RCT of Strategies to Augment Physical Activity in Black and Hispanic Breast and Prostate Cancer Survivors (ALLSTAR)

Summary

This is a two-arm, randomized, controlled trial to evaluate the effectiveness of using a behaviorally designed gamification intervention with social support compared to an attention control group to increase physical activity during a 6-month intervention with a 3-month follow-up period. We will enroll 150 Black or Hispanic breast and prostate cancer survivors who are at an especially high risk for developing major CVD from two U.S. cancer centers: the University of Pennsylvania Health System and City of Hope National Medical Center. All participants will receive a wearable activity tracker (Fitbit) and will be enrolled in the Way to Health system, a research information technology platform at the University of Pennsylvania. Within the Way to Health platform, patients will set a goal to increase daily step count from baseline, and will then be randomized to gamification plus social support or to attention control. The study will evaluate the effect of the gamification intervention on daily physical activity (as measured by daily steps and moderate to vigorous physical activity), physical function, fatigue, and health-related quality of life.

Conditions

• Cardiovascular Diseases
• Breast Cancer
• Prostate Cancer
• Physical Inactivity

Interventions

BEHAVIORAL

Gamification and Social Support

Participants will be entered into a points and levels-based game designed to help them meet their step count goals. At the start of each week, the participant will receive a set amount of points. Each day their step goal is not met, they lose points. If the participant meets a certain point value at the end of the week, they will either advance one level (of five total levels); if they do not, they will drop one level. Each participant will also select a family member or friend or the study coordinator to serve as a support partner. At the beginning of the intervention, the participant and support partner will identify at least 3 ways in which they can help the participant meet their step goals. This partner will receive a weekly email reminding them of these approaches and updating them on the participant's progress.

BEHAVIORAL

Attention control

Participants will receive a daily text message with their step count from the day prior.

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• City of Hope National Medical Center

  collaborator OTHER

• Abramson Cancer Center at Penn Medicine

  lead OTHER

Principal Investigators

• Kevin Volpp, MD, PhD · University of Pennsylvania

• Alexander C. Fanaroff, MD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-14

Primary Completion

2024-11-11

Completion

2025-02-18

Countries

• United States

Study Locations