Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
Phase: NA
Conditions: Breast Cancer Female, Physical Activity
Sponsor: Northwestern University

PROTOCOL TITLE: Designing with Dissemination in Mind: Optimization of a mHealth 
Physical Activity Intervention for Breast Cancer Survivors (Fit2Thrive) 
 
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Revised Template: November 10, 2014 
OFFICIAL CT.GOV TITLE: Optimization of Remotely Delivered 
Physical Activity Intervention for Breast Cancer Survivors 
 
NCT#:  NCT03131440 
 
DOCUMENT DATE: June 14, 2018 
 
 
IRB PROTOCOL TITLE:  
DESIGNING WITH DISSEMINATION IN MIND: OPTIMIZATION OF A 
MHEALTH PHYSICAL ACTIVITY INTERVENTION FOR BREAST 
CANCER SURVIVORS (FIT2THRIVE STUDY)  
. 
PRINCIPAL INVESTIGATOR:  
Siobhan M. Phillips, PhD, MPH 
Department of Preventive Medicine 
312-503-4235 
smphillips@northwestern.edu 
 
STUDY TEAM MEMBERS:   
Bonnie J. Spring, PhD 
 
 
 
 
 
 
Frank J. Penedo, PhD 
 
 
 
 
 
 
David E. Cella, PhD 
 
 
 
 
 
 
Juned Siddique, PhD 
 
 
 
 
 
 
Ronald T. Ackermann. MD, MPH 
Danielle Hartigan, PhD, MPH 
William E. Funk, PhD 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
VERSION NUMBER: 7 
 
 

PROTOCOL TITLE: Designing with Dissemination in Mind: Optimization of a mHealth 
Physical Activity Intervention for Breast Cancer Survivors (Fit2Thrive) 
 
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Table of Contents 
1.0 
Objectives ................................................................................................... 3 
2.0 
Background ................................................................................................ 5 
3.0 
Inclusion and Exclusion Criteria ............................................................... 11 
4.0 
Study-Wide Number of Subjects .............................................................. 13 
5.0 
Study-Wide Recruitment Methods ............................................................ 14 
6.0 
Multi-Site Research .................................................................................. 15 
7.0 
Study Timelines ........................................................................................ 15 
8.0 
Study Endpoints ....................................................................................... 16 
9.0 
Procedures Involved* ............................................................................... 17 
10.0 Data and Specimen Banking ....................... Error! Bookmark not defined. 
11.0 Data and Specimen Management ............................................................ 36 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ............. 42 
13.0 Withdrawal of Subjects ............................................................................. 42 
14.0 Risks to Subjects ...................................................................................... 42 
15.0 Potential Benefits to Subjects ................................................................... 44 
16.0 Vulnerable Populations............................................................................. 44 
17.0 Community-Based Participatory Research ............................................... 44 
18.0 Sharing of Results with Subjects .............................................................. 44 
19.0 Setting ...................................................................................................... 45 
20.0 Resources Available ................................................................................. 45 
21.0 Prior Approvals ......................................................................................... 47 
22.0 Recruitment Methods ............................................................................... 47 
23.0 Number of Subjects .................................................................................. 50 
24.0 Provisions to Protect the Privacy Interests of Subjects ............................ 51 
25.0 Compensation for Research-Related Injury .............................................. 53 
26.0 Economic Burden to Subjects .................................................................. 53 
27.0 Consent Process ...................................................................................... 53 
28.0 Process to Document Consent in Writing ................................................. 54 
 

PROTOCOL TITLE: Designing with Dissemination in Mind: Optimization of a mHealth 
Physical Activity Intervention for Breast Cancer Survivors (Fit2Thrive) 
 
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1.0 
Objectives 
1.1 Purpose and Specific Aims 
Breast cancer survivors are at an increased risk of chronic conditions and compromised 
quality of life (QOL).1,2 Increased physical activity (PA) is associated with reductions in 
negative treatment-related side effects (e.g. fatigue, depression), cancer recurrence and 
mortality and improved QOL and survival.3-6 However, breast cancer survivors 
demonstrate decreases in PA that persist post-treatment,7,8 and up to 70% do not meet 
public health recommendations for PA.9-12 Although many factors7,13-18 contribute to 
survivors’ low PA, a lack of accessible, effective PA programs is a major barrier. Most 
existing PA interventions are resource-intensive, on-site programs tested in controlled 
efficacy trials with little chance of being translated into real-world practice.19 Therefore, it 
is critically important to develop theoretically sound, cost-effective PA interventions that 
can be remotely delivered with greater dissemination and implementation (D&I) 
potential.18-22  
 
 
Our previous prospective study indicates that social cognitive23 constructs including self-
efficacy, outcome expectations, social support and goal-setting may be useful targets for 
PA interventions among breast cancer survivors.15 However, PA interventions targeting 
these constructs typically use bundled packages consisting of standardized doses of 
multiple components (i.e. daily logs, support calls, feedback) delivered simultaneously 
making  it impossible to disentangle which intervention components, at what levels, and 
in what combination(s) do, or do not, impact target constructs and maximize PA. Granular 
information about the effects of discrete components is needed to optimize intervention 
configuration so PA and scalability are maximized and burden and cost minimized.20,24 
Using traditional study designs (i.e. randomized clinical trials) to test each component one 
at a time is inefficient in terms of time and expense. More efficient research methods must 
be used to simultaneously compare the effects of multiple individual intervention 
components.   
 
The purpose of the present study is to apply the Multiphase Optimization Strategy 
(MOST)25 to develop and pilot test a set of mobile health (mHealth) PA intervention 
components for breast cancer survivors that are targeted at social cognitive constructs 
known to impact PA uptake and designed with D&I in mind from the outset. MOST is an 
innovative multi-phase framework adapted from engineering that uses highly efficient 
factorial experiments to evaluate the individual and combined effect of intervention 
components. The present study will use a MOST approach to examine the effect of PA 
intervention components that vary on cost. These data will be used to assemble an 
intervention to be evaluated in a larger R01 that is optimized to yield the maximum 
increase in PA for the minimum cost. The proposed study represents the first systematic 
effort to use MOST to design a highly disseminable PA intervention for breast cancer 
survivors. The  resulting intervention will have great potential for scalability because it 
engages relevant stakeholders (i.e. survivors, experts, community leaders) in the design, 
uses technology (smartphones) participants already own, requires no on-site visits, and 
recruits using the Army of Women,© a national breast cancer research registry the PI 
successfully used previously.  

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Physical Activity Intervention for Breast Cancer Survivors (Fit2Thrive) 
 
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Specific Aims: 
Aim #1. Use a patient-centered approach to select a set of five PA intervention 
components for breast cancer survivors designed to impact social cognitive 
constructs. Although we have identified candidate app/intervention components, 
selection of which ones to test will be made based on consensus between investigators 
and relevant stakeholders including survivors, experts and community leaders (n=10 of 
each). Survivors (n=10-20) will also be involved in iterative testing to determine app 
usability and functionality. 
 
Aim #2. Pilot test the feasibility and acceptability of candidate intervention 
components in a 12-week MOST experiment. A highly efficient experimental design 
will be used for this pilot study of survivors (n=256). Feasibility will be assessed by a) 
intervention reach, b) participant retention, and c) adherence to the intervention protocol. 
Acceptability will be assessed by ratings of the acceptability and usefulness of 
intervention components.  
 
Aim#3. Examine effects of the intervention components on PA. The effect of the 
intervention components on changes in accelerometer measured PA (minutes/week) at 
12 weeks and 24 week follow-up will be examined using a highly efficient experimental 
strategy powered to detect effects of individual components.  
 
Exploratory Aim. Examine potential effects of the intervention components on 
important patient-reported outcomes (PROs). We will examine the effect of each 
intervention component on changes in physical function, fatigue, depression and QOL at 
12 weeks and 24 week follow-up using well-validated self-report measures.  
 
Exploratory Aim 2. Examine the effects of the 5 intervention components on 
biomarkers of breast cancer (BC) progression and cardiovascular disease (CVD) 
risk in a 12 week intervention. We will collect blood samples for future research to examine 
evaluate the extent to which each intervention component ameliorates a pro-inflammatory 
phenotype associated with BC progression and CVD risk (i.e. interleukin-6, tumor 
necrosis factor-alpha interleukin-10, c-reactive protein) and cardiometabolic biomarkers 
(i.e. glucose, triglycerides, total cholesterol and high-density lipoproteins).  
 
1.2 Hypotheses to be tested. 
Aim #1. We hypothesize that a set of 5 components will emerge as favored by participants 
and approved by experts and investigators.   
 
Aim #2. The primary hypotheses are: a) 75% of eligible survivors will agree to participate 
in the intervention; (b) enrollees will demonstrate engagement by monitoring PA on >80% 
of the study days and using one or more additional app components at least weekly. 
Descriptive analyses (means, frequencies) will be used to describe these results 
 
Aim#3 and Exploratory Aim #1 and #2. Our hypothesis is that a set of components will 
emerge as most effective for increasing PA and minimizing cost but a additional 

PROTOCOL TITLE: Designing with Dissemination in Mind: Optimization of a mHealth 
Physical Activity Intervention for Breast Cancer Survivors (Fit2Thrive) 
 
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configurations of intervention component may emerge as having the largest, most cost-
efficient impact on PROs, biomarkers of BC progression and CVD risk . 
 
2.0 
Background 
2.1 Relevant Prior Experience and Gaps in Current Literature 
Breast Cancer Survivors and Physical Activity Overview. An estimated 3 million 
breast cancer survivors are  alive in the U.S. with this number expected to increase to 4 
million over the next decade.26 Cancer and its treatment are associated with a host of 
deleterious psychosocial (e.g. fatigue, depression, low self-esteem) and physical side 
effects (e.g. nausea, vomiting, lymphedema, functional limitations)  that may be chronic 
or have a late onset and result in compromised quality of life (QOL).27  Breast cancer 
survivors are also at an increased risk of early mortality and the development of both 
comorbid conditions28 and second primary cancers.29 Increased physical activity (PA) has 
been shown to be effective for reducing these negative treatment-related side effects and 
improving QOL.5,6 Increased PA is also associated with increased survival and reduced 
risk of recurrence, progression and all-cause mortality in this population.30 Consequently, 
evidence-based guidelines recommend that breast cancer survivors engage in moderate 
to vigorous intensity aerobic PA for 150 minutes per week, with the benefits believed to 
be dose-dependent.31,32  
Despite the benefits of PA, up to 70% of breast cancer survivors do not meet PA 
recommendations.9-12 Although many factors7,13-17 contribute to dismal PA levels, a lack 
of widely available disseminable evidence-based PA programs for breast cancer 
survivors may be a major barrier.19 Most existing PA interventions for breast cancer 
survivors are on-site, intensive, professionally delivered multicomponent programs. The 
few home-based PA interventions involve a large number of face-to-face or phone 
counseling sessions and do not incorporate web or mobile technology.  Historically, 
design of these time and resource intensive interventions has  largely neglected to 
engage stakeholders (i.e. clinicians, survivors) and ignored contextual barriers (i.e. cost, 
burden, and accessibility) that influence real-world intervention uptake and 
sustainability.19 Thus, existing PA interventions are often not feasible for widespread 
dissemination and implementation (D&I).19 As the number of breast cancer survivors 
continues to increase, it is of critical public health importance to develop more 
disseminable, effective PA interventions to improve health and disease outcomes and 
reduce healthcare costs. The proposed study addresses this critical need by designing 
with D&I in mind from the outset by engaging stakeholders in intervention development, 
using mobile technology for intervention delivery to increase reach and accessibility, and 
identifying “active” intervention components. 
Social Cognitive Theory (SCT)23 is well recognized as a useful framework for the design 
of PA interventions. However, the full model has been applied less-frequently in research 
with cancer survivors.33 SCT34-36 specifies a core set of determinants (self-efficacy, goal-
setting, facilitators/barriers outcome expectations) and the mechanisms through which 
they work.35 Specifically, individuals with higher self-efficacy have more positive outcome 
expectations, set higher goals, and are more likely to believe they are capable of 
overcoming barriers (see Figure 1). These relationships are all postulated to be reciprocal 
(i.e. higher self-efficacy is associated with higher outcome expectations and vice versa). 

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Our work, and the work of others, has demonstrated SCT constructs including self-
efficacy, realistic outcome expectations, facilitators/barriers (i.e. social support), and goal-
setting are associated with increased PA in breast cancer survivors.15,37-39 Most PA 
interventions that use SCT involve simultaneous delivery of multiple intervention 
components (e.g. goal-setting activities, PA logs, social support) intended to target these 
constructs. While this approach results in determination of overall intervention 
effectiveness, it provides little insight into which intervention components/SCT constructs 
were, or were not, effective. Identifying which intervention components maximize PA 
while minimizing cost can help to determine which components should be included, 
eliminated or reduced to meet specific organization or individual needs. 
 
 
Physical activity (PA), breast cancer (BC) prognosis, and cardiovascular disease 
(CVD) risk. Overall relative survival rates are high for breast cancer. However, BC 
survivors (BCS) are still at risk for recurrence and they demonstrate higher CVD incidence 
and mortality40 than healthy controls. CVD is also the leading cause of non-cancer death 
among BCS.41 Increased CVD risk in BCS likely results from a combination of treatment 
toxicities42,43 and poor lifestyle habits.44 Increasing PA may improve both BC 
progression45 and reduce CVD risk46 in BCS. A recent meta-analysis found that BCS who 
participated in the most PA post-diagnosis had a lower risk of BC-related death, death 
from any cause, BC progression, and new primary cancers and recurrence compared to 
inactive BCS. 45 Further, data from the general population indicate increased PA is 
associated with reduced CVD risk and mortality.47,48 While these findings are promising, 
the exact biologic mechanisms underlying the benefits of PA on BC progression and CVD 
risk in BCS are not well-established.  
 
