A Randomized Trial of Roadmap 2.0
Phase: NA
Conditions: Hematologic Diseases
Sponsor: University of Michigan Rogel Cancer Center

ID: UMCC 
2019.106 
     
 
 
 
Health Information Technology System ("Roadmap 
2.0") in the Context of Hematopoietic Cell 
Transplantation 
    NCT04094844 
 

MULTISITE ROADMAP 2.0 INTERVENTION 
 
 
Protocol UMCC Number:  2019.106 
NCT Number:  
 
04094844 
 
 
Principal Investigator: 
 Sung Won Choi, MD, MS 
1500 E. Medical Center Drive, D4118 MPB  
Ann Arbor, MI 48109-5718 
Phone: 734-615-5707 
Fax: 734-615-0464 
 
Coordinating Site: 
 University of Michigan  
 
Participating Sites: 
 University of Michigan 
 Oregon Health and Science University 
University of Minnesota 
 
Biostatistician: 
 Thomas Braun, PhD  
Version: 
 October 2022 

2 
 
Table of Contents 
PROTOCOL SYNOPSIS ....................................................................................................................... 4 
STUDY SCHEMA: SCHEDULE OF EVENTS ........................................................................................ 7 
TIME AND EVENTS TABLE ................................................................................................................ 10 
1.0 BACKGROUND AND SIGNIFICANCE .......................................................................................... 11 
1.1 Public Health Impact of Caregiving ............................................................................................. 11 
1.2 Caregiving in the Clinical Context of Hematopoietic Cell Transplantation (HCT) ....................... 11 
1.3 Mobile Health Technology to Support Caregiving Efforts in a Scalable Manner ................... 11 
1.4 Conceptual Framework to Address the Positive Aspects of Caregiving Efforts ..................... 12 
1.5 Positive Activity Interventions to Highlight the Positive Aspects of Caregiving .................. 12 
1.6 Biomarkers Relevant to Caregiving Efforts ................................................................................. 12 
1.7 Study Rationale .......................................................................................................................... 13 
1.8 Roadmap 1.0 Development ........................................................................................................ 14 
1.9 Positive Activity Interventions ...................................................................................................... 15 
2. STUDY DESIGN .............................................................................................................................. 16 
2.1 Study Overview........................................................................................................................... 16 
2.2 Primary Hypothesis ..................................................................................................................... 17 
2.3 Study Objectives ......................................................................................................................... 17 
2.4 Participant Eligibility .................................................................................................................... 18 
2.5 Intervention Plan ......................................................................................................................... 19 
3.0 STUDY ENDPOINTS ..................................................................................................................... 21 
3.1 Primary Endpoint ........................................................................................................................ 21 
3.2 Exploratory Endpoints ................................................................................................................. 21 
4.0 PATIENT ENROLLMENT AND EVALUATION .............................................................................. 23 
4.1 Participant Recruitment ............................................................................................................... 23 
4.2 Participant Enrollment and Evaluation ........................................................................................ 23 
4.3 Informed Consent Process ......................................................................................................... 23 
4.4 Transplant Protocol Registration................................................................................................. 24 
4.5 Randomization ............................................................................................................................ 24 
4.6 Pre-transplant Caregiver Evaluations ......................................................................................... 24 
4.7 Pre-Intervention Evaluation ........................................................................................................ 24 
4.8 Post-Intervention Evaluation ....................................................................................................... 25 
4.9 Participant Withdrawal ................................................................................................................ 25 
4.10 Study Regulations ..................................................................................................................... 25 
4.11 Risks ......................................................................................................................................... 25 
4.12 Adverse Event Reporting Requirements ................................................................................... 26 
4.13 Participant Data Security and Compliance ................................................................................ 26 
4.14 Data and Safety Monitoring Plan .............................................................................................. 27 
4.15 Quality Assurance and Audits ................................................................................................... 28 
4.16 Clinical Monitoring Procedures ................................................................................................. 28 
5.0 STATISTICAL CONSIDERATIONS ............................................................................................... 29 
5.1 Study Design .............................................................................................................................. 29 
5.2 Accrual ........................................................................................................................................ 29 
5.3 Study Duration ............................................................................................................................ 29 
5.4 Randomization ............................................................................................................................ 29 

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5.5 Blinding ....................................................................................................................................... 30 
5.6 Primary Endpoint ........................................................................................................................ 30 
5.7 Sample Size Considerations ....................................................................................................... 30 
5.8 Interim Analysis .......................................................................................................................... 31 
5.9 Demographic and Baseline Characteristics ................................................................................ 31 
5.10 Analysis Populations and General Analysis Guidelines ............................................................ 32 
5.11 Analysis of Primary Endpoint .................................................................................................... 32 
5.12 Analysis of Secondary Endpoint ............................................................................................... 32 
5.13 Analysis of Exploratory Endpoints ............................................................................................ 33 
APPENDICES ..................................................................................................................................... 35 
APPENDIX A: FITBIT CHARGE 3 .................................................................................................... 35 
APPENDIX B: ROAMDAP 2.0 COMPONENTS ................................................................................ 47 
APPENDIX C: SOCIAL RHYTHMS APP INTERFACE ..................................................................... 54 
APPENDIX D: CAREGIVER- AND PATIENT-REPORTED OUTCOME MEASURES ...................... 55 
APPENDIX E: REFERENCES ........................................................................................................ 121 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

4 
 
PROTOCOL SYNOPSIS 
 
A RANDOMIZED TRIAL OF ROADMAP 2.0 
 
 
Principal Investigator:  Sung Won Choi, MD, MS 
 
Study Design: 
This is a prospective study to investigate the use of a mobile 
health technology-mediated intervention in caregivers and 
patients undergoing allogeneic/autologous hematopoietic cell 
transplantation (HCT). The study will use a two-arm 
randomized controlled design. Each of the participants will be 
randomized to an active intervention arm or to a control arm. 
The random allocation of participants to the intervention arm or 
control arm establishes the basis for testing the statistical 
significance or difference between the groups in the measured 
outcome (caregiver health-related quality of life [HRQOL], 
assessed by the PROMIS Global Health scale). 
 
Primary Objective: 
The primary objective is to test the statistical significance or 
difference between the intervention arm and the control am in 
the measured outcome of caregiver HRQOL, assessed by the 
PROMIS Global Health scale, at day 120 post-HCT. 
 
Exploratory Objectives: Exploratory objectives will be to assess: i) caregiver and 
patient HRQOL, as assessed by PROMIS measures: Profile 
29+2, Companionship, Self-Efficacy for Managing Symptoms, 
Self-Efficacy for Managing Daily Activities, Positive Affect and 
Well-Being, and Emotional Support; ii) caregiver and patient 
HRQOL, as assessed by the Perceived Stress Scale; iii) 
patient (ages 8-17 years) and parent proxy for pediatric 
patients (ages 5-17 years) HRQOL, as assessed by measures 
of PROMIS Sleep Disturbance and Profile 25; iv) physical 
activity through physiological data capture using the wearable 
sensor; v) health care utilization (i.e., total count of hospital 
days, ED visits, readmissions, and ambulatory care clinic 
visits);vi) overall survival within the first 120 days post-HCT; vii) 
the overall feelings and helpfulness of the app measured 
through the MARS survey and qualitative interviews and; viii) 
the understanding of how circadian rhythms through the social 
rhythms app affect health and wellbeing; IX) caregiver and 
patient HRQOL, as assessed by Resilience, Optimism and 
Gratitude scales; X) caregiver and patient negative and 
positive dyadic interaction, as assessed by measures of the 
Dyadic Relationship Scale. 
 

5 
 
Eligibility Criteria: 
Caregivers (age ≥ 18 years) of patients undergoing allogeneic 
or autologous HCT; patients (age ≥ 5 years) who meet 
eligibility to undergo allogeneic/autologous HCT. Caregivers 
must be able to read and speak English, agree to participate 
as caregiver-patient dyads, and sign informed consent and 
assent forms. Caregivers and patients must possess his/her 
own smartphone or tablet to participate. 
 
Treatment Description:  The participants (caregiver-patient dyads) will be randomized 
to an active intervention arm (mobile platform + Positive 
Activities) or to a control arm (mobile platform + control). 
Blocked randomization will be used to limit bias and achieve 
an equal distribution of participants to the control and treatment 
arms. The study (intervention vs control) will be delivered from 
the time for admission of the patient’s HCT through day 120 
post-HCT. Participant data will be collected pre-intervention 
(baseline), during the intervention (day 30 post-HCT), and at 
the end of the intervention (day 120 post-HCT).  
 
Intervention arm (Positive Activities): Caregivers and 
patients randomized to the treatment arm will be instructed on 
how to operate Roadmap 1.0 on an iPad (Michigan inpatients 
only) and Roadmap 2.0 (with Positive Activities for caregivers 
only) and Social Rhythms app on a mobile phone or tablet 
(inpatient and outpatient), download the app on the mobile 
device or tablet, be provided an access code, and to use 
Roadmap 2.0 with Positive Activities freely throughout the 
intervention period. The caregiver will receive a wearable 
sensor device (Fitbit); the patient will receive a wearable sensor 
device (Fitbit). The caregiver will download the Roadmap 2.0 
app with Positive Activities, the patient will download the 
Roadmap 2.0 app without positive activities. Both the caregiver 
and patient will download the wearable sensor device (Fitbit) 
app onto their mobile phones or tablet. Both the caregiver and 
patient will download the Social Rhythms app and perform 
uploads at the survey intervals; baseline, day 30, and day 120. 
 
Control arm: Participants will receive usual care only, defined 
as standard-of-care information provided according to 
institutional guidelines. The caregiver and patient will download 
the Roadmap 2.0 app without the Positive Activities and the 
caregiver and patient will also each receive a Fitbit device. Both 
caregiver and patient will download the wearable sensor 
device (Fitbit) app onto their mobile phones or tablet. Of note, 

6 
 
neither caregiver or patient in the control arm will receive 
Roadmap 1.0. Both the caregiver and patient will download the 
Social Rhythms app and perform uploads at the survey 
intervals; baseline, day 30, and day 120. 
 
Accrual Objective: 
We will enroll a total of 300 caregiver-patient dyads (600 
participants).  
 
The study will enroll a total of 40 pediatric dyads, which will 
consist of pediatric patients (age 5-17 years) and their adult 
caregiver (age ≥ 18 years). Pediatric dyads will account for 80 
subjects. 
 
Adult patients (age ≥ 18 years) undergoing HCT and their 
caregivers (adult dyads), will account for 260 of the 300 planned 
dyads (520 subjects). At least 166 adult dyads will be 
allogeneic HCT recipients.   
 
Accrual Period: 
The estimated accrual period is 5 years. 
 
Study Duration: 
Participant intervention will be followed for 120 days post-HCT. 
Subjects will remain in follow-up for 1 year post-HCT. The 
study team will have access to the electronic medical records 
for 1 year post-HCT. 

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STUDY SCHEMA: SCHEDULE OF EVENTS 
 
 
 
Pre-HCT (Baseline) Evaluation 
PROMIS Patient-Reported Outcomes 
Instructions on use of mobile health platform 
(Positive Activities intervention arm vs control arm) 
Positive Activities 
Day 120 Post-HCT Evaluation 
Patient-Reported Outcomes (PROMIS, Others) 
Day 30 Post-HCT Evaluation 
Patient-Reported Outcomes (PROMIS, Others) 
Control 
Randomization 
Consent Caregiver and Patient and Register 
HCT patient and caregiver eligible for 
Roadmap 2.0 Study 

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TIME AND EVENTS TABLE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention Arm vs Control Arm 
Pre-HCT 
Post-HCT 
Prior to Admission to 
Transplant Unit 
Day 30 
Day 120 
Deemed eligible to undergo HCT by the Institutional 
Transplant Teams 
X 
Consent to Study 
X 
Training of wearable senor; download app 
X 
Training of Roadmap 2.0 and Social rhythms app; 
download app (if randomized to intervention arm) 
X 
Questionnaires 
X 
X 
X 
Social Rhythms 
X 
X 
X 
Qualitative Interviews* 
X 
X 
X 
INTERVENTION ARM 
USUAL CARE: 
Routine patient care (“usual care”) provided by 
usual means = laboratory studies, medications, 
health care providers, clinical trial information 
delivered through verbal communication and/or 
handwritten materials during inpatient rounds or 
routine clinic visits 
WEARABLE SENSOR (Fitbit): 
Caregiver and Patient download wearable 
sensor app onto each of their own mobile 
phones/tablet (iOS, Android) to track activity and 
sleep 
ROADMAP 1.0 (Michigan Medicine only): 
Caregiver iPad (inpatient only) * 
ROADMAP 2.0: 
Caregiver downloads Positive Activities 
Components onto her/his mobile phone/tablet 
(iOS, Android) to use freely throughout inpatient 
and outpatient (through day 120 post-transplant). 
The patient also downloads the Roadmap app, 
but will only see the control version of the app. 
 
Social Rhythms: 
Both patient and caregiver will use this app to 
upload retroactive Fitbit data. 
CONTROL ARM 
USUAL CARE: 
Routine patient care (“usual care”) 
provided by usual means = laboratory 
studies, medications, health care 
providers, clinical trial information 
delivered through verbal communication 
and/or handwritten materials during 
inpatient rounds or routine clinic visits 
WEARABLE SENSOR (Fitbit): 
Caregiver and Patient download wearable 
sensor app onto each of their own mobile 
phones/tablet (iOS, Android) to track 
activity and sleep 
ROADMAP 2.0: 
Caregiver and Patient will download 
Roadmap 2.0 app but will only have 
access to component D of the app. (See 
appendix B of the protocol). 
Social Rhythms: 
Both patient and caregiver will use this 
app to upload retroactive Fitbit data. 

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1.0 BACKGROUND AND SIGNIFICANCE 
 
1.1 Public Health Impact of Caregiving 
Millions of individuals depend on family caregivers to manage their care.1 While 
family caregivers are a central part of health care,2 they often are invisible in our 
health care system – so much that they are sometimes referred to as “hidden 
patients.”3 The economic value of unpaid hours of care by family caregivers was 
estimated at $470 billion in 2013, and their contributions continue to intensify.4 
Indeed, with the aging population in the U.S. and the rising need for caregivers, 
efforts to foster caregiver health and well-being are essential for sustaining long- 
term care.5 Caregivers assist patients with a wide range of activities, including 
managing complex medical tasks, organizing care plans, and advocating on 
their behalf.3 These demands are time- and labor-intensive and they place 
caregivers at high-risk for injury and adverse events.3, 6-8 Addressing the needs 
of at-risk caregivers is an urgent public health priority.1 
 
1.2 Caregiving in the Clinical Context of Hematopoietic Cell Transplantation (HCT) 
 
HCT is an intense, but potentially curative therapy for a number of life- 
threatening blood diseases.9 Given the high-risk associated with HCT, a 
dedicated caregiver is necessary and expected for at least the first 100 days 
post-transplant.10 However, HCT caregivers are often unprepared for this role; 
it is not surprising that HCT caregivers experience significant levels of anxiety 
and 
distress, 
especially 
during 
the 
peri-transplant 
period.11, 
12 
Psychoeducational, skills training, and therapeutic counseling interventions 
have been shown to benefit caregiver health and well-being.13 However, major 
barriers in translating successful interventions to clinical practice have included: 
i) limited understanding of the mechanism of action of an intervention, and ii) 
need for expert trainers, intensive training, and monitoring.3 Interventions that 
are mechanism-focused, low-cost, and sustainable are needed.14 
 
 1.3 Mobile Health Technology to Support Caregiving Efforts in a Scalable Manner 
 
Our ability to capture the hazards of caregiving (i.e., adverse physical and 
mental health consequences)15 accurately and in real-time has been limited by 
assessments that have traditionally relied on long-term recall and self-report of 
symptoms. Mobile health technology remains relatively new in the clinical 
research space, but it is spreading quickly, and its costs are declining.16 It can 
serve as a platform for delivery of multi-component interventions as well as 
capture of continuous, real-time measures (e.g., sleep, physical activity). The 
extreme BMT setting17 provides an ideal ‘model’ to rigorously test a mobile 
health intervention due to: i) high level of engagement by BMT caregivers; ii) 
intense and rapidly evolving caregiving needs of medically fragile patients; and 
iii) long hospital course followed by frequent outpatient follow-up that allow for 
high-resolution data collection with minimal additional burden.18 

12 
 
 1.4 Conceptual Framework to Address the Positive Aspects of Caregiving Efforts 
 
Caregiver burden is defined as the “negative reaction to the impact of providing 
care on the caregiver’s social, occupational, and personal roles.”19 Much focus 
has been placed on the wide range of negative implications associated with 
caregiving20 (e.g., depression, anxiety).21 Despite this, a majority of caregivers 
have recognized the benefits of caregiving.22, 23 The imbalance of focusing 
primarily on negative aspects may limit our ability to develop new assessment 
and intervention methods.24 Thus, a ‘corrective focus’ is needed in caregiving 
research to expand our knowledge on the positive aspects of caregiving.25, 26 
Research on self-management suggests that self-efficacy, a positive aspect, 
can promote caregiver health, well-being, and positive health behaviors (i.e., 
improved sleep and physical activity).27, 28 Carbonneau’s evidence-based 
conceptual framework on the positive aspects of caregiving suggests that self- 
efficacy may be correlated with a caregiver’s ability to positively perceive the 
caregiving role.29 
 
1.5 Positive Activity Interventions to Highlight the Positive Aspects of Caregiving 
 
The positive aspects of caregiving, such as self-efficacy and positive attitudes 
toward the caregiver role, may explain how caregivers can positively engage 
patients in self-care activities.30 Caregivers with better self-efficacy and well- 
being (e.g., health-related quality of life [HRQOL]) may positively impact 
patients’ health outcomes.31-33 Simple strategies aimed at enhancing positive 
thoughts, emotions, and behaviors have been shown to be effective and highly 
scalable.34-36 Positive activity interventions, such as daily positive reflection, 
gratitude journals, and conducting acts of kindness, have been used in heart 
disease, cancer, diabetes, and chronic pain.37-42 Our preliminary data suggest 
that BMT caregivers desire these activities to reduce stress and improve well- 
being. 
 
