Clinical trial · Interventional
RCT of Strategies to Augment Physical Activity in Black and Hispanic Breast and Prostate Cancer Survivors (ALLSTAR)
A Randomized Controlled Trial of Strategies to Augment Physical Activity in Black and Hispanic Breast and Prostate Cancer Survivors (ALLSTAR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Physical Inactivity | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention control | Behavioral | — | UNRESOLVED |
| Gamification and Social Support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Attention Control
- description
- 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.
- interventionNames
- Behavioral: Attention control
- type
- EXPERIMENTAL
- label
- Gamification and Social Support
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDFanaroff 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 Dec;7(7):816-828. doi: 10.1016/j.jaccao.2025.10.001. Epub 2025 Nov 3. PMID 41182202
- DERIVEDFanaroff 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
- DERIVEDBarrett 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