Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
Phase: NA
Conditions: Metastatic Breast Cancer, Obesity
Sponsor: Northwestern University

 
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PROTOCOL TITLE: Technology Supported Physical Activity Intervention for Metastatic Breast Cancer 
Survivors: Fit2ThriveMB (Fit2ThriveMB)  
 
PRINCIPAL INVESTIGATOR: 
Siobhan M. Phillips, PhD, MPH 
Department of Preventive Medicine 
 
CO-INVESTIGATOR: 
Julia Lee, PhD, MPH 
Department of Preventive Medicine  
 
 
Bonnie J. Spring, PhD 
 
Department of Preventive Medicine  
 
 
William Gradishar, MD 
 
Department of Medicine  
 
VERSION DATE: 
July 20, 2020 
 
 
Indicate Vulnerable 
Population(s) to be Enrolled 
☐ Children  
☐ Cognitively Impaired Adults   
☐ Pregnant Women (IF the research activities will affect   
the pregnancy or the fetus) 
☐ Prisoners (or other detained/paroled individuals)  
 
International Research 
(check this box if you will 
collect data from 
individuals located outside 
the United States) 
 
 
☐ 
Research involving external 
collaborators (some 
research activities will be 
carried out by individuals 
not employed by 
Northwestern or NU 
affiliates) 
 
 
 
☐ 
 
Research has U.S. Federal 
government funding (e.g., 
NIH, NSF, other federal 
agencies/departments) 
 
☒ 
 

 
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1.0 
Purpose of the study: 
The number of women diagnosed with metastatic breast cancer (MBC) is expected to increase by 31% in the 
next 10 years. Further, treatment advances have resulted in a doubling of 5-year survival rates in the last two 
decades to 36%, and 11% survive ≥10 years.1 Thus, the population of women with MBC is growing. Women 
with MBC have higher rates of physical impairments,2  greater symptom burden,3 and lower levels of fitness 
and strength3, 4 than early stage survivors and non-cancer controls resulting in compromised quality of life 
(QOL). Interventions are needed to alleviate adverse health effects and allow MBC patients to function 
optimally in the years they survive with advanced cancer. However, few health-enhancing interventions exist 
for women with MBC, and only 2-5%5 of research funds for breast cancer are spent on metastatic disease 
despite high morbidity rates. Thus, research in women with MBC is desperately needed.   
 
Increased physical activity (PA) is consistently associated with fewer treatment-related side effects, higher 
QOL, increased survival and reduced recurrence and mortality6-9 among early stage survivors. Increasing light 
intensity PA and reducing time spent sedentary may also reduce functional decline,10 improve QOL and QOL11, 
12 and body composition13 and reduced mortality14 independent of more intense PA. However, there is a paucity 
of research on PA in MBC patients. Two out of the three existing interventions in MBC patients15, 16 were 
deemed not feasible due to their focus on intense PA and/or requiring on-site visits. Thus, PA interventions 
which use mobile health (mHealth) technology may be particularly useful for these women because they allow 
for remote monitoring of patients which facilitates individual tailoring of PA programs to patient’s abilities and 
do not require travel to on-site, supervised PA sessions, reducing participant burden. However, no studies have 
examined effects of a mHealth intervention on PA in MBC patients. The proposed study seeks to address these 
critical research gaps by testing a highly tailored, remotely delivered mHealth intervention to promote PA of 
any intensity (i.e. light, moderate or vigorous) via increasing daily steps in MBC patients. This approach may 
have substantial health benefits for MBC patients, facilitate gradual and safe adoption of more intense PA and 
be more achievable than high volumes of more strenuous PA. 17, 18 
The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week remotely 
delivered mHealth intervention to increase PA in MBC patients using a two-arm randomized control trial 
(RCT). We will also examine the effects of the intervention on symptom burden, QOL and functional 
performance, important outcomes in MBC patients. Inactive MBC patients (n=50) 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 receive educational 
materials and calls during the intervention period and the Fitbit following completion of 12 week assessments. 
The proposed study represents the first systematic effort to test a mHealth intervention to increase PA in MBC 
patients. This study addresses a critical research question related to PA and cancer survivorship (i.e. Is there a 
role for PA in advanced cancer?)19 and supports NCI’s research priorities of creating more feasible mHealth PA 
interventions for survivors.11 Findings from this study will provide essential knowledge to help understand the 
health benefits of increasing PA in MBC patients. Specific aims are:  
 
Aim 1. To pilot test the feasibility and acceptability of Fit2ThriveMB, a 12-week mHealth PA intervention 
in MBC patients (n=50) in a two-arm RCT (Fit2ThriveMB vs. education control). We hypothesize the 
following: a) ≥80% of MBC patients will be retained in the intervention; b) enrollees will set an individualized 
PA goal, adhere to their goals and wear the Fitbit on ≥70% of study days and c) ≥70% of participants will rate 
the intervention as acceptable. 
 
Aim 2. To examine the potential effects of Fit2ThriveMB on PA. MBC patients in Fit2ThriveMB will 
demonstrate greater increases in PA as measured by average daily accelerometer-assessed steps and time spent 
in any activity intensity (light, moderate or vigorous) than education controls at 12 weeks. 
 
Aim 3. To examine outcome patterns suggesting the efficacy of Fit2ThriveMB for improving symptom 
burden (i.e. fatigue, depression, anxiety, pain, and physical function), functional performance and QOL 

 
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compared to education control. MBC patients in Fit2ThriveMB will demonstrate more favorable symptom 
profiles, functional performance and QOL than controls at 12 weeks as measured by well-validated 
standardized measures.  
 
The proposed study is the first to test the effects of a mHealth intervention to increase PA in MBC patients. The 
proposed study will inform a fully-powered R01 by providing insight into: a) feasibility and acceptability of 
Fit2ThriveMB and b) preliminary effect sizes for PA, symptom burden, functional performance and QOL. 
Ultimately, the proposed study will provide key evidence to support the feasibility, acceptability and health 
benefits of increasing PA in MBC patients using a scalable intervention strategy that could be easily integrated 
into care to improve health and disease outcomes. 
 
2.0 
Background / Literature Review / Rationale for the study: 
Increased incidence and life expectancy has resulted in a growing population of metastatic breast cancer (MBC) 
patients. 1 MBC patients have poorer quality of life (QOL) and higher rates of functional decline and premature 
mortality compared to early stage survivors and healthy controls.2-4 Interventions are needed to alleviate adverse 
health effects and allow metastatic patients to function optimally in the years they survive with advanced 
cancer. However, few health-enhancing interventions exist for women with MBC. Increased physical activity 
(PA) is consistently associated with fewer treatment-related side effects, higher QOL, increased survival and 
reduced recurrence and mortality among early stage survivors.6-9 Increasing light intensity PA and reducing 
time spent sedentary may also reduce functional decline,10 improve QOL and QOL11, 12 and body composition13 
and reduced mortality14 independent of more intense PA. However, there is a paucity of research on PA in MBC 
patients, and existing interventions have been deemed not feasible due to their focus on intense PA and/or 
requiring on-site visits. mHealth PA interventions may be particularly useful for these women because they 
allow for remote monitoring of patients which facilitates individual tailoring of PA programs to patient’s 
abilities and do not require travel to on-site, supervised PA sessions, reducing participant burden. Yet, no 
studies have examined a mHealth PA intervention in MBC patients. We propose to address these critical 
research gaps by testing a highly tailored technology-supported intervention to promote PA of any intensity (i.e. 
light, moderate or vigorous) via increasing daily steps in MBC patients. This approach may have substantial 
health benefits for MBC patients, facilitate gradual and safe adoption of more intense PA and be more 
achievable than high volumes of more strenuous PA. 17, 18 The primary aim of this study is to pilot test the 
feasibility and acceptability of a 12 week technology-supported intervention to increase PA in inactive MBC 
patients (n=50) using a two-arm randomized control trial (Fit2ThiveMB versus education control). The 
Fit2ThriveMB intervention consists of a Fitbit, coaching calls and the Fit2ThriveMB smartphone app which 
provides self-monitoring, a tailored goal-setting tool, real-time tailored feedback, app notifications, and a group 
message board. We will also examine outcome patterns suggesting the efficacy of Fit2ThriveMB on symptom 
burden, QOL and functional performance, important outcomes in MBC patients compared to the education 
control. The primary outcome time point is post-intervention 12 weeks. This project is significant because it 
will provide essential evidence to support the feasibility, acceptability and health benefits of increasing PA in 
MBC patients using a scalable intervention strategy that could be easily integrated into care to improve health 
and disease outcomes in this population. 
 
3.0 
Inclusion and Exclusion Criteria: 
 
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 

 
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• Self-report engaging in <150 minutes of moderate to vigorous PA per week.   
 