1.6 Biomarkers Relevant to Caregiving Efforts 
Caregivers experience significant stress, anxiety, and poor sleep that lead to 
physiological changes.43 Indeed, long-term caregiving has been associated with 
increased physical morbidity.44 While caregiver interventions have been shown 
to reduce emotional distress and increase well-being in caregivers,45 less is 
known about the impact of physiological changes on caregiver health and well- 
being.15 Caregiver assessments have relied on snapshot self-report measures 
(i.e., patient-reported outcomes [PROs]).46 Recent advances in wearable 
sensors facilitate non-invasive collection of continuous, real-time measures 
(e.g., sleep, physical activity). These highly time-resolved, objective parameters 
correlated with subjective PROs may help us identify the mechanism of action 
of an intervention. Further, newer data science techniques may enable data 
patterns, relationships, and interpretation in ways that were not previously 
possible.47 

13 
 
1.7 Study Rationale 
The scientific premise of this protocol stems from the literature presented in the 
Background and Significance and the large body of prior work by the study PI 
and Co-Is who have extensive experience examining the information needs of 
BMT caregivers and patients. An intensive ethnographic study conducted over 
nearly three years in the adult HCT population showed that caregivers gain most 
of their knowledge of the HCT care process via scaffolding, a process by which 
health care providers (e.g., nurses, physicians) progressively guide caregivers 
to perform new or difficult tasks.48, 49 Importantly, the execution of safe health 
care practices by HCT caregivers requires support from the health care team, 
health care system (institution), and the community (social resources).49 The 
transition from hospital to home heightens caregiver anxiety, particularly as 
responsibility for routine medical tasks, previously performed by nurses (e.g., 
line care, dressing changes, administration of medications), shift to the 
caregiver.49 The risks of life-threatening events, such as line infections, are 
substantial.50 
 
HCT caregivers at the University of Michigan were engaged in a project that 
aimed to improve patient safety by implementing bundled checklists performed 
by health care providers; this ultimately led to significant reductions in central 
line infections.51 Patient, caregiver, and health care provider focus groups also 
were conducted to discuss how to better educate future caregivers and patients 
about BMT; these discussions revealed their desire to be active participants in 
research, supporting today’s emphasis on family-centered care.52-54 Specifically, 
caregivers and patients expressed a need for more information and support 
throughout the BMT trajectory.50, 52 Additional qualitative research in the form of 
observations, interviews, and artifact collections showed that technology could 
support caregivers at three levels: i) institutional scaffolding and navigating the 
health care system; ii) managing day-to-day caregiving tasks; and iii) 
transitioning to the outpatient/home setting.55 These data led to an R21-funded 
project directed by Sung Won Choi (PI) who developed BMT Roadmap via 
methods in human-computer interaction.56 

14 
 
1.8 Roadmap 1.0 Development 
 
The app was developed on an iPad tablet as a multi-component mobile app to 
provide patient-specific information, education, and skills- building exercises for 
caregivers (Table 1).48-52, 
55-57 Patients, caregivers, 
and health care providers 
participated in iterative 
cycles of user-centered 
design, development, and 
testing. To date, >80 BMT 
caregivers have enrolled 
in IRB-approved studies 
to assess the feasibility of 
implementing 
BMT 
Roadmap.58 PROs were 
collected 
at 
baseline, 
discharge, and day 100. 
The 
most 
viewed 
modules were laboratory 
results 
 and 
medications.59-63 
 
Roadmap 1.0 Use. The app was rated highly useful and easy-to-use;59-64 
caregiver anxiety65 decreased; 
caregiver 
well-being 
or 
HRQOL66, 67 improved; and 
caregiver 
activation68 
was 
increased 
at 
discharge 
compared 
with 
baseline.59 
Following memos and coding 
for content analyses, major 
themes emerged, including: i) 
Roadmap usefulness, ease-of- 
use, and likeability; ii) positive 
aspects of caregiving (e.g., 
benefits); and iii) desire to 
expand 
BMT 
Roadmap 
directed to the caregiver with 
‘caregiver-specific resources’ 
and 
‘positive 
activities’ 
components (Table 2).59-64, 69 

15 
 
1.9 Positive Activity Interventions 
 
Positive activity interventions have been developed to improve well-being 
(i.e., HRQOL) and physical health through well-studied constructs (e.g., 
positive daily reflection,37, 40, 70, 71 gratitude,38, 39, 72, 73 savoring74). To assess 
caregiver interest and opinions about these interventions, we conducted 
semi-structured interviews with BMT caregivers (N=17). Caregivers rated 
activities on a scale of 1–10. All the positive activities in Table 2 were viewed 
as potentially useful and meaningful. The three most highly rated activities 
were Random Acts of Kindness, Savoring, and Positive Piggy Bank. The 
Positive Piggy Bank was developed and tested by Afton Hassett (Co-I). For 
this activity, participants reflect over a day’s events and identify events that 
made them happy. One such event is noted on a slip of paper, savored, and 
then deposited in a piggy bank. After 30 days, participants withdraw the slips 
of paper from the piggy bank, read them, and recall the happy memories. 
 
 
 
We have two ongoing studies on the Positive Piggy Bank. In Study 1, 18 
control and 16 Positive Piggy Bank intervention participants, who are 
generally healthy and have mild or no symptoms of depression, completed 
30-day post- intervention PROs (Figure 1). There was a significant difference 
in intervention participants’ satisfaction with life (p=0.021), reflecting changes 
in cognitive well- being. Although not statistically significant, there were 
general trends toward greater decreases in fatigue and sleep problems in the 
Positive Piggy Bank arm compared with the control arm. In Study 2, chronic 
back pain patients undergoing an epidural steroid injection in an outpatient 
setting are randomized to receive the injection and Positive Piggy Bank or the 
injection and standard follow-up care. In a preliminary analysis of the first 52 
patients, we observed significant improvement in satisfaction with life in the 
Positive Piggy Bank arm (Figure 1, far right). In addition, 77% of participants 
completed slips on at least 28 of 30 days, reflecting excellent adherence. 

16 
 
Scientific Premise. Family caregiving is an urgent public health issue.75 
Advances in technology with 
consumer-grade 
platforms 
and 
sensors, 
high 
performance computing with 
data science, and economic 
trends 
toward 
family- 
centered 
medicine 
that 
reduces health care costs 
make this an opportune time 
to develop the proposed 
approaches. 
Our 
strong 
preliminary data, coupled 
with the need to deliver an 
effective intervention in one 
of 
the 
most 
vulnerable 
caregiver populations, form 
the 
scientific 
premise 
(Figure 2). Based on the 
literature and our team’s 
prior work, it is logical to 
expand BMT Roadmap and 
test its efficacy in a randomized controlled trial. Our central hypothesis is that a 
multi-component technology-mediated intervention with focus on the positive 
aspects of caregiving will improve caregiver HRQOL. 
 
2. STUDY DESIGN 
 
2.1 Study Overview 
 
This study will use a two-arm randomized study design. Each of the caregiver- 
patient dyadic participants will be randomized to an active “treatment” arm 
(mobile platform + Roadmap 2.0) or to a control arm (mobile platform + usual 
care). The random allocation of participants to the treatment arm or control arm 
establishes the basis for testing the statistical significance or difference between 
the groups in the measured outcome (caregiver health-related quality of life, 
assessed by the PROMIS Global Health scale). Caregiver age, gender, and other 
prognostic baseline characteristics that could potentially confound an observed 
association, including those that are unknown or unmeasured, will be distributed 
equally, except through chance alone, through random assignment. Thus, this 
design is well-suited to our goal of assessing the efficacy of a mobile health 
intervention, Roadmap 2.0, on participants. 

17 
 
2.2 Primary Hypothesis 
 
The primary hypothesis is that a multi-component technology-mediated 
intervention (Roadmap 2.0) with focus on the positive aspects of caregiving will 
improve caregiver HRQOL. 
 
2.3 Study Objectives 
 
2.3.1 Primary Objective 
 
The primary objective is to test the statistical significance or difference between 
the “treatment” (Roadmap 2.0) arm and the control (usual care) arm in the 
measured outcome of caregiver HRQOL, assessed by the PROMIS Global 
Health scale, at day 120 post-HCT. 
 
 
2.3.2 Exploratory Objectives 
 
2.3.2.1 
Caregiver and patient HRQOL, as assessed by the following 
PROMIS measures: Global Health, Profile 29+2 and 25, 
Companionship, Self-Efficacy for Managing Symptoms, Self-
Efficacy for Managing Daily Activities, Positive Affect and Well-
Being, and Emotional Support. 
 
2.3.2.2 
Caregiver and patient HRQOL, as assessed by the Perceived 
Stress Scale. 
 
2.3.2.3 
Caregiver and patient HRQOL, as assessed by the Resilience, 
Optimism and Gratitude scales 
 
2.3.2.4 
Patient (ages 8-17 years) and parent proxy for pediatric patients 
(ages 5-17 years) HRQOL, as assessed by measures of PROMIS 
sleep disturbance and Profile 25. 
 
2.3.2.5 
Caregiver and patient negative and positive dyadic interaction, as 
assessed by measures of the Dyadic Relationship Scale. 
 
2.3.2.6 
Caregiver and patient physical activity through physiological data 
capture using the wearable sensors. 
 
2.3.2.7 
Caregiver and patient health care utilization data (e.g., total count of 
hospital days, readmissions, and ambulatory care clinic visits). 

18 
 
2.3.2.8 
Overall patient survival during first 120 days’ post-HCT. 
 
2.3.2.9 
Obtain user experience of the Roadmap 2.0 app through the 
Mobile Application Rating Scale (MARS) and qualitative interviews. 
 
 
2.4 Participant Eligibility 
 
Subjects must meet all of the eligibility criteria to be enrolled to the study. Study 
intervention may not begin until a subject is enrolled. 
 
2.4.1 Inclusion Criteria 
 
2.4.1.1 
The caregiver must have an eligible patient (defined in 2.4.1.5 – 2.4.1.9). 
 
2.4.1.2 
The caregiver must be of age ≥18 years. 
 
2.4.1.3 
The caregiver should be comfortable in reading and speaking English 
and signing informed consents. 
 
2.4.1.4 
The caregiver should provide at least 50% of care needs. 
 
2.4.1.5 
An eligible patient is one who identifies the eligible caregiver as their 
primary caregiver (i.e., provides at least 50% of care needs). 
 
2.4.1.6 
An eligible patient is age ≥ 5 years. 
 
2.4.1.7 
An eligible patient is scheduled to undergo HCT or recently had an HCT. 
 
2.4.1.8 
An eligible patient is able to sign informed consent/assent form or has an  
 
appropriate parent/guardian to sign on their behalf. 
 
2.4.1.9 
Patients and caregivers agree to provide informed consent that is in 
regulatory compliance and IRBMED-approved and also in accordance to 
institutional guidelines. 
 
2.4.1.10 The caregiver and patient must have his/her own smartphone to 
participate. 
 
2.4.2 
Exclusion Criteria 
 
2.4.2.1 
Patient does not meet eligibility criteria to undergo HCT at any 
participating site. 
 

19 
 
2.5 Intervention Plan 
 
2.5.1 How will the intervention work? 
 
Participants (caregiver-patient dyads) who are consented, enrolled, and 
randomized will be scheduled for a one-hour training session with the Research 
Coordinator(s) prior to or during admission to undergo the HCT. Based on our 
experience, these training sessions will be coordinated with other clinic 
appointments at the hospital in efforts to minimize burden on the caregiver and 
patient or remotely via institutionally approved virtual meeting platform. Once 
the intervention has begun, the Research Coordinator(s) will meet with the 
participants (caregiver-patient dyad) weekly to review any questions or 
concerns, to perform data download (wearable sensor device), and to ensure 
adherence to the protocol. HCT patients are typically inpatient for 
approximately four weeks. During this period, the Research Coordinator(s) will 
be available by pager and will schedule weekly visits with the participants or 
virtual visits. Once discharged, HCT patients return to clinic on a weekly visit in 
the ambulatory care setting. The Research Coordinator will meet with 
participants during those routine appointments. Roadmap 2.0 software will be 
maintained in collaboration with Arbormoon Software, Inc. 
 
2.5.2 Intervention arm (Roadmap 2.0) 
 
Participants (caregiver-patient dyads) randomized to the intervention arm will 
be instructed on how to download the wearable sensor app on their mobile 
phones or tablet (iOS, Android) and how to operate the wearable sensor. Each 
individual (caregiver, patient) will create her/his own password. The caregiver 
and  patient will each receive a wearable sensor device (Fitbit).  
 
University of Michigan inpatient only: Caregivers will be instructed on how to 
use the Roadmap 1.0 iPad. The Roadmap 1.0 iPad includes all of the features 
of Roadmap 1.0 components (see Table 1 of Section 1.8). After many rounds 
of discussion with HITS Compliance, it was deemed safest to maintain the 
previous components of Roadmap 1.0 in the inpatient setting (within the 
firewalls of Michigan Medicine due to privacy and security of patient-related 
data). 
 
Caregivers will download the Roadmap 2.0 app onto their mobile phone or tablet 
(iOS, Android) to use it freely throughout inpatient and outpatient (intervention) 
period. Roadmap 2.0 contains no patient-related information. Timestamps will 
be recorded of each caregiver’s use of Roadmap 1.0 and 2.0 (i.e., number of 
log-ins and pages viewed: when and how long and in what order). Please see 
Appendix A to view the components of Roadmap 1.0 and 2.0, and see 
Appendix B to view specifications of the wrist-worn sensor.  

20 
 
2.5.3 Control arm 
 
Participants randomized to the control arm will be instructed on how to 
download the Roadmap 2.0 (without Positive Activities) and wearable sensor app 
on their mobile phones or tablet (iOS, Android), and how to operate the 
wearable sensor. Each individual (caregiver, patient) will create her/his own 
password. 
 
2.5.4 Wearable Sensor Device (Fitbit) 
 
Each participant (caregiver, patient) will be given a wearable sensor to wear 
throughout the treatment period, except while in water or when charging. The 
goal is to collect objective, continuous, multi-parameter physiological data (e.g., 
total hours of sleep, sleep quality, total number of steps) on caregivers and 
patients throughout the treatment period to correlate with their subjective, 
snapshot caregiver- and patient-reported outcomes collected at three time 
points throughout the Intervention Period (baseline, and days 30 and 120 post- 
BMT). Participants will receive an instruction manual on how to charge and 
conveniently download data from the device. The data will be backed up to a 
HIPPA-secure data repository. For troubleshooting, detailed instructions will be 
provided for all participants, and customer support will be available 8AM – 5PM 
CST. Our team is available by pager after hours, if needed. Participants may 
use any Fitbit they may already have if they do not want to use the study 
provided Fitbit. Our study team will not be replacing any lost or broken Fitbit 
once a participant has reached Day 120 on study. 
 
2.5.5 Social Rhythms App 
 
Each participant will download the Social Rhythms app and upload their data 
at baseline (+/- 14 days), day 30 (+/- 14 days), and day 120 (+/- 30 days). At 
baseline, Social Rhythms will collect data starting 1 week prior to consenting. If 
a subject misses a Social Rhythms data upload, it will not be considered a study 
deviation. The Social Rhythms app is a tool developed by U-M investigators 
(Danny Forger PhD) that provides information regarding one’s circadian rhythm 
based on physiological data, which could inform how they organize their 
schedules. The Social Rhythms app collects data in a de-identified manner, we 
would be able to link our participants through a Fitbit identification number that 
is accounted for the Roadmap 2.0 app. We first debuted the Social Rhythms 
app in our study in University of Michigan students and COVID 
(HUM00185391). See Appendix C for details. 
 
2.5.6 Qualitative Interviews 

21 
 
Qualitative interviews may occur at day discharge (+/- 7 days), Day +30 (+/- 14 
days), Day +60 (+/-14 days), Day +90 (+/- 14 days), and/or Day +120 (+/-30 
days). Qualitative interviews will occur based on study team and participant 
choice and may include all, some, or none of the interviews for a participant.  
 
Not obtaining qualitative interviews will not be considered a deviation. Study 
subjects may be asked to participate in a 20 min interview, permission will be 
asked to audio-record the qualitative interviews. These may be conducted in 
person, through video conferencing platforms (such as Zoom), or by phone. 
Participants will opt-in or out of being audio recorded on the informed consent 
document. 
 
 
3.0 STUDY ENDPOINTS 
 
3.1 Primary Endpoint 
 
The primary endpoint is caregiver HRQOL, as assessed by the PROMIS Global 
Health scale, at day 120 post-HCT. To be evaluable for caregiver HRQOL, the 
caregiver must complete this scale at day 120 post-HCT. Caregivers of patients 
who relapse or die before this endpoint will not be evaluable for this endpoint; 
both caregiver and patient will be censored on the date the patient was last 
examined. See Appendix D for a copy of all PROMIS PROs. 
 
3.2 Exploratory Endpoints 
 
3.2.1 Caregiver HRQOL will be assessed by the PROMIS Global Health and Profile 
29+2 scales at baseline (pre-intervention) and days 30 post-HCT. 
 
3.2.2 Caregiver and patient HRQOL will be assessed by the PROMIS 
Companionship scale at baseline (pre-intervention), and days 30 and 120 post- 
HCT. 
 
3.2.3 Caregiver and patient HRQOL will be assessed by the PROMIS Self-Efficacy 
for Managing Symptoms and Self-Efficacy for Managing Daily Activities scales 
at baseline (pre-intervention), and days 30 and 120 post-HCT. 
 
3.2.4 Caregiver and patient HRQOL will be assessed by the PROMIS Positive Affect 
and Well-Being scale at baseline (pre-intervention), and days 30 and 120 post- 
HCT. 
 
3.2.5 Caregiver and patient HRQOL will be assessed by the PROMIS Emotional 
Support at baseline (pre-intervention), and days 30 and 120 post-HCT. 

22 
 
3.2.6 Caregiver and patient HRQOL will be assessed by the Perceived Stress Scale 
at baseline (pre-intervention), and days 30 and 120 post-HCT. 
 
3.2.7 Caregiver and patient HRQOL will be assessed by the Resilience, Optimism 
and Gratitude scales at baseline (pre-intervention), and days 30 and day 120 
post-HCT. 
 
3.2.8 Patient HRQOL will be assessed by the PROMIS Sleep Disturbance scale at 
baseline (pre-intervention), and days 30 and 120 post-HCT. 
 