 
Fig. 2 Proposed BC Progression and CVD Risk pathways to be Examined 

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PA and BC prognosis and CVD risk biomarkers. PA is hypothesized to improve BC 
progression via its effects on a number biobehavioral pathways, including 
inflammation.49,50 A pro-inflammatory phenotype is associated with increased BC 
progression and mortality and CVD risk and mortality51-54 while higher PA is associated 
with amelioration of a pro-inflammatory phenotype.55 Higher PA may be associated with 
further CVD risk and mortality reductions in BCS via its effects on cardiometabolic 
biomarkers.56 Figure 2 displays these pathways. The proposed study will contribute to the 
evidence needed to advance a public health-level recommendation that BCS should 
engage in PA. Inflammatory biomarkers. Interleukin-6 (IL-6) and tumor necrosis factor-
alpha (TNFα) are pro-inflammatory cytokines secreted by tumor cells, infiltrating 
macrophages, and adipocytes. Preclinical studies suggest TNFα is associated with 
increased angiogenesis and invasion57,58 and IL-6 promotes proliferation, inhibiting 
apoptosis and promoting conversion of noncancer cells into tumor stem cells.59 
Interleukin-10 (IL-10) is an anti-inflammatory immunosuppressive cytokine with both pro- 
(reduces antigen presentation, cell maturation and differentiation which may allow tumor 
cells to evade immune surveillance mechanisms)60 and anti- (inhibits gene expression, 
cytokine synthesis by T cells and macrophages, and their antigen presentation)61 tumoral 
effects.62 C-reactive protein (CRP), an acute phase protein, is a non-specific marker of 
chronic inflammation primarily regulated by IL-6. CRP may contribute to a  pro-neoplastic 
environment by inducing DNA damage, promoting angiogenesis, and favoring neoplastic 
spread and metastis.54 The pro-inflammatory phenotype propagated by these biomarkers 
is: a) more prevalent in BCS than noncancer controls,63 b) associated with increased BC 
incidence, recurrence, progression and mortality51,52,64-66 and c) associated with 
increased CVD risk53 and mortality67 via its contribution to the atherosclerotic disease 
process.68 Aerobic PA is associated with amelioration of this pro-inflammatory 
phenotype.55,69 Although the exact underlying mechanisms are unknown, hypothesized 
effects include: PA-associated reductions in visceral fat mass; increased production and 
release of anti-inflammatory cytokines from contracting skeletal muscle and reduced 
expression of Tolllike receptors (TLRs) on monocytes.55 Cardiometabolic biomarkers. 
Higher levels of blood glucose (BG), triglycerides (TG), and total cholesterol (TC) and 
lower HDL-cholesterol (HDL-C) are associated with increased risk of cardiovascular 
events.70-77 Regular PA improves liver, skeletal muscle and adipose tissue sensitivity to 
insulin resulting in decreased fasting insulin levels and the insulin response to glucose, 
resulting in increased glucose disposal rates.78 PA may improve lipid profiles via a number 
of mechanisms including enhancing skeletal muscles’ ability to utilize lipids, increased 
lipoprotein lipase activity and increased lecithin-cholesterol acyltrans.79  
 
Impact of intervention and PA dose on biomarker outcomes. Understanding the dose 
of PA needed for specific outcomes in cancer survivors and whether this dose varies by 
participant characteristics has recently been identified as a high research priority by 
NCI.80 The typical approach of testing multiple intervention components delivered 
simultaneously in a randomized control trial (RCT) only allows us to draw conclusions 
about an entire treatment package when each intervention component may differentially 
influence intervention adherence, PA dose engaged in and health outcomes. By testing 
the individual effects of PA intervention components (i.e. coaching calls, text messaging, 
breast cancer specific app, group support and online gym membership) on BC 

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progression and cardiometabolic biomarkers and examining potential mediators and 
moderators of these relationships in the proposed study, we will gain important insight 
into the “dose” of: a) PA (i.e. intervention adherence and PA volume) needed to improve 
biomarkers of interest and b) intervention [i.e. which components, at what levels, in what 
combination(s)] needed to achieve these outcomes. We will also gain preliminary insight 
into whether the needed PA and intervention dose varies by individual characteristics. 
This will allow for more specific and personalized intervention prescriptions for specific 
outcomes for BCS. 
 
Dried blood spots. Remotely-delivered, technology-supported interventions have 
greater potentially scalability than intensive, on-site interventions and allow for larger 
sample sizes and greater geographic diversity. In contrast, the cost and logistics 
associated with collecting biomarker samples, often restricts the assessment of these 
outcomes in larger-scale technology-supported interventions. The self-collection of 
DBS—drops of whole blood collected on filter paper from a simple and inexpensive finger 
prick—proposed in this study provide a minimally invasive, low cost, feasible and more 
generalizable method81 for measuring biomarkers in the context of a remotely-delivered 
PA intervention with a nationwide sample of BCS. Thus, findings will be more 
generalizable than other PA studies incorporating biomarkers in BCS.       
 
Research Team. The PI, Dr. Phillips, has extensive experience designing and conducting 
similar physical activity studies in older adults and breast cancer survivors. The co-
investigators are nationally and internationally recognized experts in cancer survivorship 
(Penedo, Cella), behavioral interventions (Spring, Ackermann, Penedo), mHealth 
(Spring), fractional factorial designs/methodology (Spring), and D&I sciences 
(Ackermann).  
2.2 Preliminary data. 
Evidence for the use of SCT.  The PI’s dissertation used a 6 month prospective study 
design to test whether the SCT model using the structural pathways proposed by 
Bandura35 explained changes in PA in a nationwide sample of breast cancer survivors. 
Results from this study indicated SCT explained 41% and 49% of the variance in PA at 
baseline and follow-up, respectively.15 Self-efficacy was the strongest predictor of PA and 
these effects were both direct, and indirect, via social support, goals and outcome 
expectations.15 Findings were largely consistent among changes in constructs over the 6 
month period and when using accelerometry to measure PA.  
Feasibility of recruitment and assessment via Army of Women©. The PI’s dissertation 
also supports the feasibility of recruiting breast cancer survivors via the Army of Women© 
and completion of the same, or similar, assessments to those in the present study. Within 
12 hours of recruitment initiation for this study, 2,500 women expressed interested in 
participating and recruitment was halted due to capacity limitations. Of that   number, 
1,631 (64%) responded to screening and qualified to participate. I randomized 500 of 
those women to wear accelerometers for 7 consecutive days. Only 4 refused to wear the 
device.  At baseline and follow-up, 1,527 women (94%) completed more than half of the 
on-line questionnaires. Valid accelerometer data were obtained from 442 (89%) women 
at baseline; 370 (83.7%) of those women also had valid data at 6 month follow-up. 

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Physical Activity Intervention for Breast Cancer Survivors (Fit2Thrive) 
 
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Reasons for missing accelerometer data at baseline and follow-up, respectively, were: 
did not wear (n=36 and n=40), insufficient valid wear time (n=8 and n=17), accelerometer 
malfunctioned (n=5 at both), lost in mail or by participant (n=4 and n=5) and submerged 
in water (n=1).  
Feasibility of mHealth intervention. Data from Pew82 indicate that, as of January 2014, 
58% of Americans own smartphones and 42% own tablet computers suggesting that a 
large proportion of breast cancers likely own this technology. Since we are recruiting from 
the Army of Women© which communicates via e-blasts, we expect these women to be 
relatively tech savvy and interested in mHealth interventions.  
DBS are valid for proposed biomarkers. In studies using self-collection of DBS, ≥90% 
of participant samples83,84 have been adequate for analyses indicating this is a highly 
feasible method for DBS collection. Dr. Funk’s has rigorously tested the performance 
parameters of the proposed immunoassay 
protocol for IL-6, IL-10 and TNFα to 
determine the limit of detection [range: 0.3 
pg/mL (IL-6) to 1.25 pg/mL (TNFα)], and 
assay linearity [range: 99.0% (IL6) to 113% 
(IL10)]. Levels of within-assay precision and 
between assay variation are displayed in 
Table 1. Performance parameters of the 
proposed 
CRP 
immunoassay 
by 
the 
Laboratory for Human Biology Research (LHBR) have also been rigorously evaluated to 
determine the limit of detection (0.03 mg/l), within- (95.9%) and between- (109%) assay 
variance and assay linearity (95.4%-109% of expected). The relationship between DBS 
and matched-serum CRP levels is strong and linear (R= 0.96). The University of 
Washington Department of Laboratory Medicine (UWLM), who will quantify 
cardiometabolic biomarkers, found high correlations between TG (R = 0.97) and BG (R= 
0.90) in matched DBS and plasma samples. However, correlations between matched 
DBS and serum samples for HDL-C (R=0.55) and TC (R=0.58)  were less optimal85 which 
was unexpected, given higher correlations were observed in comparisons using samples 
analyzed under controlled laboratory conditions. The reason for this discrepancy is 
unclear, but new assay standards are developed and these relationships are being re-
established.  
Summary. Our preliminary work provides evidence for the use of SCT to guide 
intervention design and demonstrates the feasibility of enrolling/retaining and assessing 
participants using Army of Women©.  National smartphone usage data suggest the 
acceptability of a mHealth PA intervention. 
2.3 Significance and Innovation 
The proposed study is significant because it represents the first systematic effort to use 
optimization methodology to design a theoretically-guided mHealth PA intervention for 
breast cancer survivors with D&I in mind from the outset. Ultimately, this work will 
significantly contribute to our understanding of how to effectively increase and maintain 
PA to improve health and disease outcomes in breast cancer survivors.  
Table 1. Assay Precision of DBS 
Assay 
High CV 
Med CV 
Low CV 
Within-assay precision 
IL-6  
8.98 
9.73 
9.34 
IL-10 
10.91 
12.92 
14.85 
TNF-α  
6.78 
8.47 
21.49 
Between-assay variation 
IL-6  
4.34 
8.51 
3.41 
IL-10 
5.41 
13.85 
7.89 
TNF-α  
7.56 
3.65 
2.62 

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Methodological Innovation: MOST to Design with D&I in mind from the Start. 
Intervention development typically consists of designing an intervention with multiple 
components and then testing whether the intervention, as a whole, has a significant effect 
in randomized clinical trials (RCT).86  However, information about which intervention 
components contribute to the desired effect and which do not is necessary to continue to 
increase intervention effectiveness and efficiency. Because all intervention components 
are turned “On” in the treatment group and “Off” in the control group in a typical RCT, this 
information cannot be obtained. The Multiphase Optimization Strategy (MOST)25,87 is a 
comprehensive framework that supports  optimizing an intervention by efficiently and 
systematically identifying the most promising intervention components and component 
levels.  MOST is based on is based on the engineering principles of resource 
management and continuous optimization. The overall goal of MOST is to maximize 
public health impact (efficacy x intervention reach) using available resources. MOST is 
an emerging methodology that may be particularly useful for designing mHealth 
interventions with D&I in mind from the start because of its emphasis on optimization, an 
iterative design process and public health impact.20,88 Figure 3 describes how we plan to 
use MOST to design an optimized PA intervention for breast cancer survivors. MOST, 
like all theory-based approaches to intervention development, starts by using theory, 
scientific literature, clinical experience, and results from previous studies to establish a 
conceptual model (Step 1a). Based on prior work, we am proposing to use SCT for this 
study. We will complete steps 1b to 3b as part of the proposed project. Step 1b will involve 
further refinement of the model/component selection to inform Step 2, intervention/app 
design and usability testing. These steps will be performed in collaboration with relevant 
stakeholders (cancer survivors, clinicians, research experts). Step 3a will pilot test the 
feasibility, acceptability, and effects on PA and important patient reported outcomes 
(PROs) of each of the intervention components and component combinations. Step 3b 
involves collection of participant feedback and evaluation of the intervention components 
and combinations. The present study will provide the necessary preliminary data to apply 
for future grants steps 4a-5. The MOST framework has rarely been applied to the 
development of behavioral interventions, and to the best of our knowledge, has never 
been specifically applied to the development of a PA intervention in cancer survivors.   

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Conceptual and Technological Innovation. Existing evidence indicates that:  (a) home-
based interventions can effectively increase PA among breast cancer survivors5 and (b) 
mHealth supported interventions are effective for increasing PA.89-91 However, to the best 
of our knowledge, there have been no tests of mHealth supported PA interventions in 
breast cancer survivors. As cellphones are becoming ubiquitous,82 they may offer a cost-
effective tool to change and maintain PA behavior in a manner that increases intervention 
reach and D&I potential.88,92 Moreover, mHealth interventions allow researchers to collect 
real-time data and provide real-time feedback.  Those capabilities can: a) provide 
additional insight into relationships between PA and PROs, b) increase safety by alerting 
researchers immediately to problems, c) allow better monitoring of intervention adherence 
and d) increase adherence. While many commercially available PA apps exist, the 
majority have not been empirically tested, are not evidence-based, theoretically-guided 
or designed specifically for cancer survivors.93-95 Therefore, the feasibility, acceptability 
and effectiveness of mHealth PA interventions needs to be tested in cancer survivors. 
Selection of mHealth intervention components will be guided by SCT, engage 
stakeholders in development, and incorporate cutting edge technology and functionality 
to determine, not only whether a mHealth intervention is associated with PA change and 
maintenance, but which components maximize these outcomes for the lowest cost.  
3.0 
Inclusion and Exclusion Criteria 
3.1 
Screening for Eligibility  
Figure 3. Steps for Designing with Dissemination in Mind Using MOST 

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This study will have two phases (see Figure 4). Phase 1 (Aim #1) will involve intervention 
development. Phase 2 (Aims #2, #3 and Exploratory) will involve the pilot testing of the 
intervention components to be identified in Aim #1.  
Phase 1 and Phase 2.  For both phases, interested participants will be screened for 
eligibility either via an on-line screening questionnaires or telephone interview. Eligible 
breast cancer survivors will be offered the opportunity to participate and will complete 
informed consent.  
 
