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Physical Activity Intervention for Breast Cancer Survivors (ALLSTAR Trial)

N/A

Recruiting

Led By Kevin Volpp, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to the 6-month intervention period

Awards & highlights

ALLSTAR Trial Summary

This trial is looking at whether a behaviorally designed game intervention, with social support, can increase physical activity more than an attention control group, in 150 Black or Hispanic breast and prostate cancer survivors.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions involve non-medical strategies (gamification and social support) aimed at increasing physical activity through the use of wearable technology like Fitbit, there are no direct medical side effects associated with typical drug trials.

ALLSTAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the 6-month intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to the 6-month intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the 6-month intervention period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

Change in daily step count

Other outcome measures

Change in EQ-5D-5L

Change in PROMIS Cancer Fatigue Short Form

Change in PROMIS Physical Function 6b scale

ALLSTAR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Gamification and Social SupportExperimental Treatment1 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 ControlActive Control1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,879,938 Total Patients Enrolled

4 Trials studying Sedentary Lifestyle

948 Patients Enrolled for Sedentary Lifestyle

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,545 Total Patients Enrolled

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,680 Total Patients Enrolled

2 Trials studying Sedentary Lifestyle

210 Patients Enrolled for Sedentary Lifestyle

Media Library

Sedentary Lifestyle Research Study Groups: Gamification and Social Support, Attention Control

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the sample population for this trial?

"Affirmative. Clinicaltrials.gov exhibits that the research project which initially surfaced on April 14th 2022, is actively recruiting participants. Approximately 150 individuals need to be recruited from 3 distinct sites."

Answered by AI

Are there any unfilled slots for participants in the trial?

"According to the information presented on clinicaltrials.gov, enrollment for this trial is still open. It was initially created on April 14th 2022 and subsequently modified just last month (September 16th)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "RCT of Strategies to Augment Physical Activity in Black and Hispanic Breast and Prostate Cancer Survivors (ALLSTAR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176756.