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优化干预工具以改善结直肠癌幸存者的营养和身体活动(Tools To Be Fit):一项随机析因实验的研究方案。

Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment.

机构信息

Department of Urology, University of California, San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, United States of America.

UCSF School of Medicine, University of California, San Francisco, CA, United States of America.

出版信息

Contemp Clin Trials. 2022 Dec;123:107009. doi: 10.1016/j.cct.2022.107009. Epub 2022 Nov 15.

Abstract

BACKGROUND

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States. The American Cancer Society (ACS) Nutrition and Physical Activity Guidelines are associated with longer survival among CRC survivors, but few report behaviors consistent with the guidelines.

METHODS

The Tools To Be Fit study, based on the Multiphase Optimization Strategy (MOST) framework, is a full factorial experimental to optimize a remotely delivered 48-week diet and physical activity intervention for non-metastatic CRC survivors. The intervention includes a core component (booklet and personal report). CRC survivors (N = 400) are additionally randomly assigned to one of 16 combinations of four candidate components, each with 2 options: 1) text messaging (on/off); 2) self-monitoring modality (digital/paper); 3) health coaching (on/off); and 4) support person coaching (on/off).

OUTCOMES

Our primary outcome is adherence to the ACS guidelines after 48 weeks using a score that includes physical activity from accelerometers, dietary intake from a food frequency questionnaire, and body mass index (BMI) measured by a technician. Secondary outcomes include the ACS score after 24 weeks and score components at 24 and 48 weeks. Exploratory outcomes include adherence and change in Social Cognitive Theory constructs. We will explore moderation by sociodemographic, clinical, and psychological/behavioral factors; and change in the ACS score in relation to change in levels of insulin, insulin sensitivity, inflammation, gut microbiome structure, fatigue, depression, and sleep disturbance.

DISCUSSION

The proposed study aims to inform a randomized controlled trial to determine whether an optimized intervention reduces risk of recurrence among CRC survivors.

摘要

背景

在美国,结直肠癌(CRC)是癌症死亡的第二大主要原因。美国癌症协会(ACS)的营养与身体活动指南与 CRC 幸存者的生存时间延长有关,但很少有报告表明行为符合该指南。

方法

基于多阶段优化策略(MOST)框架的“Tools To Be Fit”研究,是一项完全析因实验,旨在优化针对非转移性 CRC 幸存者的远程提供的 48 周饮食和身体活动干预措施。该干预措施包括核心组成部分(手册和个人报告)。CRC 幸存者(N=400)还被随机分配到四个候选组成部分的 16 种组合中的一种,每种组合有两种选择:1)短信(开/关);2)自我监测方式(数字/纸质);3)健康指导(开/关);4)支持人指导(开/关)。

结果

我们的主要结果是在 48 周后使用包括加速度计的身体活动、食物频率问卷的饮食摄入和由技术人员测量的体重指数(BMI)的 ACS 指南得分来衡量的依从性。次要结果包括 24 周后的 ACS 得分和 24 周和 48 周的得分成分。探索性结果包括社会认知理论结构的依从性和变化。我们将探索社会人口统计学、临床和心理/行为因素的调节作用;以及 ACS 评分的变化与胰岛素、胰岛素敏感性、炎症、肠道微生物组结构、疲劳、抑郁和睡眠障碍水平的变化之间的关系。

讨论

拟议的研究旨在为随机对照试验提供信息,以确定优化干预是否可以降低 CRC 幸存者的复发风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a7fb/10561599/6a1737ffb245/nihms-1935564-f0001.jpg

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