Figure 4. Summary of Phase 1 and 2 of Research Protocol 
 
 
 
3.2 
Inclusionary and Exclusionary Criteria 
This study will have two phases (see Figure 3). Phase 1 (Aim #1) will involve intervention 
development. Phase 2 (Aims #2, #3 and Exploratory) will involve the pilot testing of the 
intervention components to be identified in Aim #1.  
Breast Cancer Survivors in Phase 1 and 2. The same inclusionary criteria for breast 
cancer survivors will be used for all phases of the research. However, all women recruited 
into the intervention in Phase 2 will also be required to pass the Physical Activity 
Readiness Questionnaire (PAR-Q)96 (see attached) or receive medical clearance from 
their primary care physician or oncologist. 
Inclusionary Criteria for Breast Cancer Survivors:  
• Women ≥ 18 years of age who were diagnosed with Stage I-III breast cancer within 
the last 5 years 
• Have completed last cancer treatment (adjuvant chemotherapy,  radiation therapy 
or surgery) at least 3 months prior to enrollment 
• English speaking 
• Currently participate in <60 minutes of moderate and vigorous PA/week (Phase 2 
only) 

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• Own a smartphone (For Phase 2 only: iPhone –version 5 or greater or an Android 
–version 5 or greater) 
• Have access to a computer with Internet 
• Participants may be using adjuvant endocrine therapies. 
• Willing to be waitlisted for future wave if current wave reaches capacity (Phase 2 
only)  
Exclusionary Criteria for Breast Cancer Survivors: 
• Women will be excluded if they report any of the following: 
o Respiratory, joint or cardiovascular problems precluding PA 
o Metastatic disease 
o Planned elective surgery during duration of the intervention/follow-up that 
would interfere with participation (e.g., breast reconstructive surgery). 
o ONLY IF PARTICIPATING IN OPTIONAL DBS COLLECTION: 
▪ A prior cardiovascular event (i.e. stroke, myocardial infarction) 
▪ Have been diagnosed with an acute or chronic immune system 
medical conditions, or conditions that impact immune and endocrine 
function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or 
immunosuppressive treatment requiring conditions) 
 
Inclusionary Criteria for Other Stakeholders in Phase 1:  
• English-speaking 
• Have expertise in breast cancer or physical activity OR organization the individual 
works for actively works with breast cancer survivors on a regular basis 
• Own a smartphone 
 
Inclusionary Criteria for “Buddies”: 
• Must be at least 18 years old 
• Have access to a computer and internet 
• Own a smartphone 
• Be willing to receive regular emails from the study team 
• Be willing to wear a Fitbit and transmit Fitbit data to the study team 
• Be willing to “friend” participant in the Fitbit app and provide support and 
encouragement to the participant. 
3.3 
High-risk Subpopulation Inclusion.  
The following subgroups will be excluded from the present study:  
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
 
4.0 
Study-Wide Number of Subjects:  
Phase 1.  We will recruit stakeholders including breast cancer survivors (n=30 for 
interviews; up to 100 for usability testing), experts and clinicians (n=10-15; e.g. 

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oncologists, nurses, experts in D&I, PA and rehabilitation) and representatives (n=10-15) 
from local community organizations (e.g. Gilda’s Club Chicago, the YMCA and American 
Cancer Society Illinois Chapter).  
 
Phase 2.  We plan to accrue a nationwide sample of 256 women to the intervention pilot 
testing phase. Approximately 50% of these will be assigned to the buddy condition. As 
such we will accrue 128 buddies. We anticipate 80% of these “buddies” (n=102) will 
agree to participate in the optional questionnaire assessments. We will recruit up to 35 
participants for the post-intervention interviews.  
 
 
5.0 
Study-Wide Recruitment Methods: 
5.1 
When, where and how potential subjects will be recruited.  
Phase 1. Women will be recruited from the Army of Women (AOW) e-blast.© The AOW is 
an online initiative that connects breast cancer researchers with women who are willing 
to participate in research. The database currently consists of ≥375,000 women. Of these, 
~30% (112,500) self-report a breast cancer history. Women interested in participating in 
the current study will respond to the e-blast consenting to have their contact information 
released by the AOW to study investigators. Their contact information will, then, be 
forwarded to the study investigator who will provide a description of the study and further 
screen for eligibility either via on-line screening questionnaires or telephone interview. 
Eligible breast cancer survivors will be offered the opportunity to participate and will 
complete informed consent.  
 
Community representatives will be recruited in conjunction with NU’s Center for 
Community Health (led by Co-I Dr. Ackermann) via personalized e-mails and phone calls. 
Experts will be recruited through the RHLCCC and the PI’s, co-investigators’ professional 
networks via listservs and personalized e-mails and phone calls.  
 
Phase 2. Breast cancer survivors will be recruited through an e-blast sent to members of 
the Army of Women©, an online initiative that connects breast cancer researchers with 
women who are willing to participate in research. The database currently consists of 
≥375,000 women and men. Of these, ~30% (112,500) self-report a breast cancer history. 
Women interested in participating in the current study will respond to the e-blast.  Their 
contact information will be forwarded to the study investigator who will provide a 
description of the study and further screen for eligibility either via on-line screening 
questionnaires or telephone interview. Eligible breast cancer survivors will be offered the 
opportunity to participate and will complete informed consent.  
 
If our recruitment goals are not being sufficiently met via the Army of Women© we will also 
post study fliers and advertisements on social media sites (i.e. Facebook, 
PatientsLikeMe) and on-line forums (i.e. Sisters Network, Nueva Vida, Living Beyond 
Breast Cancer). In addition we will send recruitment emails to all women from previous 
studies who consented to being contacted regarding future study opportunities. All 
women who are recruited through these alternative strategies will be instructed to contact 

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the study staff who will provide a description of the study and further screen for eligibility 
either via on-line screening questionnaires or telephone interview.  Eligible breast cancer 
survivors will be offered the opportunity to participate and will complete informed consent. 
 
• Buddy recruitment: Breast cancer survivors assigned to the Buddy component, 
will be asked to contact their buddy and provide the study team with the name 
and email address of their chosen buddy. The buddy will then be emailed a brief 
description of the study and a link to the on-line buddy screening RedCap. 
Interested and eligible buddies will be offered the opportunity to participate and 
will complete informed consent. If a buddy indicates, they are not interested or 
fails to respond after 3 contact attempts, we will ask the participant for a new 
buddy name and email address. 
• Post-intervention interview:  Individuals who participated in the Fit2Thrive 
intervention within the previous 6 months and agreed to hear about future studies 
will be eligible. Women will be invited to participate via email. They will be 
selected for invitation based on adherence to the program and intervention 
component assignment to ensure broad representation. Former participants will 
be contacted up to 3 times to participate after which we will cease contact.  
 
5.2 
Methods used to identify potential subjects.  
Women who meet the following criteria will be included in the present study: a) indicate 
they are interested in the present study, b) meet all eligibility criteria and c) consent to 
participation.  
“Buddies” who meet the following the following criteria will be included in the present 
study: ) indicate they are interested in the present study, b) meet all eligibility criteria 
and c) consent to participation.  
 
5.3 
Recruitment materials.  
All recruitment materials will list study eligibility criteria and requirements, will provide a 
link to the study web-page and will not deviate from the IRB-approved language. The 
posting will also include a phone number and study e-mail address where participants 
can reach staff if they have any general questions regarding study participation.  
 
6.0 
Multi-Site Research: N/A 
 
7.0 
Study Timelines 
7.1 
Duration of an individual subject’s participation 
Phase 1. We will select 30 women to participate in interviews from those interested. We 
anticipate survivor interviews will last 45-60 minutes. We anticipate expert/clinical 
stakeholders and community/advocacy partner interviews will last approximately 30-45 
minutes. Survivors who participate in the app development process (n=100) will 
participate in up to two app development sessions (approximately 1 hour each) and 

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possibly a field testing of the app/intervention components (duration of 5 to 14 days). 
During the field testing, participants, will spend approximately 30-60 minutes interacting 
with the study app each day including entering information and providing real time 
feedback to developers on features they do and do not like. There is a chance 
saturation/consensus will be reached during the field testing before all survivors have had 
a chance to participate. Therefore, some survivors may not participate in the field testing 
and post-field testing app development session.  
Phase 2.  Survivors will participate in a 12 week intervention and a 12 week follow-up for 
a total of 24 weeks. Buddies will provide support to their participant throughout the entire 
24 week period. Women who participate in the post-intervention interview, will participate 
for approximately 30-45 minutes. 
7.2 
 Duration anticipated to enroll all study subjects.  
Table 2 details the full study timeline. Specific details for each phase are as follows:  
 
Phase 1. We anticipate it will take 3 months to recruit/complete initial interviews, 3-6 
months to design/refine and program intervention/app components, and 3 months to 
conduct several field trials with breast cancer survivors (n=100). We have planned 12-18 
months for intervention/app development and will meet bi-weekly with developers to 
ensure sufficient progress towards this goal. 
 
Phase 2. We anticipate it will take 18 to 24 months to recruit and enroll breast cancer 
survivors and buddies into the intervention pilot phase of the trial. We anticipate it will 
take approximately 6 months to enroll all women in the post-intervention interviews. 
Table 2. Study Timeline 
 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Quarter 
 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
App 
Development 
(Phase 1) 
Study Preparation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
App/Component 
Development/Refinement 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
Component 
Piloting 
(Phase 2)  
Recruitment/Baseline Data 
Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Active Intervention Component 
Delivery  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up Period 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analyses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.3 
Estimated date for study completion: June 30, 2020 
 
8.0 
Study Endpoints 
8.1 
Describe the primary and secondary study endpoints. 
Primary study endpoint: intervention feasibility/acceptability.  
Feasibility: This will be measured during the intervention, immediately post-intervention 
and after the follow-up period. Measures include:  
• Intervention reach:  # of participants enrolled/# of eligible individuals 
• Participant retention: # of participants who drop out/# of participants randomized 

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• Intervention Adherence: % of weeks adhered to exercise prescription during 
intervention period 
• Intervention Maintenance: % of weeks adhered to exercise prescription during 
follow-up period 
• Intervention component engagement:  
o During intervention: # of times, on average, participants interacted with each 
intervention component during intervention  
o During follow-up: # of times, on average, participants interacted with each 
intervention component during follow-up 
o Total: # of times, on average, participants interacted with each intervention 
component over intervention and follow-up 
 
Acceptability: This will be measured via a process evaluation immediately post-
intervention at 12 weeks and after the follow-up period at 24 weeks. This evaluation will 
assess the following:  
• Perceived effectiveness of intervention components/app; use of app/intervention 
materials; plans to continue PA/app use; elements of intervention liked/disliked; 
satisfaction with program delivery, assessments and staff 
 
Secondary study endpoints:  Secondary study endpoints include physical activity (self-
report and objectively measured), social cognitive theory constructs (self-efficacy, 
outcome expectations, social support, physical activity enjoyment),  patient-reported 
outcomes (fatigue, health-related quality of life, cognitive functioning, physical functioning 
and depression) and BC progression and CVD risk biomarkers. Secondary study 
endpoints will be assessed at baseline, post-intervention and at the end of the follow-up 
period. We will also assess covariates including demographic (i.e. marital status, number 
of children, height, body weight, occupation, age, income and education), breast cancer 
characteristics and history (date of diagnosis, type of treatment, length of treatment, 
disease stage, tumor receptor status, recurrence, etc.) and general health history (i.e. 
comorbid conditions, height, weight, fruit and vegetable consumption, smoking history, 
etc.) Covariates will be assessed at baseline.  
8.2 
Describe any primary or secondary safety endpoints: N/A 
9.0 
Procedures Involved* 
9.1 
Study Design.  
Table 3. SCT Construct and Potential Intervention Component to Target   
SCT Construct 
Potential Intervention Component to Be Turned “On/Off” 
Self-efficacy 
(1 component) 
-Daily feedback on PA accomplishments 
-Weekly motivational stories about similar survivors  
-Support for interpreting physiological responses (i.e. heart 
rate, muscle soreness) to PA 
-Messages with weekly PA tasks to master  
Outcome 
Expectations 
(1 component) 
-Text messages providing information on expected progress 
-Weekly collection/feedback on outcome of interest (e.g. 
mood) 
Goal-setting  
(1 component) 
-Daily PA tracking using a FitBit  
-Weekly goal-setting prompts/feedback on progress 
-Prompts to schedule PA for the day  

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 Phase 1. This portion of the 
study will consist of interviews 
and 
app/ 
intervention/ 
development. Initial interviews 
with breast cancer survivors, 
experts and community partners will be conducted before app development begins. The 
purpose of these sessions will be to obtain stakeholders’ perceptions of the intervention/ 
app components proposed in Table 3, identify new potential components and decide on 
5 components to test.  Survivors will also be selected to participate in a stakeholder 
advisory board session to inform decisions related to Phase 2 of the study. We have 
attached guides for the initial interviews. At the end of the interviews subject will also be 
asked if they are interested in participating in the advisory board (survivors). Phase 2.  
Following Phase 1, we will conduct a pilot experimental test of all components to evaluate 
their feasibility and accessibility (Aim 2) and preliminary effect on PA (Aim 3) and PROs 
(Exploratory Aim) at 12 weeks and 24 week follow-up in a sample of 256 breast cancer 
survivors using a MOST design (See Table 6).   
 
9.2 
 Research Procedures  
Phase 1 
We 
will 
engage 
survivors 
in 
developing and tailoring system 
components to fit their needs 
employing 
three 
user-centered 
design principles: 1) Focus on Users 
and Tasks, 2) Measure Usability 
Empirically and Design and 3) Test 
Usability 
Iteratively.97 
Similar 
procedures have been followed as 
part of app development for Dr. 
Spring’s existing, effective mHealth 
interventions. 
Additionally, 
since 
similar components 
have 
been 
developed/used 
in 
interventions 
conducted by Dr. Spring’s research 
team, the development process will 
consist largely of tailoring/refining 
these components for the present 
study.  
 
Assessments 
Interviews: 
We 
are 
currently 
conducting an online needs assessment that will inform this study. To further inform our 
design, we will conduct interviews with stakeholders (survivors, experts, community 
partners) to inform the development of intervention components that are grounded in 
SCT. Expert/community partners’ interviews will take place in-person on Northwestern’s 
Chicago campus whenever possible. However, we anticipate that the clinical/research 
Facilitators/ 
Barriers  
(2 component) 
-Choose exercise “buddy” to participate in intervention with  
-Daily tracking of facilitators/barriers 
-Group or individual competitions or games  
-Message boards for between-participant communication 
-Problem solving support calls 
-“On demand” motivational messages 
-Virtual, on-line gym membership 
Table 4. Usability Measures 
Factor 
Objective Measures Subjective Measures 
 
Users’ rating of… 
Learnability: ease with 
which use of device is 
earned so users can 
rapidly accomplish 
intended tasks 
Time taken for users 
to learn to accomplish 
intended tasks 
Ease and time to learn 
system 
Effectiveness: 
usefulness for supporting 
intended tasks 
Successful 
performance of 
intended task (y/n)  
System’s ability to 
promote performance 
and productivity 
Efficiency: productivity 
once users have learned 
the system 
Time to accomplish 
tasks once have 
learned system 
System’s ability to 
improve speed at which 
they perform 
Errors: low frequency, 
severity of errors and 
easy recovery 
Error rates trying to 
use system; severity 
of errors; recovery 
time for errors 
Impact of errors on 
using system and ability 
to recover from errors 
Flexibility: variety of 
ways to achieve intended 
tasks 
Number of different 
command or routed to 
achieve same goal 
System’s ability to 
provide different 
command or routes to 
achieve same goal 
Memorability: ease with 
which casual users can 
return to the system  
without having to relearn 
Memory failure rate 
on how to use system 
next time; time to re-
learn system after 
periods of non-use 
Ability to remember 
how to use system next 
time and ability to re-
learn system after 
periods of non-use 
User Satisfaction: 
pleasant for users 
Frequency for 
utilization of the 
system and its 
features 
Fondness, perceptions 
and opinion of system 
and its features 

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partners’ and community/advocacy partners’ interviews may be hard to arrange so these 
sessions may occur via the telephone or web (i.e. Skype), at the partner’s workplace or 
at some other public location (i.e. library, coffee house). Breast cancer survivors’ 
interviews will be completed via telephone. Because we anticipate interest will be greater 
than capacity, we will select 30 women of the up to 100 women recruited for interviews. 
All stakeholders will complete informed consent on-line. Interviews will provide input and 
feedback on desired intervention components as well as components identified in Table 
3. Stakeholders will provide insight into implementation of physical activity programs 
within their setting and feedback the perceived usefulness of these components, identify 
potential alternative components, and aid in tailoring intervention content to their needs. 
survivors to participate in a stakeholder advisory board session to further vet intervention 
components.. Community and expert stakeholders will also be provided with a study 
information sheet at the end of their interview for their reference. The interview will take 
45-60 minutes for community partners/experts and 30-45 minutes for survivors.  
 
