Optimization of a remote intervention to improve nutrition and physical activity in colorectal cancer survivors

结直肠癌（CRC）是美国癌症死亡的第二大原因。美国癌症 美国癌症学会（ACS）建议正常的身体质量指数（BMI），定期的体育活动和健康的饮食， 癌症幸存者2018年，我们估计，在诊断后5年内，38%的死亡可以预防， III期结肠癌，如果所有患者都遵循ACS指南。然而，<10%的CRC患者密切关注 这些生活方式指南。研究人员还没有优化生活方式干预，利用有效的 可扩展的组件，以改善CRC幸存者的生活方式行为。关键的研究差距包括：1） 具体的干预组件（例如，文本消息等）有效，无论是整体还是分组 (men（妇女等）; 2)对改善饮食的关注不够; 3）很少有远程干预研究 已经测量了生物学结果。为了解决这些差距，我们建议使用多相优化 一个战略（MOST）框架，以确定有效的干预组成部分，以增加ACS指南评分 （体力活动，饮食和体型的标准化测量）。MOST框架 是一种基于工程的方法，可以有效地优化行为干预，同时管理有限的 资源我们的团队在加州大学弗朗西斯科分校;丹娜-法伯癌症研究所;和 西北大学有很强的专业知识进行癌症幸存者的生活方式干预，包括 使用MOST。基于这一经验，我们建议12个月（月）随机析因试验 在400名CRC幸存者中确定4种候选干预成分的效果[短信， 数字健康工具包（身体活动跟踪器，应用程序），健康指导，伙伴培训（例如，朋友、家人）] ACS指南评分从0到12个月的变化。ACS评分的变化（我们的主要结局） 影响CRC生存率的可能性很高，并且可以远程修改和测量。我们的具体目标是： 目的1）确定4种候选干预成分中的哪一种增加了12个月时的ACS指南评分。 在CRC幸存者中。我们将确定每个组件的个体效应和交互效应。 其次，我们的目标是：目标2）检查中介和调节的干预成分的影响， ACS指南评分从0到12个月的变化。我们将研究社会认知理论的结构， 潜在的主要目标介质和社会人口统计学、临床和心理/行为因素 版主。这一目标将帮助我们了解干预成分如何以及为谁影响生活方式 行为。目的3）研究ACS指南评分与空腹胰岛素、血糖、HOMA-IR水平的关系 和12个月时的炎症标志物。本提案所有三个目标的数据将指导我们的 下一步是进行一项确定性的随机对照试验，以评估优化干预措施的效果 与标准治疗相比，总的来说，这一建议是朝着制定一项 有效和可扩展的生活方式干预，以降低CRC死亡率，并可能对公共卫生产生重大影响。

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States. The American Cancer Society (ACS) recommends normal body mass index (BMI), regular physical activity, and a healthy diet for cancer survivors. In 2018, we estimated that 38% of deaths within 5 years of diagnosis could be prevented in stage III colon cancer if all patients followed the ACS guidelines. Yet, <10% of CRC patients closely follow these lifestyle guidelines. Investigators have yet to optimize a lifestyle intervention, capitalizing on effective scalable components, to improve lifestyle behaviors in CRC survivors. Critical research gaps include: 1) whether specific intervention components (e.g., text messaging, etc.) are effective, overall or in sub-groups (men vs. women, etc.); 2) insufficient focus on improving diet; and 3) few studies with remote interventions have measured biological outcomes. To address these gaps, we propose to use the multiphase optimization strategy (MOST) framework to identify effective intervention components to increase the ACS guideline score (a standardized measure of physical activity, diet, and body size) among CRC survivors. The MOST framework is an engineering-based approach to efficiently optimize behavioral interventions while managing limited resources. Our team at the University of California, San Francisco; Dana-Farber Cancer Institute; and Northwestern University have strong expertise conducting lifestyle interventions in cancer survivors, including using MOST. Building on this experience, we propose a 12-month (mo.) randomized factorial experiment among 400 CRC survivors to determine the effect of 4 candidate intervention components [text messaging, digital health tool kit (physical activity tracker, apps), health coaching, buddy training (e.g., friend, family)] on change in the ACS guideline score from 0 to 12 mo. Changes in the ACS score (our primary outcome) have high potential to impact CRC survival, and it is modifiable and measurable remotely. Our Specific Aims are to: Aim 1) Identify which of 4 candidate intervention components increase the ACS guideline score at 12 mo. among CRC survivors. We will determine the individual and interaction effects of each component. Secondarily, we aim to: Aim 2) Examine mediators and moderators of the intervention components’ effects on change in the ACS guideline score from 0 to 12 mo. We will examine social cognitive theory constructs as primary target mediators and sociodemographic, clinical, and psychological/behavioral factors as potential moderators. This aim will help us understand how and for whom the intervention components affect lifestyle behaviors. Aim 3) Examine the ACS guideline score in relation to levels of fasting insulin, glucose, HOMA-IR and inflammatory markers at enrollment and 12 mo. The data from all three aims of this proposal will guide our next step to conduct a definitive randomized controlled trial to evaluate the effect of the optimized intervention versus standard care on risk of CRC recurrence. Overall, this proposal is a critical step toward developing an effective and scalable lifestyle intervention to reduce CRC mortality with potential for high public health impact.