3.2.9 Caregiver and patient negative and positive dyadic interaction will be assessed 
by measures of the Dyadic Relationship Scale at baseline (pre-intervention), 
and days 30 and 120 post-HCT. 
 
3.2.10 Caregiver HRQOL will be assessed by the TBI-CareQOL (PROMIS affiliate) 
Caregiver Anxiety at baseline (pre-intervention), and days 30 and 120 post- 
HCT. 
 
3.2.11 Caregiver HRQOL will be assessed by the TBI-CareQOL (PROMIS affiliate) 
Caregiver Strain scale. 
 
3.2.12 Activity data. Caregiver and patient activity (steps) and sleep will be measured 
continuously from the start to the end of the intervention (day 120 post-HCT) 
through wearable sensors. 
 
3.2.13 Health care utilization data. Patient health care utilization data (e.g., total 
count of hospital days, emergency department visits, readmissions, and 
ambulatory care clinic visits) will be captured through the electronic health 
record as well as self-report (i.e., if the patient is re-admitted at an outside 
hospital other than a participating site). Caregiver health care utilization data 
(e.g., hospital admissions, emergency department visits, and ambulatory care 
clinic visits) will be collected through self-report at the day 30 (+/-14) and day 
120 (+/- 30) post-HCT PRO assessment period. The study team may access 
the electronic medical records for 1 year from the date of study enrollment.  
 
3.2.14 Mobile Application Rating Scale (MARS) was added to the day 120 questionnaire 
to obtain user experience of the Roadmap 2.0 app. 
 
3.2.15Social Rhythms Application. We are interested in looking at how circadian 
rhythm may affect the participant’s overall health. Participants may upload 
retroactive data from the Fitbit and will receive a personalized report about their 
circadian rhythm. Participant will be encouraged to upload their data at 
baseline (+/- 14 days), day 30 (+/- 14 days), and day 120 (+/- 30 days). 
 
 

23 
 
4.0 PATIENT ENROLLMENT AND EVALUATION 
 
4.1 Participant Recruitment 
 
The Adult and Pediatric BMT Programs at the participating sites have regularly 
scheduled New Patient Evaluation meetings where patients being considered 
for BMT are presented and discussed. Investigators and study coordinators 
attend the meetings and will identify potential study subjects who meet eligibility 
for the non-invasive, wearable activity monitoring device. Study team members 
will recruit subjects to the study around the time of patient admission to undergo 
allogeneic or autologous BMT in the inpatient Adult or Pediatric BMT Units. 
Permission to approach will be obtained from subjects’ primary BMT physician 
prior to attempting to recruit them to the study. 
 
4.2 Participant Enrollment and Evaluation 
 
Participants (caregiver-patient dyads) will be approached for this study after the 
decision to proceed with transplantation is made by the patient. Caregivers will 
be identified by the patient as the primary caregiver providing at least 50% of 
the caregiving needs. Multiple caregivers are not allowed by study design. 
Eligibility criteria will be verified by the Study Team. Ineligible participants will 
proceed off study and no further follow-up will be obtained. 
 
4.3 Informed Consent Process 
 
Patient and Caregivers will be told about the study in detail, and will be given a 
copy of the consent to look through. If the patients and caregivers decide that 
they want to move forward with participation, the caregiver (who will always be 
an adult) will be provided with an access code and instructions on how to 
download the Roadmap 2.0 application on their phone or tablet (iPhone or 
Android). The application cannot be used without an access code. Once the 
access code is entered and confirmed, the caregiver will be presented with an 
electronic copy of the consent on the phone, and will have to click the button to 
confirm their willingness to proceed. After the caregiver has completed the 
consent on their phone or tablet, they will be provided with another access code 
for the patient, who might be an adult or a minor. The patient will then use this 
access code to open the app on their own device and go through their own 
electronic consent/assent process. Once the patient has completed the 
consent/assent, the pair will be officially enrolled in the trial. The database will 
store the access codes and the timestamps of when the electronic form was 
completed. The link between the access codes and the patient identifiers will be 
stored by the study team in a separate location from the application server so 
that the identity of the participants will never be stored within the application or 
the supporting application server, thus protecting privacy. 
 
The consent process relies on a waiver of documentation, meaning that 

24 
 
participants will not use their actual signature to denote consent since the act of 
consenting is done by checking boxes within the app. The app will know which 
site’s consent/assent to present to a subject based on the center ID, study ID, 
and access code. 
 
4.4 Transplant Protocol Registration 
 
Before randomization occurs, the Research Coordinator must state through the 
OnCore Clinical Trials Management System the baseline caregiver biological 
characteristics (e.g., age, gender, race/ethnicity). This will avoid potential biases 
that preferential use of gender, for example, on one arm could confer to the 
study. At this stage, the Research Coordinator will also verify that the patient is 
still a candidate for transplantation, and both caregiver and patient are eligible 
for this clinical trial. 
 
4.5 Randomization 
 
Once the caregiver-patient dyad is deemed eligible and has provided written 
informed consent, the Research Coordinator will confirm eligibility. The study 
statistician, Thomas Braun (Co-I), will create a randomization list before the 
study begins enrollment using the statistical package R. Dr. Braun will then 
forward the list to the Data Manager/Research Coordinator, who will be 
responsible for enrolling patients and assigning them to the correct study arm. 
Caregiver-patient dyads will not be randomized more than 21 days from the 
planned initiation of conditioning. All patient treatments related to the transplant 
should be scheduled PRIOR to randomization. This includes planning an 
admission date and ensuring that donors can be used in a coordinated fashion 
with the planned transplant. 
 
4.6 Pre-transplant Caregiver Evaluations 
Based on prior work, our Study Team has experience obtaining Caregiver 
Demographics on a user-friendly electronic format via Qualtrics directly through 
the Roadmap 2.0 app. The following data will be collected (i.e., caregiver self-
report) within 30 days of randomization, including demographic, caregiving, and 
personal health variables, such as marital status, alcohol/tobacco use, education, 
employment, annual household income, use of technology,  relationship to the 
patient, number of household members, health insurance status, number of 
years and number of hours per week (of caregiving), health comorbidities. 
Caregivers may also be asked in the onboarding session about their own health 
and any medications that they may be taking. 
 
 
4.7 Pre-Intervention Evaluation 
 
PROMIS Patient-Reported Outcomes (PROs) – Well-being or HRQOL 
assessments will be obtained at baseline, pre-intervention. The surveys will be 

25 
 
obtained through Qualtrics which will be linked directly to the Roadmap 2.0 app 
on mobile phones. Based on prior work, our Study Team has experience 
administering PROMIS PROs on mobile devices.  
 
4.8 Post-Intervention Evaluation 
 
PROMIS 
Patient-Reported 
Outcomes 
(PROs) 
Well-being 
or 
HRQOL 
assessments will be obtained at days 30 (+/- 14) and 120 (+/- 30) post-HCT, 
during and at the end of the intervention period, respectively. The surveys will be 
obtained through Qualtrics, which will be linked directly to the Roadmap 2.0 app 
on the mobile phone. Based on prior work, our Study Team has experience 
administering PROMIS PROs on mobile devices. If a participant relapses, our 
team will continue to collect clinical data post-transplant. In the event of a relapse, 
the patient will be censored, and we will not collect any further surveys from the 
patient or caregiver. 
 
Missing surveys will not be considered a protocol deviation. 
 
4.9 Participant Withdrawal 
 
At any time, a participant may request that her or his data no longer be collected, 
that her/his data be removed from the study database, that their physiologic data 
no longer be collected or used for research now or in the future. The participant 
may make this request to the Research Coordinator or to any member of the 
Study Team or the BMT clinical team. The participant’s research information will 
be deleted from the study database (with a comment that the participant withdrew 
consent for collection). Upon withdrawal, the participant may keep all 
physiological monitoring devices used in the study. A note will be made in the 
study record documenting the reason the patient withdrew from the study. 
 
4.10 Study Regulations 
 
The trial will be performed in accordance with all applicable regulatory 
requirements and laws. All investigators, research administrators, and other 
personnel who are involved in the studies will at a minimum be required to 
complete an online tutorial on the protection of human research subjects (this 
may be site-specific or through a multi-institutional platform like CITI). All sites 
will send their training certificates to the University of Michigan.  
 
All patient subjects will receive care either inpatient or outpatient through one of 
the participating sites by trained medical personnel skilled in the care of BMT 
recipients who will be responsible for ensuring necessary medical or professional 
intervention in the event of adverse events to subject. 
 
4.11 Risks 
 

26 
 
4.11.1 Wearable Sensor Device (Fitbit): Patient Subjects who agree to wear a device 
(s) for data collection may experience mild skin irritation, which will be 
monitored by the care team. The subject can decline to wear the device(s) or 
request to try a different device(s) that may be more comfortable. They will 
be instructed to remove the device before any scans or radiation therapy. 
 
4.11.2 Confidentiality: There is a possible risk of loss of confidentiality. However, 
every effort will be made to keep your medical information confidential. We 
will code data by assigning a number to each individual patient and then store 
the data by that number. No mention of patient subject identities is made in 
analyses of the data or in any publications, which result from such research. 
 
4.12 Adverse Event Reporting Requirements 
 
No adverse events related to this intervention are expected, as the focus of this 
intervention (if randomized to Roadmap 2.0) is on informational resources as well 
as positive activity exercises. If the PI or study team judges that an adverse event 
is related to the subject’s participation in this clinical trial, it will be reported to 
IRBMED per institutional guidelines. The coordinating site will meet with other 
sites at least once a month to review any potential adverse events.  The 
University of Michigan site will report any adverse events for all the performance 
sites.  
 
Participants will be considered on study for approximately 120-days post-HCT 
and are likely to have adverse events completely unrelated to the intervention but 
related to their underlying disease and/or allogeneic/autologous HCT. One 
example of a study-related adverse event that would be reported could include 
loss of confidentiality of data. Examples of events that would not be reported 
would include any complications from any procedures (specifically, transplant- 
related), surgeries, treatments (e.g., GVHD, chemotherapy, radiation therapy), 
or death unless due to the study. 
 
4.13 Participant Data Security and Compliance 
 
The wearable sensor device monitoring system data will be downloaded to a 
secure, password-protected University of Michigan core imaged computer and stored 
with subject codes in Dr. Sung Won Choi’s Laboratory (MPB) following rules for 
secure data storage (e.g., M+Box, Dropbox, RedCAP). Research devices will not 
interface with MiChart. All study personnel will complete training related to 
Human Subjects Research Protections and HIPAA. All study information will be 
stored in a password-protected encrypted files and identified by case number. 
The technologies proposed in this proposal have all been carefully reviewed and 
approved by the governing bodies at Michigan Medicine. All regulatory and 
security requirements have been met and have been fully documented in 
accordance with the policies and best practices that govern the use of technology 

27 
 
for patient care and research at Michigan Medicine. The MiChart web services 
were built and are supported by HITS, and their use for this project has been 
approved by HITS. All standard procedures and protocols for security and data 
integrity that apply to this project are being followed. All PHI will be stored in the 
HITS Oracle Database. Each study participant’s contact information will be 
securely stored in RedCap for use during the study. Each site will keep a master 
list of their site’s participant names and matching participant IDs. The 
coordinating center will have access to this information, though participating sites 
will not see subjects enrolled at other sites. Site personnel will keep subject 
information in password-protected files on a secure server or in a secure 
environment (e.g., locked cabinet, restricted access). No one other than the study 
team at the study site will have access to their site’s master list (except when 
needed for study monitoring). At the end of the study, all records will continue to 
be kept in a secure location for as long a period as dictated by the reviewing IRB, 
Institutional policies, or funding agency requirements. 
 
Study participant research data, which is for purposes of statistical analysis and 
scientific reporting, will be transmitted to and managed by the University of 
Michigan. Individual participants and their research data will be identified by a 
unique study identification number, where possible. The study data entry and 
study management systems (e.g., Roadmap app, REDCap, Qualtrics, M-Box, 
Dropbox, Fitbit®, etc.) used by clinical sites and by University of Michigan 
research staff are secured and password protected. Data will also be entered into 
Oncore/Velos as requested by the Rogel Cancer Center. At the end of the study, 
all study databases will be coded using subject IDs and archived at the University 
of Michigan. 
 
4.14 Data and Safety Monitoring Plan 
 
This study will be monitored in accordance with the NCI approved University of 
Michigan Rogel Cancer Center Data and Safety Monitoring Plan, with oversight 
by the Rogel Cancer Center Data and Safety Monitoring Committee (DSMC). 
 
The Study Principal Investigator will provide ongoing monitoring of data and 
patient safety in this trial and conduct regular data review with participating sites. 
 
The Study Principal Investigator and/or the Study Coordinator/Delegate will 
review data and patient safety issues with participating sites per a defined bi- 
annual meeting cadence. Depending on the protocol activity, the meeting 
cadence may be more frequent. This data review meeting may be achieved via 
a teleconference or another similar mechanism to discuss matters related to: 
 
• 
Enrollment rate relative to expectations, characteristics of participants 
• 
Safety of study participants (SAE reporting, unanticipated problems) 
• 
Adherence to protocol (protocol deviations) 
• 
Completeness, validity and integrity of study data 

28 
 
• 
Retention of study participants 
 
The Study Coordinator/Delegate is responsible for collating the data from all 
participating sites and completing the Protocol Specific Data and Safety 
Monitoring Report (DSMR) form to document the data review meeting discussion. 
 
The DSMR will be signed by the Study Principal Investigator or designated Co- 
Investigator and submitted to the DSMC on a bi-annual basis for independent 
review. 
 
4.15 Quality Assurance and Audits 
 
The Data and Safety Monitoring Committee can request a ‘for cause’ quality 
assurance audit of the trial if the committee identifies a need for a more rigorous 
evaluation of study-related issues. 
 
A regulatory authority (e.g. FDA) may also wish to conduct an inspection of the 
study, during its conduct or even after its completion. If an inspection has been 
requested by a regulatory authority, the site investigator must immediately inform 
University of Michigan Rogel Cancer Center that such a request has been made. 
Audits will be performed by the University of Michigan Rogel Cancer Quality 
Assurance Review Core (QARC), per institutional guidelines. 
 
During an audit access to relevant documentation, including patient records, 
must be given by the site investigator to the University of Michigan Rogel Cancer 
Center representative conducting the audit to verify consistency of data collected 
with the original source data. 
 
The University of Michigan Rogel Cancer Center expects the relevant 
investigational staff to be available to facilitate the conduct of the visit, that source 
documents are available at the time of the visit, and that a suitable environment 
will be provided for review of study-related documents. Issues identified during 
these visits will be communicated to the site and are expected to be resolved by 
the site in a timely manner. 
 
4.16 Clinical Monitoring Procedures 
 
Clinical studies coordinated by The University of Michigan Rogel Cancer Center 
must be conducted in accordance with the ethical principles that are consistent 
with Good Clinical Practices (GCP) and in compliance with other applicable 
regulatory requirements. 
 
Prior to subject recruitment, a participating site will undergo site initiation meeting 
to be conducted by the Study PI/Delegate. This will be done as an actual site 
visit; teleconference, videoconference, or web-based meeting. The site’s 
principal investigator and study staff should make every effort in attending the 

29 
 
site initiation meeting. Study-related questions or issues identified during the site 
initiation meeting will be followed-up by the appropriate personnel until they have 
been answered and resolved. Monitoring of this study will include centralized 
surveillance of study specific data at a defined cadence. 
 
Participating sites will also undergo a site close-out upon completion, termination, 
or cancellation of a study to ensure fulfillment of study obligations during the 
conduct of the study, and that the site Investigator is aware of his/her ongoing 
responsibilities. In general, the site close-out can occur without a site visit. 
 
5.0 STATISTICAL CONSIDERATIONS 
 
5.1 Study Design 
 
This study will use a two-arm randomized design. Each caregiver-patient dyad 
will be randomized to an active “treatment” arm (mobile platform + Roadmap 2.0) 
or to a control arm (Mobile platform + usual care). The random allocation of 
participants to the treatment arm or control arm establishes the basis for testing 
the statistical significance or difference between the groups in the measured 
outcome (caregiver health-related quality of life, assessed by the PROMIS Global 
Health scale). Caregiver age, gender, and other prognostic baseline 
characteristics that could potentially confound an observed association, including 
those that are unknown or unmeasured, will be distributed equally, except 
through chance alone, through random assignment. Thus, this design is well- 
suited to our goal of assessing the efficacy of a mobile health intervention, 
Roadmap 2.0, on caregivers. 
 
5.2 Accrual 
 
It is estimated that 5 yearswill be necessary to enroll the targeted 
sample size. Accrual will be reported by race, ethnicity, gender, and age. 
 
5.3 Study Duration 
 
Participants will be followed on intervention for 120-days post-transplant for 
primary, secondary, and exploratory endpoints. Subjects will remain in follow-up 
for 1-year post-HCT. The study team will have access to the electronic medical 
records for 1-year post-HCT. 
 
5.4 Randomization 
 
Blocked randomization will be used to limit bias and achieve an equal distribution 
of participants to the treatment and control arms. This approach will recruit 
participants in small blocks to ensure that half of the participants within each 
block will be allocated to the treatment and the other half to the control. The size 
of the blocks will be permuted to limit selection bias, and within each block, the 

30 
 
order of patients will be random. Randomization will be stratified by type of 
transplant (adult allo, adult auto, pediatric), so that three separate randomization 
lists will be created. The study statistician, Thomas Braun (Co-I), will create the 
randomization lists before the study begins enrollment using the statistical 
package R. Assignments will be allocated in list order, and an assignment will 
not be reused with future patients if a patient later declines to participate after 
being randomized. Adequate training will be given to the Project Manager and 
Research Coordinator, including enrollment of participants, allocation of 
treatment arm, and training the participants. 
 
5.5 Blinding 
 
Study arm assignments cannot be blinded to the investigators nor the subjects, 
because it will be known whether participants have the positive activity 
components of Roadmap 2.0 on their mobile device or not (due to technical 
purposes). Treatment assignments will not be blinded to the statistician/data 
scientists (Tom Braun, Co-I, and his research staff) or other Study Team members 
who will be ascertaining and adjudicating the outcomes (Noelle Carolozzi, Co-I, 
and her research staff). In addition, Research Assistants who collect the outcomes 
data (e.g., participant reported outcome measures, interviews) will be different 
from the Research Coordinator who will provide study training and ensuring 
weekly adherence to the study protocol (e.g., fidelity). 
 
