Metastatic Breast CancerFit2ThriveMBNCT07840599
Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients
A study testing Core Intervention, EHR Integration (On v. Off) and Weekly Coaching in people with Metastatic Breast Cancer and Metastatic Breast Cancer (MBC), run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Breast Cancer (MBC), Metastatic Breastcancer
- What is being tested?
- Core Intervention, EHR Integration (On v. Off) and Weekly Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 15 Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University
Chicago, Illinois, 60611
Siobhan Phillips, PhD, 312-503-4235, smphillips@northwestern.edu
About this study
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
Read the detailed description
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.
- Being tested
- Core Intervention, EHR Integration (On v. Off), Weekly Coaching, Social+ (on v. off), Static Goal Setting
- Keywords
- exercise, wearables, coaching, EMR, Social Support, Metastatic Breast Cancer, MOST, physical activity
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core InterventionBehavioural
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.
EHR Integration (On v. Off)Behavioural
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 CoachingBehavioural
Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.
Social+ (on v. off)Behavioural
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 SettingBehavioural
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 CoachingBehavioural
Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Highly Tailored Goal SettingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Weekly Coaching; Behavioral: Social+ (on v. off); Behavioral: Highly Tailored Goal Setting |
| 2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Social+ (on v. off); Behavioral: Bi-Weekly Coaching; Behavioral: Highly Tailored Goal Setting |
| 3- Core, EHR, Weekly Coaching, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Weekly Coaching; Behavioral: Static Goal Setting |
| 4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Static Goal Setting; Behavioral: Bi-Weekly Coaching |
| 5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Weekly Coaching; Behavioral: Social+ (on v. off); Behavioral: Static Goal Setting |
| 6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Social+ (on v. off); Behavioral: Static Goal Setting; Behavioral: Bi-Weekly Coaching |
| 7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Weekly Coaching; Behavioral: Highly Tailored Goal Setting |
| 8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: EHR Integration (On v. Off); Behavioral: Bi-Weekly Coaching; Behavioral: Highly Tailored Goal Setting |
| 9- Core, Weekly Coaching, Social+, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Weekly Coaching; Behavioral: Social+ (on v. off); Behavioral: Static Goal Setting |
| 10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Social+ (on v. off); Behavioral: Static Goal Setting; Behavioral: Bi-Weekly Coaching |
| 11- Core, Weekly Coaching, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Weekly Coaching; Behavioral: Highly Tailored Goal Setting |
| 12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Bi-Weekly Coaching; Behavioral: Highly Tailored Goal Setting |
| 13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Weekly Coaching; Behavioral: Social+ (on v. off); Behavioral: Highly Tailored Goal Setting |
| 14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Social+ (on v. off); Behavioral: Bi-Weekly Coaching; Behavioral: Highly Tailored Goal Setting |
| 15- Core, Weekly Coaching, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Weekly Coaching; Behavioral: Static Goal Setting |
| 16- Core, Bi-Weekly Coaching, Static Goal Setting | Experimental | Not described Receives: Behavioral: Core Intervention; Behavioral: Static Goal Setting; Behavioral: Bi-Weekly Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Steps
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.
Measured: Baseline, 12 and 24 weeks
Secondary outcomes (13)
ActiGraph measured MVPA
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.
Measured: Baseline, 12 and 24 weeks
ActiGraph measured light activity
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.
Measured: Baseline, 12 and 24 weeks
ActiGraph measured sedentary behavior
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.
Measured: Baseline, 12 and 24 weeks
Godin Leisure Time Exercise Questionnaire
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.
Measured: Baseline, 12 and 24 weeks
Short Physical Performance Battery (SPPB) Total Score
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.
Measured: Baseline, 12 weeks, 24 weeks
PROMIS Physical Function
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure physical function with 4 items over the past 7 days. Items are combined using a t-score metric where higher score is better.
Measured: Baseline, 12 and 24 weeks
PROMIS Anxiety
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Anxiety with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Measured: Baseline, 12 and 24 weeks
PROMIS Depression
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Depression with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Measured: Baseline, 12 and 24 weeks
PROMIS Fatigue
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Fatigue with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Measured: Baseline, 12 and 24 weeks
PROMIS Ability to Participate in Social Roles and Activities
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Ability to Participate in Social Roles and Activities with 4 items over the past 7 days. Items are combined using a t-score metric where the higher score is better.
Measured: Baseline, 12 and 24 weeks
PROMIS Sleep Disturbance
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure sleep disturbance with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Measured: Baseline, 12 and 24 weeks
PROMIS Pain Interference
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure pain interference with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Measured: Baseline, 12 and 24 weeks
PROMIS Pain Intensity
PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure pain intensity with 1 item using a scale 1-10 over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Measured: Baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion15 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Siobhan M Phillips, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840599
- Sponsor's protocol ID
- STU00224173
- Other IDs
- R01CA305818
- Acronym
- Fit2ThriveMB
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No