SALSA - Study of Active Lifestyle Activation

SALSA - 积极生活方式激活研究

• 批准号: 10285925
• 负责人: Eric Jessen Chow
• 金额: $ 21.7万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10285925
• 关键词: Accelerometer; Adolescent; Adult; Age; Attitude; Blood Pressure; Cancer Survivor; Cardiotoxicity; Cardiovascular Diseases; Cardiovascular system; Caring; Cause of Death; Cessation of life; Child; Childhood; Childhood Cancer Survivor Study; Chronic Disease; Competence; Counseling; Decision Making; Development; Diabetes Mellitus; Diagnosis; Diet; Diet Habits; Dietary Factors; Dyslipidemias; Exposure to; Future; General Population; Goals; Health; Healthcare; Healthcare Systems; Healthy Eating; Heart failure; Home; Hypertension; Inflammation; Insulin; Intervention; Intervention Studies; Life Style; Lipids; Long-Term Survivors; Maintenance; Malignant Neoplasms; Mediator of activation protein; Mobile Health Application; Morbidity - disease rate; Myocardial Ischemia; Neighborhoods; Outcome; Participant; Pharmacology; Physical activity; Physiological; Play; Randomized; Randomized Controlled Trials; Research; Research Design; Resources; Risk; Risk Factors; Role; Self Determination; Self Efficacy; Self Management; Sequential Multiple Assignment Randomized Trial; Survivors; Testing; Time; Training; Treatment Efficacy; Unhealthy Diet; Woman; active lifestyle; aged; arm; base; cancer therapy; cardiometabolism; cardiovascular health; cardiovascular risk factor; childhood cancer survivor; cohort; dietary; experience; follow-up; improved; indexing; innovation; intervention participants; lifestyle factors; lifestyle intervention; mHealth; malignant breast neoplasm; modifiable risk; mortality; patient engagement; peer support; premature; prospective; recruit; remote delivery; response; secondary analysis; sedentary; sex; social media; survivorship; telehealth; theories; treatment arm; trial design; young adult

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.

项目摘要 /摘要 现在，被诊断出患有癌症的儿童和青少年现在平均拥有近85％的5年生存率。然而， 早产心血管（CV）疾病已成为主要的非癌症病因 儿童癌症存活。普通人群有强大的证据，越来越多的证据 在癌症存活（即使暴露于心脏毒性癌疗法的生存）中，有更多的体育活动（PA） 改善饮食质量可以降低未来与CV相关的发病率。但是，许多一般人口和 鉴于癌症特异性干预研究的重点是单个生活方式因素（例如，单独的PA或饮食）。 PA与影响CV健康的饮食因素之间的相互作用，多方面的方法可能会导致总体 更好的长期简历健康概况。关于癌症幸存者生活方式干预措施的研究也是 主要是在乳腺癌女性中进行的，儿童癌症生存的证据是 有限的。为了实现我们的目标，我们将使用最大的前瞻性追随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），以招募成人时代的参与者 远程进行的12个月随机对照试验测试的早期CV疾病风险增加（n = 403） 一种多方面的方法，可改善PA和饮食质量。具体而言，该研究将使用顺序倍数 分配随机试验（智能）设计，在该设计中，PA或饮食低的参与者将首先随机分配 在干预和控制条件之间。干预参与者将进一步随机接收 临床主导的远程医疗课程重点是危险因素自我管理或每周移动健康（MHEAXTH） 通过社交媒体同伴支持，支持个性化的PA和饮食目标。自适应智能 设计将允许基于初始响应的干预经验进一步调整，这可能会增加 总体干预效率。最初对他们指定的干预措施做出反应的参与者将进一步 随机接受替代干预措施。该研究将使用消费级MHealth应用程序 跟踪PA和饮食，从而提高未来的传播能力。该研究的主要分析将决定 总体干预效率以及特定的干预策略和策略顺序是否是 与最佳结果相关。次级分析将检查潜在的预测因素，调解人和 随着时间的推移和参与者的变化，与PA和饮食变化相关的调节因素以及参与者的变化 心脏代谢概况。总而言之，生活方式的改变是减轻少数可用策略之一 儿童癌症中的简历风险存活。重大障碍（例如时间，培训，资源）限制了 医疗保健系统促进这种变化。填充这个空隙，基于遥远的个性化且轻松的 传播的多面MHealth支持的干预措施可能起变革性的作用。