NCT05176756Completed
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 · Last updated 1 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 15 Dec 2021
- Start date
- 14 Apr 2022
- Primary completion date
- 11 Nov 2024
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Prostate cancer
- NCT number
- NCT05176756
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 14 Apr 2022 to the primary completion date, 11 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have any medical conditions prohibiting ambulation without assistance
Lab values
- Step count \> 7500/day during the baseline data collection period
Other
- Currently participating in another physical activity research study
- Any other reason why it is not feasible or safe to complete the entire 9-month study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.