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.

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.

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 were 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 1500-3000 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.

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.

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

American heart journal. 2024 Nov 04 [Epub ahead of print]

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

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. Electronic address: ., 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., Department of Population Sciences, City of Hope Comprehensive Cancer Center, Duarte, CA., Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA., Department of Medicine, Perelman School of Medicine, 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; Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA; The Wharton School, University of Pennsylvania, Philadelphia, PA., Department of Population Sciences, City of Hope Comprehensive Cancer Center, Duarte, CA; Department of Pediatrics, City of Hope Comprehensive Cancer Center, Duarte, CA.