5.6 Primary Endpoint 
 
The primary endpoint of this trial is the self-report outcome measure of caregiver 
HRQOL. The primary objective of this clinical trial is to test Roadmap 2.0/Positive 
Activities in caregiver-patient dyads undergoing HCT and determining the 
statistical significance or difference between the treatment arm and control arm in 
caregiver HRQOL. We will use a hypothesis testing framework to assess the 
potential efficacy of a mobile health intervention (Roadmap 2.0) to improve 
caregiver HRQOL. 
 
5.7 Sample Size Considerations 
 
The power calculation was completed by Dr. Braun using simulations in the 
statistical package R. Our primary endpoint (i.e., caregiver health-related quality 
of life from the PROMIS® Global Health scale) is focused solely on this outcome 
in caregivers, while our secondary endpoints are based on outcomes for both 
caregivers and patients. Given this, we determined our sample size based solely 
on caregivers. The age- and sex-adjusted norm for the Global Health scale is 50 
points, with a standard deviation of 10 points. These statistics have been shown 
to be generalizable to the allogeneic BMT population. Our study will have power 
of 0.80, assuming a two-sided Type I error rate of 0.05, to detect an effect size of 
0.5 between the intervention and control arms if 67 caregivers are enrolled in each 
arm. A mean difference of one-half a standard deviation is biologically meaningful 

31 
 
and is considered a medium effect size for clinical trials. We will accrue a total of 
83 caregivers in each arm to account for dropout, assuming a 5% failure to 
undergo BMT, 8% death before day 120, and 10% missing day 120 PRO from 
participants. These percentages are inflated but based on adjustments of 
published BMT data. 
 
Because our main goal is to assess the primary objective in adult allo dyads, we 
plan accrue approximately 260 dyads with adult patients, as that is the expected 
number of total adult dyads needed to enroll at least 166 allo dyads.  We also plan 
to enroll approximately 40 dyads with pediatric patients in the time it takes to enroll 
the 260 adult dyads. 
 
PROMIS® measures use Item Response Theory (IRT), a family of statistical 
models that link individual questions to a presumed underlying trait or concept of 
global health represented by all items in the scale. PROMIS® instruments are 
scored using item-level calibrations. The most accurate way to score a PROMIS® 
instrument is to use the HealthMeasures Scoring Service, which our Study Team 
has experience with (Noelle Carlozzi, Co-I and Tom Braun, Co-I). This method of 
scoring uses “response pattern scoring,” which uses responses to each item for 
each participant. Response pattern scoring is especially useful when there is 
missing data (i.e., a respondent skipped an item), or different groups of 
participants responded to different items). 
 
There are four key features of the score for PROMIS® Global Health: 
1. Reliability: The degree to which a measure is free of error. It can be estimated 
by the internal consistency of the responses to the measure, or by correlating 
total scores on the measure from two time points when there has been no 
true change in what is being measured (for z-scores, reliability = 1 – SE2). 
2. Precision: The consistency of the estimated score (reciprocal of error 
variance). 
3. Information: The precision of an item or multiple items at different levels of 
the underlying continuum (for z-scores, information = 1/SE2). 
4. Standard Error (SE): The possible range of the actual final score based upon 
the scaled T-score. For example, with a T-score of 52 and a SE of 2, the 95% 
confidence interval around the actual final score ranges from 48.1 to 55.9 (T- 
score ± (1.96*SE) = 52 ± (1.96*2) = 48.1 to 55.9) 
 
The final score is represented by the T-score, a standardized score with a mean 
of 50 and a standard deviation of 10 points. 
 
5.8 Interim Analysis 
 
There will be no interim analyses for efficacy or futility for this trial. 
 
5.9 Demographic and Baseline Characteristics 
 

32 
 
Demographic and baseline characteristics will be summarized for all participants. 
Caregiver characteristics to be examined may include, age, gender, race/ethnicity, 
spirituality, employment, education (years), co-morbidities, caregiving (years), 
household members. Patient characteristics to be examined may include: age, 
gender, race/ethnicity, Karnofsky performance status, HCT-Comorbidity Index, 
primary disease, disease risk group, number of treatments received before 
transplant, conditioning regimen, donor type, donor source, degree of match. 
 
5.10 
Analysis Populations and General Analysis Guidelines 
5.10.1 Primary Analysis Population 
 
All participants enrolled, consented, and completing at least the baseline outcome 
measures will be included in the primary analysis population. Analyses for the 
primary and secondary endpoints will use the primary analysis population: 
Caregivers of adult patients [age ≥18 years] will be analyzed separately from 
caregivers of pediatric patients [age 5-17 years]). The primary analysis will occur 
once all patients have been followed for 120-days post-transplant, data 
adjudication completed, and data are locked. 
 
5.10.2 General Analysis Guidelines 
 
Primary analyses for the primary, secondary, and exploratory endpoints will use 
the primary analysis population. Analyses of each endpoint in each population will 
follow the analysis plans, as described below. We expect minimal missing data 
(<5%) for the primary endpoint and secondary endpoints based on past experience 
with Roadmap 1.0 studies. 
 
5.11 Analysis of Primary Endpoint 
 
Analysis will be an intent-to-treat analysis that includes all caregivers. Mean Global 
Health scores for each arm at day 120 will be compared using a two-sample t-test 
(or Wilcoxon Rank Sum test if non-normality is apparent) with a significance level 
of 0.05. Linear regression models will be performed to complement the results of 
the t-test and adjust for specific baseline caregiver characteristics (e.g., 
demographic, social, environmental) to increase the precision of our inference.   
We plan to do analyses separately for allo dyads, auto dyads, and pediatric dyads, 
although we have only powered the study for the analysis in the allo dyads.  There 
is a possibility that patient characteristics will be unbalanced since our 
randomization scheme will be applied to caregivers. Thus, our models also will 
assess potential moderating or mediating effects, described below.76 
 
5.12 Analysis of Secondary Endpoint 
 
Mean Profile 29+2 scores for each arm at day 120 will be compared using a two- 
sample t-test (or Wilcoxon Rank Sum test if non-normality is apparent) with a 
significance level of 0.05. Linear regression models will be performed to 

33 
 
complement the results of the t-test and adjust for specific baseline caregiver 
characteristics (e.g., demographic, social, environmental) to increase the precision 
of our inference. There is a possibility that patient characteristics will be 
unbalanced since our randomization scheme will be applied to caregivers. Thus, 
our models also will assess potential moderating or mediating effects, described 
below.76 
 
5.13 Analysis of Exploratory Endpoints 
 
5.13.1 Caregiver and patient demographics and baseline characteristics 
 
Caregivers in each arm (treatment vs. control) will be compared descriptively 
according to Consolidated Standards of Reporting Trials Guidelines.77 Continuous 
measures will be described using means and standard deviations (or medians and 
ranges if non-normality is apparent), while categorical measures will be 
summarized with frequencies and percentages. Formal comparisons will be made 
between the arms, although no significant differences are expected due to the 
randomization of the arm assignments. Similar summaries will be done for patient 
characteristics. 
 
5.13.2 Caregiver and patient PROs (see Appendix C) 
 
All questionnaires will be scored according to coding manuals. The resulting scores 
will be compared between arms at baseline and days 30 and 120 using the 
Wilcoxon Rank Sum test. Outcome measures will be compared between arms using 
linear regression modeling of day 30 and day 120 outcomes after adjusting for 
baseline scores. We also will model the outcomes from all three time points 
simultaneously using a linear mixed model to account for within-subject correlation, 
as well as adjust for possible moderating or mediating characteristics of the 
caregiver or patient.76 
 
5.13.3 Caregiver and patient overall survival 
 
Death from any cause will be calculated from randomization to death or loss to 
follow-up. Participants alive at last follow-up will be censored. Survival curves will 
be calculated for each arm using the methods of Kaplan and Meier78 and will be 
compared between arms using the log-rank test. 
 
5.13.4 Mediation and moderation 
 
Our assessment for potential mediation will follow the Baron and Kenny approach.83 
Specifically, we will first fit models examining the effect of the intervention on our 
dependent variables. We will refer to the treatment effect estimates from these 
models as Estimates A. We will then fit each of our models again, but with all 
potential mediators included as covariates. We will refer to the parameter estimates 
for these covariates as Estimates B. We will then apply the Baron and Kenny 

34 
 
approach to Estimates A and B to determine the direct and indirect effects of the 
intervention on each of the dependent variables, with corresponding standard error 
estimates determined using bootstrap methods, as described by Whittle, et al.84 
These models will be adjusted for any confounders that are discovered, although 
we expect the randomization to account for most confounding. Moderation will be 
assessed by including main effects of potential moderators and interaction terms of 
each potential moderator with the intervention. 
 
5.13.5 Caregiver and patient activity 
 
The accelerometer data of each subject will be transformed into a low-dimensional 
representation using motif discovery algorithms.79 Such techniques are completely 
data-driven, and search for motifs (i.e., patterns) in the data that occur more often 
than chance. A signal can then be represented by the number of times a particular 
motif occurs. Others have successfully used such techniques for representing a 
variety of waveform data, including accelerometer and continuous glucose data.80- 
82 The accelerometer data will be processed to derive estimates of total sleep 
duration (i.e., hours per night), wake after sleep onset, and sleep efficiency (i.e., 
ratio of sleep to wake). The variables will be compared between arms. 
 
5.13.6 Caregiver and patient health care utilization 
 
The total count of hospital days, ED visits, readmissions, and ambulatory care clinic 
visits within the first 120 days post-BMT, with adjustment for follow-up, will be 
compared between arms using a Poisson regression model, with adjustment for 
potential mediating or moderating effects of patient or caregiver characteristics, if 
needed. The data will be captured at the time of PRO assessments. Subjects will 
remain in follow-up for 1-year post-HCT. The study team will have access to the 
electronic medical record for 1-year post-HCT. 

35 
 
APPENDICES 
APPENDIX A: FITBIT CHARGE 3 
 
 
The Fitbit Charge 3 is a smart watch capable of measuring heart rate, exercise amount, 
and sleep levels. There is a retail version available, and that is the model we will be using 
for our study. The data collected by the Fitbit Charge 3 is transferred from the smart watch 
to the Fitbit application installed on the patient’s phone via Bluetooth Low Energy (BLE), a 
form of Bluetooth specifically designed to lower power consumption without compromising 
range. The app then transmits the data to Fitbit’s information management system 
securely and without identifiable information. The smart watch can be worn on either wrist 
to give accurate measurements. The Charge 3 is made of safe-to-use aluminum and 
flexible, non-elastic elastomer material common in fitness watches. 
 
Patient Fitbits will be managed through Fitbit’s proprietary management system. Each 
Fitbit will be connected to an account that is registered to a study coordinator. Using that 
account, the study coordinator will create Fitbit accounts for each unique user using a 
study gmail account. A Fitbit will then be synced to the subject account. The subject’s 
account will be given the study ID assigned to the patient and an individual password to 
protect confidentiality. 
 
The subject will wear the Charge 3 as often as they like. This will begin the collection of 
the subject’s data. The smart watch will upload the data to the patient’s phone every 15 
minutes via BLE. The data is then sent to the Fitbit, where it is housed in secure Microsoft 
Azure servers, compliant with ISO/IEC 27001:2006 industry standards of encryption. Data 
sent from the phone includes the subject ID, all of the individual measurements taken by 
the Charge 3. This data can only be accessed by the study team. 
 
Additional details of this device are provided below. 

36 
 
Wear Charge 3 
 
 
Place Charge 3 around your wrist. 
 
 
Placement for all-day wear vs exercise 
When you're not exercising, wear Charge 3 a finger's width below your wrist bone. 
 
 
 
 
 
 
 
 
 
For optimized heart-rate tracking while exercising: 
 
• Try wearing Charge 3 higher on your wrist during exercise for an 
improved fit and more accurate heart-rate reading. Many exercises, 
such as bike riding or weight lifting, cause you to bend your wrist 
frequently, which can interfere with the heart-rate signal if the tracker 
is lower on your wrist. 

37 
 
 
• Make sure the tracker is in contact with your skin. 
• Don't wear your tracker too tight; a tight band restricts blood flow, 
potentially affecting the heart-rate signal. However, the tracker should 
be slightly tighter (snug but not constricting) during exercise than during 
all-day wear. 
• With high-intensity interval training or other activities where your wrist is 
moving vigorously and non-rhythmically, the movement may limit the 
sensor's ability to provide a heart-rate reading. If your tracker doesn't show 
a heart-rate reading, try relaxing your wrist and staying still briefly. 
 
Activity and Sleep 
 
 
Charge 3 continuously tracks a variety of stats whenever you wear it. The information is 
transferred to the Fitbit app every time you sync your tracker. 
 
See your stats 
From the clock face, swipe up to see your daily stats, including: 
 
• Core stats: steps taken today, calories burned, distance 
covered, floors climbed, and active minutes 
 
• Hourly activity: steps taken this hour and the number of hours you met 
your hourly activity goal 
 
• Heart rate: current heart rate and heart-rate zone 
 
• Female health tracking: information on the current stage of your 
menstrual cycle (if you don't use the female health feature in the 
Fitbit app, this tile won't appear) 
 
Find your complete history and other information automatically detected by 
your tracker, such as sleep data, in the Fitbit app. 
 
Track a daily activity goal 
Charge 3 tracks your progress towards a daily activity goal of your choice. When 
you reach your goal, the tracker vibrates and shows a celebration. 
 
 
Choose a goal 
Set a goal to help you get started on your health and fitness journey. To begin, 
your goal is to take 10,000 steps per day. Choose to change the number of 
steps taken, or to make your goal distance traveled, calories burned, or active 
minutes instead. 
 

38 
 
For instructions on how to change your goal, see help.fitbit.com. 
 
 
See goal progress 
For information on how to see detailed progress toward your goal, see "See 
your stats" on the previous page. 
 
Track your hourly activity 
Charge 3 helps you stay active throughout the day by keeping track of when 
you're stationary and reminding you to move. 
 
Reminders nudge you to walk at least 250 steps each hour. You'll feel a 
vibration and see a reminder on your screen at 10 minutes before the hour if 
you haven't walked 250 steps. When you meet the 250-step goal after 
receiving the reminder, you'll feel a second vibration and see a congratulatory 
message. 
 
 
For more information on hourly activity, including how to customize the 
hours you receive reminders, see help.fitbit.com. 
 
 
Track your sleep 
Wear Charge 3 to bed to automatically track your time asleep and sleep stages (time spent 
in REM, light sleep, and deep sleep). To see your sleep stats, sync your tracker when you 
wake up and check the app. 
 
For more information about sleep tracking, see help.fitbit.com. 
 
Set a sleep goal 
By default, you have a sleep goal of 8 hours of sleep per night. Customize this goal to meet 
your needs. 

39 
 
For more information about your sleep goal, including how to change it, see 
help.fitbit.com. 
 
Set a bedtime reminder 
The Fitbit app can recommend consistent bedtimes and wake times to help you 
improve the consistency of your sleep cycle. You can choose to be reminded nightly 
when it's time to start getting ready for bed. 
 
For more information about how to set bedtime reminders, see help.fitbit.com. 
 
Learn about your sleep habits 
Charge 3 tracks several sleep metrics including when you go to bed, how long you're 
asleep, and your time spent in each sleep stage. Track your sleep with Charge 3 and 
check the Fitbit app to understand how your sleep patterns compare to your peers. 
 
For more information about sleep stages, see help.fitbit.com. 
 
See your heart rate 
Charge 3 tracks your heart rate throughout the day. Swipe up from the clock screen to 
see your real-time heart rate and heart-rate zone. For more information on the stats 
on your tracker, see "See your stats" on page 30. 
 
During a workout, Charge 3 shows your heart-rate zone to help you target the 
training intensity of your choice. 
For more information about heart-rate zones on Charge 3, see "Check your 
heart rate" on page 40. 
 
Adjust your heart-rate setting 
Track your heart rate day and night with Charge 3. To preserve battery life, 
turn off heart-rate tracking in the Settings app > Heart Rate. 
 
Note that the green LED on the back of Charge 3 continues to flash even if you 
turn off heart-rate tracking. 
 
For more information about adjusting the heart-rate tracker, see help.fitbit.com. 
 
Practice guided breathing 
The Relax app on Charge 3 provides personalized guided breathing sessions to 
help you find moments of calm throughout the day. You can choose between 2- 
minute and 5-minute sessions. 
 
To begin a session: 
 
On Charge 3, open the Relax app. 
 

40 
 
The 2-minute session is the first option. Swipe left to choose the 5-minute session. 
 
Tap the play icon to start the session and follow the on-screen instructions. 
 
 
After the exercise, you'll see a summary that shows your alignment (how 
closely you followed the breathing prompt), your heart rate at the start and 
end of the session, and how many days you completed a guided breathing 
session this week. 
 
All notifications are automatically disabled during the session. 
 
For more information about guided breathing sessions, including the benefits 
of practicing deep breathing and safety information, see help.fitbit.com. 
 
Fitness and Exercise  
 
Track activity with the Exercise app and set exercise goals based on distance, time, or calories, or 
choose to automatically track exercise. 
 
Sync Charge 3 with the Fitbit app and share your activity with friends and family, see how your 
overall fitness level compares to your peers, and more. 
 
Track your exercise automatically 
Charge 3 automatically recognizes and records high-movement activities at least 15 minutes 
long—including run, elliptical, and swim. Sync your device to see basic stats about your activity in 
your exercise history. 
 
For greater precision or to see real-time stats and a workout summary on your tracker, manually 
start and stop an exercise with the Exercise app. For more information, see "Track and analyze 
exercise with the Exercise app" below. 
 
For more information about tracking activity, see help.fitbit.com. 
 
 
Track and analyze exercise with the Exercise app 
Track specific exercises—such as run, bike, swim, or weights—with the Exercise app on Charge 3 to 
see real-time stats, including heart-rate data, calories burned, and elapsed time, and a post-

41 
 
workout summary on your wrist. For complete workout stats, and route and pace information if you 
used GPS, review your exercise history in the Fitbit app. 
 
Note: The connected GPS feature on Charge 3 works with the GPS sensors on 
your nearby phone. 
 
