Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer; Obesity
• Interventions: Behavioral: Healthy Living Coaching Calls; Behavioral: Fit2ThriveMB App; Behavioral: Fitbit; Behavioral: Cancer.net app; Behavioral: Physical Activity Coaching Calls

• Registration Number: NCT04129346
• Lead Sponsor: Northwestern University

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.

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2019-11-26
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Results First Submitted: 2022-06-14
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Results First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

• Female; ≥18 years of age
• 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).
• Fluent in spoken and written English
• Own a smartphone
• Have access to the internet to complete assessments
• Self-report engaging in <150 minutes of moderate to vigorous PA per week.

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Exclusion Criteria

• Untreated brain metastases
• Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
• Current enrollment in another dietary or PA trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Living Control	Healthy Living Coaching Calls	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
Fit2ThriveMB	Fitbit	Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.
Fit2ThriveMB	Physical Activity Coaching Calls	Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.
Fit2ThriveMB	Fit2ThriveMB App	Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.
Healthy Living Control	Cancer.net app	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

Primary Outcome Measures

Name	Time	Method
Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period	12 weeks	Feasibility will be assessed via participant retention during the intervention period \[(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized\].
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. Acceptability will be measured as the number of intervention participants who are satisfied/very satisfied with their overall study experience.
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. This measure the average percentage of days each participant in the Fit2ThriveMB intervention group wore the Fitbit.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life From From Baseline to 12-weeks	Baseline and 12 weeks	Quality of life will be measured at baseline and 12 weeks using the Functional Assessment of Cancer Therapy-Breast (FACT-B). Totals scores range from 0 to 148. Higher scores indicate better quality of life.
Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients	Baseline and 12 weeks	Physical activity will be measured at baseline and at 12 weeks. The change between physical activity at baseline and 12-weeks will be assessed. 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).
Change in Anxiety From Baseline to 12-weeks	Baseline and 12 weeks	Anxiety will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a health measure. T-scores range from 37.1 to 83.1. Higher scores indicate more anxiety. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Depression From Baseline to 12-weeks	Baseline and 12 weeks	Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Fatigue From Baseline to 12-weeks	Baseline and 12 weeks	Fatigue will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Pain Interference From Baseline to 12-weeks	Baseline and 12 weeks	Pain Interference will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Interference 8a health measure. T-scores range from 40.7 to 77.0 Higher scores indicate more pain interference.
Change in Physical Function From Baseline to 12-weeks	Baseline and 12 weeks	Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks	Baseline and 12 weeks	The Senior Fitness Test measures physical function. The arm curl test assesses the number of times (repetitions) a 5lb hand-weight is curled in 30 seconds. The 2-minute step test evaluates the number of times (repetitions) the right knee reaches a distance half way between the iliac crest and patella during 2-minutes. Increased number of repetitions on both tests represents better physical function.
Change in Sleep Disturbance From Baseline to 12-weeks	Baseline and 12 weeks	Sleep disturbance will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-sleep disturbance 8a health measure. T-scores range from 30.5 to 77.5. Higher scores more sleep disturbance. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks	Baseline and 12 weeks	Participants will complete the Short Physical Performance Battery which includes assessments of gait speed, chair stands and standing balance that are combined to obtain a SPPB score. This test will be conducted at baseline and 12 weeks. SPPB scores range from 0 to 12. Higher scores mean better physical functioning.
Change in 6-minute Walk Test Distance Between Baseline and 12-weeks.	Baseline and 12 weeks	Participants will complete a 6 minute walk test at baseline and 12 weeks. Distance is measured in meters. Increases in distance represent better performance.
Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks	Baseline and 12 weeks	The Senior Fitness Test measures physical function. The one leg stand test assesses how long an individual can stand on each of their feet (right and left) in seconds up to 30-seconds. Increases in time on the one leg stand tests indicate better functioning. The 8-foot up and go test assesses how long it takes in seconds to stand from a chair, walk 8 feet around an object and return to sitting. Decreases in time indicate better functioning.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States