 App Development Session 1:  Following completion of the interviews with the survivor 
subgroup, all survivors will be invited to participate in the first app development session 
which will be a two-part on-line survey. The first part will ask survivors to provide feedback 
on their preferences and opinions for app features. The second part will present 
wireframes of potential components and solicit input on their perceived usefulness and 
effectiveness. All women (n=100) will participate in this session. Both parts of the session 
will take up to 60 minutes to complete. We will use these data to work with programmers 
and breast cancer survivors in an iterative manner to create a minimally viable test version 
of the intervention components. All components selected for testing will meet the following 
criteria: a) hypothesized to target one primary SCT construct and enhance PA adherence 
via pathways detailed in Figure 1; b) have a clear relative advantage in terms of influence 
on PA and cost/burden and c) are approved by stakeholders. Participants will be sent an 
initial e-mail with a link to the survey and up to 3 additional reminder e-mails to complete 
the survey.  
 
Breast Cancer Survivor Stakeholder Advisory Board Session : Survivors will be sent an 
email asking them to participate in a conference call to go over an executive summary of 
findings from the interviews and App Development Session 1. This session will ask 
survivors their opinions on the proposed app and intervention components (see attached 
guide). The conference call will be audio recorded and then be used to reach consensus 
before proceeding with initial development of the app prototype.  
 
Field Test:  Survivors (n=100) will participate in an app field test. They will be assigned in 
waves of up to 20 women to use the intervention components for up to 2 weeks. During 
the field test, survivors will provide feedback to developers in real time when they are 
using the app regarding features they do and do not like and app functionality. At the end 
of each wave, the research team and developers will ask participants to complete an on-
line survey and participate in a telephone or web-based session to solicit feedback on the 
usability components identified in Table 4. Based on these data, the intervention 
components will be tweaked. The new iteration of the intervention components will be 
tested by the next wave using the same procedures until all participants have tested it, or 

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we have reached saturation (n=up to 100). Thus, all survivors may not participate in this 
session. The purposes of this field study is NOT to test how well it works to increase PA, 
but rather to evaluate the app’s functioning and ease of use in everyday life. Participants 
will be explicitly instructed NOT to change their usual physical activity patterns as part of 
this field test. They may be asked to enter some data on your behaviors, motivation and 
symptoms to test functionality of these components. However, participants will be 
explicitly instruct that these data do not necessarily need to reflect their true ratings. These 
data will not be used for any purposes other than to test the functioning of the app. 
Participants will spend approximately 15-60 minutes interacting with the app each day 
during the field test which will include providing any feedback to developers in real-time, 
as they use the app, regarding features you do and do not like and functionality. Prior to 
the initiation of field testing participants will be sent an update e-mail and asked to indicate 
whether they own a Fitbit and how tech savvy they are so this information can be taken 
into account when reviewing their responses.   
 
App Development Session 2:  Immediately after completing the field test, survivors will 
be asked to complete an on-line survey and/or attend a telephone or web-based session 
to provide feedback on the intervention features they liked and disliked and any ideas 
they have on what could be changed and/or improved. Depending on the ability to 
schedule survivors this may be individual or involve up to 20 other survivors. This session 
will last up to 60 minutes.  
• Wave 1 (n=10)  and Wave 3 (n=10-20) of Field Testing and App Development 
Session 2:  
o For the field test: Participants will be sent an email notifying them they have 
been selected and asking them to download and use the test version of the 
app for a minimum of 3 days over the course of a 7-10 days. Participants 
will be provided with instructions on how to download the app and provide 
feedback to the study team in real-time.  
o For App Development Session 2: At the end of that period, participants will 
be sent the app post-field test survey and asked to complete it.  
o Participants will be sent up to 3 reminders for each of the following tasks: 
using and providing feedback on the app and completion of the field test 
survey.   
• Wave 2 of Field Testing (n=10-15) and App Development Session 2:  
o For the field test: Participants will be sent an email notifying them they have 
been selected and asking them to complete the App Notification Field Test 
Survey. Participants will be sent up to 3 reminders to complete the survey.  
o For App Development Session 2: Wave 2 participants will not complete this 
since they are not using the app.  
 
Women will be contacted to schedule participation in each session via phone or e-mail.  
 
Because the design process is iterative and the content of each session is dependent 
on prior sessions, materials for each session will be submitted to the IRB as they are 
developed.  
 

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Retention Strategies.  In order to enhance subject retention we will 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.  
 
Monitoring subjects for safety for Phase 1 
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. For 
participants who engage in interviews, it will be made clear that all of their comments will 
be kept confidential and de-identified. They will also be instructed that they do not have 
to answer any questions that make them uncomfortable and that they can withdraw from 
the study at any points. For breast cancer survivors who will engage in intervention/app 
development and will be directly observed performing tasks and answer questionnaires, 
the same procedures as detailed, below for Phase 2 will be followed.   
  
Phase 2 
An overview of the flow of participants through the study is provided in Figure 5.  
 
Screening 
Women who express an interest in participating in the Fit2Thrive intervention via the Army 
of Women© will be sent an email with a brief study description and eligibility criteria. This 
email will also contain a link to the on-line (RedCap) Screening. The first part of the 
screening will provide an in-depth overview of the study. After viewing these materials, 
potential participants will first confirm interest in research participation and proceed to 
complete screening questions assessing for eligibility criteria (e.g., demographics, cancer 
diagnosis, age). After an individual passes the initial screening, they will automatically be 
redirected to complete the Physical Activity Readiness  
Questionnaire (PAR-Q).96 Once completed, they will provide detailed contact information 
and scheduling availability. Scored PAR-Q responses will be reviewed to determine if 
physician approval is required prior to participation. Those who require approval will be 
flagged for follow-up. 
• If not ineligible:  Participants will be thanked for their interest and directed to on-
line resources for physical activity and nutrition for cancer survivors.  
• If eligible: Participants will be receive a study orientation call. Prior to this call, 
they will be sent a copy of the informed consent and a study overview handout.  
• Attempts to contact: Study staff will make up to three email attempts to reach 
potential participants to complete the web screening. If unable to reach after the 
third attempt, study staff will mark the individual as “ineligible,” with the reason as 
“unable to contact.” 
 
Recruitment Phone Call  
Because participants will be recruited from all over the country, the orientation session 
will occur remotely via a telephone call. Prior to the call, study staff will email participants 
a copy of the informed consent and a study overview. During the call, study staff will 

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introduce what is required for study participation and provide instructions for completing 
baseline assessments. If they failed PAR-Q screening, they will also be instructed that 
they will need to obtain physician consent prior to participation. This session will take 
approximately 10-15 minutes.  
• If still interested: Participants will be 
sent a link to the on-line consent form. If 
they failed PAR-Q screening, they will 
also be sent a link to a RedCap form to 
consent to allowing study staff to contact 
their physician and provide physician 
contact information.   
• If no longer interested:  They will be 
thanked and asked if they would be 
willing to be contacted regarding future 
study opportunities.  
• Attempts to contact:  
o Study staff will make up to three 
call attempts to reach potential 
participants for the orientation call. 
If they are not reached at this point, 
staff will follow-up with one last call 
and email.  
o Study staff will make up to three e-
mail attempts to reach potential 
participants 
to 
complete 
the 
informed consent. If unable to 
reach after the third attempt, study 
staff will call the participant and 
send one final email. Those who 
we are unable to reach after these 
attempts 
will 
be 
marked 
as 
“ineligible,” with the reason as 
“unable to contact.” 
 
Assessments 
After completion of informed consent, women will 
be e-mailed baseline study questionnaires via 
RedCap and notification that their accelerometer 
packet has been placed in the mail. The 
accelerometer 
packet 
includes: 
accelerometer, 
accelerometer 
instructions, 
accelerometer log, printed copy of the informed consent, a self-addressed stamped return 
envelope to return the accelerometer. Questionnaires will take approximately 30-45 
minutes to complete and participants will be asked to complete the on-line study 
questionnaires within 10 days of receipt. They will be asked to wear the accelerometer 
for 7 consecutive days starting on the day indicated on the log and mail it back to study 
investigators at the end of the 7 days period.  
Figure 5. Participant Flow Through Study  

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Women will also have the option to participate in the self-collection of a 2.5 mL blood 
sample to be collected by pricking their finger with a retractable lancet and placing 5, 50 
µL spots of blood on a sample collection card.  They will be mailed all materials needed 
to collect the blood spot (i.e. lancet, alcohol swab, band-aid) and written instructions with 
pictures for collecting and returning the sample as well as a self-addressed stamped 
envelope.  
 
The same procedures will be followed for 12 week post- intervention and 24 week follow-
up data collection.  
 
o Attempts to contact: Reminder calls or emails will be conducted if 
questionnaires and/or accelerometers are not received within the specified 
time period until the activity monitor is returned. Reminders for 
questionnaires will cease after the activity monitor is returned unless the 
participant has received less than 3 email reminders and one phone/email 
reminder. In these cases, the participant will be contacted via email 3 times 
and also receive one final attempt via phone and email.      
 
Randomization 
Participants will be randomized after they have completed all baseline assessments using 
a computer-generated minimization allocation method to ensure balance in treatment 
groups.  
 
Participants will not be informed they are being randomized. Instead, they will simply be 
told about the core intervention and the potential to have other intervention strategies. 
We have decided not to disclose randomization for the following reasons: a) being 
randomized does not influence study risk, b) all participants receive the core intervention 
at a minimum and c) we hope to minimize attrition. Additionally, this will help to streamline 
the study description and, hopefully, prevent any confusion regarding the study design.  
 
Study Packet Mailing 
Participants will be sent an email informing them their study packet has been placed in 
the mail and  a study team member will be calling them shortly. If they are assigned to 
the buddy condition, this email will include a link to complete the Buddy Selection Survey, 
and they will be provided with a recruitment email to forward to their buddy.  
 
The study packet will containing the Fitbit and paper instructions for downloading the 
study app, setting up the Fitbit and for using all components to which they are assigned.  
 
Ideally, they will receive the packet prior to the study overview call, but this will not always 
be the case. If timing does not allow for this, we will email the instructions to participants 
prior to the overview call.   
 
Study Orientation Phone Call  

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Study staff will call all study participants to go over in greater detail the strategies to which 
they have been assigned. This call should take approximately 10-15 minutes.  
 
Intervention Launch Reminder/Tech Check-In  
Participants will be sent an email reminder that the intervention is launching 7-10 days 
prior to the study start date and will be reminded to contact study staff if they are having 
any technical difficulties. They will also be called or emailed reminders if they have not 
downloaded the app prior to the intervention start date or used the app on Day 1 or Day 
2 of the intervention.  
 
Intervention Components 
CORE intervention. The CORE will be delivered to all participants to build essential 
competencies needed to increase physical activity safely. The CORE will include the 
following:  
• 
Educational website: This will provide participants with information and  knowledge 
about the benefits for physical activity, safely progressing through an exercise 
program and strategies for effectively changing and maintaining physical activity 
behavior (i.e. social support, goal-setting). This site will be available as a 
standalone site and embedded within the app.  
• 
Basic smartphone app: Features of this app include, but are not limited to, the 
ability to monitor and track physical activity, pre-specified weekly physical activity 
goals and feedback on progress.  
• 
Fitbit: Participants will be instructed to wear the device on the provided belt clip or 
wristband during all waking hours every day of the study to assist in monitoring 
and tracking physical activity. The Fitbit will communicate with the app so data are 
integrated.  
Participants will also be randomized to receive the following components:  
1. App+: Participants assigned to this component will receive a “deluxe” version of 
the app.  This will include all of the features of the basic app plus additional app 
modules listed below.  
a. Weekly Goal-Setting Tool: Allows to schedule activities for specific days of 
the week and set reminders for these activities.  
b. Challenges: Provides weekly challenges (i.e. 5,000 steps/day challenge; 5 
min MVPA/day) participants can enroll in and automatically tracks progress. 
Progressively harder challenges become “unlocked” as participants 
complete less intense challenges.  
c. Newsfeed: Space where study staff will post content including, but not 
limited to, Fit Studies (lay summaries of physical activity research), Fit 
Survivor Spotlights (stories about women who have successfully changed 
their behavior), Workout Ideas and other motivational content.   
 
2. Telephone Support Calls. Participants assigned to this component will receive a 
call from study staff to check-on on their progress, provide motivation and 
troubleshoot any issues they may have. These calls will occur bi-weekly (6 total)  
during the initial 12 week intervention period. All calls will be recorded for quality 
control.  

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3. “On-line” Exercise Classes: Participants assigned to this condition will receive 
access to a digital download for a commercially available walking DVD and 
suggestions for weekly workouts from the same instructor’s YouTube channel on 
a private study YouTube playlist that will only be accessible to individuals assigned 
to this component of the intervention. These videos will be vetted by the research 
team for safety and appropriateness prior to posting. Participants will also receive 
a weekly survey to indicate how frequently they used this component.  
 
