背景:研究生活方式干预对癌症幸存者体重减轻的临床试验已被证明是安全的,可行,而且有效。然而,需要可扩展的减肥计划来支持其广泛实施。ASPIRE试验旨在评估真实世界,以生活方式为基础,整个马里兰州癌症幸存者的减肥计划。
目的:本方案文件的目的是描述非随机实际试验的设计,研究招募,和参与者的基线特征。
方法:参与者年龄≥18岁,居住在马里兰州,BMI≥25kg/m2,报告诊断为恶性实体瘤,完成治愈性治疗,并且没有正在进行或计划中的癌症治疗。最小化登记标准以增加普适性。主要招聘来源是约翰霍普金斯卫生系统电子健康记录(EHR)。参与者选择了3个远程提供的减肥计划中的1个: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个地理区域招募。使用EHR的有针对性的邀请占340名参与者中的287名(84.4%)。在通过EHR邀请的5644名患者中,5.1%(287/5644)登记。参与者的平均年龄为60.7(SD10.8)岁,74.7%(254/340)为女性,55.9%(190/340)被确定为非西班牙裔黑人,58.5%(199/340)拥有学士学位,平均BMI为34.1kg/m2(SD5.9kg/m2)。最常见的癌症类型是乳腺癌(168/340,49.4%),前列腺(72/340,21.2%),甲状腺(39/340,8.5%)。自我指导的减肥计划(n=91)包括25名参与者,他们同意通过研究量表提供体重;应用程序支持的计划(n=142)包括108名同意提供体重测量的个人;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在2024年秋季进行。
结论:使用基于EHR的招聘工作,这项研究采用了务实的方法,让癌症幸存者参与远程实施的减肥计划,并将其纳入研究.
背景:ClinicalTrials.govNCT04534309;https://clinicaltrials.gov/study/NCT04534309。
■DERR1-10.2196/54126。
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/m2, 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/m2 (SD 5.9 kg/m2). 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.
BACKGROUND: ClinicalTrials.gov NCT04534309; https://clinicaltrials.gov/study/NCT04534309.
UNASSIGNED: DERR1-10.2196/54126.