"Sitting Less, Moving More": Designing a Digital Health Intervention for Black and African American Women Breast Cancer Survivors and Their At-risk Relatives (Phase II)
Phase: NA
Conditions: Breast Cancer Survivor, Breast Cancer, Fitness Trackers
Sponsor: Dana-Farber Cancer Institute

PROTOCOL TITLE: “Sitting Less, Moving More” (Phase II) 
 
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PROTOCOL TITLE: 
 
“Sitting Less, Moving More”: Designing a digital health intervention for Black and African 
American Women breast cancer survivors and their at-risk relatives (Phase II) 
 
Sponsor-Investigator: 
 
Catherine Marinac, PhD 
 
Dana-Farber Cancer Institute 
 
CatherineR_Marinac@dfci.harvard.edu 
 
Principal Investigators (PI): 
 
Julie Wright, PhD 
 
U Mass Boston 
 
Julie.Wright@umb.edu 
 
 
Meghan Underhill-Blazey, PhD, APRN 
 
University of Rochester 
 
Meghan_Blazey@URMC.Rochester.edu  
 
VERSION NUMBER: 
1.7 
 
DATE: 
6/29/2021

PROTOCOL TITLE: “Sitting Less, Moving More” (Phase II) 
 
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Table of Contents 
1.0 
Objectives ................................................................................................................. 3 
2.0 
Background ............................................................................................................... 3 
3.0 
Inclusion and Exclusion Criteria .............................................................................. 5 
4.0 
Study-Wide Number of Subjects .............................................................................. 5 
5.0 
Study-Wide Recruitment Methods ........................................................................... 7 
6.0 
Multi-Site Research .................................................................................................. 7 
7.0 
Study Timelines ........................................................................................................ 8 
8.0 
Study Endpoints ........................................................................................................ 8 
9.0 
Procedures Involved ................................................................................................. 8 
10.0 Data and Specimen Banking ..................................................................................... 9 
11.0 Data Management and Confidentiality ................................................................... 14 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 16 
13.0 Withdrawal of Subjects .......................................................................................... 16 
14.0 Risks to Subjects ..................................................................................................... 16 
15.0 Potential Benefits to Subjects ................................................................................. 16 
16.0 Vulnerable Populations ........................................................................................... 17 
17.0 Community-Based Participatory Research ............................................................. 17 
18.0 Sharing of Results with Subjects ............................................................................ 17 
19.0 Setting ..................................................................................................................... 17 
20.0 Resources Available ............................................................................................... 17 
21.0 Prior Approvals ....................................................................................................... 18 
22.0 Recruitment Methods ............................................................................................. 18 
23.0 Local Number of Subjects ...................................................................................... 18 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 18 
25.0 Compensation for Research-Related Injury ........................................................... 18 
26.0 Economic Burden to Subjects ................................................................................. 18 
27.0 Consent Process ...................................................................................................... 19 
28.0 Process to Document Consent in Writing ............................................................... 19 
29.0 Drugs or Devices .................................................................................................... 19 
 

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1.0 
Objectives 
(1) The objective of the intervention development stage is to obtain formative data to 
guide the development of a patient-centered, family-based digital health intervention 
to promote increased activity in Black/African American (AA) women breast cancer 
survivors and their first-degree relatives through a user-centered design framework. 
(2) The objectives of the pilot study are to: 
a. Explore usability and perceived utility of the intervention, a mobile app, over 
a 4-week period; and, 
b. Assess feasibility and acceptability of procedures and measures to inform 
future trials. 
2.0 
Background 
Breast cancer is the most commonly diagnosed cancer and the second leading cause of 
cancer related death in women in the U.S. and disproportionately impacts women from 
diverse or low socioeconomic backgrounds(1). For women who are Black, Hispanic, or 
socioeconomically disadvantaged, mortality from breast cancer is up to 54% greater 
compared to non-Hispanic white mortality(1). Additionally, the incidence of breast 
cancer is increasing annually for minority women, while incidence of breast cancer in 
non-Hispanic white women remains stable(2). Certain types of breast cancers are 
considered high risk, such as those that occur at a young age (<50) or those that are of 
extreme pathology (for example, triple negative breast cancer). These high-risk diagnoses 
are more common and with more disparate outcomes in Black/AA women compared to 
all other groups; a disparity which must be addressed. 
The average woman has an approximate 12% lifetime risk of developing breast cancer, 
this lifetime risk nearly doubles to a 24% if a woman has a first degree relative with 
breast cancer, and the risk increases as multiple family members are affected. In about 5-
10% of cases, inherited or genetic changes, which predispose an individual to cancer, are 
identified through genetic testing(3). In addition to inherited risk, often individuals have 
other risk factors that lead to cancer risk. For Black/AA communities this is especially 
true, as these communities are more likely to die of a preventable illness such as cancer, 
and less likely to engage in cancer preventing behaviors such as physical activity (PA)(5, 
6).  
Reducing sedentary time can improve health outcomes and increasing physical 
activity can reduce risk for cancer. Based on the poor outcomes from breast cancer 
diagnoses in Black/AA women and the risk associated with having a first degree relative 
diagnosed with breast cancer, it is critical that research efforts focus on cancer prevention 
within this domain. While it is known that increasing physical activity (PA) reduces 
cancer risk, some reporting up to a 10-39% reduction(5), there are emerging data to 
suggest that greater rates of sedentary time, independent of PA or body mass index(6), 
are associated with increased cancer risk. Any increase in PA leads to an increased 
preventive benefit(7) and the positive effect of PA has been noted even in the context of 
hereditary or familial risk(5). Specifically in a Black/AA population, recent data suggest 
that a high total time sitting was associated with a 27-28% higher risk for breast cancer, 