4. Fitbit “Buddy”: Participants assigned to this condition will select a “buddy” from 
their personal life (friend, co-worker, child, spouse, sibling, etc.) to help support 
them. The buddy will be mailed a Fitbit. Both the participant and “buddy” will 
receive training materials on how to make the most out of their relationship which 
will include how to use the social features of the Fitbit app, how to seek support 
(participant) and provide support (buddy), and receive bi-weekly emails (6 total) 
during the initial 12 week intervention period geared towards facilitating social 
support. Participants will also receive a weekly survey to indicate how frequently 
they used this component.  
a. All buddies will receive an email from the participant explaining the study, 
complete pre-screening and undergo an on-line consent.  
i. Buddies will be required to complete the PAR-Q and will be required 
to get physician consent if they fail.  
b. Buddy Involvement: As a “buddy” individuals will be asked to agree to the 
following:  
i. Complete on-line informed consent 
ii. Regularly wear the Fitbit 
iii. “Friend” the study participant on the Fitbit app 
iv. Share their Fitbit data with study investigators 
1. Fitbit study accounts for each individual buddy will be created 
by study staff to streamline the process of obtaining the 
buddy’s Fitbit data. Each buddy will be asked to use the Fitbit 
account and password provided during their duration of 
participation in the Fit2Thrive Study.  
2. To fully protect confidentially, we will provide a study email 
address that will not include any personally identifying 
information to be used with the Fitbit app (i.e. F2Tbx100 and 
F2Tbx100@gmail.com). 
3. The RedCap study database is the only place where the 
identification number, the participant’s name, Fitbit email and 
Fitbit username will appear together and will only be 
accessible by the investigators and used for study tracking 
purposes 
4. Since participants will be allowed to keep the Fitbit device at 
the conclusion of data collection, all participants will also be 
instructed on how to change their Fitbit email and username 
at the conclusion of the study.  
v. Provide support to the study participant 

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vi. Complete optional on-line surveys at baseline, 12 weeks and 24 
week follow-up.  
5. Text messages: Participants in this component will receive regular messages that 
are motivational and target SCT constructs (i.e. “The best way to stay on top of 
your game is by scheduling your plans! Do that here and make things easier!” ; 
“Exercise not only contributes to a healthier lifestyle, but it has also been shown to 
boost productivity and creativity. Be strong, think smart!”) and provide feedback on 
intervention progress (i.e.” You only met y% of your goal last week. It can be hard 
to fit exercise into your schedule, but remember every minute counts!”).   
 
Follow-up 
At the end of 12 weeks, participants will be encouraged to maintain PA and will have 
access to all “automated” intervention materials for the condition assigned. However, all 
regular contact from the study staff will discontinue.  
 
Retention Plan 
To prevent attrition, study staff will develop good rapport with participants during 
recruitment and maintain the relationship throughout the study. Participants will be 
provided with a phone number to call immediately if they encounter any tech issues with 
the application or Fitbit. Staff will convey reminders of scheduled assessments by phone 
or email. Participants will also be incentivized $20 to complete baseline, 12 week and 24 
week assessments for a total of $60, and will be allowed to keep the Fitbit if they complete 
the 12 week intervention. Individuals who participate in the optional blood sample 
collection will be paid $15.00 at each time point ($45.00 total) upon receipt of their blood 
sample.   
 
Additionally, in order to enhance subject retention we will 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).  
 
If a participant does not track any activity via the app or Fitbit for 7 consecutive days, 
study staff will reach out to the participant via phone and/or e-mail. 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. 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 an 
active participant after 3 phone call or e-mail attempts and a final email attempt, or in the 
event of an emergency. After these initial attempts, we will attempt to contact the 
participant’s designated emergency/locator contact. 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.  

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Post-Intervention Interviews 
Approximately 35 women will be selected to complete a post-intervention email. All 
women who have agreed to be contacted regarding future studies and have completed 
the program within 6 months will be eligible. Participants will be invited based on 
adherence level and components assignment to ensure equal distribution across these 
variables. Women will be invited via email. Interested women will complete on-line 
informed consent. Once they have consented, a study team member will follow-up to 
schedule an interview. Interviews will be conducted via phone or web, depending on 
preference and will take approximately 30-45 minutes to complete.  
 
 
Monitoring subjects for safety for Phase 2 
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 8 weeks throughout the 24 week study 
period. Breast cancer survivors 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 breast cancer survivor participants and will 
query the participant as to whether they have had any health and/or medical problems 
during the preceding 8 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. The non-spontaneous Adverse Events 
Questionnaire will not be given to buddies of BCS participants to complete since they are 
not being specifically asked or encouraged to increase their physical activity participaiton. 
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 

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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. 
 
9.3 
Procedures performed to lessen the probability or magnitude of 
risks.  
Phase 1. All participants will be informed during screening and in their informed consent 
with respect to how much time interviews, and/or app development will involve. All 
interviews and telephone/web-based app development sessions and interviews will be 
digitally recorded when possible; digital files will be stored on a password-secured 
network drive. Recordings will be transcribed verbatim and de-identified. Recordings will 
be destroyed at the end of the study. For intervention development, each participant will 
be randomly assigned an identification number to ensure confidentiality of data. All raw 
data will be de-identified and kept confidential. 
Although, the purpose of this field test is NOT to test how well it works to increase 
physical activity, but rather to evaluate the app’s functioning and ease of use in everyday 
life and participants will be explicitly told NOT to change their PA behavior and that the 
data they enter does not have to be accurate, we do recognize that some individuals 
may still attempt to increase their PA and to accurately respond to questions/prompts. 
Thus, we will follow the same procedures detailed, below, for Phase 2.  
 Electronic versions of all data will be kept on a password protected network with access 
limited to study investigators. Only the investigators will have access to participant data. 
Confidentially will be further maintained by reporting only group level data in study 
publications and presentations. All staff with access to the data with have completed 

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Northwestern University requirements for the responsible conduct of research including 
the Collaborative Institutional Training Initiative (CITI) Training Modules.     
Phase 2. All participants will be informed during screening and in their informed consent 
with respect to how much time the program, questionnaire completion, and all testing will 
involve. In addition, they will also be informed of the risks associated with participating 
in an exercise program. Survivors and buddies will be informed that participation is 
completely voluntary and they can discontinue at any point. They will also be provided 
with the option “I prefer not to answer” for every question in the study so they can opt-
out of answering any questions for which they do not want to share responses or which 
make them uncomfortable.  
Breast cancer survivors will be provided with an exercise prescription to progress safely 
through the program to minimize risk (see Table 5). All participants will be able to contact 
study investigators at any point by phone, e-mail or messaging through the app should 
they have any concerns regarding participation.  
 Each participant will be randomly assigned an identification number to ensure 
confidentiality of data. RedCap does require an e-mail address to send the patient 
reported outcome measure links to participants and 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 when questionnaire data 
is downloaded and this data will then only be linked to the participant’s identification 
number. Nitro Study Tracker, NOTIS and the study RedCap tracking database are the 
only places where the identification number and the participant’s name will appear 
together in the present study and will only be accessible by the investigators. 
For post-intervention interviews, all participants will be informed during screening and in 
their informed consent with respect to how much time interviews will involve. All 
interviews will be digitally recorded when possible; digital files will be stored on a 
password-secured network drive. Recordings will be transcribed verbatim and de-
identified. Recordings will be destroyed at the end of the study.  
Table 5. Fit2Thrive Exercise Prescription 
 
Week 
Weekly Goal 
(Mins) 
# Sessions 
Per Week  
Session 
Duration (Mins) 
Session 
RPE 
Session Target Heart Rate  
 (% Max HR) 
1 
30  
2-3 
10-15 
10-12 
50-60%  
2 
45  
2-3 
15-20 
10-12 
50-60%  
3 
60 
3 
20 
10-12 
50-60%  
4 
75 
3 
25 
10-12 
50-60%  
5 
90  
3 
30 
10-12 
50-60%  
6 
105  
3 
35 
10-12 
50-60%  
7 
120  
3-4 
30-40 
10-12 
50-60%  
8 
135  
3-4 
30-45 
13-15 
60-75% 
9 
150+  
3-5 
30-60 
13-15 
60-75%  
10 
150+   
3-5 
30-60 
13-15 
60-75%  
11 
150+  
3-5 
30-60 
13-15 
60-75%  
12 
150+  
3-5 
30-60 
13-15 
60-75%  
13-24 
150+  
3-5 
30-60 
13-15 
60-75%  
RPE= Rating of Perceived Exertions; HR= Heart Rate 

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All raw data will be de-identified and kept confidential. Electronic versions of all data will 
be kept on a password protected network with access limited to study investigators. Only 
the investigators will have access to participant data. Confidentially will be further 
maintained by reporting only group level data in study publications and presentations. 
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.     
9.4 Study Measures.  
A. Phase 1 
Interviews 
• Questions for the interviews are included in the Appendix. Questions will be related to 
their perceptions of specific intervention/app components, recommendations for 
features, changes or enhancements.  
App Development Session 1 Survey 
• This survey asks participants about their preferences and opinions regarding app 
features to assist in app development and design. Participants will also provide 
opinions on images/wireframes of potential app features.  
 
Post-Field Test Survey for Individuals Given the App to Test: 
• Participants will provide information on:  
o Learnability: Ease and time to learn system 
o Effectiveness: System’s ability to promote performance and 
productivity 
o Efficiency: System’s ability to improve speed at which they perform 
o Errors: Impact of errors on using system and ability to recover from 
errors 
o Flexibility: System’s ability to provide different command or routes 
to achieve same goal 
o Memorability: Ability to remember how to use system next time and 
ability to re-learn system after periods of non-use 
o User Satisfaction: Fondness, perceptions and opinion of system 
and its features 
App Notifications Field Test Survey (Wave 2 Field Test) 
• Participants will be asked to rate app notification message content and 
provide any additional feedback for improving messages.  
 
B. Phase 2 
Primary Outcome Measures 
Feasibility: This will be measured during the intervention, immediately post-intervention 
and after the follow-up period. Measures include:  
• Intervention reach:  # of participants enrolled/# of eligible individuals 

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• Participant retention: # of participants who drop out/# of participants randomized 
• Intervention Adherence: % of weeks adhered to exercise prescription during 
intervention period 
• Intervention Maintenance: % of weeks adhered to exercise prescription during 
follow-up period 
• Intervention component engagement:  
o During intervention: # of times, on average, participants interacted with each 
intervention component during intervention  
o During follow-up: # of times, on average, participants interacted with each 
intervention component during follow-up 
o Total: # of times, on average, participants interacted with each intervention 
component over intervention and follow-up 
 
Acceptability: This will be measured via a process evaluation immediately post-
intervention and after the follow-up period. This evaluation will assess the following:  
• perceived effectiveness of intervention components/app; use of app/intervention 
materials; plans to continue PA/app use; elements of intervention liked/disliked; 
satisfaction with program delivery, assessments and staff 
 
Screening  
Physical Activity Readiness Questionnaire (PAR-Q).96 This pre-screening questionnaire 
assesses cardiovascular disease history, symptoms, risk factors and other health issues. 
Women indicating ≥1 positive statements will be required to obtain medical clearance 
from their primary care physician or oncologist. 
 
Other Measures 
All measures will be used for both breast cancer survivor participants and buddies 
unless otherwise indicated. Assessment will be conducted at baseline, 3 weeks 
(survivors only), 12 weeks and 24 weeks.  
 
Mobile Device Proficiency Questionnaire.98 This survey assess both assessing both 
basic and advanced proficiencies related to smartphone and tablet use across eight 
subscales: (a) Mobile Device Basics, (b) Communication, (c) Data and File Storage, (d) 
Internet, (e) Calendar, (f) Entertainment, (g) Privacy, and (h) Troubleshooting and 
Software Management.  
 
Demographics.  Data will be collected on participant’s current age, race, ethnicity, 
employment status, number of children, education, marital status, income, height and 
weight.  
Breast Cancer History. Participants will be asked to indicate their current menopausal 
status and provide details on the prior breast cancer diagnosis including: date of 
diagnosis, stage of disease, treatment type and duration and hormone receptor status. 
Women will be asked to indicate similar data for any cancer recurrences or second 

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cancer diagnoses. This measure will only be used for breast cancer survivor 
participants.  
Health History. Participants will be asked to rate their general, overall health status, 
indicate whether they have been diagnosed with a list of 20 chronic conditions including 
diabetes, heart disease, multiple sclerosis, depression, etc. and provide information of 
other general health behaviors (e.g. smoking, drinking, fruit and vegetable consumption, 
etc.). A slightly different version to capture potential cancer diagnoses will be used 
for buddy participants. 
Godin Leisure Time Exercise Questionnaire (GLTEQ).99 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 0.74.99  Breast cancer 
survivors will also answer a modified version asking them about their PA before 
diagnosis at baseline.  
Actigraph Accelerometer (model wGT3X-BT, Health One Technology, Fort Walton 
Beach, FL). The Actigraph is a valid and reliable objective PA measure.100,101 It is small, 
lightweight, has a rechargeable battery that lasts for up to 25 days and provides no 
feedback to participants. Participants will be instructed to wear the monitor on the non-
dominant hip during all waking hours for 7 consecutive days, except when bathing or 
swimming. Activity data will be collected in one-minute intervals (epochs). Participants 
will record any time the accelerometer was not worn on a log. The ActiLife software will 
be used to derive wear time, identify outliers and summarize daily variables of the 
minute-by-minute data. Non-wear time will be defined as intervals of at least 60 
consecutive minutes of zero counts, with allowance for up to 2 minutes of observations 
of less than 100 counts/min within the non-wear interval.102A valid day of accelerometer 
wear will be defined as ≥10 hours of wear time. Each valid minute of wear time will be 
classified according to intensity (counts/min) using commonly accepted activity count 
cut-points 102,103 as follows: sedentary (<100), light activity (100-759), lifestyle activity 
(760-2019), and MVPA (≥ 2020). This measure will only be used for breast cancer 
survivor participants.  
Sitting Time Questionnaire.104 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, 

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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).104     
PROMIS Applied Cognition-General Concerns Short Form 8a.105 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=0.95.106 
 
PROMIS Physical Function Short Form 20a.105 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=0.95.106  
 
PROMIS Fatigue Short Form 8a.105 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=0.95.106 
 
PROMIS Sleep Disturbance Short Form 8a.105 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=0.95.106 
 
PROMIS Depression Short Form 8a.105 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=0.95.106  
 
PROMIS Sleep-Related Impairment Short Form 8a. 105 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=0.95.106 
Physical Activity Neighborhood Environment Survey.107  Participants are asked to 
indicate the different facilities and features of the area around their home that they could 
walk or bike. The items on this measure have demonstrated test-retest interclass 
correlations ranging from 0.52 to 0.88 and spearman correlations between single items 

