Enhancing physical activity after breast cancer diagnosis: randomized trial

描述（由申请人提供）：大多数乳腺癌幸存者不从事定期的体力活动（PA）。我们对乳腺癌幸存者的试点PA行为改变干预显著改善了PA和干预后的健康结果。需要在其他临床试验机构进行更长时间的随访，以确认项目的短期和长期有效性。重要的是，试点干预导致了PA和社会认知理论结构的变化，增强了我们对调节PA行为变化的机制进行测试的潜力。因此，我们提出了一项多中心、随机对照试验，招募了256名乳腺癌幸存者，研究目的如下：主要研究目的：为了检查干预有效性，主要研究目的是比较BEAT Cancer PA行为改变干预与常规护理对乳腺癌幸存者短期和长期PA依从性的影响。我们假设，与常规护理相比，干预将导致干预后PA依从性显著增加，并将在干预后3个月和9个月保持。次要研究目的#1：为了更好地理解PA行为改变的机制，次要研究目的#1是比较BEAT Cancer PA行为改变干预与常规护理对社会认知因素的影响，并检查这些变化是否介导PA行为改变。我们假设，与常规护理相比，干预将导致干预所针对的社会认知因素的显着改善。我们还假设，社会认知因素将介导PA的干预效果与选定的因素介导的自我效能的干预效果和自我效能对PA的影响。次要研究目的#2：虽然本提案的主要重点是实现和理解PA行为改变，但我们还旨在比较BEAT Cancer PA行为改变干预与常规护理相比的短期和长期健康影响。我们假设，与常规护理相比，干预将导致健身，肌肉力量，腰臀比，生活质量，疲劳，睡眠质量和关节功能障碍的显着改善。在基线、3个月（即，干预后即刻）、6个月和12个月将包括加速度计（PA和睡眠）、调查（社会认知因素、生活质量、疲劳、感知睡眠和关节功能障碍）、次极量跑步机测试（健身）、测力计（肌肉力量）和腰臀比。研究目标将使用混合模型方差分析（ANOVA）进行分析，次要研究目标#1也使用多变量方差分析（MANOVA）和Freedman-Schatzkin中介系数差异检验。确定PA行为改变干预的效果和潜在机制将有助于转化为社区环境，以改善乳腺癌幸存者的健康和福祉。

DESCRIPTION (provided by applicant): Most breast cancer survivors do not engage in regular physical activity (PA). Our piloted PA behavior change intervention for breast cancer survivors significantly improved PA and health outcomes post-intervention. Testing in additional sites with longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in PA and social cognitive theory constructs, enhancing our potential for testing mechanisms mediating PA behavior change. Therefore, we propose a multi- center, randomized controlled trial enrolling 256 breast cancer survivors with the following study aims: Primary study aim: To examine intervention effectiveness, the primary study aim is to compare the effects of the BEAT Cancer PA behavior change intervention to usual care on short and longer term PA adherence among breast cancer survivors. We hypothesize that, compared with usual care, the intervention will result in a significant increase in PA adherence post-intervention that will be maintained 3 and 9 months post- intervention. Secondary study aim #1: To better understand the mechanisms of PA behavior change, secondary study aim #1 is to compare the effects of the BEAT Cancer PA behavior change intervention to usual care on social cognitive factors and examine if such changes mediate PA behavior change. We hypothesize that, compared with usual care, the intervention will result in significant improvements in social cognitive factors targeted by the intervention. We also hypothesize that social cognitive factors will mediate the intervention effect on PA with selected factors mediating the intervention effect on self-efficacy and the effect of self-efficacy on PA. Secondary study aim #2: Although the primary focus of this proposal is to achieve and understand PA behavior change, we also aim to compare the short and longer term health effects of the BEAT Cancer PA behavior change intervention when compared with usual care. We hypothesize that, compared with usual care, the intervention will result in significant improvements in fitness, muscle strength, waist-to-hip ratio, quality of life, fatigue, sleep quality, and joint dysfunction. Outcome measures obtained at baseline, 3 months (i.e., immediately post-intervention), 6 months, and 12 months will include accelerometer (PA and sleep), survey (social cognitive factors, quality of life, fatigue, perceived sleep, and joint dysfunction), submaximal treadmill test (fitness), dynamometer (muscle strength), and waist-to-hip ratio. The study aims will be analyzed with mixed-model analysis of variance (ANOVA) with the secondary study aim #1 also utilizing multivariate analysis of variance (MANOVA) and Freedman- Schatzkin difference-in-coefficients test of mediation. Identifying the effects and underlying mechanisms of PA behavior change interventions will facilitate translation to community settings for improving the health and well- being of breast cancer survivors.