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》 协会(ACS)推荐正常的身体质量指数(BMI)，有规律的体育活动，以及健康的饮食 癌症幸存者。2018年，我们估计在确诊后5年内38%的死亡可以在 如果所有患者都遵循美国癌症学会的指导方针，则为III期结肠癌。然而，10%的结直肠癌患者紧随其后 这些生活方式指南。调查人员尚未优化生活方式干预，利用有效的 可扩展组件，以改善CRC幸存者的生活方式行为。关键的研究差距包括：1) 特定的干预组件(例如，文本消息等)是有效的，整体的还是分成小组的 (男性与女性等)；2)对改善饮食的关注不够；3)远程干预的研究很少 已经测量了生物结果。为了解决这些差距，我们建议使用多阶段优化 战略(MOST)框架，以确定有效的干预组件，以提高ACS指南得分 (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，可有效优化行为干预，同时管理有限 资源。我们在加州大学旧金山分校、达纳-法伯癌症研究所的团队；以及 西北大学拥有对癌症幸存者进行生活方式干预的强大专业知识，包括 使用最多。在此经验的基础上，我们建议12个月(月)随机析因试验 在400名结直肠癌幸存者中确定4个候选干预成分的效果[文本消息， 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个月更改为12个月。ACS评分的变化(我们的主要结果)有 对结直肠癌存活率有很高的影响，而且是可以远程修改和测量的。我们的具体目标是： 目的1)确定4个候选干预成分中的哪一个在12个月时增加了ACS指南评分。 在CRC幸存者中。我们将确定每个组件的单独和交互影响。 第二，我们的目标是：目的2)考察干预成分的调节和调节作用 ACS指南评分从0个月更改为12个月。我们将考察社会认知理论的结构，如 主要目标媒介和潜在的社会人口学、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对谁影响生活方式 行为。目的3)检查ACS指南评分与空腹胰岛素、血糖、HOMA-IR水平的关系 炎症标志物在入院时和入院后12个月。来自本提案所有三个目标的数据将指导我们的 下一步，进行确定的随机对照试验，以评估优化干预的效果 对比标准护理对CRC复发风险的影响。总体而言，这项提议是朝着制定 有效和可扩展的生活方式干预措施，以降低结直肠癌死亡率，并可能对公共健康产生很大影响。

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.