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independent of PA, and associations were stronger for receptor negative tumors, which 
are considered high risk(8). Therefore, engaging in novel interventions focused on 
“sitting less” and “moving more” has the potential to reduce the risk for cancer as well as 
other co-morbid conditions. It is known that Black/AA women are interested in digital 
health interventions(9), will engage in lifestyle intervention and that interventions can 
improve health outcomes(10), specifically if these interventions are designed to be 
culturally appropriate(9, 11). 
Digital health solutions have been shown to effectively lead to behavior change, 
however significant deficits in how previous interventions have been developed and 
tested have limited the impact of these interventions on public health. Efforts to 
promote lifestyle behaviors have shifted towards evaluating technology solutions, such as 
computer or smart phone based (digital health) interventions.  Smartphone ownership is 
common with 77% of US adult’s own smartphones(12), and similar rates among Whites 
(77%) and Blacks (72%). Although ownership rates increase with level of income, 64% 
of those who earn <$30K and 74% of those who earn $30-49K own a smartphone(12). 
Review studies have concluded that increasing PA through digital health interventions 
can be effective among adults (13-15), including health disparity communities(16) and 
for cancer prevention(17).   
 
An advantage of an digital health approach is the ability to provided individualized, 
tailored messages for diverse groups of adults(16) at varying levels of literacy. However, 
a consistent finding is that many commercially available and non-market apps do not use 
evidenced-based behavior change techniques(18), are not informed by theory(17), nor are 
they rigorously evaluated (13, 19). A review study found 185 available applications for 
breast cancer, yet only 10% involved medical experts in the creation, and 11% were 
evidence based(20). Shockingly, this review found that 15.7% of applications had the 
potential to cause harm due to a lack of evidence-based development. Therefore, the 
potential translational public health benefits from these innovations are lost. In summary, 
there is a significant need for rigorously developed and tested, theory-based digital health 
interventions for cancer prevention. Leveraging design strategies that place the user input 
at the center of the development and testing of the interventions is critical for developing 
effective interventions(21).  This process, called user-centered design(22-24) , is 
imperative to the success of digital health applications (apps) for health behavior change. 
Survivors of breast cancer and at-risk relatives could be the target of digital health 
interventions focused on reduction of sedentary time and promotion of PA. Breast 
cancer survivors are often encouraged to engage in health promoting behaviors, and often 
engage in behaviors or health recommendations due to the possibility of improving the 
health of others in the family. First-degree relatives of individuals with breast cancer, 
who have higher than average risk for breast cancer, could also be provided empathic 
information to understand their own risk and how reduction in sedentary time and 
increasing PA might play a role in breast cancer prevention. Often, the patient with 
cancer is the gatekeeper of this information and the key motivator in activating at risk 
family members towards lifestyle modification. Despite having an engaged patient 
population ready to engage in personal health promotion, the current model of oncology 
care that includes providing verbal or written education materials has not been found to 

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promote behavioral change(25). We are seeking to link individuals who have had breast 
cancer with an at risk relative in the family (a family buddy) for a family-based 
intervention, which is grounded in health behavior theory. Additionally, though the field 
acknowledges that health promotion in the context of cancer risk has the potential to 
impact generations of family members, none have developed interventions to reduce 
sedentary time at the family level for Black/AA families living with high risk. The 
present study will address a gap in the need for cancer prevention digital health 
applications that are theory-based, consider ehealth and health literacy needs, and focus 
on the social support components within a family-centered intervention.  
 In study phase I, we have completed qualitative interviews with 5 community leader key 
informants, 9 breast cancer survivors and 6 first degree relatives of a survivor. 
Information shared from our community leaders as well as the perceptions of our study 
participants have led to the preliminary development of the dyad based digital health 
intervention that we propose to evaluate further in study phase II. Qualitative interview 
feedback has informed our intervention materials and content, as well as process and 
formatting. We have also completed user testing with 6 eligible participants to get 
feedback on the developed intervention and to make minor iterative changes to inform 
the use and function of the application and study materials. We have completed the initial 
IRB approved phase of the study and are now seeking approval to move forward to Phase 
II, which will be the proposed pilot study.  
3.0 
Inclusion and Exclusion Criteria 
(1a) Key informants (for interviews) 
Inclusion criteria: 
● Members of the community/advisory groups, community health 
centers, or faith-based network members (e.g., Pink and Black, 
Faces of Faith). 
● English speaking adults. 
Exclusion criteria: 
● None 
(1b) Breast cancer survivors and relatives (for interviews) 
Inclusion criteria: 
● Self-identify as Black or African American 
● Age 18 and over 
● English speaking 
● Female breast cancer survivor status post curative antineoplastic treatment 
(except ongoing hormonal treatment) with no evidence of disease, OR a 
first degree blood relative (parent, child, or full sibling), of any gender, of a 
so defined breast cancer survivor 