 
 
GPS requirements 
To use connected GPS: 
1. Turn on Bluetooth and GPS on your phone. 
2. Make sure the Fitbit app has permission to use GPS or location services. 
3. Check that connected GPS is turned on for the exercise. 
a. Open the Exercise app and swipe to find the exercise you want to 
track. 
b. Swipe up and make sure Use Phone GPS is set to On. 
4. Keep your phone with you while you exercise. 
 
Track an exercise 
To track an exercise: 
 
1. On your tracker, open the Exercise app. 
2. Swipe to find an exercise. 
3. Tap the exercise to select it. 
4. Tap Start to begin the exercise, or tap Set Goal to choose a time, 
distance, or calorie goal depending on the activity. 
Note: If the exercise uses GPS, you'll see an icon in the top left as your tracker 
connects to your phone's GPS sensors. When the screen says "connected" and 
Charge 3 vibrates, GPS is connected. 
 
 
1. Tap the play icon to begin tracking your exercise. Charge 3 shows 
several real- time stats including heart rate, calories burned, and 

42 
 
elapsed time. Tap the middle stat to see additional stats. 
 
 
 
2. When you're done with your workout or want to pause, press the button. 
Note that if you set an exercise goal, your tracker vibrates when you 
reach the goal. 
3. Press the button again and tap Finish to end the workout. 
4. Swipe up to see your workout summary. 
5. Press the button to close the summary screen. 
 
 
Customize your exercise settings and shortcuts 
Customize settings for various exercise types and change or reorder exercise 
shortcuts in the Fitbit app. For example, turn connected GPS and cues on or 
off or add a yoga shortcut to Charge 3. 
 
To customize an exercise setting: 
 
1. From the Fitbit app dashboard, tap the Account icon ( 
 ) > Charge 3 
tile > Exercise Shortcuts. 
2. Tap the exercise you want to customize. 
3. Choose the settings you want to customize, then sync your device. 
 
For more information about changing or reordering exercise shortcuts, see 
help.fitbit.com. 
 
 
Check your workout summary 
After you complete a workout, Charge 3 shows a summary of your stats. 
 
 

43 
 
 
4. Charge 3 vibrates when you reach your goal. 
 
 
 
Check your heart rate 
Heart-rate zones help you target the training intensity of your choice. Charge 
3 shows your current zone and progress toward your maximum heart rate 
next to your heart-rate reading. In the Fitbit app, you can see your time spent 
in zones during a particular day or exercise. Three zones based on American 
Heart Association recommendations are available by default, or you can 
create a custom zone if you have a specific heart rate you're targeting. 
 
Default heart-rate zones 
Default heart-rate zones are calculated using your estimated maximum heart 
rate. Fitbit calculates your maximum heart rate with the common formula of 
220 minus your age. 
 
Icon 
Zone 
Calculation 
Description 
 
Out of 
Zone 
Below 50% 
of your 
maximum 
heart rate 
Your heart rate may be elevated, but not enough to be 
considered exercise. 

44 
 
Fat 
Burn 
Between 
50% and 
69% of 
your 
maximum 
heart rate 
This is a low-to-medium intensity exercise zone. This zone 
may be a good place to start for those new to exercise. It's 
called the Fat Burn zone because a higher percentage of 
calories are burned from fat, but the total calorie burn rate 
is lower. 
Cardio Between 
70% and 
84% of 
your 
maximum 
heart rate 
This is a medium-to-high intensity exercise zone. In this 
zone you're pushing yourself but not straining. For most 
people this is the exercise zone to target. 
Peak 
Greater 
than 85% 
of your 
maximum 
heart rate 
This is a high-intensity exercise zone. This zone is for short 
intense sessions that improve performance and speed. 
 
 
Custom heart-rate zones 
Configure a custom heart-rate zone or a custom max heart rate in the Fitbit 
app if you have a specific target in mind. For example, elite athletes might 
have a target 
that differs from the American Heart Association’s 
recommendations for most people. 
 
For more information, including links to relevant American Heart Rate 
Association information, see help.fitbit.com. 
 
General Info and Specifications  
 
 
Sensors 
Fitbit Charge 3 contains the following sensors and motors: 
 
A MEMS 3-axisaccelerometer, which tracks motion patterns 
• An altimeter, which tracks altitude changes 
• An optical heart-rate tracker 
 
Materials 
The housing and buckle on Charge 3 are made of anodized aluminum. While 
anodized aluminum can contain traces of nickel, which can cause an allergic reaction 

45 
 
in someone with nickel sensitivity, the amount of nickel in all Fitbit products meets the 
European Union's stringent Nickel Directive. 
 
The Fitbit Charge 3 classic band is made of a flexible, durable elastomer material similar to that 
used in many sports watches. 
 
Wireless technology 
Charge 3 contains a Bluetooth 4.0 radio transceiver and Fitbit-Pay enabled trackers contain an 
NFC chip. 
 
Haptic feedback 
Charge 3 contains a vibration motor for alarms, goals, notifications, and 
reminders. 
 
 
Battery 
Charge 3 contains a rechargeable lithium-polymer battery. 
 
Memory 
Charge 3 stores your data, including daily stats, sleep information, and exercise history, for 7 
days. For best results, sync your tracker daily. 
 
Display 
Charge 3 has an OLED display. 
 
 
Wristband size 
Wristband sizes are shown below. Note that accessory wristbands sold separately may 
vary slightly. 
 
Small wristband Fits a wrist between 5.5 - 7.1 inches (140 - 180 mm) in circumference 
Large wristband Fits a wrist between 7.1 - 8.7 inches (180 - 220 mm) in circumference 
 
Environmental conditions 
Operating Temperature 
14° to 113° F 
(-10° to 45° C) 
Non-operating Temperature 
-4° to 14° F 
(-20° to -10° C) 
113° to 140°F 
(45° to 60° C) 
Maximum Operating Altitude 
30,000 feet 
(9,144 m) 
 
 

46 
 
Learn more 
To learn more about your tracker and dashboard, visit help.fitbit.com. 
 
Regulatory & Safety Notices 
 
 
Notice to the User: Regulatory content for certain regions can also be viewed on your 
device. To view the content: 
 
Settings > About > Regulatory Info 
 
USA: Federal Communications Commission (FCC) statement 
Model FB409 
 
FCC ID: XRAFB409 
 
Model FB410: 
 
FCC ID: XRAFB410 
 
Notice to the User: The FCC ID can also be viewed on your device. To view the content: 
 
Settings > About > Regulatory Info 
 
This device complies with Part 15 of the FCC Rules. Operation is subject to the 
following two conditions: 
This device may not cause harmful interference and 
This device must accept any interference, including interference that may cause 
undesired operation of the device. 
FCC Warning 
 
Changes or modifications not expressly approved by the party responsible for compliance 
could void the user’s authority to operate the equipment. 
 
 
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, 
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection 
against harmful interference in a residential installation. This equipment generates, uses and can 
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may 
cause harmful interference to radio communications. However, there is no guarantee that 
interference will not occur in a particular installation. If this equipment does cause harmful interference 
to radio or television reception, which can be determined by turning the equipment off and on, the 
user is encouraged to try to correct the interference by one or more of the following measures: 
 
• Reorient or relocate the receiving antenna. 
• Increase the separation between the equipment and receiver. 
• Connect the equipment into an outlet on a circuit different from that to which the 

47 
 
receiver is connected. 
• Consult the dealer or an experienced radio/TV technician for help. 
 
This device meets the FCC and IC requirements for RF exposure in public or uncontrolled 
environments. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX B: ROAMDAP 2.0 COMPONENTS 

48 
 
 
For study participants randomized to the Treatment Arm (Positive Activity Exercises), they will have 
access to components A – D outlined below. 
Study participants randomized to the Control or Usual Care Arm (defined as all informational or 
educational resources provided through verbal communication or written hand-out materials) will only 
have access to component D, outlined below. 
All study participants will respond to survey questionnaires on their mobile devices. 
A. Positive Activity Exercises (Sample Landing Screen page): 
1. Positive Piggy Bank 
2. Gratitude Diary 
3. Savoring 
4. Pleasant Activity Scheduling 
5. Random Acts of Kindness 
6. Signature Strengths 
7. Love Letter 
8. Engaging with Beauty 
 
 
 

49 
 
 
 
Sample text with instructions provided to the caregiver: 
 
1. Positive Piggy Bank: 
 
As human beings, we tend to focus on negative things, people and events. This focus on the negative 
can undermine our happiness. Keeping a Positive Piggy Bank can help us focus on all the good things in 
our world, too. 
 
Step 1: When you observe something that makes you happy, take a moment as savor it. Think about 
what makes this so special to you. 
 
Step 2: Make a note to capture this thing or moment with enough detail that you can immediately recall 
what happened later. 
 
Step 3: Now, tap the coin and it will drop into your positive piggy bank. 
 
Step 4: You can make as many of these happy memory “deposits” as you like. The best part is that when 
you need a little pick-me-up, you may “break” open your piggy bank and read all of these happy notes. 
 
 
Examples: 
 
My best friend called to cheer me up. It worked! 
Peach pie with homemade whipped cream, yummy. 
My husband paid me the kindest compliment today. 
I love the feel of grass under my feet. 
 
2. Gratitude Diary: 
 
Feeling grateful is a powerful way to ward off depression and inspire feelings of optimism. It is perhaps 
the easiest positive emotion to tap in to when things are difficult. For that reason, we encourage you to 
keep a gratitude diary. You can do that right here! This is how to go about it: 
 
Step 1: Every day, note at least 2 things for which you are grateful. It can be anything – your friends and 
family, your pets, feeling the sunshine on your face, happy that a friend phoned, receiving a present, 
being able to take a walk, chocolate cupcakes … anything. Evenings, right before you go to sleep, usually 
works best. 
 
Step 2: Make a commitment to yourself that you will note at least 2 things every day, but here is a twist - 
the   things   you   list   MUST   be   DIFFERENT.   Try   never   to   repeat   anything. 
 
Step 3: Smile as you write these things down. This will help you to feel even more grateful. 
 
 
There are examples within the instructions above, but here are some if more are needed: 

50 
 
 
Bigger things: 
 My family 
My health 
Having enough food to eat 
My dear friend, Terry 
 
Smaller things: 
Children laughing 
The beach 
Peanut butter 
Puppies! 
 
3. Savoring: 
 
Savoring involves recognizing special moments and taking efforts to make them last and be more 
memorable. You can savor food, experiences, moments with loved ones, anything that brings you 
pleasure. 
 
Step 1: Consider a typical weekday. Review your morning routine, your daily activities, and your 
evening rituals, and consider how much time you spend noticing and enjoying the pleasures of the day, 
both small and large. 
 
Step 2: Every day for the next week, be sure to savor at least two experiences (for example, your 
morning coffee, or the sun on your face as you walk to your car). Spend at least 2-3 minutes savoring 
each experience. 
 
Step 3: Log these savoring experiences here so you can revisit them later. 
 
 
Here are some more things you could savor: 
 
Sunsets 
Fresh baked cookies 
Time with your best friend 
Visiting a new place 
Playing your favorite game 
A walk on a lovely day 
 
4. Pleasant Activity Scheduling: 
Providing care for loved ones can be incredibly time consuming. You might have already noticed that you 
have stopped doing many of the fun things you used to do. Yet, these pleasant activities are incredibly 
important and can help you better cope with stress. By scheduling and taking part in pleasant activities, 
you may find that you feel happier and have more energy. 
 
Step 1: Identify activities that you find to be pleasant. These activities do not have to be expensive or time 
consuming – they just need to be things you enjoy. Activities could include taking a walk in the park, 
listening to music, working on your hobby, seeing a movie with a friend or reading a great book. 
 
Step 2: Set aside time in the next week to do at least two of these activities. Put them on your calendar 
like an appointment and treat them with the same importance as you would a doctor’s appointment. 

51 
 
 
Step 3: Log what you did for your pleasant activity. Have fun, it’s good for you! 
 
 
5. Random Acts of Kindness: 
 
Although we do kind things daily, we often do not set out to intentionally do something nice for somebody 
else. Kindness is something always available for us to both give and receive. 
 
Step 1: For this activity, one day this week, do five kind acts all in one day. Take a little time to plan what 
you are going to do. For the first four acts, do these for other people. These people can be complete 
strangers or friends and family members. These can be small acts of kindness such as holding a door 
open, sharing a genuine compliment or giving somebody a hug. 
 
Step 2: You must also do one kind thing for you. People who take care of others tend to put them first 
and forget to be kind to themselves. It's important to take care of yourself, too! Perhaps, you could take a 
long bubble bath, go for a walk in the park, enjoy a Popsicle or sleep an extra 20 minutes. 
 
Step 3: Smile as you do these kind acts. You are putting good into the world! 
 
 
Here are some more ideas about kind acts you could do: 
 
Leave inspiring message sticky notes to be found. 
Give a friend a small gift for no particular reason. 
Call a family member out of the blue and tell them how much they mean to you. 
 
 
6. Signature Strengths: 
 
Character strengths are connected with resilience and buffer people from vulnerabilities that can lead to 
depression and anxiety. Your unique set of character strengths make you, you. Using these strengths 
more regularly and in different ways can help you lead a more successful and rewarding life. 
 
Step 1: Based on the Brief Strengths Test, note your top seven strengths. 
 
Step 2: Every day for the next week, use one of these strengths in a way that you have not used it before. 
 
Step 3: Each night, note how you used one of your strengths that day, including what strength you used, 
how you felt before, during, and after the activity, and whether you plan to repeat it in the future. 
 
 
 
Examples: 
 
If “creativity” is one of your strengths and you usually use creativity for arts and crafts, try using creativity 
to solve a difficult problem at work. 
 
If “zest” is a strength of yours and you focus this on your hobby of cooking, try using zest to improve the 
quality of your friendships. 

52 
 
 
If “hope” is a strength of your and you tend to use hope to strengthen your faith, perhaps you could use 
hope in your exercise regime to envision the positive strides you can make. 
 
 
7. Love Letter: 
 
Finding ways to express warmth, care, deep positive regard, and authentic appreciation to those we love 
is important to us (the giver) to express, and for the receiver to hear and experience. 
 
Step 1: Think about the love you have for the person for whom you are providing care. 
 
Step 2: Write a brief love letter to this person. In the letter, tell your loved one about your love for him or 
her, offering your thoughts, feelings and specific examples. Also, consider linking your love to something 
that happened today or recently. 
 
Step 3: Share your letter with the person you care for. 
 
 
8. Engaging with Beauty: 
 
Beauty in nature can inspire the emotion of ‘awe,’ beauty in art and skill can inspire admiration, and the 
witnessing of beauty in positive acts of human behavior can inspire more positive acts echoing like a 
ripple in a pond. 
 
Step 1: Create a Beauty Log where you will add your observations about three different types of beauty: 
beauty in nature, beauty that is man-made (e.g., art, music, dance, architecture) or beautiful human 
behavior (e.g., kind acts, brave acts). 
 
Step 2: Look for beauty as you go through the day. When you observe something that is beautiful, add it 
to your log in text or photo form. 
 
B. Forum for Caregivers to post positive comments based on Positive Activity exercises that are shared 
with other Caregiver participants: 
1. Gratitude Room 
2. Acts of Kindness Room 
3. Observed Beauty Room 
4. Strengths Room 
5. Love Letter Room 
 
C. Caregiver-Specific Resources (Guides) 
1. Healthy Nutrition, Physical Activity, and Sleep Tips 
2. Ann Arbor Guide and Caregiver Resource Links 
3. Caregiver’s Guide to Patient’s Symptom Management Tips 
4. Navigating through Hematopoietic Cell Transplantation (HCT): A Guide for Pediatric HCT 
 
D. Mood, Sleep, and Steps 
1. Patients and caregivers will be provided graphs of daily mood, sleep, and steps data (sample data 
plot shown on next page), depending on whether the participants respond to the daily mood 
questionnaire – scale between 1-10, anchored to “worst possible” and “best possible,” respectively 
– and wear the Fitbit Charge 3. 

53 
 
 

54 
 
APPENDIX C: SOCIAL RHYTHMS APP INTERFACE 
 
 
Social rhythms is an app that collects data from either HealthKit on the app or Fitbit (health, sleep, and activity data). It 
uses this data to generate a report to the user about their circadian rhythm and supplies this report after a few days. The 
user can submit their data and obtain a report as frequently or little as they would like. 
 
