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

优化远程干预以改善结直肠癌幸存者的营养和身体活动

基本信息

批准号：
10737755
负责人：
Erin Lynn Van Blarigan
金额：
$ 19.87万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-12-10 至 2025-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10737755
关键词：
Accelerometer Address Affect Age American Cancer Society Behavior Behavior Therapy Behavioral Biological Biology Body Size Body mass index California Cancer Etiology Cancer Survivor Cessation of life Clinical Colon Carcinoma Colorectal Cancer Counseling Dana-Farber Cancer Institute Data Diagnosis Diet Dietary Fiber Disinhibition Effectiveness Engineering Enrollment Ethnic Origin Family Fasting Friends Fruit Gender Glucose Goals Guidelines Health Individual Insulin Interleukin-6 Intervention Life Style Literature Malignant Neoplasms Measurable Measures Mediating Mediator Mental Depression Monitor Outcome Participant Patients Persons Physical Function Physical activity Population Printing Public Health Race Randomized Randomized, Controlled Trials Recommendation Recurrent Malignant Neoplasm Reporting Research Research Personnel Resources San Francisco Self Efficacy Social support Subgroup Survival Rate TNF gene Telephone Testing Text Messaging Time Training United States Universities Vegetables Woman behavior change cancer recurrence cancer survival colon cancer patients colorectal cancer risk design digital health effective intervention end of life expectation experience experimental study good diet improved inflammatory marker innovation lifestyle intervention men mortality mortality risk multiphase optimization strategy nutrition pedometer prevent primary outcome psychologic remote delivery remote intervention self reported behavior social cognitive theory sociodemographics standard care standardize measure tool trial enrollment

项目摘要

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.

结直肠癌（CRC）是美国癌症死亡的第二大原因。美国癌症社会（ACS）建议正常的体重指数（BMI），常规体育锻炼和健康饮食癌症幸存者。在2018年，我们估计可以防止诊断5年内38％的死亡 III期结肠癌如果所有患者遵循ACS指南。然而，<10％的CRC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，利用有效可扩展的组成部分，以改善CRC存活中的生活方式行为。关键研究差距包括：1）整体还是在子组中，特定的干预组件（例如，文本消息传递等）是有效的（男人与女人等）； 2）不足以改善饮食； 3）很少有远程干预的研究已经测量了生物结局。为了解决这些差距，我们建议使用多相优化策略（大多数）框架以确定有效的干预组件以提高ACS指南分数（对体育锻炼，饮食和体型的标准化测量）在CRC存活中。最多的框架是一种基于工程的方法，可以有效地优化行为干预措施，同时管理有限资源。我们在加利福尼亚大学旧金山分校的团队；达娜 - 法伯癌症研究所；和西北大学拥有强大的专业知识，从事癌症生存的生活方式干预措施，包括使用大多数。在这种经验的基础上，我们提出了一个12个月（密苏里州）的随机阶乘实验在400个CRC存活中，以确定4个候选干预组件的影响[文本消息传递，数字健康工具套件（体育活动跟踪器，应用程序），健康教练，好友培训（例如，朋友，家人）] 更改ACS指南分数从0到12 mo。 ACS得分的变化（我们的主要结果）影响CRC生存的高潜力，并且可以修改且可远程测量。我们的具体目的是：目的1）确定4个候选干预组件中的哪个提高ACS指南分数为12 mo。在CRC存活中。我们将确定每个组件的个体和交互作用。次要，我们的目标是：目标2）检查干预组件对干预组件的影响的调解人和主持人对更改ACS指南分数从0到12 mo。我们将研究社会认知理论的构建主要目标介体以及社会人口统计学，临床和心理/行为因素作为潜在主持人。这个目标将有助于我们了解干预组成部分如何以及为谁影响生活方式行为。目标3）检查与禁食胰岛素，葡萄糖，HOMA-IR的水平有关的ACS指南评分和入学时的炎症标记和12个月。该提案的所有三个目标的数据将指导我们下一步进行确定的随机对照试验，以评估优化干预的效果与CRC复发风险的标准护理相对于标准护理。总体而言，该提议是开发一个关键的一步有效且可扩展的生活方式干预措施可降低CRC死亡率，并可能产生高公共卫生影响。