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● Self-report ever using a smart phone  
Exclusion criteria: 
● Requires medically supervised physical activity (Physical Activity 
Readiness Question for Everyone, PAR-Q+, Question 7) 
• Pregnant women 
(2) Breast cancer survivors and relatives (for user testing/interviews) 
Inclusion criteria: 
● Self-identify as Black or African American 
● Age 18 and over 
● English speaking 
● Female breast cancer survivor status post curative antineoplastic treatment 
(except ongoing hormonal treatment) with no evidence of disease, OR a 
first degree blood relative (parent, child, or full sibling), of any gender, of a 
so defined breast cancer survivor 
● Self-report willing/able to download the app for testing on a smart phone 
●  Self-report willing/able to meet via Zoom for interview 
Exclusion criteria: 
● Requires medically supervised physical activity (Physical Activity 
Readiness Question for Everyone, PAR-Q+, Question 7) 
• Pregnant women 
(3) Breast cancer survivors and relatives/“buddies” (for pilot testing) 
Inclusion criteria: 
● Self-identify as Black or African American 
● Age 18 and over 
● English speaking 
● Breast cancer survivor status post curative antineoplastic treatment (except 
ongoing hormonal treatment) with no evidence of disease, OR a blood 
relative, of any gender, of a so defined breast cancer survivor 
● Self-report willing/able to participate with a blood relative in survivor-
relative dyad 
● Self-report willing/able to download the app for use on a smart phone 
●  Self-report willing/able to meet via Zoom for instructions and interview 
 
 

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Exclusion criteria: 
• Meets exclusion criterion of the Modified Physical Activity Readiness 
Questionnaire (PAR-Q) (modified) 
• Participated in interviews or user testing in prior phases of the study 
4.0 
Registration Procedures 
All participants will be registered in the DFCI OnCore Clinical Trials Management 
System by the DFCI study coordinator. For any participant recruited and consented by a 
UMB research team member, the UMB research team member will provide the 
completed screening form and eligibility checklist to the DFCI study coordinator via the 
study team’s Dropbox for Business folder. The DFCI PI or PD will review eligibility 
checklists prior to registration. For the interventional pilot study, registration must occur 
before the intervention begins. 
5.0 
Study-Wide Number of Subjects 
For intervention development, we will recruit up to 38 participants: up to 8 key 
informants, and up to 30 breast cancer survivors and/or relatives (ideally 15 dyads) from 
the target population. 
 
For pilot testing, we will recruit 20 participants (10 dyads). 
6.0 
Study-Wide Recruitment Methods 
Key informants will be identified through recommendation of the project’s advisory 
panel and search of relevant community-based organizations. They will be contacted in 
person at local advocacy meetings, by mail/email, or by phone as requested (see included 
study information letter and recruitment script). They will be contacted no more than 3 
times for participation.  
Breast cancer survivors and relatives will be recruited through in-person, web-based, 
and telephone methods. A study advertisement (attached) will be utilized and advertised 
through local advocacy and social media venues or virtual meetings with permission from 
the organization and distributed by key informants to potential participants. Interested 
participants will be able to contact the study team via email or phone and will be screened 
for eligibility following a script; a study specific email and telephone number will be 
created and managed by the University of Massachusetts Boston study team. Participants 
who complete an interview and provide permission to contact them again for future 
phases of the study may be contacted by telephone to invite their participation in the user 
testing phase.  
7.0 
Multi-Site Research 
This study is a collaboration between UMass Boston (UMB) and DFCI on a funded U54 
Cancer Research Partnership pilot grant and also includes an investigator at the 
University of Rochester (UofR). UMB and UofR have requested to rely on the DFCI IRB 
as the IRB of record. Approvals of the initial protocol and subsequent amendments, and 

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relevant IRB meeting minutes, will be shared with the UMB and UofR IRBs. As 
participants will be recruited from the community and thus not from the study sites, any 
unanticipated event requiring IRB reporting will be reported to all sites’ IRBs. 
Communication from the UMB and Uof R IRB will be sent to DFCI. 
All study related communications will occur via weekly in-person/Web meetings with 
members of both study teams, or via email.  
The site investigators will be jointly responsible for monitoring study progress. Dr. 
Marinac will oversee compliance and activities of the DFCI study staff, and Dr. Wright 
will oversee the UMB study staff. Dr. Underhill-Blazey is the only study member at 
UofR. 
Accrual of up to 58 participants, completion of interviews and questionnaires, and 
transcribing recorded interviews and entering data, are data points that will be monitored 
by the site investigators on a weekly basis to ensure timely completion of the study. 
Responses to eligibility screening questionnaires and attestations by research staff of 
participant consent will be stored electronically on the study team’s Partners Dropbox 
folder. The DFCI study coordinator will register each participant in a study enrollment 
database developed by the study team. 
All data will be stored in the Partners Dropbox folder. All recordings and transcripts will 
be de-identified for analysis by the research team.  
8.0 
Study Timelines 
Key informants will be engaged throughout the study up to 4 times per year (~once a 
quarter), including the initial interview (approximately 45 minutes), either in-person, or 
by telephone email, for a total of approximately 5 hours. 
Breast cancer survivors and relatives (Interviews/User Testing):  Dyads will 
participate together or separately as requested.  Participation will include a one time, in-
person or telephone interview. Length of study participation will be approximately 45 
minutes, or as long as it takes to complete the interview conversation.  
Breast cancer survivors and relatives (Pilot Testing):  Dyads will participate together 
for a total of 5 weeks, including Baseline (Week 0) measurement and 4 weeks of 
intervention use with final measures in Week 4.   
We anticipate primary completion by August 31, 2021.  
9.0 
Study Endpoints 
Primary endpoints of the qualitative interview phase (interviews and user testing for 
intervention development) are findings that will guide the development and testing of the 
intervention, including: components of the intervention; culturally appropriate 

