A Randomized Controlled Trial of Strategies to Augment Physical Activity in Black and Hispanic Breast and Prostate Cancer Survivors (ALLSTAR)

The specific objectives of this study are the following:

1. To determine the effectiveness of a behaviorally designed gamification intervention with social support to increase physical activity in Black and Hispanic breast and prostate cancer survivors
2. To evaluate the effects of the gamification intervention on physical function, fatigue, and health-related quality of life

Recruitment: Participants will be recruited from the tumor registries at the two cancer centers or via direct referral from these two health systems. Patients identified from tumor registries will be emailed a link to the study, after obtaining provider permission to contact. Patients will then be contacted by phone two weeks later to further discuss the study. Interested patients will visit the study website on the Way to Health platform to learn more about the study, create an account, provide informed consent, and complete initial baseline eligibility surveys. Study coordinators will be available to assist patients with this process, as necessary.

Informed Consent: We will follow an IRB-approved approach taken by many studies using the Way to Health platform to obtaining informed consent. Upon reaching the portal, potential participants will be asked to create an account and will then be informed of the details of the study, including its objectives, duration, requirements, and financial payments. The Way to Health portal will then take interested participants through an online informed consent. Successive screens will explain the voluntary nature of the study, the risks and benefits of participation, alternatives to participation, and that participants can withdraw from the study at any time. On the final consent screen, potential participants who click a clearly delineated button stating that they agree to participate in the study will be considered to have consented to enroll. Participants will be provided with details regarding how to contact the research team via email or phone at any time if they subsequently wish to withdraw from the study. Support partners will provide verbal informed consent via telephone for their name, email address, and phone number to be stored in the study database. For participants who are English-speaking but illiterate, an authorized family member will be present to witness the oral presentation of the consent form and both participant and authorized family member sign the consent form. Spanish speaking patients will be consented with the aid of a medical interpreter. Directly referred patients will also complete informed consent via the Way to Health platform as above.

Enrollment: Immediately after completing the informed consent process, potentially eligible patients will be prescreened to ensure they meet the eligibility criteria. Simultaneously, participants will complete an online questionnaire to confirm eligibility and complete the study surveys.