Exclusion criteria:  
• Untreated brain metastases 
• Breast cancer with metastases to only the auxiliary lymph nodes. 
• 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 
 
All MBC patients must obtain medical clearance from their oncologist to participate.  
 
Adults unable to consent/Cognitively Impaired, individuals who are not yet adults (under 18 years of age), 
pregnant women and prisoners or other detained individuals will NOT be included in the present study.  
 
4.0 
Sample Size: 
We will recruit 50 metastatic breast cancer patients to participate in this study. Sample size calculations (n=50) 
are based on the successful completion rate defined as: a) an attrition rate of ≤20% (i.e. complete 12 week 
assessment) and b) adherence to daily goals and wearing Fitbit  ≥70% of study days (i.e. ~59/84 days). With half 
of participants (n=25) assigned to each condition, there is >85% power to differentiate between a 60% (control) 
and 80% (Fit2ThriveMB) “successful completion” rate with a one-tailed, exact test for binomial proportion at a 
0.05 significance level (SAS V9.4). 
 
5.0 
Recruitment and Screening Methods: 
Participants will be recruited from the following sites, all affiliated with Northwestern University Feinberg School of 
Medicine  and the Lurie Comprehensive Cancer Center, or additional Northwestern Medicine sites : a) outpatient 
facility at Galter Pavilion of Northwestern Memorial Hospital; b) Lynn Sage Comprehensive Breast Cancer Center 
at Prentice Women’s Hospital; and c) additional Northwestern Medicine Cancer Center locations (e.g. Cancer Center 
at Northwestern Medicine Lake Forest Hospital, Northwestern Medicine McHenry Hospital Cancer Center, 
Northwestern Medicine Cancer Center Delnor). For all methods, we will consult with patient’s oncologists on an as 
needed basis to help determine if potential patients are good potential candidates for participation.  
 
Screening 
Participants will complete initial eligibility screening online or over the phone. It will take approximately 15 
minutes. Screening will include evaluation of eligibility, the Physical Activity Readiness Questionnaire (PAR-
Q)20, which assesses cardiovascular disease history, symptoms, risk factors, and other health issues and the Fall 
Risk Assessment Questionnaire (FRQ)21, which identifies individuals who may be at risk for falling. Screening 
will also include questions regarding technology and equipment the women currently have at home that may be 
usable for the baseline and week 12 functional performance video conference assessments. All women will also 
be required to obtain medical clearance from their oncologist.  
 
Method 1: Recruitment Emails. The Northwestern Enterprise Data Warehouse (NMEDW) NMEDW 
(https://www.nucats.northwestern.edu/resources/data-science-and-informatics/nmedw/index.html) was designed to 
create a single, comprehensive and integrated repository of all clinical and research data sources on the campus to 
facilitate research, clinical quality, healthcare operations and medical education. We will use the NMEDW to obtain 
lists of NU patients who have agreed to be contacted regarding research study opportunities at Northwestern 
University and meet gross eligibility criteria with respect to diagnosis. We have also obtained an exception to view 
the clinic schedule in EPIC to compliment the NMEDW list. Patients who have come in for a visit recently, who 
meet the eligibility requirements, will be identified through this schedule.  In addition, we have been granted access 
to oncologist’s schedules via the exception process. Potential participants recruited through the NMEDW or clinic 
schedules will be e-mailed a letter notifying them about the study. This email will also contain a link to complete the 

 
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online screening housed in REDCap if they are interested in participating. If an individual does not want to participate, 
they will be asked to simply indicate this by responding to the e-mail. If we do not hear from the patient within 3-5 
business days, we will follow-up with additional phone or email contacts, but will not exceed three attempts. If at 
least 6 months pass following the initial recruitment attempt with no response from the patient, an additional, single 
recruitment attempt may be made via phone call and/or email.  
 
Method 2: Physician Referral. Clinicians will be encouraged to discuss the study with their patients. If her physician 
discusses the study with her and she agrees to have them send study staff her name, we will either e-mail her a 
description of the study and a link to complete the on-line screening, or follow-up with a phone call. If we do not hear 
from the patient within 3-5 business days, we will follow-up with additional contacts via telephone call or e-mail, but 
will not exceed 3 attempts.  
 
Method 3: Self-Referral. If an individual contacts the researcher and is interested in participating in the study, s/he 
will be screened over the phone or online. The Study Coordinator will also work with the clinical team to confirm 
eligibility and appropriateness for the study. Subjects may self-refer to the study after hearing about it via clinic flyers, 
word of mouth, or via the media/NU newsletters if the principal investigator is interviewed. 
 
6.0 
Research Locations:  
Research procedures will take place in the Department of Preventive Medicine at Northwestern University 
Feinberg School of Medicine.  
 
7.0 
Multiple sites: N/A 
 
8.0 
International Research: N/A 
 
Fig 1. Participant Flow Through Study 

 
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9.0 
Procedures Involved: 
 
Study Design 
This study uses a two-arm randomized control trial to promote 
physical activity in insufficiently active metastatic breast cancer 
patients (n=50). Participants will be randomized 1:1 to either the 
Fit2ThriveMB technology supported physical activity promotion 
intervention (Fit2ThriveMB app + Fitbit + coaching calls) or the 
education control (cancer.net app + phone calls).  The primary 
outcome measurement is post-intervention (12 weeks). The flow 
of participants through the study is detailed in Figure 1.  
 
COVID-19 Pandemic Procedures  
A group of 13 women completed all screening, recruitment and 
consent, but no other study-related procedures in February and 
March 2020 with the intention to participate in wave 2 of the 
study, which was to begin in April 2020. Due to the COVID-19 
pandemic, further recruitment for wave 2 and the start date for 
wave 2 was delayed indefinitely. Participants were notified of 
the delay in April 2020.  Because the study procedures have 
changed substantially, and whether these participants meet the 
study eligibility criteria may have changed (i.e. they may be too 
active or have had their cancer metastasize further), we have 
determined it is best to un-enroll these women, and give them 
the option to re-enroll as new participants when recruitment 
resumes. Thus, once recruitment re-starts, these 13 patients will 
be notified they have been un-enrolled and contacted to 
complete screening and recruitment procedures a second time (i.e. screening survey, recruitment phone call, and 
sign informed consent and physician consent) in order to ensure that these participants remain eligible to 
participate and understand changes made to the study protocol.  
 
Screening 
Participants will complete initial eligibility screening online or over the phone. It will take approximately 15 
minutes. Screening will include evaluation of eligibility and the Physical Activity Readiness Questionnaire 
(PAR-Q)20, which assesses cardiovascular disease history, symptoms, risk factors, and other health issues,  the 
Fall Risk Assessment Questionnaire (FRQ)21, which identifies individuals who may be at risk for falling, and  
questions relating to technology and supplies that may be used for at-home functional performance video 
conferences. All women will also be required to obtain medical clearance from their oncologist.  
 
Recruitment-phone call 
All women who are eligible and indicate interest after the online or phone screening survey will receive a 
recruitment call. Before making the recruitment call, study staff will double check participant’s medical records 
to be sure their cancer diagnosis is eligible for the study. During this call, study staff will explain the study in 
greater detail, and will confirm cancer stage and metastasis. There will be a final check for cancer stage following 
the call. If the participant is still interested and eligible, they will be sent a link to the online version of the informed 
consent and a copy of the permission to contact physician so physician consent can be obtained. If the potential 
participant screens via phone the content of the recruitment call will be completed as part of the screening phone 
call.  
 
Assessments 

 
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Those who are eligible, agree to participate, provide informed consent, and provide physician consent will be: a) 
scheduled for a functional performance testing video conference with study staff via Zoom; b) sent an email 
with an individual, secure link to study questionnaires via REDCap and c) notified an accelerometer has been 
mailed. Participants will be asked to complete questionnaires within 1 week of receipt. MBC patients will be 
provided with detailed written instructions for wearing the accelerometer and directed to wear the monitor on 
specified dates attached to on the non-dominant hip during all waking hours, except when bathing or swimming, 
for 7 consecutive days and return the monitor and monitor log to the study team through the mail using a 
postage paid envelope provided by the study team. The questionnaires will take approximately 30-45 minutes to 
complete. The functional performance  video conference will consist of completion of remote, individual 
functional performance testing (see Measures). In addition to the accelerometer and accelerometer instructions, 
participants will be mailed a remote functional performance testing kit that will include equipment required to 
complete the testing (i.e. blood pressure cuff, pedometer, hand weight, rope pre-measured for test distances, 
digital scale).  The functional performance testing video conference  will last from 60-90 minutes.  Procedures 
will be the same at baseline and 12 weeks. Participants will be asked to hold onto the functional performance 
testing kit for the 12 week study so materials can be used at baseline and 12 weeks and will be provided with a 
postage paid box to ship materials back to the study team at week 12. At 12 weeks, the control group will 
participate in a virtual functional performance testing session and an optional virtual brief orientation to the app 
and Fitbit . The intervention group will participate in video conference functional performance testing and a 
study information and feedback session, which may occur via group video conference, or an individual phone 
call or video conference. Participants in the intervention group will also be provided with instructions for how 
to delete the Fit2ThriveMB app at the conclusion of the 12-week intervention. In addition, all participants will 
be asked to complete a short questionnaire battery during week 3 that will take approximately 10-15 minutes to 
complete.   
 