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messaging; means of accessing and using the intervention; and principles and strategies 
for identifying and accruing participants in an evaluation study. 
The primary endpoint for the pilot study is feasibility. The component of feasibility 
include: recruitment, measurement, retention, and acceptability(26,27). Recruitment will 
be assessed by the number of participants screened per month; number enrolled per 
month. Measurement will be assessed by the completion rates at each time point divided 
by the number of participants enrolled at each time point. Retention will be the number 
who remain in the study at each assessment time point. Acceptability will be the rates of 
satisfaction and perceived appropriateness, attractiveness, and intent to continue as 
assessed by those who receive the intervention. Implementation will be the rate of 
delivery of the protocol and intervention to those intended to receive it.  See below for 
additional metrics that our team will use to determine the feasibility of the study and its 
intervention.  
 
• Recruitment. We will describe percentage of initial respondents who consent and 
enroll. Achieving a minimum of enrolling 3 dyads per month as an indication of 
feasibility of recruitment.   
• Measurement and retention. We will describe completion of study assessments 
including wearable device. Achieving a minimum of 70% of those enrolled who 
complete all study data collection time-points will serve as an indication of the 
feasibility of the proposed study protocol.  
• Acceptability. We will describe the percentage of study days in which the participant 
uses the Move Together app and will describe engagement with the app. Achieving a 
minimum of using any app feature 4 out of  7 days will provide an indication of 
acceptability, a subcomponent of the app’s feasibility. The acceptability of the Move 
Together app will also be assessed with The System Usability Scale (SUS) score. The 
scale has 10 items (examples: “I think that I would like to use this system frequently; 
I found the system very cumbersome to use; I found the various functions in this 
system were well integrated”) which are rated from strongly disagree to strongly 
agree. Scores range from 0-100; a SUS score above a 68 is considered above average 
(https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html.).  
• Implementation. Achieving a rate of 70% of all participants completing each of these 
components per protocol will provide a good indication of this component of 
feasibility.  
There are no safety endpoints. 
10.0 Procedures Involved 
This is a cross-sectional descriptive study using structured interviews and qualitative data 
analysis to develop an intervention, followed by a pilot test of the intervention with pre-
/post- measures. 
Key informants: We will interview Key Informants either in-person or remotely by 
telephone. Interview sessions (~45 minutes) will be audio-recorded, de-identified and 
transcribed for analysis. Field notes will also be taken. Participants will complete a short 
demographic questionnaire. We will contact Key Informants up to 4 times over a year 

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(~once per quarter, including the initial interview) to obtain feedback and guidance about 
the study’s endpoints. We anticipate that these interviews/contacts will amount to ~4-5 
hours in total per participant for the year. Key Informants will be given an incentive of 
$300 for the year as a thank you for their time.   
The primary goal of engaging with key informants will be to identify: 1) an acceptable 
and feasible approach to identify and engage at risk family members in a family-based 
intervention; 2) how to best support the breast cancer survivor to motivate and recruit one 
of their family members to participate in a “sit less, move more” intervention; 3) the 
challenges and barriers to, and benefits of, sitting less and moving more; 4) the digital 
health intervention components that are culturally acceptable and address identified 
challenges.  
Breast cancer survivors and relatives: Phase I A (Interviews): Procedures will include 
a one-time interview by telephone, and demographic questionnaire. Consent will be 
obtained prior to conducting audio-recorded interviews. All interview data will be de-
identified for analysis. Participants will receive a $30 Amazon or Target gift card (their 
choice) to thank them for their time.   
We will conduct interviews with about 10 women who are survivors after curative 
treatment for breast cancer. The focus of these interviews will be to gain insight into the 
participants’ attitudes and perceptions about “sitting less” and “moving more”, e.g., 
perceptions of the health benefits, family dynamics related to healthy behaviors, cultural 
factors related to these behaviors, preferred delivery channel for communication (e.g., 
text, Web, print), and frequency of contact with the app and family buddy. These insights 
will inform the components, content and cultural aspects of the family-based intervention 
and the role of social support.  We will also recruit about 10 first degree relatives of 
individuals with breast cancer meeting the previous criteria to independently complete 
interviews. The survivors and relatives will be interviewed separately or together, per 
their preference. We will also ask the participants for their permission to contact them 
after the interview if we have follow-up questions, e.g., we need to ask a clarifying 
question, and assess their interest in providing feedback about study findings, or to invite 
their participation in future research.  
We will also ask participants if we can contact them in the future to invite them to a 
community meeting where we share the results with those who are interested. 
Demographic questionnaires will be collected securely via Dropbox (Partners Business 
version) or REDCap (Partners) or verbally by phone per preference of the participant. 
Phase IB (User Testing): About 10 survivor/relative participants who completed 
interviews and gave permission to be contacted again for further research will be re-
contacted and consented for a second session – or new participants may also be recruited 
and consented up to a total of about 10 participants - to provide feedback on the 
intervention app in development. The sessions will be up to 45 minutes, conducted using 
UMB’s HIPAA-compliant version of Zoom, and audio recorded externally.  
After obtaining consent, a research assistant will arrange for the participant to download 
the app and use it for one to a few days before the interview. The app is being developed 
using PiLR Health software, an extensible platform for research and intervention 

