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Evaluation of a novel strategy to implement exercise evidence into clinical practice in breast cancer care: protocol for the NEXT-BRCA randomised controlled trial
BMJ Open Sport & Exercise Medicine ( IF 3.9 ) Pub Date : 2020-10-01 , DOI: 10.1136/bmjsem-2020-000922
Jenna Smith-Turchyn , Som Mukherjee , Julie Richardson , Elizabeth Ball , Louise Bordeleau , Sarah Neil-Sztramko , Oren Levine , Lehana Thabane , Arani Sathiyapalan , Catherine Sabiston

Introduction The burden of breast cancer in Canada is steadily growing. More women are surviving breast cancer, yet, survivors live with side effects for years after treatments have ended. The benefits of exercise for women with breast cancer are well established and include improvement in treatment-related physical and emotional side effects. Despite these benefits, few survivors meet exercise guidelines. Exercise programmes are needed within the cancer institution in Canada to bridge the current knowledge to practice gap. The purpose of this study is to test the effects of a novel implementation strategy that includes institution-based exercise plus self-management (SM) or SM alone versus usual care in improving exercise level, quality of life, aerobic capacity, muscle strength and use of healthcare services over 12 months for women with breast cancer receiving chemotherapy. Methods and analysis Participants: Women with stages I–III breast cancer undergoing chemotherapy. Intervention: Group 1: institution-based exercise and SM (8 exercise sessions plus 8 SM modules); Group 2: SM alone; Group 3: usual care. Outcomes: The primary effectiveness outcome is minutes per week of moderate to vigorous physical activity. Secondary outcomes include quality of life, aerobic capacity, muscle strength, and use of healthcare services. Randomisation: Participants will be randomised (1:1:1) to one of the three groups by a blinded statistician and will be stratified based on age of participant (<40, 40–60, and >60 years). Statistical analysis: Outcomes will be measured at baseline, post-intervention, 6-month and 12-month follow-up using an analysis of covariance to test changes between groups over time adjusted for age. Ethics and Dissemination This study addresses a long-standing need to help women with breast cancer undergoing chemotherapy become and stay more active by implementing novel rehabilitation strategies into real-world practice. This is vital in order for this population to minimise the lingering side effects of treatment, improve function and quality of life and prevent cancer recurrence. Trial registration number The study protocol (v1: July 2020) has been registered on ClinicalTrials.gov (NCT04109274).

中文翻译:

在乳腺癌护理的临床实践中应用锻炼证据的新策略的评估:NEXT-BRCA随机对照试验的方案

简介加拿大的乳腺癌负担正在稳步增长。越来越多的女性罹患乳腺癌,但是,幸存者在治疗结束后的数年中一直生活着副作用。运动对乳腺癌妇女的好处已得到公认,包括改善与治疗有关的身体和情绪副作用。尽管有这些好处,幸存者中很少有人遵守运动指南。在加拿大的癌症机构中,需要进行锻炼计划,以弥合当前的知识以弥补差距。这项研究的目的是测试一种新颖的实施策略的效果,该策略包括以机构为基础的锻炼加自我管理(SM)或单独使用SM相对于常规护理在改善锻炼水平,生活质量,有氧运动能力,接受化疗的乳腺癌女性超过12个月的肌肉力量和医疗保健服务的使用。方法和分析参与者:患有I–III期乳腺癌的妇女正在接受化疗。干预:第1组:基于机构的锻炼和SM(8个锻炼课程加上8个SM模块);第2组:仅SM;第三组:日常护理。结果:主要的有效性结果是每周中度到剧烈运动量的分钟。次要结果包括生活质量,有氧运动能力,肌肉力量和使用医疗保健服务。随机分组:参与者将由盲人统计学家随机分为三组之一(1:1:1),并将根据参与者的年龄(<40、40-60和> 60岁)进行分层。统计分析:结果将在基线,干预后,使用协方差分析进行6个月和12个月的随访,以检验随年龄调整的各组之间随时间的变化。道德与传播这项研究提出了一项长期的需求,即通过在现实生活中实施新颖的康复策略来帮助正在接受化疗的乳腺癌女性变得更加活跃。这对于使该人群最大程度地减少治疗的持续副作用,改善功能和生活质量以及防止癌症复发至关重要。试验注册号研究方案(v1:2020年7月)已在ClinicalTrials.gov(NCT04109274)上进行了注册。道德与传播这项研究提出了一项长期的需求,即通过在现实生活中实施新颖的康复策略来帮助正在接受化疗的乳腺癌女性变得更加活跃。这对于使该人群最大程度地减少治疗的持续副作用,改善功能和生活质量以及防止癌症复发至关重要。试验注册号研究方案(v1:2020年7月)已在ClinicalTrials.gov(NCT04109274)上进行了注册。道德与传播这项研究提出了一项长期的需求,即通过在现实生活中实施新颖的康复策略来帮助正在接受化疗的乳腺癌女性变得更加活跃。这对于使该人群最大程度地减少治疗的持续副作用,改善功能和生活质量以及防止癌症复发至关重要。试验注册号研究方案(v1:2020年7月)已在ClinicalTrials.gov(NCT04109274)上进行了注册。
更新日期:2020-10-01
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