Enhancing physical activity after breast cancer diagnosis: randomized trial

项目摘要 大多数乳腺癌幸存者不从事定期的体力活动（PA）。我们的飞行员PA行为改变 对乳腺癌幸存者的干预显著改善了干预后的PA和健康结果。 在额外的研究中心进行测试，并进行更长时间的随访，以确认短期和长期的项目有效性 term.重要的是，试点干预导致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，我们提出了一个多- 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：为了检验干预效果，主要研究目的是比较 BEAT Cancer PA行为改变干预对短期和长期PA依从性的常规护理 在乳腺癌幸存者中。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个月维持 干预 次要研究目的#1：为了更好地了解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，并检查这些变化是否介导PA行为变化。我们假设， 在常规护理下，干预将导致目标社会认知因素的显着改善， 干预。我们还假设社会认知因素将介导对PA的干预效果 有选择的因素介导的干预效果对自我效能感和影响PA的自我效能。 次要研究目标#2：虽然本提案的主要重点是实现和理解PA行为 改变，我们还旨在比较BEAT Cancer PA行为的短期和长期健康影响 与常规护理相比，改变干预措施。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。 在基线、3个月（即，干预后即刻）、6个月和12个月 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），次最大跑步机测试（健身），测力计（肌肉力量）， 和腰臀比例将采用混合模型方差分析（ANOVA）分析研究目的， 次要研究目标#1也使用多变量方差分析（MANOVA）和Freedman- 沙茨金调解系数差异检验。确定PA的作用和潜在机制 行为改变干预措施将有助于转化为社区环境，以改善健康和福祉， 是乳腺癌幸存者的

Project Abstract 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.