Physical Activity Promotion for Breast Cancer

(Fit2ThriveMB Trial)

SP
Overseen BySiobhan Phillips, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify which parts of a digital program effectively increase physical activity in people with metastatic breast cancer. Participants will use a Fitbit and an app, along with components like coaching and goal setting, to determine what best boosts their daily steps. The core intervention includes these elements to promote physical activity. Ideal candidates have metastatic breast cancer, exercise less than 150 minutes a week, and own a smartphone.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve the quality of life for those with metastatic breast cancer.

What prior data suggests that this digital health intervention is safe for metastatic breast cancer patients?

Research has shown that digital health tools, like the Core Intervention in this trial, are generally safe. Participants will use a Fitbit and an app to boost physical activity in those with metastatic breast cancer. Previous studies on similar tools found them well-tolerated, with most side effects being minor, such as mild skin irritation from wearing the device. The trial's "Not Applicable" phase label likely indicates non-invasive activities, suggesting a low risk. Participants can feel confident about the safety of this approach.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to promote physical activity among breast cancer patients. Unlike traditional treatments that primarily focus on medication or surgery, this trial emphasizes lifestyle changes through personalized coaching and dynamic goal setting. The unique aspect here is the use of Electronic Health Records (EHR) to tailor physical activity plans, combined with options for either weekly or bi-weekly coaching. This approach is not only highly individualized but also integrates social support elements, which can boost motivation and adherence. By exploring these tailored interventions, researchers hope to improve overall well-being and potentially enhance recovery outcomes for breast cancer patients.

What evidence suggests that this trial's treatments could be effective for increasing physical activity in metastatic breast cancer patients?

This trial will explore various strategies to promote physical activity among breast cancer survivors. Studies have shown that exercise can significantly enhance the quality of life for women diagnosed with breast cancer. Research suggests that active women may reduce their breast cancer risk by up to 25% compared to inactive women. Home-based exercise programs have helped breast cancer survivors perform daily tasks more easily. Additionally, increased activity has been linked to a reduced need for healthcare services during cancer treatment. These findings support the idea that staying active benefits those with breast cancer.678910

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with metastatic breast cancer who are able and willing to use a Fitbit, smartphone app, and participate in coaching calls. Participants should be physically able to increase their daily activity and complete online assessments.

Inclusion Criteria

Self-report engagement in less than 150 minutes per week of moderate to vigorous physical activity
Ownership of an Android or iPhone with an up-to-date version of the operating system
Internet access to complete assessments
See 4 more

Exclusion Criteria

Currently pregnant or plans to become pregnant
Plans to move out of the United States in next 12 months
Current enrollment in another dietary or physical activity trial
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Fit2ThriveMB app and Fitbit, with 0 to 3 additional components, and attend coaching calls to increase daily steps

12 weeks
6 or 12 coaching calls (virtual)

Follow-up

Participants continue to use the app and Fitbit to monitor physical activity and complete assessments

12 weeks
Assessments at week 12 and week 24 (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Bi-Weekly Coaching
  • Core Intervention
  • EHR Integration
  • Highly Tailored Goal Setting
  • Social+
  • Static Goal Setting
  • Weekly Coaching

Trial Overview

The study tests different combinations of digital tools—like an app, Fitbit tracking, goal setting (static or tailored), social support features, EHR integration, and varying levels of coaching—to see which best help patients with metastatic breast cancer become more active over 24 weeks.

How Is the Trial Designed?

16

Treatment groups

Experimental Treatment

Group I: 9- Core, Weekly Coaching, Social+, Static Goal SettingExperimental Treatment4 Interventions
Group II: 8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal SettingExperimental Treatment4 Interventions
Group III: 7- Core, EHR, Weekly Coaching, Highly Tailored Goal SettingExperimental Treatment4 Interventions
Group IV: 6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal SettingExperimental Treatment5 Interventions
Group V: 5- Core, EHR, Weekly Coaching, Social+, Static Goal SettingExperimental Treatment5 Interventions
Group VI: 4- Core, EHR, Bi-Weekly Coaching, Static Goal SettingExperimental Treatment4 Interventions
Group VII: 3- Core, EHR, Weekly Coaching, Static Goal SettingExperimental Treatment4 Interventions
Group VIII: 2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal SettingExperimental Treatment5 Interventions
Group IX: 16- Core, Bi-Weekly Coaching, Static Goal SettingExperimental Treatment3 Interventions
Group X: 15- Core, Weekly Coaching, Static Goal SettingExperimental Treatment3 Interventions
Group XI: 14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal SettingExperimental Treatment4 Interventions
Group XII: 13- Core, Weekly Coaching, Social+, Highly Tailored Goal SettingExperimental Treatment4 Interventions
Group XIII: 12- Core, Bi-Weekly Coaching, Highly Tailored Goal SettingExperimental Treatment3 Interventions
Group XIV: 11- Core, Weekly Coaching, Highly Tailored Goal SettingExperimental Treatment3 Interventions
Group XV: 10- Core, Bi-Weekly Coaching, Social+, Static Goal SettingExperimental Treatment4 Interventions
Group XVI: 1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal SettingExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Physical activity may reduce breast cancer risk

Women who are physically active may have a risk of breast cancer that is 25% lower than sedentary women, according to an article published ...

Exercise recommended to improve lives of women with ...

A new study shows strong evidence that physical activity can improve quality of life after a breast cancer diagnosis.

Home-based exercise interventions' impact on breast ...

Conclusion HBE interventions may be feasible to improve functional performance and promote physical activity among breast cancer survivors.

Exercise during early-stage breast cancer decreases ...

Exercise during early-stage breast cancer decreases health care utilization · 1. Patients in the control group had higher mean health care ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29713835/

Physical Activity and Breast Cancer: an Opportunity to ...

Observational evidence suggests that physical activity is associated with a reduced risk of developing breast cancer, a reduced risk of ...

Breast Cancer Screening Update

7,8 Great strides have been made to improve overall breast cancer outcomes, but more research and quality improvement initiatives are needed to ...

Behind the Breakthroughs: Global Breast Cancer Disparities

In honor of World Health Day 2023, BCRF investigators Drs. Sonya Reid and Lawrence Shulman discuss breast cancer's impact worldwide—and what ...

Medications for Risk Reduction of Primary Breast Cancer in ...

After conducting a formal breast cancer risk assessment, the Task Force recommends that doctors talk with women who are at increased risk for breast cancer.

Key Insights on Mammography Research, Breast MRI Studies ...

The NCCN issued updated breast cancer screening and diagnosis guidelines that include AI-powered five-year risk assessment beginning at age 35, ...

Screening for Breast Cancer: U.S. Preventive Services ...

Limited data suggests that ultrasonography or MRI will detect additional breast cancer in women who have dense breasts. DBT also detects ...