Physical Activity Program for Breast Cancer

(MFT4 Trial)

Overseen By Madison Kindred, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Stage 4 cancer, Medical, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help breast cancer survivors become more active through a 3-month physical activity program. Participants will either receive weekly guidance from a peer coach to boost their activity or self-monitor their progress with a Fitbit. The goal is to increase moderate-intensity exercise to meet national recommendations, which can improve health and well-being. The trial seeks individuals diagnosed with Stage 0-3 breast cancer in the past five years who are currently inactive and have access to a smartphone. As an unphased trial, this study offers a unique opportunity for participants to enhance their health and well-being through increased physical activity.

Do I need to stop my current medications for this trial?

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 check with the trial organizers or your doctor.

What prior data suggests that this physical activity program is safe for breast cancer survivors?

Research has shown that exercise programs, like the one under testing, are generally safe for breast cancer survivors. Studies have found that these programs increase activity levels without causing serious side effects. In past trials with webMFT, participants reported no major problems from the exercises or peer coach support.

Exercise differs from medication, as it doesn't carry the same risk of side effects. Instead, it focuses on gradually increasing activity in a safe and enjoyable way, such as walking. Participants use tools like Fitbits to track their progress, helping them safely increase their activity levels.

Overall, evidence suggests that this type of program is well-tolerated and can positively contribute to recovery for many breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative ways to promote physical activity among breast cancer survivors, which is crucial for recovery and long-term health. Unlike traditional exercise recommendations that often lack personalized guidance, this trial compares two approaches: self-monitoring physical activity with a Fitbit and a web-based program offering tailored counseling and activity tracking. These methods aim to make staying active more engaging and achievable by aligning with personal readiness and preferences, potentially leading to better adherence and outcomes. This trial hopes to uncover how these tailored approaches can enhance motivation and support survivors in meeting national exercise guidelines, ultimately improving their quality of life.

What evidence suggests that this physical activity program is effective for breast cancer survivors?

Research has shown that exercise can help breast cancer survivors improve their health and well-being. In this trial, participants will follow different approaches to increase physical activity. One group will join the webMFT program, which includes weekly support from a peer coach and aims to help survivors meet national physical activity guidelines. Studies have found that programs like webMFT effectively encourage participants to engage in at least 150 minutes of moderate activity each week, such as walking. Another group will self-monitor their moderate-to-vigorous physical activity (MVPA) using a Fitbit Inspire 2 without receiving MVPA counseling. Both methods aim to help survivors become more active and healthier. ^{1 2 3 6 7}

Who Is on the Research Team?

Bernardine M Pinto, PhD

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors diagnosed within the last 5 years, who are currently inactive. They should be able to walk unassisted, read and speak English, and have access to a smartphone with Bluetooth and internet. Participants must not engage in more than 30 minutes of vigorous or 90 minutes of moderate-intensity physical activity weekly.

Inclusion Criteria

I was diagnosed with Stage 0-3 breast cancer in the last 5 years.

Access to a smartphone with Bluetooth and internet

I can walk on my own without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 3-month physical activity intervention with weekly guidance from a peer coach or self-monitoring using a Fitbit

12 weeks

Weekly virtual calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity adoption
• Self monitoring

Trial Overview

The study tests if guidance from a peer coach can help increase moderate-intensity physical activity over three months compared to self-monitoring. Participants will be randomly placed into two groups: one receiving weekly virtual coaching and the other monitoring their own activity levels. Both groups get a Fitbit.

How Is the Trial Designed?

Group I: webMFT Experimental Treatment 1 Intervention

Survivors randomized to webMFT will receive the evidence-based intervention for moderate-to-vigorous physical activity (MVPA) promotion that consists of MVPA counseling matched to patients' motivational readiness, and self-monitoring of MVPA (via Fitbit Inspire 2). The goal for the 3-month program will be to gradually increase the amount of moderate-intensity aerobic exercise that is performed, to the current national recommendations of at least 150 minutes of MPVA per week. Our goal is to promote aerobic exercise that is safe and enjoyable, such as walking.

Group II: MVPA tracking Active Control 1 Intervention

These survivors will be asked to self-monitor moderate-to-vigorous physical activity (MVPA) participation by wearing the Fitbit Inspire 2 each day over 12 weeks. This group will not receive the MVPA counseling from the coaches.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

InquisitHealth, Inc.

Collaborator

Trials

3

Recruited

400+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Published Research Related to This Trial

A 3-month adapted physical activity program for 61 breast cancer patients led to a significant increase in moderate physical activity by an average of 13 minutes per day, helping to combat inactivity during treatment.