Randomization and Orientation  
After remote functional performance testing is complete, assessment materials (i.e. accelerometer, activity wear 
log, etc.) are received in the mail by study staff, and all data are verified, MBC patients (n=50) will be randomized 
1:1 to Fit2ThriveMB intervention or education control group using computer-generated randomly permuted 
blocks. Individuals randomized to the Fit2ThriveMB intervention group will receive all intervention materials in 
the mail, and will participate in a remote, group or individual (depending on scheduling conflicts) orientation via 
Zoom video conference which will consist of instructions on all intervention procedures and  assistant with 
downloading and setting up the Fit2ThriveMB app, Fitbit and Fitbit app. MBC patients assigned to the education 
control will also receive all control group materials via mail and will participate in a remote, group or individual 
(depending on scheduling conflicts) orientation session via Zoom video conference, during which they will 
receive instructions on study procedures and assistance with downloading and setting up the Cancer.Net app. 
Individuals in the control group will be informed they will receive the Fitbit after completion of 12 week 
assessments. The study orientation video conferences will take approximately 60-90 minutes. As in our previous 
studies, participants will start the intervention in cohorts of 6-12 individuals per condition to ensure an adequate 
number of participants for the Fit2ThriveMB message board.   
 
Intervention Components  
 Fit2ThriveMB Intervention 
The Fit2ThriveMB intervention will consist of the Fitbit, Fit2ThriveMB app, and weekly coaching calls that will 
last from 10-15 minutes each. Table 1 provides an overview of the weekly schedule of content for the intervention.  
 
Table 1. Fit2ThriveMB Weekly Schedule of Intervention Content  
Week 
Theme    
Daily Goal 
Setting  
Daily 
Symptom 
Report  
Tailored Push 
Notifications  
Weekly 
Coaching 
Call  
1 
Intro to coaching calls/Getting 
started/SMART Goals 
Yes 
Yes 
2-3/day 
Yes 

 
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Intervention components 
include:  
 
   Fitbit 
MBC patients will be 
provided with the Fitbit InspireHR). They will be asked to download the Fitbit app and wear the Fitbit 24/7 
throughout the 12 week study period. 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.  
 
 Fit2ThriveMB App 
The Fit2thriveMB app will encourage MBC 
patients to increase their PA via increasing their 
step count. Patients will be provided with 
educational information on PA and effective 
behavior change strategies for incorporating more 
PA into their daily lives to increase their step count 
(i.e. 10 minute lunch time walk, parking further from 
entrances, pacing while on the phone, etc.). 
Participants will be prompted each morning to 
report the intensity of their symptom burden (0 to 5). 
Based on their symptom rating and their previous 
day’s step counts, MBC patients will be provided 
with three different options or levels of goals for 
that day to either increase or decrease 10-20% or 
remain constant, depending on symptom burden 
and previous day’s progress as measured by the 
Fitbit (see Table 2 for example options). The first 
day’s PA goal-setting options will be based on that 
day’s symptom reporting and their Actigraph PA 
data from baseline assessments. If they fail to 
choose a goal, they will be provided with the 
middle level goal as their goal for the day. 
Participants will be instructed to self-monitor progress towards these goals via the feedback on Fitbit Inspire 
HR monitor and the daily, weekly and monthly progress information provided in the Fit2ThriveMB app. The 
app will send MBC patients 2-3 reminders, encouragement or real-time PA feedback messages each day. These 
messages will be tailored to Fitbit PA data and reported symptom burden. Similar messages and tailoring strategies 
have been used in Dr. Phillips’ Fit2Thrive study and Dr. Spring’s ongoing NIH-funded behavior change studies 
(R01DK097364/R01DK108678). Finally, participants will have access to a message board where they can 
communicate with other MBC patients in the intervention to provide encouragement and support. Participants will 
have a profile where they can opt to share information including their first name, a self-portrait, their age, hobbies, 
favorite activities, motivation for becoming more active, goals for participating in the program, and favorite quote.  
Each participant’s relative progress toward their daily goal (i.e. a circle that fills in as they meet their goal) will be 
2 
Benefits Reducing Sitting and 
Overcoming Barriers to Reducing 
Sedentary Behavior 
Yes 
Yes 
2-3/day 
Yes 
3 
Benefits of Increasing PA and 
increasing steps 
Yes 
Yes 
2-3/day 
Yes 
4 
Finding Activities You Enjoy 
Yes 
Yes 
2-3/day 
Yes 
5 
Self-monitoring 
Yes 
Yes 
2-3/day 
Yes 
6 
Managing symptoms  
Yes 
Yes 
2-3/day 
Yes 
7 
Overcoming barriers 
Yes 
Yes 
2-3/day 
Yes 
8 
Increasing Self-Efficacy 
Yes 
Yes 
2-3/day 
Yes 
9 
Realistic Outcome Expectations   
Yes 
Yes 
2-3/day 
Yes 
10 
Social Support 
Yes 
Yes 
2-3/day 
Yes 
11 
Healthy Rewards 
Yes 
Yes 
2-3/day 
Yes 
12 
Relapse Prevention 
Yes 
Yes 
2-3/day 
Yes 
IF MET 
PREVIOUS 
DAY’S STEP 
GOAL =…  
AND 
SYMPTOM 
BURDEN IS… 
THEN DAILY STEP GOAL 
OPTIONS ARE:  
YES 
LOW 
1) 
Stay the same 
2) 
Increase 10% 
3) 
Increase 20% 
YES 
MODERATE 
1) 
Decrease 10% 
2) 
Stay the same 
3) 
Increase 10% 
YES 
HIGH 
1) 
Decrease 20% 
2) 
Decrease 10% 
3) 
Stay the Same  
NO 
LOW 
1) 
Decrease 10% 
2) 
Stay the same 
3) 
Increase 10% 
NO  
MODERATE 
1) 
Decrease 20% 
2) 
Decrease 10% 
3) 
Stay the Same  
NO 
HIGH 
1) 
Decrease 20% 
2) 
Decrease 10% 
3) 
Stay the Same 
Table 2. Example Daily Step Goal Logic  

 
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posted at the top of the message board and all members will receive a notification when a member reaches their 
daily goal to facilitate encouragement and support from the group. This board will be closely monitored and 
facilitated by study staff to enhance use and prevent misuse.  
 
Though not part of the intervention, participants may choose to keep the Fit2thriveMB study app on their 
phones and continue to use it. The functionality of the app depends on data collection. Data will continue to be 
collected after the conclusion of the 12 week intervention if a participant chooses to keep and use the app. Data 
collected includes: login frequency, app usage, data entered into the app including symptom burden, goal 
selection and physical activity and data transmitted from the Fitbit, including physical activity and steps taken. 
The app will remain functional and data will be collected for 12 months after the participant completes the 
initial 3 month intervention. The data is collected and stored for the purpose of analyzing post-intervention app 
usage and physical activity patterns. At the end of 12 months the app will no longer function. Participants will 
be provided with written instructions on how to remove the app if they wish during the 12 week functional 
performance video conference. Once the app is removed we will be unable to collect any data from their phone. 
 
Coaching Calls 
Fit2ThriveMB intervention 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 (see Table 1 for 
listing of topics to be covered) and d) inquire about any issues or injuries. Participants will be instructed to call or 
email their coach throughout the week if they encounter any issues. Coaching calls will be semi-structured and 
recorded to ensure fidelity. Coaching calls are expected to last from 10-15 minutes each. 
 
Education Control 
Participants assigned to this condition will be instructed to go about their usual activities and will receive 
education about PA and a healthy lifestyle for MBC patients. They will be encouraged to download the free 
Cancer.Net app which contains a Metastatic Breast Cancer Coach module. The Cancer.Net App content includes 
information about health and well-being, treatment guidelines specific to their cancer type medication and 
symptom tracking, a spot to save questions for future appointments and an appointment calendar.  
 
At the end of the 12 week intervention, participants in the education control group will receive a Fitbit and have 
access to the Fit2ThriveMB study app. If they choose to download the app and use it, the app will collect data 
including: login frequency, app usage, data entered into the app including symptom burden, goal selection and 
physical activity and data transmitted from the Fitbit, including physical activity and steps taken. This data will 
be collected for 12 months and stored for the purpose of analyzing post-intervention app usage and physical 
activity patterns. At the end of 12 months the app will no longer function. Participants will be instructed in how 
to download, and provided with written instructions for removing the app, if they wish following the 12 week 
assessment. Once the app is removed we will be unable to collect any data from their phone. 
 