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and similar subscales from a more detailed measure were significant and ranged from 
0.27 to 0.81.107  
Exercise Self-efficacy Scale.108 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).108  
Barriers Self-efficacy Scale.108 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).108  
Social Support for Exercise Scale.109 This 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).  109 
Effective Social Support for Physical Activity.110 This scale assesses perceptions of support 
given (for buddy) and received (for BCS). The scale assesses three different types of help or 
support: 1) Help with practical needs, 2) Advice or information, and 3) Emotional support. There 
will be a separate version for Buddies and breast cancer survivor participants assigned 
to the buddy condition only.  
Exercise Goal-setting Scale.111 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). 111 
Multidimensional Outcome Expectations for Exercise Scale.112 This scale will assess 
participants’ social (4 items), self-evaluative (5 items), and physical (6 items) outcome 
expectations for exercise participation 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).112 
Physical Activity Enjoyment Scale.113 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).113 

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Table 6. Schedule of Measures  
 
Screening  Baseline 
3 
weeks 
12 
weeks 
24 
weeks 
Physical Activity Readiness 
Questionnaire  
X 
 
 
 
 
Mobile Device Proficiency 
Questionnaire  
 
X 
 
 
 
Demographics 
 
X 
 
 
 
Breast Cancer History  
 
X 
 
X 
X 
Health History  
 
X 
 
X 
X 
Actigraph Accelerometer 
 
X 
 
X 
X 
Godin Leisure Time Exercise 
Questionnaire-Current  
 
X 
X 
X 
X 
Godin Leisure Time Exercise 
Questionnaire-Before 
diagnosis 
 
X 
 
 
 
Sitting Time Questionnaire  
 
X 
 
X 
X 
PROMIS Physical Function 
Short Form 20a 
 
X 
 
X 
X 
PROMIS Fatigue Short Form 
8a 
 
X 
 
X 
X 
PROMIS Depression Short 
Form 8a 
 
X 
 
X 
X 
PROMIS Anxiety Short Form 
8a 
 
X 
 
X 
X 
PROMIS Emotional Support 
Short Form 8a 
 
X 
 
X 
X 
PROMIS Sleep Disturbance 
Short Form 8a 
 
X 
 
X 
X 
PROMIS Sleep-Related 
Impairment Short Form 8a 
 
X 
 
X 
X 
Rosenberg Self-Esteem Scale 
 
X 
 
X 
X 
Physical Self-Perception 
Profile Physical Self-worth 
Subscale 
 
X 
 
X 
X 
Physical Activity Neighborhood 
Environment Survey 
 
X 
 
 
 
Exercise Self-efficacy Scale 
 
X 
X 
X 
X 
Barriers Self-efficacy Scale 
 
X 
X 
X 
X 
Social Support for Exercise 
Scale 
 
X 
X 
X 
X 
Effective Social Support for 
Physical Activity 
 
X 
X 
X 
X 
Exercise Goal-setting Scale 
 
X 
X 
X 
X 

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Physical Activity Enjoyment 
Scale 
 
X 
X 
X 
X 
Multidimensional Outcome 
Expectations for Exercise 
Scale 
 
X 
X 
X 
X 
Post-Program Evaluation 
 
 
 
X 
X 
*Values in bold indicate BOTH survivors and buddies will be asked to complete 
measure at a given time point. Italics indicate only survivors in buddy condition and 
buddies will complete.  
Post-intervention Interviews. Questions for the interviews are included in the Appendix. 
Questions will be related to their perceptions and opinions of the intervention, overall, 
and specific intervention/app components and recommendations for improving the 
intervention in the future.  
10.0 Data and Specimen Banking 
All data will be kept for 7 years after publication, as required by Northwestern University. 
Blood specimens will be banked in a freezer in the basement of 680 N Lake Shore Drive, 
Chicago, IL for future use. Specimens will not be stored linked to direct identifiers (only 
by randomly assigned participant identification number, as described below in data 
security section). The specimens will not be destroyed, and they will only be used in the 
future for research purposes. Specimens will be accessible by Dr. Phillips and co-
investigators with IRB approval. 
 
11.0 Data and Specimen Management 
11.1 Data Analysis Plan. 
Phase 1. Stakeholders will contribute to intervention component development via 
interviews which will be digitally recorded; digital files will be stored on a password-
secured network drive. Recordings will be transcribed verbatim and de-identified. Three 
coders will independently review the de-identified transcripts, identify emergent themes, 
and assign initial codes using constant comparative analysis. This iterative process codes 
data based on identified conceptual themes.  Data will be organized using NVivo 
software. Coders will meet often to discuss and refine the emerging themes, and 
triangulate their perspectives. Once a final coding structure is identified, coders will 
independently return to the transcripts to re-examine them and recode as necessary to 
ensure consistency. Disagreements will be resolved through deliberation and consensus. 
Analysis will identify the three stakeholder groups (survivors, experts, community 
organizations) perspectives on desirable components for inclusion. All groups’ 
perceptions of components, how to implement the proposed intervention and strategies 
for tailoring intervention content, and tactics for overcoming challenges to implementation 
will be integrated. These components will be vetted via the Breast Cancer Survivor 
Stakeholder Advisory Board Session. After vetting from the advisory board, the final 5 
components will be selected for development.   
Once components to be tested are identified and the app is under development, usability 
testing will begin. For this, survivors will be given a defined set of tasks to complete. They 

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will be observed to determine the ease with which they navigate using various app 
functions (e.g. error rates, time to complete tasks, etc.). Survivors will also provide 
qualitative and quantitative feedback regarding features, ease of use, and likeability. 
Usability tests will be rapid and iterative. During the field testing period, design changes 
will be completed after receipt of 2 to 5 survivors’ feedback and then tested with the next 
set of 2 to 5 survivors. The app will be refined to eliminate issues that impeded usability. 
We anticipate 10-20 survivors will be needed to achieve saturation on issues identified 
during testing.  Following the field testing, they will participate in a session to provide 
feedback on the app features and functioning. Because consensus may be reached 
during the field testing before all participants have a chance to participate, survivors may 
or may not participate in the field testing and post-field testing sessions. Finally, survivors 
will participate in a final lab visit where they evaluate the close-to-final intervention and 
provide feedback.  
 
 Phase 2. The effects of the five individual intervention components will be examined by 
means of a factorial experiment (see Table 4 for an example). The final factors will be 
determined based on the findings from Phase 1 of the study. Although these components 
will be evidence-based and have been included in bundled PA interventions previously 
found to be successful, none of these prior studies were designed to estimate the impact 
of any individual component.  
 
We chose a factorial experimental design factorial experiments have two characteristics 
essential to the success of MOST. These experiments: a) separate component effects 
enabling the estimation of the main effect contribution of each candidate component and 
interactions between components114 and b) are more economical compared to alternative 
designs because they often require substantially fewer subjects to achieve the same 
power and use less resources .114,115  
 
A complete factorial experiment requires 25=32 experimental conditions. It is important to 
understand that this design should not be considered a multiple arm RCT. All of the 
estimated main effects and interactions will be based on all experimental conditions. 
Table 7 displays the experimental conditions for this study. For example, main effect of 
telephone support calls would be estimated by comparing the mean of experimental 
conditions 1-7 with the mean of conditions 8-16. Similarly, the main effect of the App+ 
would be estimated by comparing conditions1-4 and 9-12 with conditions 5-8 and 13-16. 
Thus, all 256 participants will be included in all effect estimates.  
 
Table 7. Experimental Conditions 
Exp 
Condition 
Support 
Calls 
App+ 
Buddy 
Online 
Gym 
App 
Notifications 
1 
yes 
no 
no 
no 
no 
2 
yes 
yes 
no 
no 
no 
3 
yes 
no 
yes 
no 
no 
4 
yes 
no 
no 
yes 
no 
5 
yes 
no 
no 
no 
yes 

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6 
no 
yes 
no 
no 
no 
7 
no 
yes 
yes 
no 
no 
8 
no 
yes 
no 
yes 
no 
9 
no 
yes 
no 
no 
yes 
10 
no 
no 
yes 
no 
no 
11 
no 
no 
yes 
yes 
no 
12 
no 
no 
yes 
no 
yes 
13 
no 
no 
no 
yes 
no 
14 
no 
no 
no 
yes 
yes 
15 
no 
no 
no 
no 
yes 
16 
yes 
yes 
yes 
no 
no 
17 
yes 
yes 
no 
yes 
no 
18 
yes 
yes 
no 
no 
yes 
19 
yes 
no 
yes 
yes 
no 
20 
yes 
no 
yes 
no 
yes 
21 
yes 
no 
no 
yes 
yes 
22 
no 
yes 
yes 
yes 
no 
23 
no 
yes 
yes 
yes 
yes 
24 
yes 
no 
yes 
yes 
yes 
25 
no 
no 
yes 
yes 
yes 
26 
no 
yes 
no 
yes 
yes 
27 
yes 
yes 
yes 
yes 
no 
28 
yes 
yes 
yes 
no 
yes 
29 
yes 
yes 
no 
yes 
yes 
30 
no 
no 
no 
no 
no 
31 
no 
yes 
yes 
no 
yes 
32 
yes 
yes 
yes 
yes 
yes 
 
 
Planned analyses for each aim are as follows:  
Aim 1. All individual interviews will be digitally recorded; digital files will be stored on a 
password-secured network drive. Recordings will be transcribed verbatim and de-
identified. Three coders will independently review the de-identified transcripts, identify 
emergent themes, and assign initial codes using constant comparative analysis. This 
iterative process codes data based on identified conceptual themes.  Data will be 
organized using NVivo software. Coders will meet often to discuss and refine the 
emerging themes, and triangulate their perspectives. Once a final coding structure is 
identified, coders will independently return to the transcripts to re-examine them and 
recode as necessary to ensure consistency. Disagreements will be resolved through 
deliberation and consensus. Analysis will identify both aides’ and clients’ perceptions of 
implementing the proposed intervention, strategies for tailoring the existing intervention 
content, and tactics for overcoming identified challenges to implementation.  

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All information obtained from direct observation with be entered and analyzed using 
descriptive statistics to determine the learnability, effectiveness, efficiency, errors, 
flexibility, memorability, and user satisfaction of the app components. We will also 
transcribe verbatim the de-identified digitally audio recorded files and use these data to 
further assess qualitatively any themes that emerge relative to the components’ 
learnability, effectiveness, efficiency, errors, flexibility, memorability and user satisfaction. 
Finally, descriptive statistics (means, standard deviation, frequencies) of questionnaire-
based feedback will be used to further assess the app’s the learnability, effectiveness, 
efficiency, errors, flexibility, memorability and user satisfaction.  
Data from participant interviews and questionnaires completed related to the field 
experiment will be analyzed as described, above, and used to refine the app until 
saturation is reached.   
 
Aim 2. Feasibility and acceptability will be evaluated using the measures detailed above. 
The primary hypotheses are: a) 75% of eligible survivors will agree to participate in the 
intervention; (b) enrollees will demonstrate engagement by monitoring PA on >80% of the 
study days and using one or more additional app components at least weekly. Descriptive 
analyses (means, frequencies) will be used to describe these results. Data from post-
intervention interviews will be digitally recorded; digital files will be stored on a password-
secured network drive. Recordings will be transcribed verbatim and de-identified. Three 
coders will independently review the de-identified transcripts, identify emergent themes, 
and assign initial codes using constant comparative analysis. This iterative process codes 
data based on identified conceptual themes.  Data will be organized using qualitative data 
analyses software. Coders will meet often to discuss and refine the emerging themes, 
and triangulate their perspectives. Once a final coding structure is identified, coders will 
independently return to the transcripts to re-examine them and recode as necessary to 
ensure consistency. Disagreements will be resolved through deliberation and consensus. 
Analysis will identify both aides’ and clients’ perceptions of implementing the proposed 
intervention, strategies for tailoring the existing intervention content, and tactics for 
overcoming identified challenges to implementation.  
 
 
Aim 3 and Exploratory Aim 1. These aims are to determine the preliminary effectiveness 
of intervention components on minutes of accelerometer-measured moderate and 
vigorous PA (Aim 3) and PROs (physical function, fatigue, depression, QOL; Exploratory 
Aim). Our hypothesis is that a set of components will emerge as most effective for 
increasing PA and minimizing cost, but a second set of intervention component may 
emerge as having the largest, most cost-efficient impact on PROs. These hypotheses will 
be tested using intention-to-treat mixed linear model analyses to test differences in 
outcomes by intervention components. The study was not designed to have statistical 
power to detect differences over time with inferential tests. If descriptive statistics suggest 
that the intervention (a) is feasible and acceptable and (b) seems likely to increase PA, 
we will plan a future randomized controlled trial with sufficient power (>.80) to detect 
clinically-meaningful effects in this population. If we fail to achieve certain benchmarks for 

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feasibility, acceptability, or safety, we will refine the protocol as needed prior to 
proceeding. 
 