Despite no significant changes in weight or waist circumference, the program effectively reduced sedentary time by 18 minutes per day, highlighting the importance of promoting physical activity early in cancer care to mitigate health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of health risk factors through an adapted physical activity program in patients with breast cancer. Foucaut, AM., Berthouze-Aranda, SE., Touillaud, M., et al.[2021]

A systematic review of 20 studies on digital physical activity interventions for breast cancer survivors found that common behavior change techniques (BCTs) like self-monitoring and goal setting were effective, with 60% of studies showing improved physical activity levels.

Despite the effectiveness of these techniques, many potential BCTs were underutilized, suggesting that incorporating a wider variety of strategies could enhance the effectiveness of future digital interventions for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior change techniques in digital physical activity interventions for breast cancer survivors: a systematic review. Cooper, KB., Lapierre, S., Carrera Seoane, M., et al.[2023]

A systematic review of 28 randomized controlled trials found that various exercise programs, particularly resistance training combined with cardiovascular endurance training, significantly improve physical performance and reduce perceived fatigue in breast cancer patients undergoing initial treatment.

Quality of life improvements were less pronounced compared to physical performance and fatigue, indicating that while exercise is beneficial, it may not greatly enhance overall quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of training interventions on physical performance, quality of life, and fatigue in patients receiving breast cancer treatment: a systematic review. Gebruers, N., Camberlin, M., Theunissen, F., et al.[2019]

A randomized controlled trial involving 76 breast cancer survivors tested a 12-week telephone-based physical activity intervention delivered by trained volunteers, but the intervention did not show significant effects on physical health, mental health, or quality of life outcomes.

The study found that factors such as age, chemotherapy use, and baseline health status significantly influenced how effective the physical activity intervention was, suggesting that these variables should be considered when designing future programs for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer mentorship to promote physical activity among cancer survivors: effects on quality of life. Pinto, B., Stein, K., Dunsiger, S.[2022]

In a study involving breast cancer survivors at risk for lymphedema, weightlifting showed a higher rate of musculoskeletal injuries compared to standard care, with injury rates of 2.3 per 1,000 bouts for the weightlifting group.

Despite the efficacy of weightlifting as a rehabilitative exercise, 20.9% of participants required medical attention that led to modifications in their exercise regimen, highlighting the need for well-trained health and fitness professionals to safely implement such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. Brown, JC., Troxel, AB., Schmitz, KH.[2021]

Physical activity is linked to a lower risk of developing breast cancer and recurrence, as well as improved survival rates, based on observational studies.

Engaging in physical activity can alleviate treatment-related side effects, such as fatigue from chemotherapy and musculoskeletal issues from aromatase inhibitors, highlighting its importance in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. Peterson, LL., Ligibel, JA.[2019]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40423894/

Effects of web platform delivery of a physical activity ...

Our goal was to test the efficacy of webMFT on survivors' MVPA. Methods: In a randomized controlled trial, we trained ten peer coaches from ...

2.

link.springer.com

link.springer.com/article/10.1007/s11764-025-01811-7

Effects of web platform delivery of a physical activity ...

In a randomized controlled trial, we trained ten peer coaches from cancer care organizations to deliver webMFT or MVPA Tracking to 61 breast cancer survivors.

3.

reporter.nih.gov

reporter.nih.gov/project-details/11019721

Peer Coaching for Physical Activity Promotion among Breast Cancer ...

We will collect feasibility and acceptability data about webMFT from the coaches. We will examine survivor outcomes (objectively measured MVPA and self ...

4.

academic.oup.com

academic.oup.com/tbm/article/doi/10.1093/tbm/ibaf051/8266635

Adopting and implementing an efficacious peer-delivered physical ...

The webMFT intervention is a 3-month PA program where survivors of breast cancer (i.e. recipients) receive weekly phone calls from a trained, peer mentor.

5.

cancer.jmir.org

cancer.jmir.org/2025/1/e79610

Evaluation of a Translatable Web-Based Intervention for ...

Results of this preliminary investigation support the feasibility and short-term efficacy of a 3-month, fully automated, web-based intervention ...

6.

researchprotocols.org

researchprotocols.org/2024/1/e52494

Adapting an Efficacious Peer-Delivered Physical Activity ...

We will recruit 56 survivors of breast cancer and randomize them to webMFT (assigned a coach to deliver intervention via the web platform) or an ...

7.

academic.oup.com

academic.oup.com/tbm/article/doi/10.1093/tbm/ibaf051/8266635?rss=1

Adopting and implementing an efficacious peer-delivered ...

The webMFT intervention is a 3-month PA program where survivors of breast cancer (i.e. recipients) receive weekly phone calls from a trained, ...