Support Calls 
To match Fit2ThriveMB contacts, participants will also receive weekly calls that will cover health and well-being 
topics (see Table 3). They will be provided with the Fitbit after completion of week 12 assessments.    
 
Table 3: Healthy Living Control Coaching Call Content 
 
Week 
Theme 
1 
Mindfulness 
2 
Social Support: Friends, Family, 
Counseling and Support Groups 
3 
Social Support: Online Communities 
4 
Symptom Tracking 

 
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5 
Art Therapy/Doing Activities you 
Enjoy (focus on quality of life 
6 
Sleep 
7 
Fatigue 
8 
Cognition 
9 
Hydration 
10 
Nutrition 
11 
Healthy Grocery Shopping 
12 
Stress Management 
 
 
Study Retention Plan  
To minimize attrition, study staff will develop good rapport with participants during recruitment and maintain 
the relationship throughout the study (e.g., by sending birthday cards). Participants will be provided with a 
phone number to call immediately if they encounter issues with any aspect of the intervention. Staff will convey 
reminders of scheduled assessments by phone, email, or text message, per participant preference. Participants 
will also be incentivized to complete assessments ($41.50 at baseline and 12 weeks) for a total of $83.00. 
Participants will be paid $40.00 for completing the assessments in their entirety, and will be paid an additional 
$1.50 at each time point to cover the cost of transferring the electronic payment to a personal checking account, 
if the participant chooses. Also, participants will receive a free Fitbit.  
 
In order to enhance subject retention we will send a monthly study newsletter with educational materials and 
study reminders. We will also occasionally send greeting cards for various holidays (i.e. Winter holidays, 
Thanksgiving, Breast Cancer Awareness month, birthdays, etc.) or milestones (i.e. study completion, half way 
through the study, etc.) via the USPS or an on-line service (i.e. Paperless Post or  Evite). All greeting card 
language will be submitted and approved by the IRB prior to sending to participants.  
 
If a participant in the intervention group does not track any activity via the Fitbit for 7 consecutive days and 
does not respond to any other study-related requests, study staff will reach out to the participant via phone 
and/or e-mail so they can be contacted for troubleshooting and engagement support. Participants will also 
identify two friends or relatives that can be notified if contact with the study participant fails to respond to our 
contact attempts. If we are unable to reach a participant after 3 phone calls or emails and a final email attempt, 
or they do not start recording data again after 2 weeks, we will contact the participant’s emergency/locator 
contacts.  For control participants, we will contact emergency/locator contacts if the individual does not respond 
to two weekly telephone calls (with 3 phone call attempts each) and a final email attempt. Participants will 
identify two emergency/locator contacts that may be notified if contact with the study participant is lost. 
Emergency/locator contacts will be associates of the participant who have a different telephone and email 
address from the participant and who agree to serve as emergency contacts for the participant. One 
locator/emergency contact must not live in the same house as the participant. We will only attempt to contact an 
emergency/locator contact if we are unable to reach a participant according to the rules outlined above or in the 
event of an emergency. We will only make one phone call attempt to reach an emergency/locator contact. If we 
are unable to reach the contact, we will attempt to leave a voice mail and follow-up with an email with the 
participant copied. 
 
Measures 
Table 4 displays a timetable for all assessments that occur at a discrete time point.  
 
Primary Outcome: Feasibility and Acceptability 
Feasibility 

 
Page 11 of 25 
 
Feasibility will primarily be assessed via: a) participant retention (# of participants who drop out/ # 
randomized) and b) intervention adherence (% days adhere to daily goal and % of days wear Fitbit). The Fitbit 
is sufficiently well-validated for steps to support its role as an adherence measure in this study.  
 
Adherence 
Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app. As in 
our ongoing Fit2Thrive trial, we will obtain tracker wear time, steps, and time spent in sedentary, light, 
moderate, and vigorous intensity activity. Acceptability will be measured via a process evaluation of 
perceptions of MBC patients’ experiences with Fit2ThriveMB. 
 
Secondary Outcomes 
 
Physical Activity and Sedentary Behavior 
 
Actigraph Accelerometer: The ActiGraph accelerometer (model wGT3X- BT, ActiGraph, Pensecola, FL), a 
well-validated and reliable measure of objective PA22, 23 will be used. It is blinded to the participant (i.e., no 
display or feedback). At each time point, participants will wear the device for 7 consecutive days during all 
waking hours, except when bathing or swimming. Participants will be instructed on how to wear the device and 
will use a log to record wear time and note any deviations from the wear protocol. After each wear period, data 
will be downloaded and screened for completeness and irregularities. Participants will be asked to re-wear the 
ActiGraph if it was not worn for at least 10 hrs/day for ≥5 days. Sixty consecutive zeros will be designated as 
non-wear time. Data will be collected in one-minute intervals (epochs). 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 MVPA (≥2020).24, 25  
 
Sitting Time Questionnaire.26 Women will be asked to indicate the amount of time they spend on a typical 
weekday and weekend sitting in the following activities: traveling to and from places, while at work, while 
watching television, while using a computer at home in leisure time NOT including television (e.g. visiting 
friends, movies, dining out, etc.). Test-retest reliability coefficients were high for weekday sitting time at work, 
watching television and using a computer at home (rs=0.78-0.84) but are more variable for weekend days across 
all domains (rs=0.23-0.74). 
 
Godin Leisure Time Exercise Questionnaire (GLTEQ).27 The GLTEQ is a simple, self-administered instrument 
that has been widely used in epidemiological, clinical, and behavioral change studies and has been shown to be 
both a valid and reliable measure of PA participation. Participants will be asked indicate the frequency and 
average amount of time they spent engaging in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild 
(e.g., easy walking) exercise over the past seven days. Weekly frequencies of strenuous, moderate, and light 
activities are multiplied by nine, five, and three, respectively. These values are added to obtain a total leisure 
activity score.  Test-retest reliability coefficient range from r=0.48 for light and moderate activity to 0.94 for 
strenuous. For total values the test-retest reliability coefficient is 0.74.27  Breast cancer survivors will also 
answer a modified version asking them about their PA before diagnosis at baseline.  
 
Symptom Burden and QOL 
 
PROMIS Fatigue Short Form 8a.28 The PROMIS Fatigue Short Form 8a will be used to assess participants’ 
frequency of fatigue symptoms ranging from 1 (not at all) to 5 (very much) and fatigue interference ranging 
from 1 (never) to 5 (always) over the past 7 days. Higher scores reflect higher levels of fatigue. The reliability 
of this measure ranges from α=0.90 to α=0.95.29 
 

 
Page 12 of 25 
 
PROMIS Depression Short Form 8a.28 Participants are asked to indicate the frequency of a variety of 
depressive symptoms over the past 7 days on a 5 point scale from 1 (never) to 5 (always). Higher scores reflect 
higher depressive symptoms. The reliability of this measures ranges from α=0.90 to α=0.95.29  
 
PROMIS Anxiety Short Form 8a.30 This measure assesses self-reported fear (fearfulness, panic), anxious 
misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to 
arousal (racing heart, dizziness). Participants indicate how frequently they felt each anxiety symptom over 
the past 7 days on a scale from 1 (never) to 5 (always). Higher scores reflect higher more anxiety symptoms. 
The reliability of this measures ranges from α=0.90 
to α=0.95. 
 
PROMIS Emotional Support Short Form 8a. This measure assesses perceived feelings of being cared for and 
valued as a person; having confidant relationships. Participants indicate on a scale from 1 (never) to 5 
(always) how often they feel they have emotional support when needed. Higher scores indicate greater 
emotional support. 
 
