌症的初步数据，以及与锻炼相关的有据可查的好处 对于提出的CRCI机制(例如，心肺健康、疲劳)，提供了令人信服的论点 有氧运动训练对改善BCS患者认知功能的支持虽然有证据表明在 这一领域正在扩大，进行的大型试验很少，据我们所知，没有一次考虑到 传播和实施是先验的。我们建议一项临床试验，在该试验中，绝经后的BCS(3-24 主要辅助治疗后几个月)将随机参加基于社区的有氧运动计划或 注意力控制。本研究采用一种混合I型有效性实施设计来研究临床 效率，同时收集与我们的新社区相关的实施成功的信息- 基于策略的方法。我们的锻炼方案是基于我们之前的研究，证明了对老年人的有效性 成人，我们的基于社区的方法是基于我们之前的研究，展示了 在BCS和绝经后非癌症妇女中实施成功。具体目标是：1)考核 为期6个月的以社区为基础的有氧运动计划与对照相比，对指标的有效性 认知功能(即认知表现、大脑健康的神经成像指标、自我报告的认知能力 绝经后BCS的损害)；以及2)收集关于干预的可伸缩性潜力的信息，如 由RE-AIM框架定义(即，覆盖范围、有效性、采用、实施、维护)。我们会 也探索干预与临床变量的相互作用(例如，调节因素：化疗方案， 肥胖状态)以及有氧运动与对照组相比影响认知的可能途径 功能(即，介体：神经成像结果、心肺健康、疲劳)。