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

NCT05176756 | Completed

• 2 other identifiers: UPCC 21921849679
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

physical activity; cardiovascular disease; randomized controlled trial; breast cancer; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Change in daily step count

  Change in daily step count for patients in intervention arm versus patients in the attention control arm

  Baseline to the 6-month intervention period

Secondary Outcomes (3)

• Change in daily step count

  Baseline to the 3-month follow-up period

• Change in daily minutes of moderate or vigorous physical activity (MVPA)

  Baseline to the 6-month intervention period

• Change in daily minutes of moderate or vigorous physical activity (MVPA)

  Baseline to the 3-month follow-up period

Other Outcomes (6)

• Change in PROMIS Physical Function 6b scale

  Baseline to the 6-month intervention period

• Change in PROMIS Physical Function 6b scale

  Baseline to the 3-month follow-up period

• Change in PROMIS Cancer Fatigue Short Form

  Baseline to the 3-month follow-up period

Study Arms (2)

Attention Control

ACTIVE COMPARATOR

In addition to using a wearable device, participants in this arm will receive a daily notification of their step count from the previous day. This notification serves as an 'attention control' and allows us to better isolate the impact of the gamification with social support. It may also help to reduce differential attrition across arms.

Behavioral: Attention control

Gamification and Social Support

EXPERIMENTAL

Participants in this arm will receive the same devices and daily messaging as control. They will also be entered into a game designed using behavioral economic principles for 6 months. This intervention has been adapted from our prior successful pilot studies. The game runs automatically and does not require any effort on the part of the participant to 'play' the game other than to strive for physical activity goals. Participants in this arm will also select a family member or friend who will serve as a support partner to encourage the participant to meet their step goals. The gamification and social support interventions will end after 6 months at which point participants will receive the same treatment as the attention control arm for the 3-month follow-up period.

Behavioral: Gamification and Social Support

Interventions

Gamification and Social Support BEHAVIORAL

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.

Gamification and Social Support

Attention control BEHAVIORAL

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

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed with breast or prostate cancer and treated with cardiotoxic therapy (e.g. anthracyclines, chest radiation, trastuzumab, aromatase inhibitors, or ADT)
• Have ≥1 cardiovascular risk factors (e.g. hypertension, diabetes, dyslipidemia, obesity) or known coronary artery disease (prior coronary revascularization, myocardial infarction, or coronary stenosis \> 70%), or are 65+ years of age at time of enrollment
• Self-identify as Black or Hispanic
• Are at least 2 years from their cancer diagnosis and have no evidence of active malignancy or acute illness that would limit study participation
• Own a smartphone or tablet compatible with the wearable device
• Are able to read English or Spanish
• Are able to provide informed consent

You may not qualify if:

• Currently participating in another physical activity research study
• Have any medical conditions prohibiting ambulation without assistance
• Any other reason why it is not feasible or safe to complete the entire 9-month study
• Step count \> 7500/day during the baseline data collection period

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• American Heart Association: collaborator
• City of Hope National Medical Center: collaborator

Study Sites (2)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Fanaroff AC, Orr JA, Anucha C, Kim E, Rareshide C, Zhu J, Echevarria M, Rodarte S, Kassabian M, Balasian E, Ky B, Volpp KG, Armenian SH. Behaviorally Designed Gamification and Physical Activity Among Breast and Prostate Cancer Survivors. JACC CardioOncol. 2025 Nov 3:S2666-0873(25)00348-5. doi: 10.1016/j.jaccao.2025.10.001. Online ahead of print.

  PMID: 41182202 DERIVED

• Fanaroff AC, Orr JA, Anucha C, Kim E, Rareshide C, Echevarria M, Rodarte S, Kassabian M, Balasian E, Ky B, Volpp KGM, Armenian S. 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. Am Heart J. 2025 Feb;280:42-51. doi: 10.1016/j.ahj.2024.10.021. Epub 2024 Nov 4.

  PMID: 39505121 DERIVED

• Barrett M, Wilcox NS, Huang A, Levy R, Demissei B, Narayan V, Ky B. Bearing allostatic load: insights into a more equitable future within cardio-oncology. Trends Mol Med. 2022 Dec;28(12):1040-1049. doi: 10.1016/j.molmed.2022.09.006. Epub 2022 Oct 4.

  PMID: 36207229 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Breast Neoplasms; Prostatic Neoplasms; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Kevin Volpp, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Alexander C. Fanaroff, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: April 14, 2022
• Primary Completion: November 11, 2024
• Study Completion: February 18, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)