Physical Activity Intervention for Breast Cancer Survivors

(ALLSTAR Trial)

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a game-like system with social support to help Black or Hispanic breast and prostate cancer survivors increase their physical activity. Participants wear a Fitbit to track their steps and set personal goals, making exercise more fun and motivating. Fitbit devices have been widely used in various studies to promote physical activity among cancer survivors.

Research Team

Kevin Volpp, MD PhD

Principal Investigator

University of Pennsylvania

Alexander Fanaroff, MD, MHS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+