Trial Outcomes & Findings for Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB (NCT NCT04129346)

NCT ID: NCT04129346

Last Updated: 2022-11-10

Results Overview

Feasibility will be assessed via participant retention during the intervention period \[(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized\].

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-11-10

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	25	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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	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
Overall Study Death	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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	Total n=49 Participants Total of all reporting groups
Age, Continuous	57.2 Years STANDARD_DEVIATION 11.9 • n=5 Participants	52.2 Years STANDARD_DEVIATION 29.7 • n=7 Participants	54.8 Years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Number of Participants Randomized	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All participants who were randomized.

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].

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period	24 Participants	24 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=24 Participants 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	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
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 outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Fit2ThriveMB n=23 Participants 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	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
Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients	24 Participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients	-3.5 Minutes Standard Deviation 56.6	-18.7 Minutes Standard Deviation 63.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Quality of Life From From Baseline to 12-weeks	1.7 score on a scale Standard Error 1.9	2.0 score on a scale Standard Error 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Anxiety From Baseline to 12-weeks	0.8 t-score on a scale Standard Error 1.2	1.1 t-score on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Depression From Baseline to 12-weeks	0.1 t-score on a scale Standard Error 1.3	-0.05 t-score on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Fatigue From Baseline to 12-weeks	-2.7 t-score on a scale Standard Error 1.3	0.6 t-score on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Pain Interference From Baseline to 12-weeks	3.2 score on a scale Standard Error 1.8	-1.5 score on a scale Standard Error 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Physical Function From Baseline to 12-weeks	-0.1 t-score on a scale Standard Error 1.3	1.4 t-score on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fit2ThriveMB n=25 Participants 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	Healthy Living Control n=24 Participants 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
Change in Sleep Disturbance From Baseline to 12-weeks	-0.3 t-score on a scale Standard Error 0.8	-0.2 t-score on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The SPPB was only conducted on a subset of participants due to disruptions in research related to the COVID-19 pandemic.

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.

Outcome measures

Measure	Fit2ThriveMB n=12 Participants 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	Healthy Living Control n=11 Participants 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
Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks	.41 score on a scale Standard Error .29	-.55 score on a scale Standard Error .37

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The Senior Fitness Test was conducted on a subset of participants due to disruptions in research caused by the COVID-19 pandemic.

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.

Outcome measures

Measure	Fit2ThriveMB n=12 Participants 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	Healthy Living Control n=11 Participants 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
Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks Arm Curl Test	1.42 Repetitions Standard Error 0.96	2.91 Repetitions Standard Error 2.48
Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks 2-Minute Step Test	12.92 Repetitions Standard Error 5.16	3.70 Repetitions Standard Error 4.87

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The 6-minute walk test was conducted on a subset of participants due to disruptions in research caused by the COVID-19 pandemic.

Participants will complete a 6 minute walk test at baseline and 12 weeks. Distance is measured in meters. Increases in distance represent better performance.

Outcome measures

Measure	Fit2ThriveMB n=12 Participants 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	Healthy Living Control n=11 Participants 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
Change in 6-minute Walk Test Distance Between Baseline and 12-weeks.	19.42 Meters Standard Error 17.4	15.10 Meters Standard Error 5.50

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The Senior Fitness Test was conducted on a subset of participants due to disruptions in research caused by the COVID-19 pandemic.

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.

Outcome measures

Measure	Fit2ThriveMB n=12 Participants 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	Healthy Living Control n=11 Participants 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
Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks One Leg Stand: Right Leg	1.48 Seconds Standard Error 1.84	-1.33 Seconds Standard Error 2.71
Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks One Leg Stand: Left Leg	4.40 Seconds Standard Error 2.64	1.87 Seconds Standard Error 1.04
Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks 8-foot-up-and-go	-0.23 Seconds Standard Error 0.26	0.29 Seconds Standard Error 0.40

Adverse Events

Fit2ThriveMB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Healthy Living Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Siobhan Phillips

Northwestern University Feinberg School of Medicine

Phone: 312-503-4235

Email: smphillips@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place