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
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
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
Factorial
Core Intervention
BehavioralThe core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.
EHR Integration (On v. Off)
BehavioralParticipant 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
BehavioralParticipants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.
Social+ (on v. off)
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Highly Tailored Goal Setting
BehavioralParticipants 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.
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Treatment groupsSee each treatment group below.
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.
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.
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.
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.
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.
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Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