PROMIS Pain Interference Short Form 8a.30 This measure assesses the self-reported consequences of pain 
on relevant aspects of one’s life. This includes the extent to which pain hinders engagement with social, 
cognitive, emotional, physical, and recreational activities. Participants how much pain had interfered with 
different aspects of their life on scale from 1 (not at all) to 5 (very much). Higher scores reflect greater pain 
interference. The reliability of this measures ranges from α=0.90 to α=0.95.36 
 
PROMIS Physical Function Short Form 20a.28 The PROMIS Physical Function Short Form 20a will be used 
to assess participants’ physical function. The scale has two subscale limitations and interference. For the 6 
limitations items, participants will rate the level of difficulty they have had executing discrete activities over 
the past 7 days on a scale from 1 (unable to do) to 5 (without any difficulty). For the 4 limitations items, patients 
will rate the degree to which their health limits them in specific activities on a scale from 1 (cannot do) to 5 
(not at all).  Higher scores reflect better physical function. The reliability of this measure ranges from α=0.90 
to α=0.95.29  
 
Functional Assessment of Cancer Therapy-Breast30 The 27-item Functional Assessment of Cancer Therapy- 
Breast (FACT-B)37 will assess participants’ physical, social/family, emotional and functional well-being as 
well as breast cancer specific concerns. Participants will be asked to indicate how true each of the items had 
been for them over the last 7 days on a five-point Likert-scale ranging from 0 (not at all true) to 4 (very much 
true). The total score is obtained by summing all of the items and then dividing by the number of items 
answered. Well-being subscale scores are calculated by multiplying the sum of the items from each subscale 
by the number of items in the subscale and then dividing by the number of items answered. Higher scores 
reflect better QOL. The internal consistency for the total score is high (α=0.90). Subscale alpha coefficients 
range from 0.63 to 0.86. 
PROMIS Applied Cognition-General Concerns Short Form 8a.28 The PROMIS Applied Cognition General 
Concerns Short Form 8a will be used to assess participants’ frequency of perceived cognitive function over 
the past 7 days ranging  from 1 (not at all) to 5 (very often). Higher scores reflect higher levels of cognitive 
concerns. The reliability of this measure ranges from α=0.90 to α=0.95.29 
 
PROMIS Applied Cognition-Abilities Short Form 8a.28 The PROMIS Applied Cognition Abilities Short 
Form 8a will be used to assess participants’ functional abilities with regard to cognitive tasks including the 
perception that one’s cognitive ability with regard to the domain of inquiry (e.g. concentration, memory) has 
not changed. Participants will indicate their responses on perceptions of change over the past 7 days on a 
scale from 1 (not at all) to 5 (very often). Higher scores reflect higher levels of cognitive concerns. The 
reliability of this measure ranges from α=0.90 to α=0.95.29 

 
Page 13 of 25 
 
 
 
 
 
PROMIS Sleep-Related Impairment Short Form 8a. 28 The PROMIS Sleep –Related Impairment Disturbance 
Short Form 8a will be used to assess participants’ perceptions or sleep-related impairment on a scale ranging  
from 1 (not at all) to 5 (very much). Higher scores reflect higher levels of sleep-related impairment. The 
reliability of this measure ranges from α=0.90 to α=0.95.29 
 
PROMIS Sleep Disturbance Short Form 8a.28 The PROMIS Sleep Disturbance Short Form 8a will be used to 
assess participants’ rating of overall sleep quality from 1 (very good) to 5 (very poor) and perceptions of 
specific characteristics of sleep quality on a scale ranging  from 1 (not at all) to 5 (very much). Higher scores 
reflect higher levels of sleep disturbance. The reliability of this measure ranges from α=0.90 to α=0.95.29 
 
Functional Performance 
 
Short Physical Performance Battery (SPPB). Participants will also complete the Short Physical Performance 
Battery (SPPB), a well-validated physical function performance measure.31-33 The SPPB score is based on timed 
measures of gait speed, ability to rise from a chair, and standing balance. Gait speed will be measured using the 
better of two recorded times over a 4-meter course. Chair stand time will be measured as the time needed to rise 
five times from a seated position in a chair, with arms folded across the chest. For the balance test, participants 
will be asked to maintain their feet side-by-side, semi-tandem, and tandem positions for 10 seconds each. Each 
individual performance measure will be scored according to established cutpoints31, 33 and aggregated for a total 
SPPB score.  
 
Senior Fitness Test.34 We will use several items from the Senior Fitness Test including a) the 8-Foot Up-and-
Go, a test of physical agility and dynamic balance, which measures the speed at which an individual walks 
around a cone or other object 8 feet away and back; b) the Arm Curl test, which assesses arm muscle strength 
endurance, specifically of the biceps, by measuring the number of arm curls that can be completed using a 5 lb 
weight in 30 seconds; c) and the 2 Minute Step Test, an aerobic endurance test, which counts the number of 
full in-place steps completed in two minutes. Participants will also complete a 30- second one leg stand test on 
each side (right and left) where they are instructed to stand on one foot for up to 30 seconds and timed.    
 
6 minute walk.35 MBC patients will complete a 6 minute walk test to assess their submaximal level of 
functional capacity. The goal is for the participant to walk as far and she can during these 6 minutes. Distance 
is measured once the 6 minute walk is complete, and provides information regarding cardiopulmonary and 
musculoskeletal systems that are used during physical activity that points toward exercise tolerance.  
Participants will be instructed to wear the accelerometer and a pedometer for the duration of the 6 minute 
walk test and will be instructed in the use of the provided blood pressure monitor and heart rate monitor.  
 
 
Additional Exploratory or Confounding Variables 
Demographics/Health History. Participants will self-report demographic information (i.e. age, race) and 
health history.  
 
Medical Record Data. Medical record data will be obtained on clinical factors (date of diagnosis, treatment 
received, medication, comorbid conditions).  
 
Body weight and height. Weight and height will be self-reported by participants. Weight will be measured on 
the subset of participants who own a digital scale, to the nearest 0.1 lb.  
 

 
Page 14 of 25 
 
COVID-19 Assessment Questions. Participants will answer questions regarding the impact the COVID-19 
pandemic has on physical activity habits, work, and their current living situation. These questions will only be 
asked of participants who participate in the study during the COVID-19 pandemic.  
 
Social Cognitive Theory Constructs 
Exercise Self-efficacy Scale.32 The 6-item Exercise Self-Efficacy Scale will be used to assess participants’ 
beliefs in their ability to exercise five times per week, at a moderate intensity, for 30 or more minutes per 
session at two week increments over the next 12 weeks. Items will be rated on a 100-point percentage scale 
with 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). The internal 
consistency for this measure has demonstrated acceptability (α=0.90).32  
Barriers Self-efficacy Scale.32 The 15-item Barriers Self-Efficacy Scale will be used to assess participants’ 
beliefs in their ability to exercise three times per week for the next 3 months in the face of commonly 
experiences barriers to activity. Items will be rated on a 100-point percentage scale with 10-point increments, 
ranging from 0% (not at all confident) to 100% (highly confident).  The internal consistency for this measure 
has demonstrated acceptability (α=0.86).32  
Rosenberg Self Esteem Scale 36. Global self-esteem was assessed via the Rosenberg Self-esteem scale.  This 
scale has been widely used in several domains of self-esteem research including physical activity (Fox, 1997).  
This scale consists of 10-items asking participants to indicate their level of agreement/disagreement with each 
statement.  Sample items include: “I feel that I’m a person of worth, at least on an equal basis with others;” 
and “I am able to things as well as most people.”  Participants respond on a 5-point Likert scale ranging from 
1 (strongly agree) to 5 (strongly disagree).  Responses are summed to yield a total score ranging from 10 to 
50.  Several researchers have demonstrated acceptable internal consistency and convergent validity (Curbow 
& Somerfield, 1991; Wylie, 1989).   
 
Physical Self-Perception Profile (PSPP)37. The PSPP is a 30-item instrument used to assess self-esteem 
relative to several domains of physical functioning in a hierarchical, multidimensional fashion.  The 
instrument contains a general physical self-worth scale (PSW) which subsumes four more specific scales of 
perceived sport competence (SPORT), physical condition (COND), attractive body (BODY), and strength 
(STRENGTH), with six items per scale.  Participants indicated on a four-point scale the degree to which each 
item is characteristic or true of them.  Responses range from 1 (not at all true) to 4 (completely true). 38  
 
Multidimensional Outcome Expectations for Exercise Scale.33 This scale will assess participants’ social (4 
items), self-evaluative (5 items), and physical (6 items) outcome expectations for exercise participation as 
well as cancer specific outcomes (4 items) on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly 
agree).  The three subscales have demonstrated good internal consistency (α= 0.82 for physical outcome 
expectations, α= 0.81 for social outcome expectations, and α= 0.84 for self-evaluative outcome 
expectations).33  
Exercise Goal-setting Scale.34 This 10-item scale will assess participants exercise-related goal-setting, self-
monitoring and problem solving and instructs participants to indicate the extent to which each of the 
statements describes them on a scale from 1 (does not describe) to 6 (describes completely). This scale has 
demonstrated good internal consistency (α= 0.89). 34 
Social Support for Exercise Scale.36This scale assesses the degree to which friends and family have 
demonstrated support for exercise behaviors in the previous 3 months. The frequency for each item is rated 
once for both family and friends on a 5-point Likert scale, ranging from 1 (never) to 5 (very often). The friend 
and family subscales have demonstrated acceptable internal consistency (α=0.84 and α=0.84, respectively).  38 

 
Page 15 of 25 
 
Physical Activity Enjoyment Scale.37  This 18-item scale will assess the degree to which participants, at the 
current moment, enjoy doing any sort of physical activity.  This 18-item scale rates enjoyment on a 7-point 
bipolar scale (“It makes me depressed”…”It makes me happy”).  This measure has demonstrated good 
internal consistency in previous studies (α= 0.93 to α= 0.96).39 
Lifestyle Self-Efficacy 10,000 Steps.  This 6-item scale assesses participants’ beliefs in their ability to 
accumulate 10,000 steps per day for most days at two week increments over the next 12 weeks. Items will be 
rated on a 100-point percentage scale with 10-point increments, ranging from 0% (not at all confident) to 
100% (highly confident). This measure was added as part of modification 13 so will only be asked at baseline 
and week 3 for those participants who begin the intervention after approval of that modification.  
 
