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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04129346

Enrollment

Registered

2019-10-16

Start date

2019-11-26

Completion date

2021-05-01

Last updated

2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer, Obesity

Keywords

Inactivity, Breast Cancer, Metastatic Breast Cancer, Quality of life, Sedentary

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.

Interventions

BEHAVIORALFit2ThriveMB 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.

BEHAVIORALFitbit

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.

BEHAVIORALPhysical 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

BEHAVIORALHealthy 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.

BEHAVIORALCancer.net app

Cancer.net app content includes information about health and well-being, treatment guidelines specific to cancer type, symptom tracking and medication tracking

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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 \[(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized\].
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

Measure	Time frame	Description
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 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 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 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 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.
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 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 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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Fit2ThriveMB Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. 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	25
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 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	24
Total	49

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	1	0

Baseline characteristics

Characteristic	Fit2ThriveMB	Total	Healthy Living Control
Age, Continuous	57.2 Years STANDARD_DEVIATION 11.9	54.8 Years STANDARD_DEVIATION 11.3	52.2 Years STANDARD_DEVIATION 29.7
Number of Participants Randomized	25 Participants	49 Participants	24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) White	21 Participants	42 Participants	21 Participants
Region of Enrollment United States	25 participants	49 participants	24 participants
Sex: Female, Male Female	25 Participants	49 Participants	24 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 25	0 / 24
other Total, other adverse events	0 / 25	0 / 24
serious Total, serious adverse events	0 / 25	0 / 24

Outcome results

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.

Time frame: 12 weeks

Population: One participant did not complete the acceptability questionnaire at 12 weeks.

Arm	Measure	Value (NUMBER)
Fit2ThriveMB	Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients	24 Participants

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.

Time frame: 12 weeks

Arm	Measure	Value (MEAN)	Dispersion
Fit2ThriveMB	Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients	98.2 Percentage of days the Fitbit was worn.	Standard Deviation 2.5

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 \[(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized\].

Time frame: 12 weeks

Population: All participants who were randomized.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Fit2ThriveMB	Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period	24 Participants
Healthy Living Control	Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period	24 Participants

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.