SALSA - Study of Active Lifestyle Activation

项目摘要/摘要 现在，被诊断患有癌症的儿童和青少年平均有近85%的5年存活率。然而， 过早的心血管疾病已成为晚年死亡的主要非癌症原因。 儿童癌症幸存者。有来自普通人群的强有力的证据，而且越来越多， 在癌症幸存者中(即使是那些接受心脏毒性癌症治疗的人)，更多的体力活动(PA) 改善饮食质量可以减少未来心血管相关疾病的发病率。然而，虽然许多普通人口和 癌症特异性干预研究侧重于单一的生活方式因素(例如，PA或单独的饮食)，考虑到 PA和饮食因素在影响CV健康方面的相互作用，多方面的方法可能导致总体 更好的长期简历健康状况。对癌症幸存者生活方式干预的研究也一直在进行 主要在患有乳腺癌的女性中进行，儿童癌症幸存者的证据是 有限的。为了实现我们的目标，我们将使用最大的预期跟踪儿童癌症幸存者队列 在世界上，儿童癌症幸存者研究(CCSS；N&>；24,000)招募成年参与者，在 远程进行为期12个月的随机对照试验增加早期心血管疾病的风险(n=403) 多方面的方法来改善PA和饮食质量。具体地说，这项研究将使用顺序倍数 分配随机试验(SMART)设计，其中低PA或饮食不良的参与者将首先被随机分组 在干预和控制条件之间。干预参与者将进一步随机接受 临床医生主导的远程医疗会议侧重于风险因素自我管理，或每周移动医疗(MHealth) 通过社交媒体同龄人的支持，支持个性化PA和饮食目标设定。自适应智能 设计将允许根据初始响应进一步调整干预体验，这可能会增加 总体干预效果。最初对分配给他们的干预没有反应的参与者将进一步 随机接受替代干预。这项研究将使用消费级移动健康应用程序， 跟踪PA和饮食，从而增加未来的传播能力。这项研究的初步分析将确定 总体干预效果以及具体的干预策略和策略序列是否 与最佳结果相关。二次分析将检查潜在的预测者、中介者和 随着时间的推移，与PA和饮食变化相关的缓和因素，以及参与者的 心脏代谢特征。总而言之，改变生活方式是为数不多的缓解 儿童癌症幸存者的心血管风险。重大障碍(例如，时间、培训、资源)限制了 医疗保健系统，以促进这种变化。为了填补这一空白，基于远程的、个性化的、轻松的 传播的、多方面的、由移动健康支持的干预措施可能发挥变革性作用。

PROJECT SUMMARY / ABSTRACT Children and adolescents diagnosed with cancer now have, on average, nearly 85% 5-year survival. However, premature cardiovascular (CV) disease has become the leading non-cancer cause of late mortality among childhood cancer survivors. There is a robust body of evidence from the general population, and increasingly, among cancer survivors (even those exposed to cardiotoxic cancer therapies), that greater physical activity (PA) and improved diet quality can reduce future CV-related morbidity. However, while many general population and cancer-specific intervention studies have focused on a single lifestyle factor (e.g., PA or diet alone), given the interplay between PA and dietary factors in influencing CV health, a multi-faceted approach may result in overall better long-term CV health profiles. Research on lifestyle interventions in cancer survivors also has been predominantly conducted in women with breast cancer, and the evidence for survivors of childhood cancer is limited. To accomplish our aims, we will use the largest prospectively followed childhood cancer survivor cohort in the world, the Childhood Cancer Survivor Study (CCSS; n>24,000), to recruit adult-aged participants at increased risk of early CV disease (n=403) for a remotely conducted 12-month randomized controlled trial testing a multi-faceted approach at improving PA and diet quality. Specifically, the study will use a sequential multiple assignment randomized trial (SMART) design, where participants with low PA or poor diet will first be randomized between intervention and control conditions. Intervention participants will be further randomized to receive either clinician-led telehealth sessions focused on risk factor self-management, or weekly mobile health (mHealth) supported individualized PA and dietary goal-setting with social media peer support. The adaptive SMART design will allow further tailoring of the intervention experience based on initial response, which may increase overall intervention efficacy. Participants not initially responsive to their assigned intervention will be further randomized to receive an alternate intervention. The study will use consumer-grade mHealth applications that track PA and diet, thereby increasing future dissemination capacity. The study’s primary analyses will determine the overall intervention efficacy and whether specific intervention strategies and sequence of strategies are associated with optimal outcomes. Secondary analyses will examine potential predictors, mediators, and moderating factors associated with PA and dietary changes over time, as well as changes in participants’ cardiometabolic profiles. In summary, lifestyle change represents one of the few available strategies to mitigate CV risk in childhood cancer survivors. Significant barriers (e.g., time, training, resources) limit the ability of healthcare systems to facilitate such change. To fill this void, remote-based, personalized, and easily disseminated multi-faceted mHealth-supported interventions may play a transformative role.