Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07840599

Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Metastatic Breast Cancer Behavior Breast Diseases Breast Neoplasms Metastatic Breast Cancer (MBC) Metastatic Breastcancer Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

Multiphase Optimization Strategy (MOST) methodology will be used to determine which intervention components or component combinations optimally increase daily steps in a 12-week intervention with a 12-week follow-up. MOST is a framework adapted from engineering that uses highly efficient factorial experiments to evaluate individual, and combined, effects of intervention components to determine which ones can be reduced, eliminated, or replaced to improve efficiency. Insufficiently active people with metastatic breast cancer (MBC) will receive a core intervention consisting of the FIt2ThriveMB app and Fitbit and be randomly assigned to four components, each with two-levels, under consideration for inclusion in the optimized intervention: 1) EHR-integration (on v. off); 2) coaching dose (weekly v. bi-weekly; 3) social+ (on v. off) and 4) goal-setting type (highly tailored v. static). The effects of increasing PA on symptom burden, other intensity activities (i.e. moderate to vigorous, light and sedentary), and functional performance and potential mediators and moderators of component effects will also be examined. Knowledge gained from this study will inform the development of more effective and scalable interventions to improve health and disease outcomes in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female sex assigned at birth, age 18 years or older
  • Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection.
  • Self-report engagement in <150 min/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
  • Fluency in spoken and written English
  • Willingness to obtain medical clearance to participate.

Exclusion criteria

  • Untreated brain metastases
  • Breast cancer with metastases to only the axillary lymph nodes.
  • Self-reported absolute contraindications to exercise (i.e., non-ambulatory, acute myocardial infarction, severe cognitive or functional impairment)
  • 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

Treatment and study plan

Core Intervention

Behavioral

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

EHR Integration (On v. Off)

Behavioral

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Weekly Coaching

Behavioral

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Social+ (on v. off)

Behavioral

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Static Goal Setting

Behavioral

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).

Bi-Weekly Coaching

Behavioral

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.

Highly Tailored Goal Setting

Behavioral

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.

Primary outcomes

  1. Change in Steps

    Time frame: Baseline, 12 and 24 weeks

    The ActiGraph accelerometer will be used. Participants will wear the device during all waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip.

Secondary outcomes

  1. ActiGraph measured MVPA

    Time frame: Baseline, 12 and 24 weeks

    Moderate to vigorous physical activity will be measured using the ActiGraph. Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cut points will be used to determine this activity as 2,690-9,642 CPM.

  2. ActiGraph measured light activity

    Time frame: Baseline, 12 and 24 weeks

    Light intensity physical activity will be measured using the ActiGraph. I Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cutpoints for light activity are defined as Light: 0 - 2,689 CPM.

  3. ActiGraph measured sedentary behavior

    Time frame: Baseline, 12 and 24 weeks

    Sedentary behavior will be measured using the ActiGraph. Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cutpoints for sedentary behavior are defined as <100 CPM.

  4. Godin Leisure Time Exercise Questionnaire

    Time frame: Baseline, 12 and 24 weeks

    Participants will be asked to indicate frequency of participation in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and average time spent in each activity. Activity frequencies will be multiplied by 9, 5, and 3 metabolic equivalents, respectively, and summed to create a total leisure time activity score. Weekly minutes of total, light, moderate, and vigorous activity will be calculated by multiplying the frequency and time of each activity. This value will be divided by 7 to obtain daily averages.

  5. PROMIS 29 Profile

    Time frame: Baseline, 12 and 24 weeks

    This well-validated measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain over the past 7 days.

  6. Short Physical Performance Battery (SPPB) Total Score

    Time frame: Baseline, 12 weeks, 24 weeks

    The SPPB score is based on timed measures of gait speed, ability to rise from a chair, and standing balance. Gait speed will be measured using the better of two recorded times over a 4-meter course. Chair stand time will be measured as the time needed to rise five times from a seated position in a chair, with arms folded across the chest. For the balance test, participants will be asked to maintain their feet side-by-side, semi-tandem, and tandem positions for 10 seconds each. Each individual performance measure will be scored according to established cut points and aggregated for a total SPPB score.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: Fit2ThriveMB

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.