Ehlers Diane K, Austin Jessica D, Ernst Brenda, Page Lindsey L, Ofori Edward, Porter Gwenndolyn C, Fanning Jason, Hickman Gabriella, McKim Paul, Cole Melissa, Donaldson Maliyah, Braden B Blair, Kunze Katie L, Butterfield Richard J, Baxter Leslie C, Ahles Tim A, Estabrooks Paul
Department of Quantitative Health Sciences, Mayo Clinic, Phoenix, Arizona, USA
Department of Quantitative Health Sciences, Mayo Clinic, Phoenix, Arizona, USA.
BMJ Open. 2025 Jul 13;15(7):e104378. doi: 10.1136/bmjopen-2025-104378.
Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The reast cancer easoning and ctivity tervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.
This Hybrid Type I effectiveness-implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I-IIIa breast cancer and within 3-36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.
This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.
NCT04816006.
尽管越来越多的证据描述了乳腺癌女性患者的癌症相关认知功能下降（CACD），但减轻CACD的干预措施却很有限。新出现的证据表明，有氧运动可能会提高乳腺癌诊断和治疗后的认知能力；然而，CACD仍然是运动研究中一个未被充分研究的结果，并且很少有高质量的研究。除了在有效性方面存在知识空白外，将运动干预措施推广到社区环境仍然具有挑战性。乳腺癌推理与活动干预（BRAIN）研究在社区环境中进行的有氧运动训练对改善乳腺癌女性患者认知功能的有效性，并收集有关该干预措施实施成功情况的信息。
这项混合型I类有效性-实施研究在美国西南部的一个学术医疗中心与一个非营利性社区健康与保健组织合作开展。该研究招募160名被诊断为I-IIIa期乳腺癌且在治疗完成后3至36个月内的女性，进行1:1随机对照试验。随机分配到运动组的个体接受为期6个月、由当地社区健身中心聘请的运动教练提供的个性化有氧运动计划。该计划本质上是循序渐进的，旨在帮助参与者达到与癌症幸存者指南一致的有氧运动水平。随机分配到对照组的个体接受由医院健康教育工作者通过虚拟方式提供的为期6个月的健康教育对照干预。在基线、6个月（干预后）和12个月（随访）时测量认知表现（主要指标）、自我报告的认知、患者报告的结果、身体活动和心肺适能。在基线和6个月时通过磁共振成像（MRI）测量脑结构和功能。实施结果由RE-AIM框架定义，该框架包括覆盖范围、有效性、采用情况、实施情况和维持情况。RE-AIM结果在基线、6个月、12个月以及研究期间持续测量。
本研究已获得梅奥诊所机构审查委员会批准（#23-000020）。所有参与者在参与前均提供知情同意书。研究结果将通过论文、报告和时事通讯传播给科学、临床和社区受众。
NCT04816006。
