Enhancing physical activity after breast cancer diagnosis: randomized trial

描述(申请人提供)：大多数乳腺癌幸存者不从事常规体力活动(PA)。我们对乳腺癌幸存者进行的PA行为改变干预试验显著改善了干预后PA和健康结果。有必要在其他地点进行测试，并进行更长时间的跟踪，以确认计划的短期和长期有效性。重要的是，先导干预导致了PA和社会认知理论结构的变化，增强了我们测试调节PA行为变化的机制的潜力。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：为了检验干预的有效性，主要研究目的是比较BEAT癌症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，并在干预后3个月和9个月保持不变。第二研究目的一：为了更好地了解PA行为改变的机制，第二研究第一个目标是比较节拍癌症PA行为改变干预与常规护理对社会认知因素的影响，并检验这种改变是否中介了PA行为改变。我们假设，与通常的护理相比，干预将导致干预目标社会认知因素的显著改善。我们还假设社会认知因素将中介对PA的干预效应，其中选定的因素中介了对自我效能感的干预效应和自我效能对PA的影响。次要研究目标2：虽然这项建议的主要焦点是实现和理解PA行为改变，但我们也旨在比较与常规护理相比，BEAT癌症PA行为改变干预措施对健康的短期和长期影响。我们假设，与常规护理相比，干预将导致健康、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著改善。在基线、3个月(即干预后即刻)、6个月和12个月时获得的结果测量将包括加速计(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)、次极量跑步机试验(健康)、测力计(肌肉力量)和腰臀比。研究目的将使用混合模型方差分析(ANOVA)进行分析，第二研究目标1还将使用多变量方差分析(MANOVA)和Freedman-Schatzkin差异系数中介检验。确定PA行为改变干预措施的效果和潜在机制将有助于将其转化为社区环境，以改善乳腺癌幸存者的健康和福祉。公共卫生相关性：重要的是制定计划，成功地帮助乳腺癌幸存者适应和维持身体活跃的生活方式。了解为什么这样的计划能够帮助幸存者更有规律地锻炼，并确定这些计划可以预期的健康益处，将指导计划的完善和转化为临床和社区环境。这些信息有望改善健康和生活质量，同时可能减少乳腺癌幸存者的疲劳和癌症复发的风险。

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. PUBLIC HEALTH RELEVANCE: It is important to develop programs that successfully assist breast cancer survivors in adapting and maintaining physically active lifestyles. Learning why such programs are able to help survivors exercise more regularly and identifying the health benefits that can be expected from these programs will guide program refinement and translation to clinical and community settings. Such information is expected to improve the health and quality of life while possibly reducing fatigue and risk of cancer recurrence in breast cancer survivors.