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Can a fitbit and app get metastatic breast cancer patients moving?

NCT ID NCT07840599

Symptom relief Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers at Northwestern University are testing which parts of a digital health program help women with metastatic breast cancer increase their daily steps. Participants wear a Fitbit, use a smartphone app, and receive coaching calls over 24 weeks. The study measures changes in step counts and moderate-to-vigorous activity using a research-grade monitor. The goal is to learn which combination of app features, health record integration, and coaching is most useful for promoting physical activity in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A digital health program combining a Fitbit activity tracker, a smartphone app, health record integration, and coaching calls to encourage walking
What this could lead to
If it works, this could show which parts of a digital activity program matter most, giving doctors a clearer way to help people with metastatic breast cancer stay active.
What could go wrong
The study tests a behavioral program, not a drug, and activity levels can be hard to change. Results may not apply to people who are less tech-comfortable or in different stages of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer Metastatic breast cancer (MBC) Metastatic breastcancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwestern University

    Chicago, Illinois, 60611, United States

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