Department of Medicine, Southern Illinois University School of Medicine, Springfield, IL 62794-9636, USA.
Contemp Clin Trials. 2012 Jan;33(1):124-37. doi: 10.1016/j.cct.2011.09.004. Epub 2011 Sep 29.
Most breast cancer survivors do not engage in regular physical activity. Our physical activity behavior change intervention for breast cancer survivors significantly improved physical activity and health outcomes post-intervention during a pilot, feasibility study. Testing in additional sites with a larger sample and longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, enhancing our potential for testing mechanisms mediating physical activity behavior change. Here, we report the rationale, design, and methods for a two-site, randomized controlled trial comparing the effects of the BEAT Cancer physical activity behavior change intervention to usual care on short and longer term physical activity adherence among breast cancer survivors. Secondary aims include examining social cognitive theory mechanisms of physical activity behavior change and health benefits of the intervention. Study recruitment goal is 256 breast cancer survivors with a history of ductal carcinoma in situ or Stage I, II, or IIIA disease who have completed primary cancer treatment. Outcome measures are obtained at baseline, 3 months (i.e., immediately post-intervention), 6 months, and 12 months and include physical activity, psychosocial factors, fatigue, sleep quality, lower extremity joint dysfunction, cardiorespiratory fitness, muscle strength, and waist-to-hip ratio. Confirming behavior change effectiveness, health effects, and underlying mechanisms of physical activity behavior change interventions will facilitate translation to community settings for improving the health and well-being of breast cancer survivors.
大多数乳腺癌幸存者没有进行规律的身体活动。我们的乳腺癌幸存者身体活动行为改变干预措施在一项试点可行性研究中,在干预后即刻、短期和长期都显著改善了身体活动和健康结果。在更多的地点进行更大样本量和更长时间随访的测试是有必要的,以确认该项目在短期和长期内的有效性。重要的是,试点干预措施导致了身体活动和社会认知理论结构的变化,增强了我们测试身体活动行为改变中介机制的潜力。在这里,我们报告了两项随机对照试验的原理、设计和方法,比较了 BEAT Cancer 身体活动行为改变干预措施与常规护理对乳腺癌幸存者短期和长期身体活动依从性的影响。次要目标包括检验身体活动行为改变的社会认知理论机制和干预的健康益处。研究的招募目标是 256 名乳腺癌幸存者,这些幸存者患有导管原位癌或 I 期、II 期或 IIIA 期疾病,且已完成主要癌症治疗。结果测量在基线、3 个月(即干预后即刻)、6 个月和 12 个月时获得,包括身体活动、心理社会因素、疲劳、睡眠质量、下肢关节功能障碍、心肺适能、肌肉力量和腰臀比。确认行为改变的有效性、健康影响和身体活动行为改变干预措施的潜在机制,将有助于将其推广到社区环境,以改善乳腺癌幸存者的健康和福祉。