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

• 批准号: 10317106
• 负责人: Erin Lynn Van Blarigan
• 金额: $ 67.58万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 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/10317106
• 关键词: Accelerometer; Address; Affect; 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 of activation protein; Mental Depression; Monitor; Outcome; Participant; Patients; Persons; Physical Function; Physical activity; Population; Public Health; Race; Randomized; Randomized Controlled Trials; 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; base; behavior change; cancer diagnosis; cancer recurrence; cancer survival; colon cancer patients; colorectal cancer risk; design; digital health; effective intervention; efficacy outcomes; 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

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 协会 (ACS) 建议正常的体重指数 (BMI)、定期的体力活动和健康的饮食 癌症幸存者。 2018 年，我们估计诊断后 5 年内 38% 的死亡可以通过以下方式预防： 如果所有患者均遵循 ACS 指南，则为 III 期结肠癌。然而，<10% 的 CRC 患者密切关注 这些生活方式指南。研究人员尚未充分利用有效的生活方式干预措施 可扩展的组件，以改善结直肠癌幸存者的生活方式。关键研究差距包括：1) 具体的干预措施（例如短信等）是否有效、总体有效还是在分组中有效 （男性与女性等）； 2）对改善饮食重视不够； 3）远程干预的研究很少 测量了生物学结果。为了解决这些差距，我们建议使用多阶段优化 策略 (MOST) 框架，以确定有效的干预措施以提高 ACS 指南评分 （对 CRC 幸存者的体力活动、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，同时管理有限的行为 资源。我们在加州大学旧金山分校的团队；达纳法伯癌症研究所；和 西北大学在对癌症幸存者进行生活方式干预方面拥有丰富的专业知识，包括 使用最多。基于这一经验，我们提出了一项为期 12 个月的随机析因实验 在 400 名 CRC 幸存者中进行研究，以确定 4 种候选干预措施的效果 [短信、 数字健康工具包（身体活动跟踪器、应用程序）、健康指导、好友培训（例如朋友、家人）] ACS 指南评分从 0 个月更改为 12 个月。 ACS 评分（我们的主要结果）的变化 影响 CRC 存活的潜力很大，并且可以远程修改和测量。我们的具体目标是： 目标 1) 确定 4 个候选干预措施中的哪一个可提高 12 个月时的 ACS 指南评分。 CRC 幸存者中。我们将确定每个组件的单独效果和交互效果。 其次，我们的目标是： 目标 2）检查干预成分对 ACS 指南评分从 0 个月更改为 12 个月。我们将研究社会认知理论的构建 主要目标中介因素和潜在的社会人口统计学、临床和心理/行为因素 主持人。这一目标将帮助我们了解干预措施如何以及对谁影响生活方式 行为。目标 3) 检查 ACS 指南评分与空腹胰岛素、葡萄糖、HOMA-IR 水平的关系 以及入组时和 12 个月时的炎症标志物。该提案所有三个目标的数据将指导我们 下一步将进行明确的随机对照试验，以评估优化干预措施的效果 与标准治疗对 CRC 复发风险的比较。总体而言，该提案是朝着发展 有效且可扩展的生活方式干预可降低结直肠癌死亡率，并可能对公共卫生产生重大影响。