Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
Study Details
Study Description
Brief Summary
This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mHealth intervention to increase PA in metastatic breast cancer (MBC) patients using a two-arm randomized control trial (RCT). We will also examine the effects of the intervention on symptom burden, quality of life, and functional performance. Inactive MBC patients (n=50) will be assigned to Fit2ThriveMB or education control. Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. Participants in the education control will be asked to download the app cancer.net from the American Society of Clinical Oncology, will receive educational materials and calls during the intervention period and the Fitbit following completion of 12 week assessments.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fit2ThriveMB Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. |
Behavioral: Fit2ThriveMB App
The Fit2thriveMB app will encourage participants to increase their physical activity. Participants will be provided with educational information on physical activity and effective behavior change strategies for incorporating more physical activity into their daily lives to increase their step count. Participants will be prompted each morning to report the intensity of their symptom burden (0 to 10). Based on their symptom rating and their previous day's step counts, participants will be provided with three different options or levels of goals for that day to either increase or decrease 10-20% or remain constant.
Behavioral: Fitbit
The Fitbit measures PA intensity, steps, and heart rate and syncs directly with the smartphone and will automatically sync with the Fit2ThriveMB app and provide Fitbit data to the study team in real-time.
Behavioral: Physical Activity Coaching Calls
Participants will receive weekly coaching calls which will: a) provide feedback on the previous week's symptom burden and progress on PA goals; b) review personalized goals and strategies for increasing PA for the next week; c) provide instruction on effective behavioral change techniques
|
| Active Comparator: Healthy Living Control Participants in the healthy living group will receive the American Society of Cancer Oncologists smartphone app, cancer.net. They will also receive calls during the intervention period and the Fitbit following completion of 12 week assessments |
Behavioral: Healthy Living Coaching Calls
Participants will receive weekly calls that will cover health and well-being topics for instance: symptom and stress management, healthy diet, hydration, sun safety, sleep hygiene, and meditation.
Behavioral: Cancer.net app
Cancer.net app content includes information about health and well-being, treatment guidelines specific to cancer type, symptom tracking and medication tracking
|
Outcome Measures
Primary Outcome Measures
- Feasibility of a 12 week technology supported physical activity intervention in metastatic breast cancer patients [12 weeks]
Feasibility will be assessed via participant retention (# of participants who drop out/ # randomized).
- Adherence to a 12 week technology supported physical activity intervention by metastatic breast cancer patients [12 weeks]
Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app. Tracker wear time, steps, and time spent in sedentary, light, moderate, and vigorous intensity activity will be obtained.
- Acceptability of a 12 week technology supported physical activity intervention to metastatic breast cancer patients [12 Weeks]
Acceptability will be measured via a process evaluation of perceptions of MBC patients' experiences with Fit2ThriveMB.
Secondary Outcome Measures
- Physical Activity before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients [12 weeks]
Physical activity will be measured at baseline and at 12 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
- Quality of life, as assessed by FACT-B survey, before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients [12 weeks]
Quality of life will be measured at baseline and 12 weeks using the Functional Assessment of Cancer Therapy-Breast (FACT-B)
- Symptom Burden-Anxiety [12 weeks]
Symptom burden of anxiety will be measured at baseline and 12 weeks using the PROMIS-Anxiety 8a health measure.
- Symptom Burden-Depression [12 weeks]
Symptom burden of depression will be measured at baseline and 12 weeks using the PROMIS-depression 8a health measure.
- Symptom Burden-Fatigue [12 weeks]
Symptom burden of fatigue will be measured at baseline and 12 weeks using the PROMIS-Fatigue 8a health measure.
- Symptom Burden-Pain Interference [12 weeks]
Symptom burden will be measured at baseline and 12 weeks using the PROMIS health measure.
- Symptom Burden-Physical Function [12 weeks]
Symptom burden will be measured at baseline and 12 weeks using the PROMIS-physical function 20 a health measure.
- Symptom Burden-Sleep Disturbance [12 weeks]
Symptom burden of sleep disturbance will be measured at baseline and 12 weeks using the PROMIS-Sleep Disturbance 8a health measure.
- Functional Performance before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients-Short Physical Performance Battery [12 weeks]
Participants will complete the Short Physical Performance Battery at baseline and 12 weeks.
- Functional Performance before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients-Senior Fitness Test [12 weeks]
Participants will complete the Senior Fitness Test at baseline and 12 weeks.
- Functional Performance before and after a 12 week technology supported physical activity intervention in metastatic breast cancer patients-6 minute walk test [12 weeks]
Participants will complete a 6 minute walk test at baseline and 12 weeks.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female; ≥18 years of age
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Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify).
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Fluent in spoken and written English
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Own a smartphone
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Have access to the internet to complete assessments
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Self-report engaging in <150 minutes of moderate to vigorous PA per week.
Exclusion Criteria:
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Untreated brain metastases
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Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
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Current enrollment in another dietary or PA trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- National Cancer Institute (NCI)
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- SP00049673
- R21CA239130