Self-Efficacy of Walking Number of Steps. This 10-item scale assesses participants’ beliefs in their ability to 
accumulate a step value in a day at 1,000 step increments starting at 3,000 steps until 12,000 steps. Items will 
be rated on a 100-point percentage scale with 10-point increments, ranging from 0% (not at all confident) to 
100% (highly confident). This measure was added as part of modification 13 so will only be asked at baseline 
and week 3 for those participants who begin the intervention after approval of that modification. 
 
Fidelity  
Fidelity will be examined via the following metrics: % of days reported symptom burden; % of days set 
personalized goal; % of coaching calls attended, % of days posted on message board; % of app notifications 
read.  
 
Table 4. Measures Time Table 
Measure 
w0 
w3 
w12 
PAR-Q 
X 
 
 
FRQ 
X 
 
 
Demographics 
X 
 
 
Health History 
X 
 
X 
Physical Activity History 
X 
 
 
Barriers Self Efficacy (BARSE) 
X 
X 
X 
Rosenberg Self Esteem Scale 
X 
 
X 
Physical Self-Perception Profile (PSPP) 
X 
 
X 
Exercise Goals Setting Scale (EGSS) 
X 
X 
X 
Exercise Self-Efficacy Scale (EXSE) 
X 
X 
X 
FACT-B 
X 
 
X 
Godin GLTEQ_Current 
X 
 
X 
Godin GLTEQ_Before Cancer 
X 
 
 
Lifestyle Self-Efficacy 10,000 Steps 
X 
X 
X 
MOEES 
X 
X 
X 
Physical Activity Enjoyment (PACES) 
X 
X 
X 
PROMIS 
Applied 
Cog. 
General 
Concerns 
X 
 
X 
PROMIS Anxiety 8a 
X 
 
X 
PROMIS Depression 8a 
X 
 
X 

 
Page 16 of 25 
 
PROMIS Fatigue 8a 
X 
 
X 
PROMIS Emotional Support 
X 
 
X 
PROMIS Pain Interference 8a 
X 
 
X 
PROMIS Phys. Function 20a 
X 
 
X 
PROMIS Sleep Disturbance 8a 
X 
 
X 
PROMIS Sleep-related Impairment 8a 
X 
 
X 
PROMIS Applied Cognition 
X 
 
X 
Self-Efficacy of Walking Number of 
Steps 
X 
X 
X 
Social Support Exercise (SSE) 
X 
X 
X 
Sitting Time Questionnaire (STQ) 
X 
X 
X 
Process Evaluation 
 
 
X 
COVID-19 Assessment 
X 
X 
X 
Weight 
X 
 
X 
Blood Pressure 
X 
 
X 
SPPB 
X 
 
X 
Senior Fitness Test 
X 
 
X 
6 minute Walk  
X 
 
X 
 
Data quality control/checking 
The majority of data is collected (PA, symptoms, acceptability) or uploaded electronically. The quality of these 
data will be checked by examining descriptive statistics and score ranges of all variables for missing and/or 
erroneous values. All data will be examined for violation of basic statistical assumptions (i.e. normality, 
multicollinearity) and transformed, if needed. Participants will be asked to complete all assessments, regardless 
of group assignment or adherence. Strategies for handling missing data (i.e. maximum likelihood estimation, 
multiple imputation) will be chosen based on the type and extent of the problem.   
 
Statistical Analyses Plan 
 Aim 1. Feasibility and acceptability will be analyzed using descriptive statistics (frequencies, means and 
standard deviations). Feasibility will primarily be evaluated using the “successful completion rate” defined as:  a) 
≥80% of MBC patients who enroll in the intervention will remain in the intervention and b) MBC patients will 
adhere to daily goals and wear Fitbit  ≥70% of study days (i.e. ~59/84 days) If a successful completion rate is 
achieved, Fit2ThriveMB will be deemed feasible. Additional measures of feasibility, fidelity, acceptability and 
safety will also be summarized and considered with the “successful completion” rate before proceeding with a 
more definitive trial.  
 
 Aim 2 and Exploratory Aim. We will employ an intent-to-treat (ITT) approach by including all participants 
recruited into the study regardless of compliance. Every effort will be made to collect all outcome measures even 
if a participant does not engage in assigned treatments. Analysis of covariance (ANCOVA) will be used to 
compare study groups with respect to mean changes in each outcome from baseline to 12 weeks with baseline 
adjustment. Data from these analyses will provide estimated means, standard errors, and preliminary effect sizes 
for the Fit2ThriveMB intervention. These data will be used for future sample size calculations, to identify a 
primary endpoint and further refine the Fit2ThriveMB intervention to be tested in a more definitive trial. We will 
also use regression models to explore the relationship between changes in each outcome and intervention 
adherence. This study is not designed to make conclusions about Fit2ThriveMB efficacy without further study.  

 
Page 17 of 25 
 
 
Timeline 
The overall duration of the study will be 2 years, and each participant will be actively participating for 12 weeks.  
 
10.0 Research with Vulnerable Populations: 
Non-English Speaking Subjects: N/A 
Subjects who are not yet adults (infants, children, teenagers): N/A 
Cognitively Impaired Adults: N/A 
Adults Unable to Consent: N/A 
 
11.0 Incomplete Disclosure or Deception: N/A 
 
12.0 Consent Process:  
Consent will always be obtained before a subject participates in any component of the current protocol. Patients 
who are eligible after screening and express interest in the study will be scheduled for a recruitment phone call. 
Study staff will review details of the study and answer any questions. Patients who are still interested will be 
sent an email with a link to the online consent form housed in REDCap.  All participants will complete an 
online version of the informed consent. Because we are asking participants to type their full name on any on-
line consents, this is considered equivalent to a written signature.  They will also be emailed a copy and 
instructed to print a copy or to contact the study team at any time if they would like a copy for their records. A 
telephone number and e-mail address for the PI will be provided on the informed consent page, in the event they 
should have any questions or need clarification. The informed consent will clearly state that participation in the 
present study is completely voluntary and participants can discontinue or withdraw at any point without penalty. 
Initial data collected prior to obtaining informed consent includes name, contact information, demographic 
information and basic medical and health information to determine eligibility for the project. This information is 
obtained on-line or through a phone conversation or in-person after the patient is given details about the project. 
These data are recorded in a password protected REDCap database only accessible by study investigators. All 
data are provided freely by the subject. Data for CONSORT purposes will be linked by subject ID, not by name, 
thus protecting the subject’s privacy. Thus, this aspect of the study contains little, if any, risk to the subject. This 
waiver is requested because determining subject eligibility is only possible by obtaining basic medical healthy 
history information during screening. Potential participants will be provided with reason(s) for ineligibility via 
our online tool or initial phone conversation. All subjects will be given the opportunity to be contacted regarding 
future research opportunities if they so choose, and their contact information will be kept in the database for this 
purpose. If they prefer no future contact, their name and contact information will be deleted from the database 
but the information they have previously provided will be used for final CONSORT purposes. 
 
This study is covered by a certificate of confidentiality. Language describing the Certificate of Confidentiality 
will be included in the consent form.  
 
13.0 Research with children: N/A 
 
14.0 Waiver of Participant Signature on Consent Form:  
This waiver is being requested as part of the screening process. Screening data collected prior to obtaining 
informed consent includes name, contact information, demographic information and basic medical and health 
information. Demographic information collected during the screening survey is used to help the study team 
understand relations between demographic information and study eligibility as well as who chooses to 
participate in the study. Basic medical and health information collected during the screening survey helps to 

 
Page 18 of 25 
 
determine eligibility for the project. This information is obtained online or through a phone conversation after 
potential participants are given the research study details. Participants agree to provide this information online 
or verbally, and allow us to retain it even if they do not participate in the study, however, they are not required 
to sign the screening. Thus, a waiver of participant signature is required. These data are recorded in RedCap, a 
password-protected database, only accessible by the research team. The subject provides all data freely. Data for 
CONSORT purposes will be linked by subject ID, not by name, thus protecting the subject’s privacy. Therefore, 
this aspect of the study contains little, if any, risk to the subject. This waiver is requested because determining 
subject eligibility is only possible by obtaining basic demographic and medical health history information 
during screening, and understanding the effects demographic information has on study eligibility and 
recruitment may help to strengthen future recruitment strategies Potential participants will be provided with 
reason(s) for ineligibility via our online survey (RedCap) or initial phone conversation. All subjects will be 
given the opportunity to be contacted regarding future research opportunities if they so choose, and their contact 
information will be kept in the database for this purpose. If they prefer no future contact, their name and contact 
information will be deleted from the database but the information they have previously provided will be used 
for final CONSORT purposes.  
 