The report gives information on; 
a. Activity pattern: How your body’s time clock has shifted due to the pandemic 
b. Regularity: Has your schedule become more or less regular during COVID 
c. Shift: Has your internal clock shifted to become earlier or later 
d. Sleep time: What time does your body start preparing for sleep 
e. Avoid light: What time should you begin to avoid bright light to avoid delaying your clock 
f. 
Light exposure: What time being exposed to light help you stay on track 
 
 
 
 
 

55 
 
APPENDIX D: CAREGIVER- AND PATIENT-REPORTED OUTCOME MEASURES 
 
NIH PROMIS Tools 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*A collection of 4-item short forms assessing anxiety, depressive symptoms, fatigue, pain interference, physical function- 
mobile, and peer relationships as well as a single pain intensity item. 
†A collection of 4-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep 
disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. 
SELF-REPORT 
Adult Patient 
(age ≥ 18 years) 
Pediatric Patient 
(ages 8-17 
years) 
Adult Caregiver 
(≥ 18 years) 
Parent Proxy for 
Pediatric 
Patients (ages 5-
17 years) 
Baseline 
Caregiver 
Assessment 
44 
Global Health 
10 
9 
10 
9 
Companionship 
4 
4 
Self-Efficacy 
for Managing 
Symptoms 
4 
4 
Self-Efficacy 
for Managing 
Daily Activities 
4 
4 
Positive Affect 
and Well-Being 
9 
10 
(ages 13-17 
years) 
9 
Emotional 
Support 
8 
7 
8 
Sleep 
Disturbance 
4 
4 
Caregiver 
Anxiety 
6 
Caregiver 
Strain 
6 
Perceived 
Stress Scale 
10 
10 
Profile 25* and 
29+2† 
29 
25 
29 
25 

56 
 
CAREGIVER PARTICIPANT DEMOGRAPHICS 
 
ABOUT YOU 
 
1. What is your age?  
 
 
2. What is the age fo the patient you care for? 
a. 5‐17 years old 
b. 18 years old or older 
 
3. What is your zip code?  
 
 
 
4. What is your gender? 
a. Female 
b. Male 
c. Not listed (Please specify 
) 
 
5. Are you of Spanish, Hispanic or Latino origin or descent? 
a. No 
b. Yes 
 
6. What is your race? (choose all that apply) 
a. White 
b. Black or African American 
c. Asian 
d. Native Hawaiian or other Pacific Islander 
e. American Indian or Alaska Native 
f. 
Other (please specify)  
 
 
 
7. What is your marital status? 
a. Single, never married 
b. Married or in domestic partnership 
c. Widowed 
d. Divorced 
e. Separated 
 
8. What is the highest grade or level of schooling that you have completed? 
a. Elementary school 
b. 8th grade or less 
c. Some high school, did not graduate 
d. High school graduate or GED 
e. Some college or 2‐year degree 
f. 
4‐year college graduate 
g. More than 4‐year college degree 
h. Not applicable 

57 
 
9. Including yourself, how many adults 18 years or older currently live in your household? 
Write in number of adult(s):  
 
 
10. How many children under 18 years old currently live in your household? 
Write in number of children:  
 
 
11. What is your current occupation, or if not currently working, what was your last job for pay? 
Please specify occupation:  
 
 
 
12. What is your current employment status? 
a. Employed full‐time (40 or more hours per week) 
b. Employed part time (up to 39 hours per week) 
c. Self‐employed 
d. Student 
e. Retired 
f. 
Homemaker 
g. Unemployed and currently looking for work 
h. Unemployed and not currently looking for work 
i. 
Unable to work (i.e. due to caregiving) 
 
13. What was your job for pay during the week of your transplant? 
Please specify occupation:  
 
 
14. What is your monthly income from employment at this time? 
Less than $1,000 
$1,000 to $2,999 
 
$3,000 to $4,999 
 
$5,000 to $6,999 
 
$7,000 or more 
 
15. How supportive has your employer been about your loved one’s (the patient) illness and need to undergo transplant? 
 
Unsupportive 
Completely 
Supportive 
Not 
Applicable 
 
1 
2 
3 
4 
5 
NA 
 
16. Have you been able to use family and medical leave (FMLA) provided through your employer? 
Yes 
No, not offered by employer 
No, did not need it 
No, self‐employed or not employed 
 
17. Have you used any of the following to help care for your loved one? Please mark yes or no for each. 

58 
 
Vacation time............................................................................. 
Yes 
No 

59 
 
Employer paid sick days or paid medical leave.......................... 
Personally purchased or employer-sponsored disability insurance 
Unpaid time off.......................................................................... 
Yes 
No 
Yes 
No 
Yes 
No 
 
 
18. Since your loved one’s transplant, about how much total time have you taken off from work? 
Write in number of weeks:  
 
 
19. How much of the time you took off was paid time off? 
None 
Less than half 
About half 
 
More than half 
 
All 
 
 
CURRENT HOUSEHOLD FINANCES 
 
20. In general, how satisfied are you with your family’s present financial situation? Please circle one. 
Not satisfied at all 
Completely satisfied 
1 
2 
3 
4 
5 
 
21. How difficult is it for you/your family to meet monthly payments on your bills? Please circle one. 
Not difficult at all 
Extremely difficult 
1 
2 
3 
4 
5 
 
22. How do your family’s finances usually work out at the end of the month? 
Some money left over 
Just enough money 
 
Not enough money 
 
23. Compared to before your loved one’s transplant, how has your monthly household income changed? 
It has decreased 
It is about the same 
It has increased 
 
24. The following questions ask about things people do when money is tight. Since your loved one’s transplant, how 
often did you or your family have to do any of the following? Please circle one. 
 
Never 
Rarely 
Sometimes 
Often 
Reduce spending on essential household expenses 
(food, clothing, rent/mortgage)?............................ 
1 
2 
3 
4 

60 
 
Withdraw from retirement or savings accounts?... 
1 
2 
3 
4 
Borrow money to help pay for bills?..................... 
1 
2 
3 
4 
Reduce leisure activities?....................................... 
1 
2 
3 
4 
Cut back on prescribed medications?..................... 
1 
2 
3 
4 
 
25.  Related to your loved one’s transplant, have you received any of the following resources to help cover expenses? 
Please check all that apply. 
Social Security Disability Insurance or Social Security Insurance 
Government assistance programs (food stamps, fuel or cash assistance) 
Institutional financial assistance from the hospital or university(discount hotel rooms, gas, food gift cards) 
Local or national charities (churches/synagogues) 
None of the above 
26. What is your annual household income? 
a. Less than $10,000 
b. $10,000 ‐ $14,999 
c. $15,000 ‐ $24,999 
d. $25,000 ‐ $34,999 
e. $35,000 ‐ $49,999 
f. 
$50,000 ‐ $74,999 
g. $75,000 ‐ $99,999 
h. $100,000 ‐ $200,000 
i. 
More than $200,000 
j. 
Prefer not to answer 
 
HEALTH INSURANCE AND MEDICAL COSTS 
 
 
27. Are you currently covered by any of the following types of health insurance or health coverage plans? 
Please check all that apply. 
Insurance through a current or former employer or union (of you or another family member) 
Insurance purchased directly from an insurance company (of you or another family member) 
 
Medicare, for people 65 and older, or people with certain disabilities 
 
Medicaid 
 
VA or TRICARE or other military health care 
 
28. How satisfied are you with your current insurance coverage? Please circle one. 
Not satisfied at All 
Completely satisfied 

61 
 
1 
2 
3 
4 
5 
 
29. About how much of your own money did you spend last year for your medical care (including prescriptions, co‐ 
payments, deductibles, and premiums)? 
$ 
dollars per month 
 
30. The next questions are about costs associated with your loved one’s transplant that are not direct medical costs. 
Since your loved one’s transplant, how difficult has it been for you to pay for the following costs? Please circle one 

62 
 
number or “N/A” if you did not have the type of cost after your transplant. 
 
 
 
 
 
Not 
Applicable 
 
N/A 
 
 
N/A 
 
 
N/A 
 
 
N/A 
 
 
31. How difficult is it for you to pay your medical bills (including prescriptions, co‐payments, premiums, and 
deductibles)? Please circle one. 
Not difficult at all 
Extremely difficult 
1 
2 
3 
4 
5 
 
 
32. The following questions ask about things that may make your life more difficult or stressful. 
During the last year, how much have each of the following added stress in your life? 
 
Worry about being a burden on your family… 
Worry about not having money for necessities like 
food, utilities, and housing………………. 
Worry about losing or not having health 
insurance……………………………………... 
Worry about cost of your health insurance....... 
Worry about paying medical bills……………. 
33. Thinking back to before your loved one’s transplant, how informed do you feel you are about post‐transplant related 
costs? 
Not at all informed 
 
Somewhat informed 
 
Extremely informed 
Not at all 
difficult 
Extremely 
difficult 
Paying to temporarily relocate closer 
to transplant center............... 
1 
2 
3 
4 
5 
Paying for transportation to and from 
your appointments (gas, 
parking)........................................... 
1 
2 
3 
4 
5 
Paying for transplant‐related changes 
at home (cleaning, 
1 
2 
3 
4 
5 
special foods).................................. 
Paying for care services for children 
or parents usually in my 
care.................................................. 
1 
2 
3 
4 
5 
Not at all 
A lot 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 

63 
 
34. Who gave you information about post‐transplant related costs? (Check all that apply) 
Doctor 
Nurse 
 
Social worker 
 
Resource specialist 
Someone else → Who?  
 
 
No one 
35. What is your relationship to the person you are caring for who will receive a transplant? I am the patient’s: 
a. Mother 
b. Father 
c. Daughter/Son 
d. Daughter/Son 
e. Wife 
f. 
Husband 
g. Grandmother 
h. Grandfather 
i. 
Sister 
j. 
Brother 
k. Aunt 
l. 
Uncle 
m. Cousin 
n. Neighbor 
o. Friend 
p. Other (please specify  
) 
 
 
YOUR CURRENT HEALTH AND WELL‐BEING 
 
 
36. For the following questions please circle the number between 1 and 7 that best applies to you. 
How would you rate your overall health during the past year? 
 
Very Poor 
Excellent 
1 
2 
3 
4 
5 
6 
7 
 
 
 
 
How would you rate your overall quality of life during the past year? 
Very Poor 
Excellent 
1 
2 
3 
4 
5 
6 
7 

64 
 
YOUR CAREGIVING EXPERIENCES 
37. At the time of transplant, how many hours of caregiving did you provide per week for (NAME)? By caregiving, we mean 
help with meals, dressing, bathing, errands, cooking and cleaning, as well as medical care. Please do not include time 
that you would usually spend caring for young children. 
a. Less than 5 hours 
b. 5 – 10 hours 
c. Between 10 – 20 hours 
d. Between 20 – 30 hours 
e. Between 30 – 40 hours 
f. 
More than 40 hours 
 
38. What is the proximity of the patient’s primary residence to your primary residence? 
a. Lived with me 
b. Same state 
c. In a different state 
d. In a different country 
e. Other (please specify)  
 
 
 
39. [IF Q2=b,c, or e] How far do you live from the patient? 
a. Less than 30 minutes by car 
b. 30 minutes ‐1 hour by car[TS1] 
c. 1 – 2 hours by car 
d. 2 – 5 hours by car 
e. More than 5 hours by car 
f. 
Other (please specify)  
 
 
 
40. While caring for your loved one during the upcoming transplant, who else are you supporting with medical care? 
(Please mark all that apply)? 
a. Child(ren) 
b. Spouse 
c. Parent 
d. Sibling 
e. Other (please specify)  
 
f. 
No one else 
 
41. Did you receive financial support for providing medical care for the patient? 
a. Yes 
b. No 
c. I’m not sure 
 
YOUR USE OF MOBILE DEVICES/TECHNOLOGY 
We would like to learn about how caregivers use mobile technology. We refer to mobile technology as devices such as 
cell phones (smartphones), tablets (iPads), laptop computers, and wearable devices (e.g., Fitbit, Apple Watch). 

65 
 
41. What is your primary type of cell phone? 
a. Apple iPhone 
b. Android smartphone (e.g., Samsung, Google) 
c. Microsoft windows smartphone (e.g., Microsoft, HP Elite) 
d. Cell phone that is not a smartphone 
e. Other (please specify)  
 
f. 
I do not own a cell phone 
 
42. Do you own a mobile tablet device? (selectall that apply) 
a. Apple iPad 
b. Android tablet (e.g., Samsung, Kindle) 
c. Microsoft windows tablet (e.g., Microsoft Surface, Dell Venue) 
d. Other (please specify)  
 
e. I do not own a tablet 
 
43. Do you own a fitness or smart watch? (select all that apply) 
a. Apple iWatch 
b. Fitbit Fitness Watch 
c. Garmin Fitness Watch 
d. Other (please specify)  
 
e. I do not own a fitness or smart watch 
42. How many different mobile applications or “apps” do you have on your cell or tablet phone? 
a. 5 or less applications 
b. 6 – 10 applications 
c. 11 – 20 applications 
d. 21 – 50 applications 
e. More than 50 applications 
 
f. 
How many different apps do you use at least once a day on your cell phone or tablet?5 or less applications 
g. 6 – 10 applications 
h. 11 – 20 applications 
i. 
21 – 50 applications 
j. 
More than 50 applications 
 
43. Which of the following health or wellness‐related apps do you use on your smartphone or tablet? (Select all that apply) 
a. Fitness workouts 
b. Counting steps 
c. Nutrition (e.g., tracking calories, recording diet) 
d. Meditation or stress management 
e. Sleep 
f. 
Other (please specify)  
 
g. None, or I do not own a smartphone or tablet 
 
44. Do you have any of the following health conditions? (Selectall that apply) 
a. High blood pressure 
b. High cholesterol 

66 
 
c. Heart disease 
d. Stroke 
e. Arthritis 
f. 
Diabetes 
g. Kidney disease 
h. Migraine headaches 
i. 
Seasonal allergies 
j. 
Anxiety 
k. Depression 
l. 
Post‐traumatic stress disorder 
m. Other mental health disorder 
n. COPD 
o. Alzheimer’s disease 
p. Cancer 
q. Asthma 
r. Multiple sclerosis (MS) 
s. Parkinson’s disease 
t. 
Brain injury 
u. Spinal cord injury 
v. None 
w. Other (please specify)  
 
 
Do you use any apps to help you manage any specific health conditions for yourself? (please check all that apply) 
 
YES 
NO 
a.  Diabetes 
b. Heart conditions 
c.  Mental health (e.g., depression, anxiety) 
d. Cognitive behavioral therapy 
e.  Allergies 
f. 
Migraine headaches 
g. Other (please specify)  
 
 
Other than your calendar, do you use any apps to help you manage your health? 
 
YES 
NO 
x. Medication management 
y. Appointment reminders 
z. Menstruation or fertility planning 
aa. Food intake or diet 
bb. Weight management 
cc. 
Other (please specify)  
 
 
45. Overall, how satisfied are you with these applications to self‐manage your health? 
a. Satisfied 
b. Neutral 
c. Dissatisfied 

67 
 
46. In the space below, please feel free to add any comments about the survey, the study or how the transplant has 
made an impact on your financial situation. 
 
Thank you for completing this survey! 

68 
 
Patient PARTICIPANT DEMOGRAPHICS 
 
ABOUT YOU 
 
47. What is your age?  
 
 
48. What best describes you? 
a. 18 and older 
b. 16‐17 
c. 13‐15 
d. 10‐12 
e. 8‐9 
f. 
5‐7 
 
49. What is your gender? 
a. Female 
b. Male 
c. Not listed (Please specify 
) 
 
50. Are you of Spanish, Hispanic or Latino origin or descent? 
a. No 
b. Yes 
 
51. What is your race? (choose all that apply) 
a. White 
b. Black or African American 
c. Asian 
d. Native Hawaiian or other Pacific Islander 
e. American Indian or Alaska Native 
f. 
Other (please specify)  
 
 
 
52. What is your marital status? 
a. Single, never married 
b. Married or in domestic partnership 
c. Widowed 
d. Divorced 
e. Separated 
 
53. What is the highest grade or level of schooling that you have completed? 
a. Elementary school 
b. 8th grade or less 
c. Some high school, did not graduate 
d. High school graduate or GED 
e. Some college or 2‐year degree 
f. 
4‐year college graduate 
g. More than 4‐year college degree 

69 
 
h. Not applicable 
 
54. Including yourself, how many adults 18 years or older currently live in your household? 
 
 
55. How many children under 18 years old currently live in your household? 
 
 
The following questions are only for participants that are at least 18 years old 
 
56. What is your current occupation, or if not currently working, what was your last job for pay? 
 
 
 
57. What is your current employment status? 
a. Employed full‐time (40 or more hours per week) 
b. Employed part time (up to 39 hours per week) 
c. Self‐employed 
d. Student 
e. Retired 
f. 
Homemaker 
g. Unemployed and currently looking for work 
h. Unemployed and not currently looking for work 
i. 
Unable to work (i.e. due to caregiving) 
 
58. What is your monthly income from employment at this time? 
Less than $1,000 
$1,000 to $2,999 
 
$3,000 to $4,999 
 
$5,000 to $6,999 
 
$7,000 or more 
 
59. How supportive has your employer been about your illness and need to undergo transplant? Please circle one. 
 
Completely 
Unsupportive 
Unsupportive 
Neutral 
Supportive 
Completely 
Supportive 
Not 
Applicable 
 
1 
2 
3 
4 
5 
NA 
 
60. Have you been able to use family and medical leave (FMLA) provided through your employer? 
Yes 
No, not offered by employer 
No, did not need it 
 
CURRENT HOUSEHOLD FINANCES (Only displayed if the patient is at least 18 years old) 

70 
 
61. In general, how satisfied are you with you/your family’s present financial situation? 
a. Extremely satisfied 
b. Somewhat satisfied 
c. Neither satisfied nor dissatisfied 
d. Somewhat dissatisfied 
e. Extremely dissatisfied 
 
62. How difficult is it for you/your family to meet monthly payments on your bills? 
a. Extremely easy 
b. Somewhat easy 
c. Neither easy nor difficult 
d. Somewhat difficult 
e. Extremely difficult 
 
 
63. How do your family’s finances usually work out at the end of the month? 
Some money left over 
Just enough money 
 
Not enough money 
 
64. Compared to before your transplant, how has your monthly household income changed? 
It has decreased 
It is about the same 
It has increased 
 
65. The following questions ask about things people do when money is tight. Since your transplant, how often did you or 
your family have to do any of the following? Please circle one. 
 
Never 
Rarely 
Sometimes 
Often 
Reduce spending on essential household expenses 
(food, clothing, rent/mortgage)? 
1 
2 
3 
4 
Withdraw from retirement or savings accounts? 
1 
2 
3 
4 
Borrow money to help pay for bills? 
1 
2 
3 
4 
Reduce leisure activities? 
1 
2 
3 
4 
Cut back on prescribed medications?..................... 
1 
2 
3 
4 
 
66.  Related to your transplant, have you received any of the following resources to help cover expenses? Please check 
all that apply. 
Social Security Disability Insurance or Social Security Insurance 
Government assistance programs (food stamps, fuel or cash assistance) 
University of Michigan financial assistance (discount hotel rooms, gas, food gift cards) 
Local or national charities (churches/synagogues) 
None of the above 
67. What is your annual household income? 
a. Less than $10,000 

71 
 
b. $10,000 ‐ $14,999 
c. $15,000 ‐ $24,999 
d. $25,000 ‐ $34,999 
e. $35,000 ‐ $49,999 
f. 
$50,000 ‐ $74,999 
g. $75,000 ‐ $99,999 
h. $100,000 ‐ $200,000 
i. 
More than $200,000 
j. 
Prefer not to answer 
 
HEALTH INSURANCE AND MEDICAL COSTS (Only displayed if the patient is at least 18 years old) 
 
 
68. Are you currently covered by any of the following types of health insurance or health coverage plans? 
Please check all that apply. 
Insurance through a current or former employer or union (of you or another family member) 
Insurance purchased directly from an insurance company (of you or another family member) 
 
Medicare, for people 65 and older, or people with certain disabilities 
 
Medicaid 
 
VA or TRICARE or other military health care 
 
69. How satisfied are you with your current insurance coverage? 
a. Extremely satisfied 
b. Somewhat satisfied 
c. Neither satisfied nor dissatisfied 
d. Somewhat dissatisfied 
e. Extremely dissatisfied 
 
70. About how much of your own money did you spend last year for your medical care (including prescriptions, co‐ 
payments, deductibles, and premiums)? 
$ 
dollars per month 
 
71. How difficult is it for you to pay your medical bills (including prescriptions, co‐payments, premiums, and 
deductibles)? 
a. Extremely easy 
b. Somewhat easy 
c. Neither easy nor difficult 
d. Somewhat difficult 
e. Extremely difficult 
f. 
Not applicable 
 
72. The next questions are about costs associated with your loved one’s transplant that are not direct medical costs. 
Related to your transplant, how difficult has it been for you to pay for the following costs? Please circle one number 
or “N/A” if you did not have the type of cost after your transplant. 

