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

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a 3-month physical activity intervention aimed to increase moderate-intensity activity among previously inactive breast cancer survivors. Participants will be eligible if they are not currently active, and have recently been diagnosed with breast cancer. Upon eligibility, participants will be randomized into one of two groups. The intervention group will receive weekly guidance from a peer coach to increase their activity throughout the three month intervention. The control group will be encouraged to self-monitor their physical activity throughout the three month intervention. Both groups will receive a Fitbit. Peer coaches will be trained to deliver the physical activity program using a web-based platform; all calls will be virtual. Participants will be assessed before and after the intervention.

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.

Is physical activity safe for breast cancer survivors?

Research shows that physical activity, including weightlifting, is generally safe for breast cancer survivors, with low rates of musculoskeletal injuries (injuries related to muscles and bones) and healthcare referrals. This suggests that with proper guidance, physical activity can be safely incorporated into rehabilitation programs for breast cancer survivors. ^{1 2 3 4 5}

How does the physical activity treatment for breast cancer differ from other treatments?

The physical activity treatment for breast cancer is unique because it focuses on improving quality of life and reducing health risk factors through exercise, rather than using medication. It involves behavior change techniques like self-monitoring and goal setting, which are underutilized in digital interventions, making it a novel approach compared to traditional treatments. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Physical activity adoption, Self monitoring for breast cancer?

Research shows that adopting physical activity can improve the quality of life for breast cancer survivors and help reduce health risk factors like weight gain. Studies also indicate that physical activity programs can enhance physical performance and reduce fatigue during breast cancer treatment. ^{2 7 10 11 12}

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 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]

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 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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Peer mentorship to promote physical activity among cancer survivors: effects on quality of life. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Reduction of health risk factors through an adapted physical activity program in patients with breast cancer. [2021]

3. Germany 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. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Moderators of physical activity and quality of life response to a physical activity intervention for breast cancer survivors. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Diverse strategies are needed to support physical activity engagement in women who have had breast cancer. [2023]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Physical activity during and after adjuvant chemotherapy in patients with breast cancer. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Physical activity levels and preferences of patients with breast cancer receiving chemotherapy in Chile. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Behavior change techniques in digital physical activity interventions for breast cancer survivors: a systematic review. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Taking the next step: a systematic review and meta-analysis of physical activity and behavior change interventions in recent post-treatment breast cancer survivors. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Exploring the Feasibility of a Broad-Reach Physical Activity Behavior Change Intervention for Women Receiving Chemotherapy for Breast Cancer: A Randomized Trial. [2022]