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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?

The purpose of this study is to examine which of four components of a digital health intervention using an App and Fitbit meaningfully contribute to increased physical activity in Metastatic Breast Cancer Patients.

Participants will be asked to:

* Wear a Fitbit and use an app, use 0 to 3 other components for 24 weeks and attend 6 or 12 coaching coaching calls in the first 12 weeks to increase daily steps.

* Complete a questionnaire at baseline, week 12 and week 24

* Complete functional performance test (FPT) via Zoom at baseline, week 12 and week 24

* Wear a research activity monitor (Accelerometer) for 7 days at baseline, week 12 and week 24

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

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+

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