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一项关于游戏化增加黑人和西班牙裔乳腺癌及前列腺癌幸存者身体活动的随机对照试验:ALLSTAR临床试验的原理与设计

A randomized controlled trial of gamification to increase physical activity among black and Hispanic breast and prostate cancer survivors: Rationale and design of the ALLSTAR clinical trial.

作者信息

Fanaroff Alexander C, Orr Jennifer A, Anucha Chinyere, Kim Emily, Rareshide Charles, Echevarria Meagan, Rodarte Stephanie, Kassabian Mareen, Balasian Elina, Ky Bonnie, Volpp Kevin G M, Armenian Saro

机构信息

Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, PA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA; Penn Center for Digital Cardiology, University of Pennsylvania, Philadelphia, PA.

Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA.

出版信息

Am Heart J. 2025 Feb;280:42-51. doi: 10.1016/j.ahj.2024.10.021. Epub 2024 Nov 4.

DOI:10.1016/j.ahj.2024.10.021
PMID:
39505121
Abstract

BACKGROUND

Survivors of breast and prostate cancer, especially those that are Black and/or Hispanic, are at high risk for cardiovascular events. Physical activity can reduce the risk of cardiovascular events in cancer survivors, but Black and Hispanic people are less likely to engage in routine physical activity. Concepts from behavioral economics have been used to design scalable, low-touch gamification interventions that increase physical activity in individuals at high risk for cardiovascular events, but the effectiveness of these strategies in Black and Hispanic survivors of breast and prostate cancer is uncertain.

STUDY DESIGN AND OBJECTIVES

ALLSTAR (NCT05176756) is a pragmatic, virtual randomized controlled trial designed to evaluate the effectiveness of a gamification intervention informed by behavioral economic concepts to increase daily physical activity in Black and Hispanic breast and prostate cancer survivors who received cardiotoxic therapies and have additional risk factors for cardiovascular disease. Patients are either referred by their cancer care team or identified by electronic health record searches; contacted by letter, email, text message and/or phone; and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 1,500-3,000 steps from baseline, and are randomized 1:1 to control or gamification. Interventions continue for 6 months, with follow-up for an additional 3 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 150 participants, with a primary endpoint of change from baseline in daily steps over the 6-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 3-month post-intervention follow-up period, change in moderate to vigorous physical activity over the intervention and follow-up periods, and change in patient-reported measures of physical function, fatigue, and overall quality of life.

CONCLUSIONS

ALLSTAR is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification is superior to control in increasing physical activity in Black and Hispanic breast and prostate cancer survivors. Its results will have important implications for strategies to promote physical activity in survivors of breast and prostate cancer, specifically among minority populations.

CLINICAL TRIAL REGISTRATION

clinicaltrials.gov; https://clinicaltrials.gov/study/NCT05176756.

摘要

背景

乳腺癌和前列腺癌幸存者,尤其是黑人及/或西班牙裔幸存者,心血管事件风险较高。体育活动可降低癌症幸存者发生心血管事件的风险,但黑人和西班牙裔人群进行日常体育活动的可能性较低。行为经济学的概念已被用于设计可扩展、低接触的游戏化干预措施,以增加心血管事件高风险个体的体育活动,但这些策略在黑人及西班牙裔乳腺癌和前列腺癌幸存者中的有效性尚不确定。

研究设计与目标

ALLSTAR(NCT05176756)是一项实用的虚拟随机对照试验,旨在评估基于行为经济学概念的游戏化干预措施在增加接受心脏毒性治疗且有心血管疾病其他风险因素的黑人和西班牙裔乳腺癌和前列腺癌幸存者日常体育活动方面的有效性。患者由其癌症护理团队转诊或通过电子健康记录搜索识别;通过信件、电子邮件、短信和/或电话联系;并在宾夕法尼亚健康之路在线平台上完成注册和知情同意。然后为患者提供可穿戴健身追踪器,确定每日步数基线,设定目标将每日步数比基线增加1500 - 3000步,并以1:1的比例随机分为对照组或游戏化组。干预持续6个月,再进行3个月的随访以评估行为改变的持续性。该试验已达到150名参与者的招募目标,主要终点是在6个月干预期内每日步数相对于基线的变化。关键次要终点包括干预后3个月随访期内每日步数相对于基线的变化、干预和随访期内中度至剧烈体育活动的变化,以及患者报告的身体功能、疲劳和总体生活质量的变化。

结论

ALLSTAR是一项虚拟、实用的随机临床试验,有能力证明游戏化在增加黑人和西班牙裔乳腺癌和前列腺癌幸存者体育活动方面是否优于对照组。其结果将对促进乳腺癌和前列腺癌幸存者,特别是少数族裔人群体育活动的策略产生重要影响。

临床试验注册

clinicaltrials.gov;https://clinicaltrials.gov/study/NCT05176756

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