15.0 Waivers and Alterations of Consent Information: N/A 
 
16.0 Financial Compensation: 
Participants will be paid for completion of assessments ($41.50 at baseline and 12 weeks) for a total of $83.00. 
Participants will be paid $40.00 for completing the assessments in their entirety, and will be paid an additional 
$1.50 at each time point to cover the cost of transferring the electronic payment to a personal checking account, 
if the participant chooses. The payment will be sent as an e-giftcard that participants will receive in their email. 
If participants only complete a portion of the assessment at either time point or withdraws before completing 
any portion of the assessment at either time point, payment will be pro-rated as follows: $10 for completing the 
questionnaires, $15 for wearing the accelerometer and $15 for completing functional performance testing.  
 
All participants that complete baseline and 12 week testing will also be allowed to keep their Fitbit (intervention 
group) or be given a Fitbit (control group).  
 
17.0 Audio/Video Recording:  
 
All participant coaching calls (intervention group) and weekly calls (control group) will be digitally audio 
recorded for quality control and training purposes for those participants who agree. All participant remote 
functional performance video conference testing will also be recorded for research, training and quality control 
purposes. Digital files will be stored on a password-secured network drive that is only accessible by the study 
team. Only participants’ first names will be used during any recorded sessions. Recordings may be transcribed 
verbatim and de-identified. Recordings will be destroyed at the end of the study. All subjects will have the 
option to withdraw from recordings at any time for any reason. 
 
Participants who agree may be photographed or video recorded during Zoom video conferences.Participants 
may also post photographs or videos of themselves on the study application message board. Photographs or 
videos we obtain either way may be used for scholarly presentations or publications if a participant agrees.  
 
18.0 Potential Benefits to Participants:  
 
The benefits of physical activity are well established. Intervention participants may experience significant 
decreases in symptom burden and improved physical and psychological functioning and quality of life. If the 
proposed Fit2ThriveMB intervention proves to be feasible, acceptable and shows promise for efficacy it could 
have high scalability potential and be applicable to other advanced cancer populations or other populations with 

 
Page 19 of 25 
 
chronic disease. Additionally, this study will produce societal benefit regarding new knowledge about how 
technology-supported physical activity interventions can effectively change behavior in metastatic breast cancer 
patients.  
 
Given the minimal risk of study participation and potential benefits, we believe the risks to subjects are 
reasonable in relation to the anticipated benefits to research participants and others.  
 
19.0 Risks to Participants: 
Potential risks are considered minimal. Engaging in a PA program when one has been sedentary for a considerable 
period of time incurs some risk of injury such as muscle soreness, strains, aggravation of arthritic conditions, etc. 
However, serious physical injury is considered unlikely. In order to reduce and/or prevent any physical harm or 
injury subjects will gradually increase their PA. Additionally, each participant will be required to receive medical 
approval prior to enrollment to ensure PA is appropriate. Furthermore, all participants, regardless of the 
intervention components they receive, will be provided access to a study website that is also embedded within the 
app which will include an overview of safety issues and stress the need to contact study investigators should they 
experience any adverse effects of PA.  Finally, the intervention content will emphasize safety and present 
instruction to reflect safe progressions.  
There is also the small chance a participant could strain, fall or injure themselves during the functional 
performance video conference. However, again, serious physical injury is considered unlikely. In order to reduce 
and/or prevent injuries during testing, two study staff members will be present on the video conference to provide 
remote assistance. Study staff will be thoroughly trained on assessment procedures and be required to follow 
specific scripts to ensure safety. Further, all staff who participate in testing will be required to be First-
Aid/CPR/AED certified and will be available to provide verbal instructions to a participant or a participant’s 
support person if needed in the unlikely event of an emergency situation. Staff will be required to use a computer 
for the functional performance video conference, and keep their cell phone available in the event of an emergency. 
Study staff will take measures to ensure participants will be able to receive timely medical assistance in the 
unlikely event of an emergency. At the beginning of each functional performance video conference session, study 
staff will confirm and record the address of the residency that the participant is completing testing, the 
participant’s phone number, whether there is someone at home with the participant, the closest cross streets to the 
residency and whether there is a support person in the house. Further, if there is someone at home with the 
participant, we will ask for, record his or her name, and ask if this person is available within shouting distance if 
needed. Study staff will be prepared to use this information to call the participant’s local non-emergency phone 
number, if necessary, to be directed to their local emergency dispatch team  to ensure that medical help will arrive 
as quickly as possible. In addition, participants will be instructed to keep a telephone close by and a sturdy chair 
close by to aid in balance. Finally, if possible, participants will be asked to have a support person present in the 
house during the video conference session and have that person within shouting distance for the duration of the 
test.   
In addition to the potential minimal risk associated with PA participation and remote functional performance 
testing, there are some potential minimal psychological risks associated with answering some of the 
questionnaires required for participation in this study. However, participants will be given the option to skip any 
questions that make them feel uncomfortable. Should any individuals report scores on the PROMIS Cancer 
Depression Scale, that are in the 75th percentile (i.e. ≥ 4.3) or confer a high level of distress in interactions with 
research study staff, they will be referred to the Supportive Oncology program at Northwestern: 
https://www.cancer.northwestern.edu/cancer-care/patient-support/index.html.    
 
There may also be a security risk in using Zoom video conference software to communicate with participants 
during remote functional performance testing and orientation sessions. In order to minimize the risk of using 
Zoom video conference software and enhance security, all participants will be sent individual links to attend the 

 
Page 20 of 25 
 
video conference to their email with a password that will be required to enter the meeting. Study staff will also 
enable the ‘waiting room’ feature on Zoom so that only members permitted by the meeting host (study staff 
member) will present in the video conference.  
There is also a small risk to individuals’ privacy when using the mHealth app but this will be minimized by the 
procedures described, above.  
Participants are permitted to refuse to participate in any aspect of the research and may withdraw from the study 
at any point, for any reason without penalty. For any participant who elects to withdraw, permission will be sought 
to continue to collect outcome data for use in the analysis. However, all participants in the intervention will be 
accounted for in all follow-up analyses following the intent-to-treat principle. If participants withdraw from the 
study, and do not agree to return for follow-up assessments, data from their most recent assessment will be carried 
forward and imputed in subsequent assessment points (Last Observation Carried Forward). 
Protection against Risk 
The following procedures will be used to minimize risk: 
• Numerous studies have demonstrated that physical activity is safe, feasible, and beneficial for cancer 
patients and survivors, including those with advanced disease.  
• Potential participants will be screened using a standard tool to assess readiness to engage in physical 
activity. 
• All participants will be required to obtain medical clearance from their oncologist. This ensures that we will 
enroll only those patients whose clinicians approve for the study. 
• Our study physician, Dr. Gradishar, will be available to assist with medical questions that may arise during 
screening or the intervention itself. If the study physician has any concerns, participants will be referred to 
their own physician for consultation. 
• Participants will be instructed to increase physical activity gradually and tailored to their own abilities.   
• Participants will receive tips to help prevent soreness and injury. 
• Participants will be asked to contact the study coordinator at any time if they have questions or concerns 
about increasing their physical activity level. 
• All study files, folders, and records will be kept in locked file cabinets that can be accessed only by study 
personnel. 
• All data will be exchanged over an SSL-protected connection, and all data will be encrypted prior to storage 
using an encryption key known only to the investigators. No PHI will be included in the Fit2ThriveMB app.  
• The study database and all survey data will be collected and stored in REDCap, which has the protections 
needed for storage of PHI. 
 
20.0 Provisions to Protect the Privacy and Confidentiality of Participants and the Research Data: 
Participant databases and survey responses 
Each participant will be randomly assigned an identification number to ensure confidentiality of data. This will 
be the only way of matching data with a specific person. Nitro Study Tracker and the REDCap tracking database 
designed for this study will be the only place where the ID will appear with the participant’s name in the present 
study. This database will only be accessible by the investigators. This electronic database will house participant 
contact information and is stored on a secured, password-protected network, accessible only by the investigators.  
To ensure the integrity of the data collected from study participants several procedures will be implemented. All 
personnel involved in data collection will be thoroughly trained in all assessment methods thus ensuring consistent 
applications of procedures and measurement consistency across participants. All questionnaire assessment data 
will be automatically saved in the secured, password protected REDCap system and will be downloaded to a 
password protected network folder protected ensuring access only by the investigators. Any hard copies of data 
will only include the participants ID number and will be entered into the REDCap system only using this ID 
number and will be stored in a separate, locked cabinet from the informed consents in the PI’s laboratory. 