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development in an ecological momentary assessment (EMA) framework, in which a 
participant may be prompted to repeatedly report what they are doing in their daily life 
context and receive tailored feedback and messaging to promote health behavior change. 
Depending on the app version and which features are being tested, a participant might be 
prompted, e.g., to answer a few questions about physical activity goals, then later allowed 
to report their activity, or queried if goals were met, or if not, what the barriers were, or 
may be able to view visualizations of activity data that they entered, or receive 
motivational messages via text. In addition to their use of the app, during the interview 
session, researchers may present a series of screenshots via Zoom of the app in 
development, other apps (such as, FitBit), or a linked educational website to illustrate 
potential features, messaging, and look of the app, and will ask participants for their 
impressions and suggestions.  
A recruitment script, interview guide, and sample screens and prompts for this part of the 
research are attached. As the design process is iterative and responsive to participant 
feedback, new screens and prompts will be developed and variations on the questions in 
the interview guide will be added as the sessions continue. Individual iterations will not 
be submitted for IRB review during the iterative development. Of note, only feedback 
provided in the interview session will be stored and used for app development; PiLR 
Health software provides functionality for researchers to monitor and store data related to 
participants’ use of an app or responses to questions, but no data will be stored or used 
for this phase of the study. Participants will be able to download and use the app without 
providing identifiers, and security of the software has been reviewed and approved by 
DFCI Information Security Officer Mark Tomilson via the MGB Vendor Information 
Security Plan (VISP) process. 
Phase II (Pilot Testing): 
Participants in the pilot study will participate as members of family-based dyads (n=10 
dyads). One member of each dyad will be a breast cancer survivor and one will be a 
blood relative. Either person can respond to the study recruitment postings. A research 
assistant will remotely (as above) provide a study information sheet containing all 
elements of consent, describe the study, obtain informed consent, and screen them for 
eligibility following attached scripts. The participant will then invite a relative to contact 
the study team for consent and eligibility screening. When both participants have 
consented and been determined eligible, they will be scheduled to begin the study.  
The intervention and study are designed for breast cancer survivors and at-risk relatives. 
However, in case it is not feasible to recruit sufficient family-based dyads, if an interested 
participant does not have a relative they are willing and able to have join the study with 
them, we will ask if they would like to be placed on a wait list in case the eligibility 
criteria for the study would be broadened (IRB amendment would be submitted). 
Baseline: To begin the study, dyad participants will be scheduled for a joint HIPAA-
compliant Zoom meeting with a research assistant, who will send a baseline package in 
advance to each participant by FedEx or US Mail. If it is not possible to meet at the same 
time, participants will be scheduled to start within no more than 3 days of one another. In 
the baseline Zoom session, the research assistant will instruct participants to open their 

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baseline package and remove the activPAL device/instructions and will be instructed in 
the baseline, 1-week duration (Week 0) activPAL wear protocol (see attached 
instructions). The activPAL device is a research grade wearable for monitoring physical 
activity (https://www.palt.com/). Research study staff will configure the activPAL device 
to collect data using a study ID number only. Participants will also complete the baseline 
questionnaire via REDCap during Week 0. All instruments selected for the baseline 
questionnaire are intended to serve as a reference measure for a future efficacy trial. 
Therefore, they are primarily used to gather information on cultural relevance and 
appropriateness, which we will assess quantitatively by %completion rate (>70% is 
deemed acceptable) as well as qualitatively using debriefing interviews. Additionally, a 
distal goal of our study is to reduce cancer/health disparities in minoritized communities.  
It is important to describe the racial and ethnic characteristics and social economic factors 
that are known social determinants of health. To fully describe our sample, we will gather 
self-reported demographic and social economic questions.   
If participants are not able to use REDCap, the research assistant will schedule a 
telephone call to collect the baseline questionnaire. 
Week 1 Start: A second Zoom session will be scheduled at the beginning of Week 1. 
Participants will be instructed how to remove and return the activPAL to the research 
team to download data and re-charge the devices. Participants will also at this time be 
instructed how to download the PiLR EMA app to their smartphone and will be given 
user IDs and passwords to access the MoveTogether Boston app on it. The research 
assistant will direct them to the printed PiLR EMA privacy policy included in their 
baseline package (attached; also accessible electronically at any time through the app 
“Settings”) and will be advised that the app does not collect any private information or 
identifiers (including device ID) from their phone; they will also be advised again not to 
include PHI in the text fields or dyad partner (“buddy”) messages that they type into the 
app so that their use remains anonymous.  
In the same Zoom session, participants will be instructed in how to begin wearing the 
Garmin vivofit® 4 (https://buy.garmin.com/en-US/US/p/582444) that they can use 
throughout the intervention and keep when the study ends. The Garmin device is a 
consumer-oriented fitness tracker. Participants will be shown in the device instructions 
(attached) where it explains the limited use of the device possible without creating 
accounts with the Garmin company, which would collect user data and be Participant to 
the company’s terms of use and privacy policy. Participants will be told that for the 
purpose of the study, they do not need to create accounts but can use the Garmin watch 
independently of account registration and manually enter information from it (e.g., 
number of steps in a day) into the Move Together PiLR app. If they choose to create 
Garmin accounts, it is at their discretion and the study team cannot provide technical 
support for doing so.    
Week 1-4 (Intervention): Participants will use the Move Together app and Garmin 
trackers during Weeks 1-4. The participants will be encouraged to interact with the app 
every day but the study team will not personally contact the participants during the 
intervention period.  The participants will be invited to use the app as follows: Each day 
the app will send a push notification in the morning to remind the participant to set a 

