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

This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.

Study Overview

• Status: Completed
• Conditions: Obesity; Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: Fit2ThriveMB App; Behavioral: Fitbit; Behavioral: Physical Activity Coaching Calls; Behavioral: Healthy Living Coaching Calls; Behavioral: Cancer.net app

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period	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].	12 weeks
Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients	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.	12 weeks
Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients	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).	Baseline and 12 weeks
Change in Quality of Life From From Baseline to 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.	Baseline and 12 weeks
Change in Anxiety From Baseline to 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.	Baseline and 12 weeks
Change in Depression From Baseline to 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.	Baseline and 12 weeks
Change in Fatigue From Baseline to 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.	Baseline and 12 weeks
Change in Pain Interference From Baseline to 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.	Baseline and 12 weeks
Change in Physical Function From Baseline to 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.	Baseline and 12 weeks
Change in Sleep Disturbance From Baseline to 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.	Baseline and 12 weeks
Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 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.	Baseline and 12 weeks
Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between 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.	Baseline and 12 weeks
Change in 6-minute Walk Test Distance Between 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.	Baseline and 12 weeks
Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between 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.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Phillips S, Solk P, Welch W, Auster-Gussman L, Lu M, Cullather E, Torre E, Whitaker M, Izenman E, La J, Lee J, Spring B, Gradishar W. A Technology-Based Physical Activity Intervention for Patients With Metastatic Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 23;10(4):e24254. doi: 10.2196/24254.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Quality of life; Metastatic Breast Cancer; Sedentary; Inactivity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SP00049673; R21CA239130 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy. We welcome inquiries by investigators who are not associated with the study to review or analyze data that we have collected. All requests for data sharing will be handled by the PI, Dr. Phillips, in conjunction with co-investigators, on a case by case basis to ensure that the proposed work does not conflict with planned analyses; we will also establish that the proposed project has sufficient scientific merit before proceeding.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No