Exploratory Aim 2. This aim is to explore the relationship between the 5 intervention 
components and each BC progression (IL-6, IL-10, CRP and TNFα) and cardiometabolic 
(CRP, BG, TG, TC, HDL-C) biomarker. We will also examine effects on overall risk for 
each category using composite z-scores. Our hypothesis is a set of components will 
emerge as most effective for changing each biomarker, but a second set of components, 
which may not be the same, may emerge as having the greatest composite effect or being 
most cost-efficient to achieve these outcomes. We will employ an intention-to-treat (ITT) 
approach by including all participants recruited into the study regardless of compliance. 
These hypotheses will be tested using intention-to-treat linear mixed model analyses to 
test differences in outcomes by intervention components. We will also test 2-way 
interactions between selected intervention components. Because we will use effect (-1,1) 
coding rather than dummy (0,1) coding, the power for tests to detect main effects and 
interaction effects are identical for effects of identical size. These data will be used in 
conjunction with parent study data to determine which intervention components will be 
tested in a more definitive trial. 
11.2 Power Analysis. 
Because this is a pilot test to evaluate the feasibility, acceptability, and preliminary 
efficacy of the different intervention components, sample size planning was determined 
by resource constraints (vs. a power analysis) for the primary aims. 
Dried Blood Spots. To determine if the sample size (n=256) is sufficient to address our 
exploratory  aim to explore biomarkers obtained via DBS, we conducted a power analysis 
to calculate the minimal detectable difference 
(MDD)116 for each biomarker assuming 20% 
attrition at 24 weeks, an alpha of 0.05, and two-
sided testing. The MDD defines the difference 
that must exist between those with the 
component “on” vs. “off” to detect a statistically 
significant effect. We used standard deviations 
from published BCS PA interventions117 and intra-class correlations (ICC) from Dr. 
Spring’s prior study,118 if available. Otherwise, a conservative ICC of 0.8 is assumed. 
Table 8 displays MDDs for component main effects and two-way interactions at 12 and 
24 weeks. We have 80% power to detect differences at least equal to between group 
differences observed in prior intervention studies for all inflammatory119,120 and CVD 
markers121,122 except for BG. Given no study has evaluated specific PA intervention 
component effects on biomarkers in BCS in the context of a MOST design, we accept this 
limitation.  
11.3 Data Security 
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 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. 
Table 3.Minimal Detectable Differences   
Marker 
SD ICC 
Study 
MDD 
IL-6 
1.1 0.80 Jones 2013  
0.40 pg/mL 
IL-10 
3.8 0.80 Rogers 2012 
1.37 pg/mL 
TNFα 
0.6 0.80 Jones 2013 
0.21 pg/mL 
CRP 
2.4 0.44 Jones 2013 
0.78 mg/dL 
BG 
7.8 0.49 Guinan 2013 
2.57 mg/dL 
HDL-C 
0.3 0.87 Fairey 2005 
0.11 mmol/L 
TG 
0.7 0.79 Fairey 2005 
0.27 mmol/L 
TC 
0.3 0.75 Fairey 2005 
0.10 mmol/L 
Table 8. Minimal Detectable Differences 

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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 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. All raw data will be de-identified (with the 
exception of the study ID number). These data will be saved to a portable hard drive 
which will be stored in a locked cabinet in the PI’s laboratory. Any hard copies of data 
will be stored in a separate, locked cabinet from the informed consents in the PI’s 
laboratory. 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.  
11.4 Quality Control of Collected Data 
Given that the majority of data will either be recorded electronically, entered electronically 
by participants or collected electronically via accelerometers or cellphones, we anticipate 
limited issues with quality control. However, all hard copy data that is entered by study 
staff will be double entered and checked to ensure data integrity Additionally, all data will 
be checked for missing data and erroneous data by examining descriptive statistics and 
score ranges of all variables. Subsequently, all data will be examined for violation of basic 
statistical assumptions (i.e., normality, multicollinearity, and homoscedascity) and 
transformed if necessary. In order to ensure data are missing at random, we will compare 
participants who have data on a given variable to those who do not on demographic and 
disease characteristics to ensure there is no pattern to the missingness. 
 
11.5 Specimen Handling 
Blood specimens will be self-collected by participants in their homes and mailed back to 
680 N Lake Shore Drive, Chicago, IL using the U.S. Postal Service for analysis and 
storage for future use which may include analysis of biomarkers of BC progression and 
CVD risk, whole genome sequencing, and epigenetic profiling. Everyone handling the 
blood products will receive Bloodborne Pathogens Training. As described above, 

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specimens will not be stored linked to direct identifiers (only by ID number). Specimens 
will be accessible by Dr. Phillips and co-investigators with IRB approval. 
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A as this study involves only Minimal Risk to subjects.  
 
13.0 Withdrawal of Subjects 
13.1 Procedures for early termination. 
Participants may withdraw from either Phase 1 or Phase 2 of the study at any time.  
Procedures specific to Phase 2. 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). 
13.2 Procedures to follow when subjects withdraw from research.  
Participants may withdraw from the study at any time during Phase 1 or Phase 2. For 
phase 2, permission will be sought to continue to collect outcome data for use in the 
analysis.  
 
14.0 Risks to Subjects 
14.1 Reasonably foreseeable risks, discomforts, hazards, or inconveniences 
related to participation in the research.  
Phase 1.  Potential risks are considered minimal. There are some potential minimal 
psychological risks associated with participation in the interviews, intervention 
development sessions and answering some of the intervention development 
questionnaires. However, participants will be given the option to not answer or skip any 
questions that make them feel uncomfortable. Further, although the research team will 
take every precaution to maintain confidentiality of the data, the nature of some web-
based sessions prevent the researchers from guaranteeing confidentiality. The research 
team will be sure to reiterate this risk during all group sessions and remind participants to 
respect the privacy of your fellow participants and not repeat what is said in these 
sessions to others. 
For the app field study, participants may increase their PA compared to their usual level 
of PA, although they will be explicitly told this is not the purpose of the field test. Engaging 
in a PA program when one has been sedentary for a considerable period of time incurs 
some risk of injury such as l muscle soreness, strains, aggravation of arthritic conditions, 
etc. However, serious physical injury is considered unlikely. Participants will be instructed 
to notify study investigators immediately if they experience any adverse effects of using 
the app.   

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For the app field study, there is also a small risk to individuals’ privacy when using the 
mHealth app. However, 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. 
Phase 2. 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 l 
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 pass a screening test or 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.  
In addition to the potential minimal risk associated with PA participation, 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 American Psychosocial Oncology Society (APOS) Toll-Free 
HELPLINE - 1-866-276-7443 (1-866-APOS-4-HELP).  We have chosen this method 
because women will be selected from all over the United States. APOS's Helpline is a 
national resource to help people with cancer and their caregivers find emotional support 
in their own communities. This is a referral program that is part of the Cancer Support 
Helpline® (affiliated with the Cancer Support Community) and connects cancer patients, 
their caregivers and advocacy organizations with psychiatrists, psychologists, nurses, 
social workers, and counselors skilled in the management of cancer-related distress. If 
Helpline counselors cannot find local support services, and there is an immediate need 
for help, a Helpline mental health counselor can provide short-term emotional support by 
phone while patients seek professional help with coping in their community.  Calls are 
accepted Mon-Fri 9 am- 8 pm ET.  
There is also a small risk to individuals’ privacy when using the mHealth app but this will 
be minimized by the procedures described, above.  
Finally, for those participating in the optional blood sample collection, pricking the finger 
for the blood sample may cause some minor discomfort. Additionally, the risks of taking 
blood include pain, a bruise at the point where the blood is taken, redness and swelling 
of the collection site and infection, and a rare risk of fainting. The risk of fainting could be 
elevated if a participant is already feeling faint or dizzy. They will be instructed to delay 
collecting the blood sample until they are feeling better if this is the case. 
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. 

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15.0 Potential Benefits to Subjects 
Phase 1. The benefits of this portion of the study are largely scientific. Participants will 
have the benefit of contributing to the advancement of science by contributing to the 
development of a mHealth intervention for breast cancer survivors. This information is 
crucial to the effective development and implementation of the PA intervention to be 
tested in Phase 2.   
 
Phase 2. Although not guaranteed, the potential benefits of participating in this study 
include improved cardiorespiratory fitness, physical functioning, quality of life, depression 
and fatigue. All participants will be able to participate in the program for free. This study 
has the potential to inform science by improving the understanding of how to promote PA 
in breast cancer survivors, a large, and growing population with many health concerns. 
Additionally, the approach used to develop the intervention has the potential to be applied 
to other areas of science to facilitate the efficiency by which research can be disseminated 
into practice. We believe that the minimal risk involved with study participation are 
reasonable in relation to the anticipated benefits.  
 
 
16.0 Vulnerable Populations 
N/A 
 
 
17.0 Community-Based Participatory Research 
17.1 Involvement of the community in the design and conduct of the research. 
Stakeholders including local, Chicago-area breast cancer survivors and representatives 
from relevant Chicago-area and national cancer organizations will be involved in 
designing and choosing the intervention components to be tested as part of Phase 1 of 
this study.  
 
18.0 Sharing of Results with Subjects 
Phase 1.  Women who participate in this portion of the study will have the option of 
selecting to receive a plain language study summary at the end of Phase 1 and to indicate 
whether they would like to receive any manuscripts that result from Phase 1 or Phase 2 
of the present study. All women who indicate they would like to receive either the plain 
language summary or have manuscripts shared with them, will be e-mailed final versions 
of any manuscripts that result from the data upon publication in peer-reviewed journals. 
These manuscripts will also be posted on the PI’s website which study participants will 
have access to. 
 
Phase 2. Results will be shared with subjects via a plain-language study summary that 
will be sent via e-mail to participants at the conclusion of all data collection and cleaning. 
Women will also be given the option to indicate they would like manuscripts that are 

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published as a result of these data to be shared with them. All women who indicate they 
would like to have manuscripts shared with them, will be e-mailed final versions of any 
manuscripts that results from the data upon publication in peer-reviewed journals. These 
manuscripts will also be posted on the PI’s website which study participants will have 
access to.  
 
 
19.0 Setting 
19.1 Sites or locations where research will be conducted. 
Phase 1. Recruitment. Breast cancer survivors will be recruited from the Lynn Sage 
Breast Cancer Program at RHLCC using pamphlets/fliers and physician referrals. Fliers 
and pamphlets will also be posted in the local community, sent to listservs and posted 
on social media and on-line forums. Additionally, the PI will send a recruitment e-mail to 
an existing database of breast cancer survivors. Community representatives will be 
recruited in conjunction with NU’s Center for Community Health (led by Co-I Dr. 
Ackermann) via personalized e-mails and phone calls. Experts will be recruited through 
the RHLCCC and the PI’s, co-investigators’ professional networks via listservs and 
personalized e-mails and phone calls. Research Procedures: All research procedures 
will be performed in the Department of Preventive Medicine, 680 N. Lakeshore Drive, 
Suite 1400, Chicago, IL 60611. 
Phase 2. Recruitment: Our main source of recruitment will be e-blasts sent to women 
registered with the Army of Women.©  Other recruitment sources will include posting on 
on-line forums and websites, RHLCC, and fliers distributed at local community 
organizations and events. Research Procedures: All research procedures will be 
performed in the Department of Preventive Medicine, 680 N. Lakeshore Drive, Suite 
1400, Chicago, IL 60611. 
 
20.0 Resources Available 
20.1 Qualifications PI and staff  
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. The PI (Dr. Phillips) is an Assistant 
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. Frank J. Penedo, PhD is the 

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Director of the Cancer Survivorship Institute at RHLCC, Program Leader of Cancer 
Control and Survivorship at the RHLCC, and Professor in Medical Social Sciences at NU. 
D. Penedo has extensive experience in behavioral interventions in cancer survivors and 
biopsychosocial mechanisms underlying health and disease outcomes in cancer 
survivors. Dr. David Cella, PhD is the Chair of the Department of Medical Social Sciences 
and Director of the Center for Patient-Centered Outcomes at NU. He is a leading expert 
in cancer survivorship and patient reported outcomes. He also has experience in 
designing and conducting stakeholder focus groups and interviews. Dr. Ronald T. 
Ackerman, MD, MPH is the Director of the Center for Community Health and Professor 
in General Internal Medicine and Geriatrics. He is an expert in dissemination and 
implementation of behavioral interventions and stakeholder engagement. Dr. Juned 
Siddique, 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. Danielle Hartigan, PhD, MPH is an Assistant Professor at 
Bentley University in Natural and Applied Sciences. She has expertise in qualitative data 
collection and analyses and will provide guidance on these aspects of the study.   
20.2 Other resources available to conduct the research.  
Feasibility of recruiting subjects for Phase 1. We will use the Army of Women© to 
recruit survivors. Given the large number of survivors in the database and the fact that no 
on-site lab visits are required, we do not anticipate recruitment to be a problem. We 
believe we should be able to recruit participants for the other stakeholder groups relatively 
easily through NU resources including RHLCC and the Center for Community Health in 
addition to the PI’s and Co-I’s professional networks. 
Feasibility of recruiting subjects for Phase 2. Women will primarily be recruited 
through an e-blast sent to members of the Army of Women©, an online initiative that 
connects breast cancer researchers with women who are willing to participate in research. 
The database currently consists of ≥375,000 women and men. Of these, ~30% (112,500) 
self-report a breast cancer history. This means we only need to recruit (0.2%) of these 
women.  
We are confident sample recruitment through the Army of Women© is feasible, based on 
my prior experience recruiting and retaining a much larger sample. In our prior study, we 
had 2,500 women express interest within 12 hours of recruitment initiation and 
recruitment was halted due to capacity limitations. Of that   number, 1,631 (64%) 
responded to screening and qualified to participate. I randomized 500 of those women to 
wear accelerometers for 7 consecutive days. Only 4 refused to wear the device.  At 
baseline and follow-up, 1,527 women (94%) completed more than half of the on-line 
questionnaires. Valid accelerometer data were obtained from 442 (89%) women at 
baseline; 370 (83.7%) of those women also had valid data at 6 month follow-up. Reasons 
for missing accelerometer data at baseline and follow-up, respectively, were: did not wear 
(n=36 and n=40), insufficient valid wear time (n=8 and n=17), accelerometer 
malfunctioned (n=5 at both), lost in mail or by participant (n=4 and n=5) and submerged 
in water (n=1).  
If we are not able to sufficiently meet our recruitment goals using the Army of Women©, 
additional NU resources (e.g. RHLCC and the Center for Community Health), on-line 

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forums and social media sites (i.e. Facebook, the Sisters Network and Nueva Vida) and 
fliers at community organizations and events will be used. 
Percentage of PI’s Effort Dedicated to Project. The PI will dedicate approximately 60-
80% of her effort to this project during data collection and between 30-40% during data 
analyses.  
Facilities. Phase 1 will be conducted in the Department of Preventive Medicine in private 
conference rooms or using the Northwestern University’s IT services (for web-based 
conferences). Phase 2 will be conducted via a mobile app. All data from this will be stored 
on a secure, password protected server that will only be accessible to study investigators.   
Process to Ensure all Staff are Adequately Informed on Protocol. 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. A manual of procedures will be developed for the current project which 
will include scripts for any contact research staff will have with study participants. The PI 
will meet with the research assistant (TBD) from the Department of Preventive Medicine 
to train them in these procedures. Additionally, the PI will meet with the RA on a weekly 
basis, and as needed, to ensure study procedures are being adhered to. 
21.0 Prior Approvals 
We will obtain approval from the National Cancer Institute before beginning the present 
study.  
 