72 
 
As 
73. The 
 
Not 
Applicable 
 
 
N/A 
 
 
N/A 
 
N/A 
N/A 
 
following questions ask about things that may make your life more difficult or stressful. 
During the last year, how much have each of the following added stress in your life? 
Worry about being a burden on your family 
Not at all 
1 
2 
3 
A lot 
4 
Worry about not having money for necessities like 
food, utilities, and housing 
1 
2 
3 
4 
Worry about losing or not having health insurance 
1 
2 
3 
4 
Worry about cost of your health insurance 
1 
2 
3 
4 
Worry about paying medical bills 
1 
2 
3 
4 
 
74. Thinking back to before your transplant, how informed do you feel you are about post‐transplant related costs? 
Not at all informed 
Somewhat informed 
 
Extremely informed 
 
75. Who gave you information about post‐transplant related costs? (Check all that apply) 
Doctor 
Nurse 
 
Social worker 
 
Resource specialist 
Someone else → Who?  
 
 
No one 
 
 
YOUR USE OF MOBILE DEVICES/TECHNOLOGY 
Not at all 
difficult 
difficult 
as usual 
Extremely 
difficult 
Paying to temporarily relocate closer 
to transplant center 
1 
2 
3 
4 
5 
Paying for transportation to and from 
your appointments (gas, parking, bus 
fares, etc) 
1 
2 
3 
4 
5 
Paying for transplant‐related changes 
at home (cleaning, 
1 
2 
3 
4 
5 
special foods) 
Paying for care services for children 
or parents usually in my care 
1 
2 
3 
4 
5 

73 
 
We would like to learn about how caregivers use mobile technology. We refer to mobile technology as devices such as 
cell phones (smartphones), tablets (iPads), laptop computers, and wearable devices (e.g., Fitbit, Apple Watch). 
 
 
44. What is your primary type of cell phone? 
a. Apple iPhone 
b. Android smartphone (e.g., Samsung, Google) 
c. Microsoft windows smartphone (e.g., Microsoft, HP Elite) 
d. Cell phone that is not a smartphone 
e. Other (please specify)  
 
f. 
I do not own a cell phone 
 
45. Do you own a mobile tablet device? (slecetall that apply) 
a. Apple iPad 
b. Android tablet (e.g., Samsung, Kindle) 
c. Microsoft windows tablet (e.g., Microsoft Surface, Dell Venue) 
d. Other (please specify)  
 
e. I do not own a tablet 
 
46. Do you own a fitness or smart watch? (select all that apply) 
a. Apple iWatch 
b. Fitbit Fitness Watch 
c. Garmin Fitness Watch 
d. Other (please specify)  
 
e. I do not own a fitness or smart watch 
47. How many different mobile applications or “apps” do you have on your cell or tablet phone? 
a. 5 or less applications 
b. 6 – 10 applications 
c. 11 – 20 applications 
d. 21 – 50 applications 
e. More than 50 applications 
 
48. How many different apps do you use at least once a day on your cell phone or tablet? 
a. 5 or less applications 
b. 6 – 10 applications 
c. 11 – 20 applications 
d. 21 – 50 applications 
e. More than 50 applications 
 
49. Which of the following health or wellness‐related apps do you use on your smartphone or tablet? (select all that apply) 
a. Fitness workouts 
b. Counting steps 
c. Nutrition (e.g., tracking calories, recording diet) 
d. Meditation or stress management 
e. Sleep 
f. 
Other (please specify)  
 

74 
 
g. None, or I do not own a smartphone or tablet 
 
50. Do you have any of the following health conditions? (select all that apply) 
a. High blood pressure 
b. High cholesterol 
c. Heart disease 
d. Stroke 
e. Arthritis 
f. 
Diabetes 
g. Kidney disease 
h. Migraine headaches 
i. 
Seasonal allergies 
j. 
Anxiety 
k. Depression 
l. 
Post‐traumatic stress disorder 
m. Other mental health disorder 
n. COPD 
o. Alzheimer’s disease 
p. Cancer 
q. Asthma 
r. Multiple sclerosis (MS) 
s. Parkinson’s disease 
t. 
Brain injury 
u. Spinal cord injury 
v. None 
w. Other (please specify)  
 
 
If none is not selected above: If any, for which of the following of your illnesses do you use an app to help manage? 
(please check all that apply) 
 
YES 
NO 
High blood pressure 
High cholesterol 
Heart disease 
Stroke 
Arthritis 
Diabetes 
Kidney disease 
Migraine headaches 
Seasonal allergies 
Anxiety 
Depression 
Post‐traumatic stress disorder 
Other mental health disorder 
COPD 
Alzheimer’s disease 
Cancer 
Asthma 
Multiple sclerosis (MS) 

75 
 
Parkinson’s disease 
Brain injury 
Spinal cord injury 
None 
Other (please specify)  
 
 
Other than your calendar, do you use any apps to help you manage your health? 
 
YES 
NO 
x. Medication management 
y. Appointment reminders 
z. Menstruation or fertility planning 
aa. Food intake or diet 
bb. Weight management 
cc. 
Other (please specify)  
 
 
51. Overall, how satisfied are you with these applications to self‐manage your health? 
a. Satisfied 
b. Neutral 
c. Dissatisfied 

76 
 
Feasibility and Acceptability (Provided for caregivers and patients that are older than 12) 
Regarding the Fitbit watch; 
The instructions for the Fitbit® set up were easy to understand. 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
The Fitbit® was easy to set up. 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
The Fitbit® was easy to use. 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
The Fitbit® was comfortable to wear. 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
The Fitbit® data was easy to sync with my phone. 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
I was confident using the Fitbit®. 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
Regarding the Roadmap 2.0 App; 
The instructions for the Roadmap app set up were easy to understand 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
The Roadmap 2.0 app was easy to download and set up 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
The Roadmap 2.0 app was easy to use 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
I am confident using the Roadmap 2.0 app 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
 
Regarding the questionnaires 
 
The survey questions were easy to understand 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
 
The survey questions were easy to answer 
1 = Totally disagree, 2 = Disagree, 3 = Sometimes agree/disagree, 4 = Agree, 5 = Totally agree 
Regarding the overall experience 
What is your overall rating of the design of the screens on the app, including the colors and the layout? 
1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, 5 = Excellent 
Please comment any thoughts or suggestions to make the app more user-friendly, enjoyable, or helpful? 
How likely would you be to engage in a similar study that lasted 6 months? 
1. Extremely unlikely 
2. Unlikely 
3. Neutral 

77 
 
4. Likely 
5. Extremely likely 
 
How likely would you be to engage in a similar study that lasted 1 year? 
1. Extremely unlikely 
2. Unlikely 
3. Neutral 
4. Likely 
5. Extremely likely 
 
Compared to what you expected, how would you rate your experience in participating in this research study? 
1. A lot worse than expected 
2. A little worse than expected 
3. About the same as expected 
4. A little better than expected 
5. A lot better than expected 

78 
 
Global Health: Adult Patient and Caregiver will complete 
 
 
 
 

79 
 
 

80 
 
Global Health: Pediatric Patient (age 8-17 years) will complete 
 

81 
 
Global Health: Parent Proxy for Pediatric Patients (age 5-17 years) will complete 
 

82 
 
Companionship: Adult Patient and Caregiver will complete 
 

83 
 
Self-Efficacy for Managing Symptoms: Adult Patient and Caregiver will complete 
 

84 
 
Self-Efficacy for Managing Daily Activities: Adult Patient and Caregiver will complete 
 

85 
 
Positive Affect and Well-Being: Adult Patient and Caregiver will complete 
 

86 
 
Positive Affect: Pediatric Patients (age 13-17 years) will complete 
 

87 
 
NIH Toolbox Item Bank v2.0 – Emotional Support (Ages 18+) – Fixed Form 
 
Emotional Support (Ages 18+) – Fixed Form 
 
Please respond to each question or statement by marking one box per row. 
 
 
In the past month, please describe how 
often… 
 
 
Never 
Rarely 
Sometime 
s 
 
 
Usually 
Always 
 
SOC222 I can get helpful advice from others 
when dealing with a problem 
.............................. 
 
 
 
 
 
 
 
 
 
 
SOC200 
I have someone who understands 
my problems 
.................................................... 
 
 
 
 
 
 
 
 
 
 
SOC203 I have someone who will listen to 
me when I need to 
talk..................................... 
 
 
 
 
 
 
 
 
 
 
SOC204 I feel there are people I can talk to if 
I am 
upset................................................. 
.......... 
 
 
 
 
 
 
 
 
 
 
SOC205 I have someone to talk with when I 
have a bad 
day................................................... 
.... 
 
 
 
 
 
 
 
 
 
 
SOC206 I have someone I trust to talk with 
about my problems 
.............................................. 
 
 
 
 
 
 
 
 
 
 
SOC207 I have someone I trust to talk with 
about my 
feelings............................................ 
..... 
 
 
 
 
 
 
 
 
 
 

88 
 
 
 
I have someone to turn to for 
suggestions about how to deal 
with a problem.............. 
 
 
 
 
 
 
 
 
 
 

89 
 
NIH Toolbox Item Bank v2.0 – Emotional Support (Ages 8‐17) – Fixed 
Form 
 
Emotional Support (Ages 8‐17) – Fixed Form 
 
Please respond to each question or statement by marking one box per row. 
 
 
In the past month, please describe 
how 
often… 
 
 
 
Never 
Rarely 
Sometime 
s 
 
 
 
Usually 
Always 
 
 
6 November 2016 
©2006-2016 National Institutes of Health and Northwestern University Page 1 of 1 
SOC200 I have someone who understands 
my problems 
.................................................... 
 
 
 
 
 
 
 
 
 
 
SOC203 I have someone who will listen to 
me when I need to talk 
..................................... 
 
 
 
 
 
 
 
 
 
 
SOC205 I have someone to talk with when I 
have a bad day 
....................................................... 
 
 
 
 
 
 
 
 
 
 
SOC216 There is someone around to help 
me if I need it 
........................................................ 
. 
 
 
 
 
 
 
 
 
 
 
SOC222 I can get helpful advice from 
others when dealing with a 
problem............................... 
 
 
 
 
 
 
 
 
 
 
SOC225 I get useful advice about important 
things in my life 
.................................................... 
 
 
 
 
 
 
 
 
 
 
SOC226 I have someone to talk with about 
school problems 
..................................................... 
 
 
 
 
 
 
 
 
 
 

90 
 
Sleep Disturbance: Pediatric Patients (age 8-17 years) will complete 

91 
 
Sleep Disturbance: Parent Proxy for Pediatric Patients (age 5-17 years) will complete 
 

92 
 
Caregiver Anxiety: Adult caregiver will complete 
 
 
TBI‐CareQOL SF v1.0‐ Caregiver‐Specific Anxiety 
 
Caregiver-Specific Anxiety- Short Form 
 
Please respond to each item by marking one box per row. 
 
Never 
Rarely 
Sometimes 
Usually 
Always 
 
 
 
 
TBICQ_CW67r 
I feel like I have to choose my words 
carefully around the person I care 
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
TBICQ_CW28r 
I feel drained because of the person 
with the injury's unpredictable 
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
TBICQ_CW8r 
I cannot enjoy myself because I am 
worried about the person I care 
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
TBICQ_CW24r 
I cannot focus on other activities 
because of my worry for the person 
I care for. 
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
TBICQ_CW79r 
I feel frightened that the person I 
care for might behave 
☐ 
☐ 
☐ 
☐ 
☐ 
TBICQ_CW11r 
I worry that something small will irritate 
the person I care for. 
☐ 
☐ 
☐ 
☐ 
☐ 

93 
 
injury. 
Caregiver Strain: Adult caregiver will complete 
 
 
TBI‐CareQOL SF v1.0‐ Caregiver Strain 
 
Caregiver Strain‐ Short Form 
 
Please respond to each item by marking one box per row. 
 
 
Never 
Rarely 
Sometimes 
Usually 
Always 
TBICQ_S46r 
I feel that there are not enough hours in 
☐ 
☐ 
☐ 
☐ 
☐ 
the day to get everything done. 
1 
2 
3 
4 
5 
 
I feel stressed when it comes to 
TBICQ_S27r 
providing care for the person with the 
☐ 
☐ 
☐ 
☐ 
☐ 
 
1 
2 
3 
4 
5 
 
 
 
 
TBICQ_S32r 
I feel drained by my responsibilities as a 
☐ 
☐ 
☐ 
☐ 
☐ 
 
caregiver. 
1 
2 
3 
4 
5 
 
 
I cannot handle any more responsibility 
☐ 
TBICQ_S24r 
when it comes to providing care for the 
1 
☐ 
2 
☐ 
3 
☐ 
4 
☐ 
5 
 
 
 
TBICQ_S62r 
I feel burdened with the responsibility of 
☐ 
☐ 
☐ 
☐ 
☐ 
 
caring for the person with the injury. 
1 
2 
3 
4 
5 
TBICQ_S43r 
I feel that stress makes it difficult to 
start anything new. 
☐ 
1 
☐ 
2 
☐ 
3 
☐ 
4 
☐ 
5 

94 
 
Perceived Stress Scale 
The questions in this scale ask you about your feelings and thoughts during the last month. In each case, you 
will be asked to indicate by circling how often you felt or thought a certain way. 
Name 
Date 
 
 
Age 
Gender (Circle): 
M F 
Other  
 
 
 
0 = Never 
1 = Almost Never 
2 = Sometimes 
3 = Fairly Often 
1. In the last month, how often have you been upset because of something that 
happened unexpectedly?..................................... 
 
2. In the last month, how often have you felt that you were unable to control the 
important things in your life?...................................................... 
3. In the last month, how often have you felt nervous and “stressed”? .............. 
 
4. In the last month, how often have you felt confident about your ability to handle your 
personal problems?................................................................. 
 
5. In the last month, how often have you felt that things were going your 
way?...................................................................................... 
 
6. In the last month, how often have you found that you could not cope with all the 
things that you had to do? ............................................................. 
 
7. In the last month, how often have you been able to control irritations in your 
life?....................................................................... 
 
8. In the last month, how often have you felt that you were on top of things?..... 
 
9. In the last month, how often have you been angered because of things that were 
outside of your control? ..................................... 
 
10. In the last month, how often have you felt difficulties were piling up so high that you 
could not overcome them?............................ 
 
 
Please feel free to use the Perceived Stress Scale for your research. The PSS Manual is in the process of development, please let us know if 
you are interested in contributing. 
Mind Garden, Inc. 
1690 Woodside Road, Suite #202 Redwood 
City, CA 94061 USA 
Phone: (650) 261‐3500 
Fax: (650) 261‐3505 
e‐mail: mindgarden@msn.com 
www.mindgarden.comReferences 
The PSS Scale is reprinted with permission of the American Sociological Association, from Cohen, S., Kamarck, T., and Mermelstein, 
R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386‐396 
 
Cohen, S and Williamson, G. Perceived Stress in a probability sample of the United States. Spacapan, S. and Oskamp, S. (eds.) 
The Social Psychology of Health. Newbury Park, CA: Sage, 1988 
4 = Very Often 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 
0 
1 
2 
3 
4 

95 
 
Profile 25: Pediatric Patient (age 8-17 years) will complete 
 

96 
 
 

97 
 
Profile 25: Parent Proxy for Pediatric Patients (age 5-17 years) will complete 
 

98 
 
 

99 
 
Profile 29+2: Adult Patient and Caregiver will complete 

100 
 
 

101 
 
 

102 
 
 

103 
 
Mobile Application Rating Scale (MARS)- Caregiver/Patients Day 120 (Ages 10 or older) 
 
App Quality Ratings 
The Rating scale assesses app quality on four dimensions. All items are rated on a 5-point scale from “1.Inadequate” 
to “5.Excellent”. Circle the number that most accurately represents the quality of the app component you are rating. 
Please use the descriptors provided for each response category. 
 
