马里兰州癌症幸存者行为减重计划：一项实用试验方案及参与者特征描述。

Behavioral Weight Loss Programs for Cancer Survivors Throughout Maryland: Protocol for a Pragmatic Trial and Participant Characteristics.

机构信息

Department of Kinesiology, Towson University, Towson, MD, United States.

Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.

出版信息

JMIR Res Protoc. 2024 Jun 12;13:e54126. doi: 10.2196/54126.

DOI:10.2196/54126

PMID:38865181

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11208825/

Abstract

BACKGROUND

Clinical trials examining lifestyle interventions for weight loss in cancer survivors have been demonstrated to be safe, feasible, and effective. However, scalable weight loss programs are needed to support their widespread implementation. The ASPIRE trial was designed to evaluate real-world, lifestyle-based, weight loss programs for cancer survivors throughout Maryland.

OBJECTIVE

The objectives of this protocol paper are to describe the design of a nonrandomized pragmatic trial, study recruitment, and baseline characteristics of participants.

METHODS

Participants were aged ≥18 years, residing in Maryland, with a BMI ≥25 kg/m, who reported a diagnosis of a malignant solid tumor, completed curative treatment, and had no ongoing or planned cancer treatment. Enrollment criteria were minimized to increase generalizability. The primary recruitment source was the Johns Hopkins Health System electronic health records (EHRs). Participants selected 1 of 3 remotely delivered weight loss programs: self-directed, app-supported, or coach-supported program.

RESULTS

Participants were recruited across all 5 geographic regions of Maryland. Targeted invitations using EHRs accounted for 287 (84.4%) of the 340 participants enrolled. Of the 5644 patients invited through EHR, 5.1% (287/5644) enrolled. Participants had a mean age of 60.7 (SD 10.8) years, 74.7% (254/340) were female, 55.9% (190/340) identified as non-Hispanic Black, 58.5% (199/340) had a bachelor's degree, and the average BMI was 34.1 kg/m (SD 5.9 kg/m). The most common types of cancers were breast (168/340, 49.4%), prostate (72/340, 21.2%), and thyroid (39/340, 8.5%). The self-directed weight loss program (n=91) included 25 participants who agreed to provide weights through a study scale; the app-supported program (n=142) included 108 individuals who agreed to provide their weight measurements; and the coach-supported weight loss program included 107 participants. We anticipate final analysis will take place in the fall of 2024.

CONCLUSIONS

Using EHR-based recruitment efforts, this study took a pragmatic approach to reach and enroll cancer survivors into remotely delivered weight loss programs.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04534309; https://clinicaltrials.gov/study/NCT04534309.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54126.

摘要

背景

已证实，针对癌症幸存者的减肥生活方式干预的临床试验是安全、可行且有效的。然而，需要可扩展的减肥项目来支持它们的广泛实施。ASPIRE 试验旨在评估整个马里兰州基于生活方式的、针对癌症幸存者的真实减肥项目。

目的

本方案论文的目的是描述一项非随机实用试验的设计、研究招募情况以及参与者的基线特征。

方法

参与者年龄≥18 岁，居住在马里兰州，BMI≥25kg/m²，报告有恶性实体瘤诊断，已完成根治性治疗，且无正在进行或计划进行的癌症治疗。纳入标准最小化以提高通用性。主要招募来源是约翰霍普金斯卫生系统电子健康记录 (EHR)。参与者从 3 种远程提供的减肥计划中选择 1 种：自我指导、应用程序支持或教练支持的计划。

结果

参与者在马里兰州的所有 5 个地理区域均有招募。使用 EHR 进行有针对性的邀请占 340 名入组者中的 287 名（84.4%）。在通过 EHR 邀请的 5644 名患者中，5.1%（287/5644）入组。参与者的平均年龄为 60.7（SD 10.8）岁，74.7%（254/340）为女性，55.9%（190/340）是非西班牙裔黑人，58.5%（199/340）拥有学士学位，平均 BMI 为 34.1kg/m²（SD 5.9kg/m²）。最常见的癌症类型是乳腺癌（168/340，49.4%）、前列腺癌（72/340，21.2%）和甲状腺癌（39/340，8.5%）。自我指导的减肥计划（n=91）包括 25 名同意通过研究秤提供体重的参与者；应用程序支持的减肥计划（n=142）包括 108 名同意提供体重测量的参与者；教练支持的减肥计划包括 107 名参与者。我们预计最终分析将于 2024 年秋季进行。