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movement goal for the day. Once the participant is in the app, they can visit any of its 
content as they wish. During the day, a reminder will be sent to send a message to their 
buddy/dyad. At the end of the day, a push notification will be sent to the participant about 
reporting his or her steps and progress made on the goal set for the day.  These 
notifications can be turned on or off by the research team or the participant if they wish 
not to see them.   
The Move Together app allows users to set daily goals for increasing physical activity 
and decreasing sedentary time, track progress on goals, message their buddy, and access 
external educational infographics and other resource links hosted on a Wix website 
maintained at UMass Boston, which uses a hidden URL and does not require 
authentication to access (see attached Move Together Screenshots, Infographics, and 
Resource List). The Move Together app does not collect or store identifiers on the user’s 
phone, and users will not be required to enter identifiers as their login credentials (users 
will be provided anonymized credentials which will be recorded in the study enrollment 
log). The app will track usage including frequency and type of task completed on the app 
and will store data that users enter (such as the number of steps taken in a day, or the 
content of a text message). These data will be analyzed to understand usage patterns and 
evaluate utility of app features. 
The purpose of the Garmin activity tracker in this study is for participants to track their 
steps and sedentary time. They may also use the basic device features without creating an 
account and sharing identifiers: progress bar that compares their number of steps each 
day and basic clock. Participants will be shown how to use the Garmin devices without 
creating accounts (see attached Garmin Instructions). If they choose to create accounts to 
synch their watches to computers/phones and use advanced features, they will be 
Participant to the manufacturer’s terms of use and privacy policy, and we will not provide 
technical support for those advanced uses. 
Week 4: Participants will complete a second REDCap questionnaire and wear the 
activPAL tracker for 1 week as post-intervention measures. 
Participants will also meet with a member of the research team for 30-minutes via DFCI 
or UMB HIPAA-compliant Zoom to complete an individual structured interview about 
their experience in the study and with the app (see attached Pilot Study Interview Guide). 
 
 
 
 
 

PROTOCOL TITLE: “Sitting Less, Moving More” (Phase II) 
 
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Table 1. Summary of pilot study procedures and measures 
 
Week 0 
Weeks 1-4 
Week 4 
 
Baseline 
Intervention Pilot Post-Intervention 
Demographic questionnaire 
(REDCap)1 
X 
 
 
Physical activity2, sedentary 
behavior3, quality of life4, and 
social support for exercise5 
questionnaires (REDCap) 
X 
 
 
X 
App usability6, utility and 
acceptability7 questionnaires 
(REDCap) 
 
 
X 
activPAL wear protocol 
X 
 
X 
Use of Move Together app with 
Garmin activity tracker watch 
 
X 
 
PiLR app platform collects data 
on frequency of use, tasks 
completed (e.g., goal setting, 
messaging), content of 
messaging 
 
X 
 
Semi-structured qualitative 
interview about experience with 
the app and study participation 
(Zoom) 
 
 
X 
1Demographic questions drawn from standard measures including from the U.S. Census Bureau, 
Pew Surveys, and financial toxicity measures. 
2Physical activity assessed using the Global Physical Activity Questionnaire(28).  
3Sedentary behavior assessed using the Sedentary Behavior Questionnaire(29). 
4Quality of life assessed using the PROMIS Global Health Scale v 1.2(30). 
5Social support for exercise assessed using a measure developed by Sallis and colleagues(31). 
6App usability assessed using the mHealth App and System Usability Scales(32). 
7Utility and acceptability assessed using the App Acceptability and New Information/Utility 
questionnaire, developed by the study team (see Appendix). 
 
 
11.0 Data and Specimen Banking 
N/A 
12.0 Data Management and Confidentiality 
Phase I 
No power analysis will be conducted for this descriptive study. The number of 
participants is based on common practice in qualitative research.  
Interview data will be analyzed using content analysis in NVivo® v11 software 
(QSR International). Questionnaire data will be summarized using descriptive 
statistics. 

