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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129346
• Other study ID #: SP00049673
• Secondary ID: R21CA239130
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: October 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Obesity

Intervention

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.
• 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.
• 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
• 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.
• 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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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