SALSA - Study of Active Lifestyle Activation

项目总结 拟议的补充资金申请是对PA 20-272的回应，并支持R01 CA263144 (SASA：积极生活方式激活研究；NCT05075759；资助期2021-2026)。萨尔萨是一个遥不可及的 进行了为期12个月的随机对照试验，测试了一种改善体力活动的多方面方法 早期心血管风险增加的儿童癌症长期存活者的饮食质量 疾病。试验的主要结果是减少了久坐时间和改善了饮食质量 12个月后。次要结果包括其他心血管风险因素，如血压和 体重，以及已知与心血管疾病相关的各种血液生物标志物(例如，脂质)的测量 个人资料、胰岛素抵抗、全身炎症和脂肪因子)。总而言之，这些简历风险因素中的许多 可能会导致加速衰老和过早虚弱的表型，现在这种表型越来越多 在癌症幸存者中得到认可，包括儿童癌症幸存者。拟议的补编旨在 目的：加深我们对儿童癌症幸存者加速衰老表型的了解。 具体地说，我们建议与完成为期12个月干预的SASA参与者进行以下接触： 1)更深入的生理功能表型(通过远程方法)，而不是收集的动作图数据 通过父母试验，以及2)收集其他已知与加速衰老有关的生物标记物 癌症幸存者。利用SASA的随机试验设计，我们还将通过研究臂来探索差异 (即，对照组；临床医生主导的目标设定；基于mHealth的目标设定)，以及在这些参与者中 (与研究组无关)在调整心毒性癌症病史的同时有更好的生活方式 暴露在治疗中。虽然这份补充材料的有限性质可能会妨碍我们在统计上识别 组之间的显著差异，这将提供重要的初步数据，证明可行性 使用远程方法评估身体功能，以及关于可能检测到的差异的数据 告知针对特定功能结果和其他生物标记物的未来干预措施的设计 虚弱和加速衰老。

PROJECT SUMMARY The proposed supplemental funding request is in response to PA 20-272, and to support R01 CA263144 (SALSA: Study of Active LifeStyle Activation; NCT05075759; funding period 2021-2026). SALSA is a remotely conducted 12-month randomized controlled trial testing a multi-faceted approach at improving physical activity and diet quality in long-term survivors of childhood cancer at an increased risk of early cardiovascular (CV) disease. The primary outcomes of the trial are reductions in sedentary time and improvements in diet quality after 12 months. Secondary outcomes include other CV risk factors such as changes in blood pressure and weight, and the measurement of various blood biomarkers known to be associated with CV disease (e.g., lipid profile, insulin resistance, general inflammation, and adipokines). Collectively, many of these CV risk factors may contribute to the phenotype of accelerated aging and premature frailty, which is now increasingly recognized among cancer survivors, including survivors of childhood cancer. The proposed supplement seeks to enhance our understanding of the accelerated aging phenotype in survivors of childhood cancer. Specifically, we propose to approach SALSA participants who have completed the 12-month intervention with: 1) more in-depth phenotyping of physical function (via remote methods) beyond the actigraphy data collected by the parent trial, and 2) collect additional biomarkers known to be associated with accelerated aging in cancer survivors. Leveraging SALSA’s randomized trial design, we will also explore differences by study arms (i.e., control group; clinician-led goal-setting; mHealth-based goal setting), and among those participants (irrespective of study arm) who have better lifestyle profiles while adjusting for history of cardiotoxic cancer treatment exposures. While the limited nature of this supplement may preclude our ability to identify statistically significant differences between groups, it will provide important preliminary data demonstrating feasibility of assessing physical function using remote methods, and data on potentially detectable differences that may inform the design of future interventions that seek to target specific functional outcomes and other biomarkers of frailty and accelerated aging.