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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests which parts of a digital program using an app and Fitbit help people with advanced breast cancer be more active. It is for adults assigned female at birth whose breast cancer has spread or cannot be removed by surgery. Participants use the program for 24 weeks, have coaching calls, and complete surveys and activity tests.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Assigned female at birth and age 18 or older.
  • Have breast cancer that has spread to distant body parts, or nearby areas where it cannot be removed by surgery.
  • Report less than 150 minutes a week of moderate to hard physical activity.
  • Own an Android phone or iPhone with an up-to-date operating system.
  • Have internet access to complete study assessments.
  • Speak and read English fluently.
  • Be willing to get medical approval to take part.

Who can't join

  • Have cancer that has spread to the brain and has not been treated.
  • Have breast cancer that has spread only to lymph nodes in the armpit.
  • Report a health problem that makes exercise unsafe, such as being unable to walk, a recent heart attack, or severe problems with thinking or daily tasks.
  • Are pregnant or plan to become pregnant.
  • Plan to move out of the United States in the next 12 months.
  • Are currently in another study about diet or physical activity.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

IL