SALSA - Study of Active Lifestyle Activation

项目概要/摘要 被诊断患有癌症的儿童和青少年现在平均有近85%的5年生存率。然而，在这方面， 早发心血管（CV）疾病已成为晚期死亡的主要非癌症原因， 儿童癌症幸存者。有一个强大的身体的证据，从一般人群，并越来越多， 在癌症幸存者中（即使是那些暴露于心脏毒性癌症治疗的人）， 改善饮食质量可以降低未来CV相关的发病率。然而，尽管许多普通民众和 癌症特异性干预研究集中于单一的生活方式因素（例如，PA或单独饮食）， PA和饮食因素在影响CV健康方面的相互作用，多方面的方法可能会导致总体 更好的长期CV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。 主要在乳腺癌妇女中进行，儿童癌症幸存者的证据是 有限公司为了实现我们的目标，我们将使用最大的前瞻性随访儿童癌症幸存者队列 在世界范围内，儿童癌症幸存者研究（CCSS; n> 24，000），招募成年参与者， 一项远程进行的12个月随机对照试验检测的早期CV疾病风险增加（n=403） 一个多方面的方法来改善PA和饮食质量。具体而言，该研究将使用连续多个 分配随机化试验（SMART）设计，其中PA低或饮食不良的受试者将首先随机化 干预和控制之间的关系。干预受试者将进一步随机接受 临床医生主导的远程医疗会议，重点是风险因素自我管理，或每周移动的健康（mHealth） 通过社交媒体同伴支持支持个性化PA和饮食目标设定。自适应SMART 设计将允许根据初步反应进一步调整干预经验，这可能会增加 整体干预效果。参与者最初对其分配的干预措施没有反应， 随机接受替代干预。该研究将使用消费级移动健康应用程序， 跟踪PA和饮食，从而提高未来的传播能力。这项研究的主要分析将确定 总体干预效果，以及具体的干预策略和策略顺序是否 与最佳结果相关。次要分析将检查潜在的预测因子、介导因子和 随着时间的推移，与PA和饮食变化相关的调节因素，以及参与者 心脏代谢特征总之，生活方式的改变是为数不多的缓解 儿童癌症幸存者的CV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 广泛传播的多方面移动保健支持的干预措施可能发挥变革作用。

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.