22.0 Recruitment Methods 
22.1 
When, where and how potential subjects will be recruited.  
Phase 1. Women will be recruited through an e-blast sent to members of the Army of 
Women©, an online initiative that connects breast cancer researchers with women who 
are willing to participate in research. The database currently consists of ≥375,000 women 
and men. Of these, ~30% (112,500) self-report a breast cancer history. Women interested 
in participating in the current study will respond to the e-blast.  Their contact information 
will be forwarded to the study investigator who will provide a description of the study and 
further screen for eligibility either via on-line screening questionnaires or telephone 
interview. Eligible breast cancer survivors will be offered the opportunity to participate and 
will complete informed consent. Breast cancer survivors may also be recruited from the 
Lynn Sage Breast Cancer Program at RHLCC using pamphlets/fliers and physician 
referrals. Fliers and pamphlets will also be posted in the local community sent to listservs 
and posted on social media and on-line forums. Additionally, the PI will send a recruitment 
e-mail to an existing database of breast cancer survivors. Community representatives will 
be recruited in conjunction with NU’s Center for Community Health (led by Co-I Dr. 
Ackermann) via personalized e-mails and phone calls. Experts will be recruited through 
the RHLCCC and the PI’s, co-investigators’ professional networks via listservs and 
personalized e-mails and phone calls.  
 
All individuals interested in participants will be instructed to contact study investigators 
who will provide a description of the study and further screen for eligibility either via on-

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line screening questionnaires or telephone interview. Eligible stakeholders will be offered 
the opportunity to participate and will complete informed consent.  
 
Phase 2. Breast cancer survivors will be recruited through an e-blast sent to members of 
the Army of Women©, an online initiative that connects breast cancer researchers with 
women who are willing to participate in research. The database currently consists of 
≥375,000 women and men. Of these, ~30% (112,500) self-report a breast cancer history. 
Women interested in participating in the current study will respond to the e-blast.  Their 
contact information will be forwarded to the study investigator who will provide a 
description of the study and further screen for eligibility either via on-line screening 
questionnaires or telephone interview. Eligible breast cancer survivors will be offered the 
opportunity to participate and will complete informed consent.  
 
If our recruitment goals are not being sufficiently met via the Army of Women© we will also 
post study fliers and advertisements on social media sites (i.e. Facebook, 
PatientsLikeMe) and on-line forums (i.e. Sisters Network, Nueva Vida, Living Beyond 
Breast Cancer). All women who are recruited through these alternative strategies, will be 
instructed to contact the study staff who will provide a description of the study and further 
screen for eligibility either via on-line screening questionnaires or telephone interview.  
Eligible breast cancer survivors will be offered the opportunity to participate and will 
complete informed consent. 
 
Buddies will be identified by participants and subsequently contacted by investigators 
via email. Identified potential buddies will have access to an online screening tool via 
RedCap which will provide a study overview and allow them to screen for eligibility if 
interested. Eligible buddies will be offered the opportunity to participate and will 
complete informed consent. They will also be offered the opportunity to answer an 
online questionnaire battery that is almost identical to that of the breast cancer survivors 
at baseline, 12 weeks and 24 weeks.  
 
Participants for the post-intervention interviews will be identified by investigators based 
on willingness to be contacted regarding future studies, study adherence and condition 
assignment to ensure an equal distribution across the latter two variables.  
 
22.2 Source of subjects. 
Phase 1. Women will be recruited through an e-blast sent to members of the Army of 
Women©, an online initiative that connects breast cancer researchers with women who 
are willing to participate in research. The database currently consists of ≥375,000 women 
and men. Of these, ~30% (112,500) self-report a breast cancer history. Women interested 
in participating in the current study will respond to the e-blast.  Their contact information 
will be forwarded to the study investigator who will provide a description of the study and 
further screen for eligibility either via on-line screening questionnaires or telephone 
interview. Eligible breast cancer survivors will be offered the opportunity to participate and 
will complete informed consent.  

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If we are not able to sufficiently meet our recruitment goals using the Army of Women©, 
additional NU resources (e.g.  Lynn Sage Breast Cancer Program, RHLCC and the 
Center for Community Health), on-line forums and social media sites (i.e. Facebook, the 
Sisters Network and Nueva Vida) and pamphlets fliers at community organizations and 
events and clinics will be used. Additionally, the PI may send a recruitment e-mail to an 
existing database of breast cancer survivors. Community representatives will be recruited 
in conjunction with NU’s Center for Community Health (led by Co-I Dr. Ackermann). 
Experts will be recruited through the RHLCCC and the PI’s, co-investigators’ professional 
networks. 
Phase 2. Women will primarily be recruited through an e-blast sent to members of the 
Army of Women©, an online initiative that connects breast cancer researchers with 
women who are willing to participate in research. The database currently consists of 
≥375,000 women and men. Of these, ~30% (112,500) self-report a breast cancer history.  
If we are not able to sufficiently meet our recruitment goals using the Army of Women©, 
additional NU resources (e.g. RHLCC and the Center for Community Health), on-line 
forums and social media sites (i.e. Facebook, the Sisters Network and Nueva Vida) and 
fliers at community organizations and events will be used. 
 
Buddies will be identified by study participants.  
 
Participants for the post-intervention interview will be identified by investigators based 
on willingness to be contacted regarding future studies, study adherence and condition 
assignment to ensure an equal distribution across the latter two variables.  
 
22.3 Methods used to identify potential subjects. 
Phase 1. Breast cancer survivors will be recruited through The Army of Women.© The 
Army of Women.© will send all women in their database an e-blast to advertise the present 
study. Women interested in participating in the current study will respond to the e-blast.  
Their contact information will be forwarded to the study team who will contact them via 
phone or e-mail to provide a description of the study and further screen for eligibility via 
on-line screening questionnaires or telephone interview (based on participants 
preference). Fliers and pamphlets will also be posted in the local community sent to 
listservs and posted on social media and on-line forums. Additionally, the PI will send a 
recruitment e-mail to an existing database of breast cancer survivors.  
 
Community representatives will be recruited in conjunction with NU’s Center for 
Community Health (led by Co-I Dr. Ackermann) via personalized e-mails and phone calls. 
Experts will be recruited through the RHLCCC and the PI’s, co-investigators’ professional 
networks via listservs and personalized e-mails and phone calls.  
Phase 2. The Army of Women© will send all women in their database an e-blast to 
advertise the present study. Women interested in participating in the current study will 
respond to the e-blast.  Their contact information will be forwarded to the study team who 
will contact them via phone or e-mail to provide a description of the study and further 

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screen for eligibility via on-line screening questionnaires or telephone interview (based 
on participants preference).  
Similar procedures will be followed for survivors recruited through other channels. All 
interested women will contact study investigators who will provide them with additional 
details about the study, and if interested, screen them for eligibility.  
Buddies will be identified by study participants.  
All eligible breast cancer survivors and buddies will be offered the opportunity to 
participate and will complete informed consent. 
22.4 Recruitment materials.   
Phase 1. Potential subjects will be recruited using IRB-approved e-blast to the Army of 
Women©, scripted phone calls and IRB-approved pamphlets/fliers and e-mails.  
Phase 2 For survivors, our primary recruitment method will be an e-blast to the Army of 
Women©. If this is not successful, we will post advertisements on on-line forums and 
distribute fliers at local community organizations and events. Fliers will be posted and 
handed out to potential participants.  
Potential buddy participants will be identified via breast cancer survivor participants and 
invited to participate in the online screening by study staff.  
Potential post-intervention interview participants will be identified by the study team and 
invited to participate in the interview by study staff via email.  
All recruitment materials will be IRB-approved.  
22.5 Payments to subjects. 
Phase 1. Survivors will be paid $15.00 via Amazon.com e-gift card following participation 
in the interview session. Experts and community partners will be paid $20.00 via an 
Amazon.com e-gift card following participation in each interview session. Survivors will 
be paid $10.00 via an Amazon.com e-giftcard for each app development session (up to 
2) and another $20.00 via an Amazon.com e-giftcard for the field test.    
Phase 2. Survivors will be paid $20.00 via check following completion of baseline, 12 
week and 24 week follow-up assessments (on-line questionnaires and accelerometer). If 
they only complete one aspect of the assessment (i.e. wear the accelerometer or answer 
questionnaires), their pay will be pro-rated to $10 for each component completed. Women 
who choose to participate in the optional blood sample collection will receive a $15.00 
check after receipt of their sample at each of the three time points.  
“Buddies” who agree to complete the optional baseline, 12 week and 24 week on-line 
questionnaire assessments, and complete at least two assessments, will get to keep the 
Fitbit ($60 value). Those who do not complete at least two assessments will be asked to 
mail the Fitbit back to the study team.    
Participants who agree to participate in post-intervention interviews will be paid $20.00 
via Amazon.com e-gift card for participation in this portion of the study. 
23.0 Number of Subjects 

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23.1 Total Number of Subjects to be accrued.  
A total of 356 breast cancer survivors, 30 other stakeholders and 128 “buddies” will be 
accrued.  
Phase 1.  In phase 1, we plan to recruit breast cancer survivors up to 100 breast cancer 
survivors, a subgroup (n=30) will participate in interviews and the full sample (n=100) has 
the potential to participate in the app development sessions and field test. A total of 20-
30 experts (n=10-15) (n=10-15) will be recruited for interviews.   
Phase 2.  For the pilot intervention, we will accrue 256 breast cancer survivors. 
Approximately 50% of these will be assigned to the buddy condition. As such we will 
accrue 128 buddies. We anticipate 80% of these “buddies” (n=102) will agree to 
participate in the optional questionnaire assessments. For the post-intervention 
interviews, we plan to accrue up to 35 women.  
 
24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 Steps that to protect subjects’ privacy interests.  
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 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. All raw data will be de-
identified (with the exception of the study ID number). These data will be saved to a 
portable hard drive which will be stored in a locked cabinet in the PI’s laboratory. Any 
hard copies of data will be stored in a separate, locked cabinet from the informed consents 
in the PI’s laboratory. 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 

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with have completed Northwestern University requirements for the responsible conduct 
of research including the Collaborative Institutional Training Initiative (CITI) Training 
Modules.  
Procedures Specific to Phase 1. All interviews and telephone/web-based app 
development sessions will be digitally recorded whenever possible; digital files will be 
stored on a password-secured network drive. Only participants’ first names will be used 
during any recorded sessions and participants will have the option of using a “fake” name 
if they would like. Regardless, all recordings will be transcribed verbatim and de-identified. 
Recordings will be destroyed at the end of the study. Upon download, all data obtained 
via cellphone, will be de-identified and only be linked to participant via study ID number.  
Procedures Specific to Phase 2. 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-identifed and only be linked to 
participant via study ID number. 
24.1 Steps taken to make subjects feel at ease with research situation.  
It will be clearly stated during all phases of this protocol that all subjects will have the 
option to withdraw at any time for any reason.  
Phase 1. All interviews and direct observation app telephone/web-based app 
development sessions will be digitally recorded; digital files will be stored on a password-
secured network drive. Only participants’ first names will be used during any recorded 
sessions and participants will have the option of using a “fake” name if they would like. 
Regardless, all recordings will be transcribed verbatim and de-identified. Recordings will 
be destroyed at the end of the study. All subjects will have the option to withdraw at any 
time for any reason.  
For the app field study, participants may increase their PA compared to their usual level 
of PA, although they will be explicitly told this is not the purpose of the field test. Engaging 
in a PA program when one has been sedentary for a considerable period of time incurs 
some risk of injury such as l muscle soreness, strains, aggravation of arthritic conditions, 
etc. However, serious physical injury is considered unlikely. Participants will be 
instructed to notify study investigators immediately if they experience any adverse effects 
of using the app.   
Phase 2. Engaging in a PA program when one has been sedentary for a considerable 
period of time incurs some risk of injury such as l 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 participation will be required to pass a screening 
test or receive medical approval prior to enrollment to ensure PA is appropriate. To make 
sure subjects are educated on what may be typical, normal side effects of beginning to 
exercise and what might be more serious, all participants, regardless of the intervention 
components they receive, will be required to attend an on-line study orientation which 

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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 and weekly e-mails will emphasize safety and present instruction to reflect safe 
progressions.  
There are also some potential minimal psychological risks associated with answering 
some of the questionnaires required for participation in this study. In addition, for those 
participating in the optional blood sample collection, pricking the finger for the blood 
sample may cause some minor discomfort. However, we see no psychological, social, 
or legal risks beyond those of participation in questionnaire based health-related 
research in general. Regardless, women will have the option to indicate they “prefer not 
to answer” any questions that make them uncomfortable. Participants will also be 
instructed that they can withdraw at any time and be provided with the PI’s contact 
information should they have any specific questions or concerns. 
All post-intervention interviews sessions will be digitally recorded; digital files will be 
stored on a password-secured network drive. Only participants’ first names will be used 
during any recorded sessions and participants will have the option of using a “fake” name 
if they would like. Regardless, all recordings will be transcribed verbatim and de-
identified. Recordings will be destroyed at the end of the study. All subjects will have the 
option to withdraw at any time for any reason. 
25.0 Compensation for Research-Related Injury 
N/A. This study does not involve more than Minimal Risk to the subjects. 
 
26.0 Economic Burden to Subjects 
There is no cost to subjects for participation in this study. Should any subject need to 
park on NU’s campus, study staff will cover the cost of parking for the duration of their 
participants.  
 
27.0 Consent Process 
27.1 Consent Process. 
Phase 1.  All stakeholder participants will complete an on-line version of the informed 
consent. They will be instructed to print a copy of the informed consent for their records 
or to contact the study team at any time if they would like a copy for their records.  
Phase 2. All breast cancer survivor participants will complete an on-line version of the 
informed consent. 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. 
All buddy participants will complete an on-line version of the informed consent. They will 
be 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 

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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. 
All participants in the post-intervention interviews will complete an on-line version of the 
informed consent. They will also be 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. 
27.2 This study is covered by a certificate of confidentiality. This was not 
included in the original consent form participants signed. All consented 
participants who are currently enrolled as of 6/14/18 will be informed of this 
certificate of confidentiality in June 2018 via a letter that will be emailed to the 
email address we have on file per instructions from the IRB on 6/7/18. Waiver or 
Alteration of Consent Process.  
Initial data collected prior to obtaining informed consent includes name, contact 
information, and basic medical and health information to determine eligibility for the 
project. This information is obtained on-line, through a phone conversation or in-person 
after the subject is given details about the project. These data are recorded in a password 
protected 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. 
 
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 
 
28.0 Process to Document Consent in Writing 
 

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Consent will always be obtained before a subject participates in any component of the 
current protocol.  Because we are asking participants to type their full name on any on-
line consents, this is considered equivalent to a written signature.  
 
 
 
 
 
 
 

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