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Interview recordings will be electronically de-identified using Sony Sound Forge 
Audio Studio® v10 software and stored on a secure Partners Health Care server 
that requires user authorization and authentication for access and will be limited 
to the study team. Recordings will be transcribed, and transcripts will be analyzed 
with only a study ID number. Recordings will be deleted at the end of the study. 
 
Phase II 
No power analysis was conducted for the pilot study. We have proposed a sample 
size of 10 dyads, which is consistent with previous literature(33,34), as well as 
practical within the scope and timeline of the study funding.  
For our pilot phase the following self-reported measures will be utilized:  
Sedentary time will be assessed with a thigh worn device, activPal3, the most 
sensitive and valid objective measure of sedentary time.  
The measures in Table 1 were included as potential endpoints or covariates to 
include in future larger trials. In this study we will ensure that the measures are 
appropriate, accessible, and sensitive to this population.  This will be assessed in 
our end of study exit interviews, as well as in reviewing patterns of data 
completion and missing data.  
Data Analysis Plan. 
 All enrollment, attrition, and completion data, and self-report survey measures 
will be summarized using descriptive statistics (i.e. frequency, percentage, mean). 
We will evaluate single item responses as well as survey scores as presented in 
the user manual. Patterns of missing data will be described for both self-report 
and objective measures.  Exit interview data will be thematically content analyzed 
by the study team, including trained students. A summary of the study outcomes 
will be circulated to the Advisory Panel of community leaders. All findings will 
inform future work within a larger powered trial.  
Data Confidentiality. A single password protected file will link participant 
identifiers to study ID numbers during the research to manage logistics and assure 
organization and quality of the final data. When analysis of the primary study 
outcomes is completed, the linking key will be removed. 
Data and the participant list will be (separately) electronically stored after the 
study is complete per SOP: Record Retention for Completed Research (RCL-101). 
The study team is comprised of experienced researchers trained in human 
Participants’ protections. The study staff and all research activities will be 
monitored by the PIs. The PIs and Project Director will train all study staff in 
procedures for maintaining participant confidentiality and securing data. All 
members of the research team will be responsible for immediately reporting 
breaches of confidentiality or data security to the PI, local compliance office per 
institutional policy, and the IRB.  

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13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
The PIs and Project Director will monitor data on device usage, text comments in 
the app, outliers in reported physical activity and sedentary behavior, 
questionnaire responses, calls to the research team, and responses in the interview 
for indications of privacy loss, injury or distress. All subject-submitted data will 
be reviewed by the study team weekly, and weekly project meetings will be used 
to debrief. Safety issues will be reported to the review board per DF/HCC policy. 
14.0 Withdrawal of Subjects 
Participants will be able to withdraw at any time with no impact on their current 
or future medical care or relationship with the UMass Boston – Dana-
Farber/Harvard Cancer Care Partnership.   
15.0 Risks to Subjects 
We anticipate the study to be no greater than minimal risk. The questions that we ask are 
not intended to be sensitive in nature.  However, if a study participant is upset or 
distressed during the study, the interviewer will ask if the participant would like to stop 
the interview and will refer the participant for follow-up to local resources as necessary.  
Participants will also be able to skip any questions that they do not feel comfortable 
answering.   
Another potential risk is that, in the course of recruitment and screening, e.g., explaining 
eligibility criteria, a potentially eligible breast cancer survivor or relative may learn or 
come to understand their increased cancer risk in a way that had not previously 
understood it, and may become distressed as a result. If this happens, the study team 
member will refer the participant to local resources (i.e. local genetic counseling services) 
for follow-up assessment and discussion of cancer risk and potential genetic testing. The 
study team will facilitate providing information about local genetics resources.  
In the Pilot Study, there is additional minimal risk of loss of privacy by using wearable 
devices and a mobile app. We have selected the devices and app platform and designed 
instructions to participants to minimize risk (see Section 9 above, attached participant 
device Instructions, Pilot Study Information Sheet and Pilot Study Recruitment 
Script/Consent Form). 
In the Pilot Study, there is additional minimal risk of physical injury from gradually 
increasing physical activity. We will use the Modified PAR-Q (modified) to screen out 
participants who do not meet criteria to safely begin a physical activity program (see 
attached Pilot Study Screening Form) and also will tell participants that the study does 
not require that they do vigorous physical activity but instead the intensity of activity to 
which they are accustomed and is comfortable. 
16.0 Potential Benefits to Subjects 
There are no benefits of participating in this study. Participants will be informed 
that there are no direct benefits, but that their participation may help us design a 

PROTOCOL TITLE: “Sitting Less, Moving More” (Phase II) 
 
