Physical Activity Intervention for Breast Cancer Survivors

(ALLSTAR Trial)

No longer recruiting at 2 trial locations

Overseen By Jennifer Orr, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Physical activity study, Ambulation assistance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a gamification approach, combined with social support, can boost physical activity in breast and prostate cancer survivors. It aims to determine if this method improves daily activity levels, physical function, fatigue, and overall quality of life. Participants will wear a Fitbit and join a health platform to track and set goals for their daily steps. The trial seeks Black or Hispanic survivors of breast or prostate cancer who were diagnosed at least two years ago, have undergone certain cancer treatments, and own a smartphone. They should also have or be at risk for heart problems, such as high blood pressure or diabetes. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing physical activity, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this intervention is safe for breast cancer survivors?

Research has shown that incorporating game-like elements and social support in treatment is safe. Studies have found no serious side effects from this approach. For instance, a digital program for breast cancer survivors demonstrated that using game-like features was safe, with no major negative effects reported. Although the program did not significantly increase physical activity, it led to some positive changes.

Overall, using game-like elements enhances patient involvement and outcomes without causing harm. This suggests that participants receive the method well, making it a promising option for those interested in joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how gamification and social support can boost physical activity in breast cancer survivors. Unlike standard care options that might focus on medication or traditional exercise programs, this approach integrates game elements with behavioral economics to motivate participants. The treatment involves a game that automatically tracks progress, coupled with encouragement from a chosen support partner, making it a novel and engaging way to help survivors stay active. By comparing this method to a simple attention control (daily step count notifications), researchers hope to uncover new ways to enhance physical activity and improve quality of life for those recovering from breast cancer.

What evidence suggests that this trial's interventions could be effective for increasing physical activity in cancer survivors?

Research has shown that game-like activities, known as gamification, can help cancer patients become more active. In past studies, these activities significantly increased moderate-to-vigorous exercise compared to those who didn't use them. Specifically, one study found that breast cancer patients in a gamification program improved their walking and overall activity levels in just three months. In this trial, one arm will test the combination of gamification with social support, which has been found to encourage more activity and improve fitness. These findings suggest that gamification and social support can effectively boost physical activity in breast cancer survivors. Another arm will focus on attention control, where participants receive daily notifications of their step count to help isolate the impact of gamification with social support. ^{6 7 8 9 10}

Who Is on the Research Team?

Kevin Volpp, MD PhD

Principal Investigator

University of Pennsylvania

Alexander Fanaroff, MD, MHS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

The ALLSTAR trial is for Black or Hispanic breast and prostate cancer survivors who are over two years post-diagnosis with no active cancer. Participants must have had cardiotoxic therapy, be at risk of heart disease, or be 65+. They need to read English/Spanish, own a compatible smartphone/tablet, and not be in another exercise study.

Inclusion Criteria

Are at least 2 years from their cancer diagnosis and have no evidence of active malignancy or acute illness that would limit study participation

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

You need to have walked at least 7500 steps per day during the period before the study started.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Run-in

Participants get used to the wearable device and establish baseline activity measures

2-4 weeks

Remote monitoring

Treatment

Participants are randomized to gamification plus social support or attention control to increase physical activity

6 months

Remote monitoring with periodic check-ins

Follow-up

Participants are monitored for changes in physical activity and health-related quality of life

3 months

End-of-study questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• Attention control
• Gamification and Social Support

Trial Overview This trial tests if a gamification intervention with social support can boost physical activity compared to an attention control group. It involves using Fitbits and aims to increase daily steps over six months plus three months follow-up among participants from two U.S. cancer centers.

How Is the Trial Designed?

Group I: Gamification and Social Support Experimental Treatment 1 Intervention

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.

Group II: Attention Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

City of Hope National Medical Center

Collaborator

Trials

17

Recruited

8,900+

Montefiore Medical Center

Collaborator

Trials

468

Recruited

599,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9446134/

Feasibility and Acceptability of an Active Video Game–Based ... The combination of active video games (AVGs) and group-based PA counseling may hold potential for motivating PA adoption and improving physical function.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36585478/

Effect and feasibility of gamification interventions for ... The aim of this study is to examine the effectiveness and feasibility of gamification interventions for improving PA and health-related outcomes among cancer ...

3. games.jmir.org games.jmir.org/2025/1/e68151

Effectiveness of Gamification Interventions to Improve Physical ... Our findings showed that the gamification interventions significantly increased moderate-to-vigorous physical activity (MVPA; standardized mean ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000802

Effectiveness of a theory-based tailored mHealth physical ... Compared to the baseline data, breast cancer patients in the intervention group had significant improvements in walking and overall PA after three months (P < ...

5. binasss.sa.cr binasss.sa.cr/feb25/2.pdf

A randomized controlled trial of gamification to increase ... In prior studies, a gamification intervention based on behavioral economic concepts substantially increased physical activity more than controls in patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12417285/

Empowering Cancer Patients: A Scoping Review on ... This study aims to explore and map how gamification can promote health literacy for self-care of oncological diseases. A scoping review was conducted following ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10742971/

Gamification as an Educational Approach for Oncological ... Gamification improves patient engagement and biopsychosocial outcomes and could represent a valid approach to cancer patient education.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2777858

Effect of Behaviorally Designed Gamification With a Social ... Gamification with social incentives did not affect mobility or functional decline in all participants but may be beneficial for patients with higher levels of ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1532046420300678

A methodology for the design and development of gamified ... In this work we introduce a methodology for developing gamification apps for cancer survivors that aims at increasing engagement when collecting PROs data.

10. mdpi.com mdpi.com/2072-6694/16/23/4084

Digital Rehabilitation Program for Breast Cancer Survivors ... It was found to be safe with no serious side effects. While physical activity levels did not significantly increase, there were statistically significant ...