An interventional study of Core Intervention and EHR Integration (On v. Off) in Metastatic Breast Cancer, Metastatic Breast Cancer (MBC) and Metastatic Breastcancer, sponsored by Northwestern University. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
Among 64 studies in Breast Neoplasms by Northwestern University — 4 open to participants now, 6 under way, 1 of them phase 3. Breast Neoplasms · Northwestern University.
Among the 64 studies in Breast Neoplasms by Northwestern University, this one is the 3rd largest by planned enrollment of the 50 interventional ones, is the only one that started in 2027, is one of 19 with no phase, and was the 64th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 224 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →4 of the 64 studies in Breast Neoplasms by Northwestern University are open now, in 2 countries. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →64 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 1 started in 2027.
Median enrollment 31 across the 50 interventional studies, 79 across the 7 observational. Of the 47 that completed or were terminated, 15 (32%) have results posted.
Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
2 of the studies in Breast Neoplasms by Northwestern University that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05703178Phase 3Northwestern UniversityWeb-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia | 2026-11-30 |
| NCT05931874Northwestern UniversityOptimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors | 2027-08-31 |
Among the 64 studies in Breast Neoplasms by Northwestern University, from their registry updates:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Weekly Coaching · Behavioral: Social+ (on v. off) · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Social+ (on v. off) · Behavioral: Bi-Weekly Coaching · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Weekly Coaching · Behavioral: Static Goal Setting
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Static Goal Setting · Behavioral: Bi-Weekly Coaching
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Weekly Coaching · Behavioral: Social+ (on v. off) · Behavioral: Static Goal Setting
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Social+ (on v. off) · Behavioral: Static Goal Setting · Behavioral: Bi-Weekly Coaching
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Weekly Coaching · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: EHR Integration (On v. Off) · Behavioral: Bi-Weekly Coaching · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: Weekly Coaching · Behavioral: Social+ (on v. off) · Behavioral: Static Goal Setting
Behavioral: Core Intervention · Behavioral: Social+ (on v. off) · Behavioral: Static Goal Setting · Behavioral: Bi-Weekly Coaching
Behavioral: Core Intervention · Behavioral: Weekly Coaching · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: Bi-Weekly Coaching · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: Weekly Coaching · Behavioral: Social+ (on v. off) · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: Social+ (on v. off) · Behavioral: Bi-Weekly Coaching · Behavioral: Highly Tailored Goal Setting
Behavioral: Core Intervention · Behavioral: Weekly Coaching · Behavioral: Static Goal Setting
Behavioral: Core Intervention · Behavioral: Static Goal Setting · Behavioral: Bi-Weekly Coaching
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.
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.
Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.
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.
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.).
Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
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.
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.
Time frame: Baseline, 12 and 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 and 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2031, 48 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 48 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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