Page 17 of 22 
 
health promotion intervention for breast cancer survivors and their first-degree 
relatives, which could benefit others, and design a future study. 
17.0 Vulnerable Populations 
Vulnerable populations will not be included.  
18.0 Community-Based Participatory Research 
This study is not community-based participatory research. 
19.0 Sharing of Results with Subjects 
Any publications resulting from this work will be disseminated to the community 
organizations and participants as requested. We anticipate inviting the research 
participants to a one-time event to present the findings of this study. The data will 
be presented in aggregate and no identifiable information will be presented.  
20.0 Setting 
Participants will be recruited through local community organizations and key informants 
by distributing flyers/advertisements both in person or online and through word of mouth. 
The online advertisement will be posted on any social media sites with the permission of 
the hosting community organization.   
Research will be conducted in the community virtually and interviews will be 
conducted by telephone. Survivor/participant user testing interviews for Part B 
and Part C pilot study sessions will be conducted via UMB’s or DFCI’s HIPAA 
compliant Zoom; participants can connect using their own desktop, laptop or 
tablet device, or smart phone. 
21.0 Resources Available 
The study team is well equipped to complete the proposed research. Dr. Marinac at DFCI 
will have all resources available through the Phyllis F. Cantor Center and Population 
Sciences to conduct the study and provide study oversight, including research assistants, 
coordinators, and project directors. The Cantor Center has all software to conduct the 
study, including NVivo and software to de-identify audio files, and transcription will 
occur with trained transcriptionists, either professional or students from UMB. Dr. 
Wright at UMB will have the support of student research assistants and telecoms to host 
remote meetings and facilitate recruitment. Dr. Underhill-Blazey was previously faculty 
at Harvard Medical School and served as overall PI of nine protocols under the DFCI 
IRB. Her effort will be the only resource from UofR. 
Each member of the team is experienced in user-centered design and qualitative methods, 
specifically community based qualitative research.  
We anticipate no recruitment challenges based on previous research experience 
with the community advocate organizations. The study team will allocate time 

PROTOCOL TITLE: “Sitting Less, Moving More” (Phase II) 
 
Page 18 of 22 
 
resources to conduct the study per the timeline. The study team will be available 
to triage any psychosocial concerns or distress that may arise during the study. 
22.0 Prior Approvals 
N/A 
23.0 Recruitment Methods 
Local recruitment is as described above in section 5.0 Study Wide Recruitment, as 
all participants will be recruited from the community, not clinical sites. 
Participants will be recruited through online or telephone methods, using letters 
and advertisements that are attached. We will ask interested individuals to contact 
the study office for more information about the study and to find out if they might 
be eligible. A study team member will follow up to explain the study and obtain 
informed consent, and a payment will be made after completion of the interview. 
24.0 Local Number of Subjects 
For intervention development, up to 38 individuals – up to 8 key informants, and up to 30 
patients/family members (ideally dyads) – will be recruited and enrolled.  
 
For pilot testing, 20 participants (10 dyads) will be recruited and enrolled. 
Institutions will register eligible participants from the pilot study in the Clinical Trials 
Management System (CTMS) OnCore as required by DF/HCC Policy REGIST-101. 
 
25.0 Provisions to Protect the Privacy Interests of Subjects 
Procedures include: the screening and enrollment logs will be kept in a secure, encrypted 
database that requires authenticated login and password protection; consent forms will be 
locked in study offices; all audio recordings of interviews will be de-identified (using 
digital voice editing software) prior to transcription; transcripts will identify participants 
only by a study ID number; individually identifiable private information will be 
accessible only to study staff who are trained in the protections of human subjects and 
study procedures and IRB approved. 
26.0 Compensation for Research-Related Injury 
N/A 
27.0 Economic Burden to Subjects 
There are no costs to participating in the research. If the participant prefers an in-
person interview, we will pay transportation costs with a transit or taxi voucher. 
 
 

PROTOCOL TITLE: “Sitting Less, Moving More” (Phase II) 
 
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28.0 Consent Process 
Key informant participants will receive an information sheet that includes elements of 
consent through both the mail and email letters (attached). In a follow-up phone call, a 
study team member will explain the study and all elements of consent, answer any 
questions, and obtain consent to participate in the interview prior to engaging in study 
procedures. Participants will be asked if they agree to be audio recorded; if they prefer 
not to be, they will be told that an additional research assistant will participate in the 
interview to take notes. The mode, date and time of the consent discussion, and whether 
the participant agrees to be audio recorded, will be documented in the enrollment 
database kept by the study team. When the interview starts, the interviewer will confirm 
agreement to being recorded.    
Breast cancer survivors and relative participants will be screened by telephone to 
ensure that they meet eligibility criteria and a study team member will explain the study 
procedures and all elements of consent. A study information sheet will be provided 
electronically or by mail to all participants. Participants will be able to ask questions and 
given time to consider participation. Their consent to participate, and if so, to be audio 
recorded, will be documented by the study team member on the Screening/Consent Form 
(attached) and in the study team’s Screening/Enrollment Log. 
29.0 Process to Document Consent in Writing 
For the Key informants, we request a waiver of written documentation of consent as 
they will be stakeholders, experts and community leaders focused on improving breast 
cancer health disparities in Black/AA women.    
For the breast cancer survivors and relatives, we request a waiver of written 
documentation of consent to minimize the burden of mailed consent during the COVID-
19 pandemic. The study team member who consents the participant by telephone will 
complete contemporaneous documentation of the consent discussion. 
30.0 Drugs or Devices 
N/A 
 
 
 
 
 

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