 
Page 21 of 25 
 
 
Files containing identifying information obtained for purposes of tracking participants and monitoring of subject 
payments are kept in a locked file in a locked office separate from study related data. Data will only be linked to 
identifying information through a study ID. Under no circumstances will individually identifiable data be released 
to anyone without the written consent of the subject. Results will be reported as group findings only. In the past 
we have found that all of these procedures are effective at reducing risk for study participants. 
Issues related to data integrity will be discussed on a weekly basis as a recurring agenda item in the weekly project 
meeting to ensure constant monitoring of our data integrity. Only the investigators will have access to participant 
data. All staff with access to the data with have completed Northwestern University requirements for the 
responsible conduct of research including the Collaborative Institutional Training Initiative (CITI) Training 
Modules.  
REDCap does require an e-mail address to send the survey link to participants. Thus, data will be temporarily 
linked to individuals’ e-mail addresses and first names which may be included in the e-mail for personalization 
purposes. However, these links will be removed after completion of the questionnaires and these data will then 
only be linked to the participant’s identification number. Upon download, all data obtained via cellphone, will 
be de-identified and only be linked to participant via study ID number. 
Fit2thriveMB app data 
The Fit2Thrive mobile application was developed at Northwestern and is hosted by Northwestern.  Participants 
will download the app to their own personal device.  Data collected from the app is associated with an ID number 
not participants name or other identifying information. All data will be exchanged over an SSL-protected 
connection, and all data will be encrypted prior to storage using an encryption key known only to the 
investigators. All data are encoded during transfer between devices and the web server and prior to storage on 
the webserver. These data will reside on a secure, password protected server. Accordingly, these data are 
inaccessible to any person aside from the investigative team. These data are backed up regularly and are available 
for download only to the study investigators and must be accessed with a unique identifier and password 
combination.  
All data will be kept for 7 years after publication, as required by Northwestern University.  
Zoom Video Conference Software  
Participants will participate in scheduled video conferences via Zoom at baseline and the 12 week assessment. 
Zoom video conferences will be recorded for research, quality control and training purposes, if the participant 
consents. Zoom recordings will be saved on a password-protected network folder. In order to protect patient 
safety and privacy during the Zoom video conference, each participant will receive an individual, secure link to 
join the meeting. All video conferences will require a password to enter, and we will enable the waiting room 
feature on all meetings so that the meeting host (study staff member) has to approve entry to every user that 
requests to enter the meeting.  
21.0 Data Monitoring Plan to Ensure the Safety of Participants: 
This study is classified as minimal risk because the probability and magnitude of harm or discomfort anticipated 
is not greater than those ordinarily encountered in daily life or during the performance of routine physical and 
psychological examinations or tests and confidentiality is adequately protected. The PI and study investigators 
will conduct continuous review of data and patient safety. Any staff member or investigator can spontaneously 
identify an adverse event. Participants will be instructed to call or e-mail the PI in the event of any emergencies 
or medical events within 24 hours of the event occurring. These instructions will be included in all cover letters 
that accompany study materials and displayed prominently within the app.  
 
Events may also be spontaneously reported to staff during contact time. Adverse events and serious adverse 
events may also be identified during regularly scheduled calls or emails by researchers blinded to the treatment 
condition of the participant.  These phone interviews or emails will be conducted every 4 weeks throughout the 

 
Page 22 of 25 
 
12 week study period. Participants will be asked to complete the Non-spontaneous Adverse Events 
Questionnaire either via REDCap or via an interview with study staff. This form will be completed for all 
metastatic breast cancer survivor participants and will query the participant as to whether they have had any 
health and/or medical problems during the preceding 4 week period. Participants will be called or emailed until 
a response is received.   Participants will also be required to provide the investigators with at least one 
emergency contact to have on file in the event we are fail to reach the participant after 5 or more attempts. If 
participant reports “YES” to item 5A-5D (see REDCap form), an adverse event form will be filed with the IRB.  
 
All identified adverse events will be reported to the PI and recorded and reported in an adverse event log 
(includes subject’s name, date and event description). The PI will consult with co-investigators, the IRB and 
NU Office for the Protection of Research Subjects to determine whether the event should be classified as ‘non-
attributable’, ‘possibly attributable’ or ‘attributable’ to the current project and ‘serious’ or ‘non-serious.’ 
Adverse event reports will be submitted to the IRB within 5 business days of the event or notification to the PI 
that the event has occurred. All serious adverse events will be reported to the RHLCCC Clinical Research 
Office for review by the Data Monitoring Committee, IRB, and the National Cancer Institute, as applicable, 
using appropriate forms. Any action to be taken will be recorded in the adverse event log. 
 
An adverse events is defined as an unanticipated problem which meets all of the following criteria: a) 
unexpected (in terms of nature, severity, or frequency) given the research procedures described in protocol-
related documents and the characteristics of the subject population being studied, b) related or possibly related 
to participation in the research and c) suggests that the research places subjects or others at a different or greater 
risk of harm than was previously known or recognized. A ‘serious’ adverse event is defined as any event in 
which the outcome results in any of the following: death, a life-threatening adverse drug experience, inpatient 
hospitalization or prolongation of existing hospitalization (for > 24 hours), a persistent or significant disability/ 
incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly or birth 
defect; important medical events that may not result in death, be life threatening, or require hospitalization may 
be considered a serious adverse drug experience when, based upon medical judgment, they may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes listed, above. All 
other events will be considered ‘non-serious.’ 
 
In addition to reporting any events as they occur to the IRB, a progress report and request for IRB renewal will 
be submitted the Northwestern University IRB annually. All non-serious adverse events will also be submitted 
to the RHLCCC Clinical Research office semi-annually. Furthermore, study progress reports will be submitted 
to the RHLCCC Clinical Research Office Data Monitoring Committee semi-annually. These reports will 
include accrual, withdrawals, reported adverse events and compliance issues. 
 
22.0 Long-term Data and Specimen Storage and Banking:  
All data will be kept for 7 years after publication, as required by Northwestern University. Questionnaire and 
accelerometer data will be stored electronically on a password network only accessible by study investigators. 
All hard copies of functional performance testing sheets will be stored in a secure, locked cabinet only 
accessible by study investigators and will also be manually entered into a REDCap database. The hard copies 
will also be scanned and uploaded to the password network. All data will be stored de-identified with study ID 
number only.  
23.0 Qualifications to Conduct Research and Resources Available: 
All staff (project coordinator, research assistants, interns) who are part of this study will complete Northwestern 
University requirements for the responsible conduct of research including the Collaborative Institutional Training 
Initiative (CITI) Training Modules. They will also undergo extensive training on research methods and study 
procedures.  
 

 
Page 23 of 25 
 
The PI (Dr. Phillips) is an Associate Professor in the Department of Preventive Medicine and has a PhD in 
Kinesiology from the University of Illinois Urbana Champaign, MPH in Quantitative Methods from Harvard 
University and completed a postdoc at the National Cancer Institute. She has extensive training in randomized 
physical activity intervention in cancer survivors and older adults and has successfully conducted several other, 
similar, studies while at the University of Illinois Urbana Champaign.  
 
Co-Investigators. Dr. Bonnie J. Spring, PhD is the Director of The Center for Behavior and Health and 
Professor in Preventive Medicine, and Co-Leader of the Cancer Prevention Program at RHLCC at NU. Dr. 
Spring has extensive experience in mHealth, behavioral intervention trials and MOST methodology. Dr. Julia 
Lee, PhD is an Associate Professor in Biostatistics and Preventive Medicine and an expert in using cutting-edge 
statistical techniques to analyze behavioral interventions and accelerometer data.  Dr. Gradishar is the Betsy 
Bramsen Professor of Breast Oncology in the Department of Hematology and Oncology with expertise in breast 
cancer management and precision medicine clinical trials. 
 
24.0 Data Sharing: 
 
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. If a request is approved, we will develop data sharing agreements with outside investigators to 
safeguard the confidentiality of the data collected in our study in compliance with the NIH Data Sharing Policy. 
Before releasing data, we will reach an agreement with outside investigators regarding the need for scientific 
involvement on the part of the PI or other members of the research team. Before making the data available to 
researchers not involved in the proposed study, we will ensure that the data to be shared are de-identified and 
comply with both IRB regulations and the Privacy Rule under HIPAA regulations. Under no circumstances will 
personal identifying information, such as name, address, or telephone be shared with anyone outside our 
research team.  
 
 
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