What side effects are associated with this type of intervention?

Common treatments for sedentary lifestyle that involve behavioral motivation and social reinforcement, such as gamification with social support, generally have minimal side effects. Participants may experience mild adverse events such as musculoskeletal discomfort or arthritic pain due to increased physical activity. Psychological effects like frustration or decreased motivation can occur if goals are not met. However, these interventions are typically well-tolerated and focus on promoting gradual increases in physical activity, which helps mitigate severe side effects.

What prior FDA approvals exist?

The FDA has not specifically approved drugs for the treatment of a sedentary lifestyle. Instead, interventions typically focus on behavioral strategies, such as those studied in the Gamification with Social Support trial, which use behavioral motivation and social reinforcement to increase physical activity. These interventions often involve the use of wearable activity trackers, mobile health (mHealth) applications, and structured programs that encourage goal setting and provide feedback. While pharmacological treatments are not the primary approach, the emphasis remains on lifestyle modifications supported by technology and social networks.

What other types of research exist?

Promising, novel alternatives to gamification with social support for sedentary lifestyle patients include: 1) Mobile health (mHealth) interventions using smartphone apps for self-monitoring and personalized feedback, 2) Internet-based interventions that provide structured programs and virtual coaching, 3) Cognitive-behavioral therapy (CBT) tailored for physical activity promotion, and 4) Wearable activity trackers integrated with behavioral nudges and real-time feedback.

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Physical Activity Intervention for Breast Cancer Survivors (ALLSTAR Trial)

N/A

Waitlist Available

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

No Placebo-Only Group

Summary

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in daily step count

Secondary study objectives

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

Other study objectives

Change in EQ-5D-5L

Change in PROMIS Cancer Fatigue Short Form

Change in PROMIS Physical Function 6b scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sedentary lifestyle include behavioral interventions, physical activity programs, and technology-supported initiatives like gamification with social support. Behavioral motivation involves setting goals and providing incentives to encourage physical activity, while social reinforcement leverages support from peers or groups to maintain engagement and accountability. These mechanisms are crucial for sedentary lifestyle patients as they help to create sustainable behavior changes, increase adherence to physical activity, and improve overall health outcomes by reducing the risk of chronic diseases associated with inactivity.

Breast cancer survivors' beliefs and preferences regarding technology-supported sedentary behavior reduction interventions.