SECTION A 
Engagement – fun, interesting, customisable, interactive (e.g. sends alerts, messages, 
reminders, feedback, enables sharing), well-targeted to audience 
 
1. Entertainment: Is the app fun/entertaining to use? Does it use any strategies to increase 
engagement through entertainment (e.g. through gamification)? 
1 Dull, not fun or entertaining at all 
2 Mostly boring 
3 OK, fun enough to entertain user for a brief time (< 5 minutes) 
4 Moderately fun and entertaining, would entertain user for some time (5-10 minutes total) 
5 Highly entertaining and fun, would stimulate repeat use 
2. Interest: Is the app interesting to use? Does it use any strategies to increase engagement by 
presenting its content in an interesting way? 
1 Not interesting at all 
2 Mostly uninteresting 
3 OK, neither interesting nor uninteresting; would engage user for a brief time (< 5 minutes) 
4 Moderately interesting; would engage user for some time (5-10 minutes total) 
5 Very interesting, would engage user in repeat use 
3. Customisation: Does it provide/retain all necessary settings/preferences for apps features (e.g. 
sound, content, notifications, etc.)? 
1 Does not allow any customisation or requires setting to be input every time 
2 Allows insufficient customisation limiting functions 
3 Allows basic customisation to function adequately 
4 Allows numerous options for customisation 
5 Allows complete tailoring to the individual’s characteristics/preferences, retains all settings 
4. Interactivity: Does it allow user input, provide feedback, contain prompts (reminders, sharing 
options, notifications, etc.)? Note: these functions need to be customisable and not 
overwhelming in order to be perfect. 
1 No interactive features and/or no response to user interaction 
2 Insufficient interactivity, or feedback, or user input options, limiting functions 
3 Basic interactive features to function adequately 
4 Offers a variety of interactive features/feedback/user input options 
5 Very high level of responsiveness through interactive features/feedback/user input options 
5. Target group: Is the app content (visual information, language, design) appropriate for your 
target audience? 
1 Completely inappropriate/unclear/confusing 
2 Mostly inappropriate/unclear/confusing 
3 Acceptable but not targeted. May be inappropriate/unclear/confusing 
4 Well-targeted, with negligible issues 
5 Perfectly targeted, no issues found 
 
SECTION B 
Functionality – app functioning, easy to learn, navigation, flow logicand gestural design of app 
 
6. Performance: How accurately/fast do the app features (functions) and components 
(buttons/menus) work? 
1 App is broken; no/insufficient/inaccurate response (e.g. crashes/bugs/broken features, etc.) 
2 Some functions work, but lagging or contains major technical problems 
3 App works overall. Some technical problems need fixing/Slow at times 
4 Mostly functional with minor/negligible problems 
5 Perfect/timely response; no technical bugs found/contains a ‘loading time left’ indicator 

104 
 
7. Ease of use: How easy is it to learn how to use the app; how clear are the menu labels/icons and 
instructions? 
1 No/limited instructions; menu labels/icons are confusing; complicated 
2 Useable after a lot of time/effort 
3 Useable after some time/effort 
4 Easy to learn how to use the app (or has clear instructions) 
5 Able to use app immediately; intuitive; simple 
8. Navigation: Is moving between screens logical/accurate/appropriate/ uninterrupted; are all 
necessary screen links present? 
1 Different sections within the app seem logically disconnected and random/confusing/navigation 
is difficult 
2 Usable after a lot of time/effort 
3 Usable after some time/effort 
4 Easy to use or missing a negligible link 
5 Perfectly logical, easy, clear and intuitive screen flow throughout, or offers shortcuts 
9. Gestural design: Are interactions (taps/swipes/pinches/scrolls) consistent and intuitive across 
all components/screens? 
1 Completely inconsistent/confusing 
2 Often inconsistent/confusing 
3 OK with some inconsistencies/confusing elements 
4 Mostly consistent/intuitive with negligible problems 
5 Perfectly consistent and intuitive 
 
SECTION C 
Aesthetics – graphic design, overall visual appeal, colour scheme, and stylistic consistency 
 
10. Layout: Is arrangement and size of buttons/icons/menus/content on the screen appropriate or 
zoomable if needed? 
1 Very bad design, cluttered, some options impossible to select/locate/see/read device display 
not optimised 
2 Bad design, random, unclear, some options difficult to select/locate/see/read 
3 Satisfactory, few problems with selecting/locating/seeing/reading items or with minor screensize 
problems 
4 Mostly clear, able to select/locate/see/read items 
5 Professional, simple, clear, orderly, logically organised, device display optimised. Every design 
component has a purpose 
11. Graphics: How high is the quality/resolution of graphics used for buttons/icons/menus/content? 
1 Graphics appear amateur, very poor visual design - disproportionate, completely stylistically 
inconsistent 
2 Low quality/low resolution graphics; low quality visual design – disproportionate, stylistically 
inconsistent 
3 Moderate quality graphics and visual design (generally consistent in style) 
4 High quality/resolution graphics and visual design – mostly proportionate, stylistically consistent 
5 Very high quality/resolution graphics and visual design - proportionate, stylistically consistent 
throughout 
12. Visual appeal: How good does the app look? 
1 No visual appeal, unpleasant to look at, poorly designed, clashing/mismatched colours 
2 Little visual appeal – poorly designed, bad use of colour, visually boring 
3 Some visual appeal – average, neither pleasant, nor unpleasant 
4 High level of visual appeal – seamless graphics – consistent and professionally designed 
5 As above + very attractive, memorable, stands out; use of colour enhances app features/menus 
 
SECTION D 
Information – Contains high quality information (e.g. text, feedback, measures, references) 
from a credible source. Select N/A if the app component is irrelevant. 
 
13. Accuracy of app description (in app store): Does app contain what is described? 
1 Misleading. App does not contain the described components/functions. Or has no description 
2 Inaccurate. App contains very few of the described components/functions 
3 OK. App contains some of the described components/functions 
4 Accurate. App contains most of the described components/functions 

105 
 
5 Highly accurate description of the app components/functions 
14. Goals: Does app have specific, measurable and achievable goals (specified in app store 
description or within the app itself)? 
N/A Description does not list goals, or app goals are irrelevant to research goal (e.g. using a game 
for educational purposes) 
1 App has no chance of achieving its stated goals 
2 Description lists some goals, but app has very little chance of achieving them 
3 OK. App has clear goals, which may be achievable. 
4 App has clearly specified goals, which are measurable and achievable 
5 App has specific and measurable goals, which are highly likely to be achieved 
15. Quality of information: Is app content correct, well written, and relevant to the goal/topic of the 
app? 
N/A There is no information within the app 
1 Irrelevant/inappropriate/incoherent/incorrect 
2 Poor. Barely relevant/appropriate/coherent/may be incorrect 
3 Moderately relevant/appropriate/coherent/and appears correct 
4 Relevant/appropriate/coherent/correct 
5 Highly relevant, appropriate, coherent, and correct 
16. Quantity of information: Is the extent coverage within the scope of the app; and comprehensive 
but concise? 
N/A There is no information within the app 
1 Minimal or overwhelming 
2 Insufficient or possibly overwhelming 
3 OK but not comprehensive or concise 
4 Offers a broad range of information, has some gaps or unnecessary detail; or has no links to 
more information and resources 
5 Comprehensive and concise; contains links to more information and resources 
17. Visual information: Is visual explanation of concepts – through charts/graphs/images/videos, etc. 
– clear, logical, correct? 
N/A There is no visual information within the app (e.g. it only contains audio, or text) 
1 Completely unclear/confusing/wrong or necessary but missing 
2 Mostly unclear/confusing/wrong 
3 OK but often unclear/confusing/wrong 
4 Mostly clear/logical/correct with negligible issues 
5 Perfectly clear/logical/correct 
18. Credibility: Does the app come from a legitimate source (specified in app store description or 
within the app itself)? 
1 Source identified but legitimacy/trustworthiness of source is questionable (e.g. commercial 
business with vested interest) 
2 Appears to come from a legitimate source, but it cannot be verified (e.g. has no webpage) 
3 Developed by small NGO/institution (hospital/centre, etc.) /specialised commercial business, 
funding body 
4 Developed by government, university or as above but larger in scale 
5 Developed using nationally competitive government or research funding (e.g. Australian 
Research Council, NHMRC) 
19. Evidence base: Has the app been trialled/tested; must be verified by evidence (in published 
scientific literature)? 
N/A The app has not been trialled/tested 
1 The evidence suggests the app does not work 
2 App has been trialled (e.g., acceptability, usability, satisfaction ratings) and has partially positive 
outcomes in studies that are not randomised controlled trials (RCTs), or there is little or no 
contradictory evidence. 
3 App has been trialled (e.g., acceptability, usability, satisfaction ratings) and has positive 
outcomes in studies that are not RCTs, and there is no contradictory evidence. 
4 App has been trialled and outcome tested in 1-2 RCTs indicating positive results 
5 App has been trialled and outcome tested in > 3 high quality RCTs indicating positive results 
 
App subjective quality 
SECTION E 
 
20. Would you recommend this app to people who might benefit from it? 

106 
 
1 Not at all I would not recommend this app to anyone 
2 There are very few people I would recommend this app to 
3 Maybe There are several people whom I would recommend it to 
4 There are many people I would recommend this app to 
5 Definitely I would recommend this app to everyone 
21. How many times do you think you would use this app in the next 12 months if it was relevant to 
you? 
1 None 
2 1-2 
3 3-10 
4 10-50 
5 >50 
22. Would you pay for this app? 
1 No 
3 Maybe 
5 Yes 
23. What is your overall star rating of the app? 
1 Star: One of the worst apps I’ve used 
2 .Stars 
3 .Stars: Average 
4. Stars 
5 .Stars: One of the best apps I've used 
These added items can be adjusted and used to assess the perceived impact of the 
app on the user’s knowledge, attitudes, intentions to change as well as the likelihood 
of actual change in the target health behavior. 
 
SECTION F: On A Scale of 1-5 
(1:Strongly disagree 5:Strong agree) 
1. Awareness: This app is likely to increase awareness of the importance of addressing health related quality 
of life or well-being 
2. Knowledge: This app is likely to increase knowledge/understanding of addressing health related quality of 
life or well-being 
3. Attitudes: This app is likely to change attitudes toward improving addressing health related quality of life 
or well-being 
4. Intention to change: This app is likely to increase intentions/motivation to address addressing health 
related quality of life or well-being 
5. Help seeking: Use of this app is likely to encourage further help to enhance your health related quality of 
life or well-being 
6. Behavior change: Use of this app is likely increase/decrease addressing health related quality of life or 
well-being 

107 
 
Qualitative Interviews: Discharge, Day 30, Day 60, Day 90, Day 120 
 
General semi-structured interview questions (both caregiver and patient participants) 
 
 
1) In your opinion, what information is most important for you to have post-transplant? 
 
 
2) Would an app with this information be beneficial to you? 
 
 
3) If you could design an app or additional intervention post-transplant, what would it involve? 
 
 
4) Do you think this additional app or intervention would be helpful, burdensome, or neutral? 
 
 
5) What information do you feel was missing during your stay? For days +30, +60, +90, and 
+120: What do you wish you had been told between discharge and now? 
 
 
6) Do you have an interest in tracking some of your symptoms post-transplant? Which ones 
would you want to track? 
 
 
7) Are you interested in tracking your sleep, heart rate, temperature, etc. post-transplant? 
 
 
8) What has helped you cope post-transplant? 
 
 
BMT Roadmap 2.0-directed questions (both caregiver and patient participants) 
 
 
1) What do you think of BMT Roadmap 2.0, wearable sensor, and positive activities (if 
applicable)? 
• 
What do you find most helpful? 
• 
What do you find least helpful? 
 
2) Would you change anything about any of the above (add, change, take away)? 

108 
 
Social Rhythms App Questionnaire: 
The social rhythms app has a few baseline questions for the user upon entry into 
the app. 
1. What is your age, in years? 
 
2. Please select your gender? 
 
3. If they select "Prefer to self‐describe" then they also get a question: "Please enter your gender" with 
a text box. 
4. What is your race? 
 
5. Did you social distance for COVID‐19, or are you currently doing so? 
 
6. When did you begin social distancing for COVID‐19? 
 
7. Have you ended Social distancing for COVID‐19 
 
8. When did you end social distancing for COVID‐19?9. What type of Urban or Rural environment do 
you live in? 

109 
 
Revised Life Orientation Test (LOT-R) 
 
Instructions: 
Please answer the following questions about yourself by indicating the extent of your agreement using 
the following scale: 
 
I 0 I = strongly disagree 
I l l = disagree 
I 2 I = neutral 
I 3 I = agree 
I 4 I = strongly agree 
 
Be as honest as you can throughout, and try not to let your responses to one question influence your 
response to other questions. There are no right or wrong answers 
1. In uncertain times, I usually expect the best. 
2. It's easy for me to relax. 
3. If something can go wrong for me, it will. 
4. I'm always optimistic about my future. 
5. I enjoy my friends a lot. 
6. It's important for me to keep busy. 
7. I hardly ever expect things to go my way. 
8. I don’t get upset too easily. 
9. I rarely count on good things happening to me. 
10 Overall, I expect more good things to happen to me than bad. 
 
 
 
Scoring: 
1. Reverse code items 3, 7, and 9 prior to scoring (0=4) (1=3) (2=2) (3±1) (4=0). 
2. Sum items l, 3, 4, 7, 9, and 10 to obtain an overall score. 
Note Items 2, 5, 6, and 8 are filler items only. They are not scored as part of the revised scale. 

110 
 
Conner-Davidson Resilience Scale 10 (CD-RISC-10) 
 
Initials 
ID# 
date 
/ 
/ 
visit 
age 
 
 
Please indicate how much you agree with the following statements as they apply to you over the 
last month. If a particular situation has not occurred recently, answer according to how you think 
you would have felt. 
 
not true 
at all 
rarely 
true 
sometimes 
true 
often 
true 
true nearly 
all the time 
(0) 
(1) 
(2) 
(3) 
(4) 
1. I was able to adapt when change occur. 
2. I can deal with whatever comes my way. 
3. I try to see the humous side of things when I 
< 
< 
< 
< 
< 
< 
< 
< 
< 
< 
< 
< 
< 
am faced with problems. 
4. Having to cope with stress can make me 
< 
< 
< 
< 
< 
stronger. 
5. I tend to bounce back after illness, injury or 
< 
< 
< 
< 
< 
other hardships. 
6. I believe I can achieve my goals, even if 
< 
< 
< 
< 
< 
there are obstacles. 
7. Under pressure, I stay focused and think 
< 
< 
< 
< 
< 
clearly. 
8. I am not easily discouraged by failure. 
< 
< 
< 
< 
< 
9. I think of myself as a strong person when 
< 
< 
< 
< 
< 
dealing with life’s challenges and difficulties. 
< 
< 
< 
< 
< 
10. I am able to handle unpleasant or painful 
feelings like sadness, fear, and anger. 
< 
< 
< 
< 
< 

111 
 
The Gratitude Questionnaire-Six Item Form (GQ-6) 
 
By Michael E. McCullough, Ph.D., Robert A. Emmons, Ph.D., Jo-Ann Tsang, Ph.D. 
 
 
Using the scale below as a guide, write a number beside each statement to indicate how much 
you agree with it. 
 
 
1 = strongly disagree 
2 = disagree 
3 = slightly disagree 
4 = neutral 
5 = slightly agree 
6 = agree 
7 = strongly agree 
 
 
 
 
1. I have so much in life to be thankful for. 
 
 
2. If I had to list everything that I felt grateful for, it would be a very long list. 
 
 
3. When I look at the world, I don’t see much to be grateful for.* 
 
 
4. I am grateful to a wide variety of people. 
 
 
5. As I get older I find myself more able to appreciate the people, events, and situations 
that have been part of my life history. 
 
 
6. Long amounts of time can go by before I feel grateful to something or someone.* 
 
 
* Items 3 and 6 are reverse-scored. 

112 
 
Dyadic Relationship Scale 

113 
 
COVID-19 Patient Questions 
 
Please indicate if you have experienced any of the following during the COVID‐19 pandemic: 
a. You have contracted COVID 
b. A member of your household contracted COVID‐19 
c. 
You or your partner where considered essential personnel 
d. Loss or involuntary reduction of your employment income 
e. Loss or involuntary reduction of your partner’s employment income 
f. 
Loss of childcare or school closure 
g. You worked primarily from home 
h. You voluntarily reduced your work hours 
i. 
You are considering reducing your work hours 
j. 
Your partner worked primarily from home 
k. Your partner voluntarily reduced their work hours 
l. 
Your partner is considering reducing their work hours 
m. You or your partner has health insurance benefits reduced or lost 
 
To what extent did you find that COVID19 made it more difficult to get essential supplies including food, 
medicine, hygiene products, and healthcare? 
a. Significantly more difficult than prior to COVID 
b. A little more difficult than prior to COVID 
c. About the same as prior to COVID 
d. A little easier than prior to COVID 
e. Significantly easier than prior to COVID 
Did a family member or close friend… 
a. Have symptoms of COVID‐19 
a. Fever 
b. Chills 
c. Shortness of breath 
d. New or worsening cough 
e. Sore throat 
f. 
Body aches 
g. Vomiting 
h. Diarrhea 
i. 
Loss of smell 
j. 
Loss of taste 
k. Other 
b. Have a confirmed COVID‐19 diagnosis 
c. Have a hospitalization for COVID 
d. Die from COVID 
What was your relation to that family member or close friend? 
a. A brother or sister 

114 
 
b. Your parents 
c. Your child 
d. A cousin 
e. An aunt/uncle 
f. 
A close friend 
Did you… 
a. Have any of the following symptoms of COVID‐19 
a. Fever 
b. Chills 
c. Shortness of breath 
d. New or worsening cough 
e. Sore throat 
f. 
Body aches 
g. Vomiting 
h. Diarrhea 
i. 
Loss of smell 
j. 
Loss of taste 
k. Other 
b. Have a confirmed COVID diagnosis 
c. Have a hospitalization for COVID 
d. Have an ICU visit as a result of COVID 
If “Have a confirmed COVID diagnosis”, “hospitalization”, or “ICU visit” is selected: 
How many times did you get COVID? 
Did you receive any treatments for COVID? (Yes/No) 
If yes, please select the type of treatment(s) you received (check all that apply): 
Oral medication at home 
Infusion at a hospital or an infusion center 
Other (please describe) 
Have you had a confirmed diagnosis of Long COVID? 
Yes 
No, but I suspect I have/had Long COVID 
No, never had Long COVID 
If “yes” or “suspected” to confirmed diagnosis of Long COVID: 
• 
Please select the following symptoms of Long COVID that you experienced: 
o Fatigue 
o Shortness of breath or difficulty breathing 
o Cough 

115 
 
o Joint or muscle pain 
o Chest pain 
o Stomach pain 
o Difficulty thinking or concentrating (“brain fog”) 
o Sleep problems 
o Headache 
o Fast or pounding heartbeat (heart palpitations) 
o Loss of smell or taste 
o Depression or anxiety 
o Fever 
o Dizziness when you stand 
o Pins‐and‐needles feelings 
o Diarrhea 
o Rash 
o Changes in menstrual cycles 
o Worsened symptoms after physical or mental activities (“post‐exertional malaise”) 
Have you been vaccinated against COVID? (Y/N) 
If yes: 
How many doses? 
Which brand(s) of the COVID vaccine did you receive? Select all that apply 
 
Pfizer 
 
Moderna 
 
Johnson & Johnson/Jassen 
 
Other (please specify) 
 
Was your treatment changed or delay as a result of COVID? Yes/No 
If yes, please select all that apply 
a. Treatment delayed including chemotherapy or radiation 
b. Imaging or scans delay 
c. Initial consult appointment delayed 
If yes, please select 
a. I or my family wanted to reschedule 
b. Provider recommendation to reschedule 
c. Other; please specify  
 
If yes, do you feel the delay has or will negatively change the outcome of your disease? 
a. Yes 
b. No 
c. Not sure 
d. Other; please explain  
 

116 
 
Overall, what was the effect of COVID on your physical well‐being? 
a. Made it a lot better 
b. Made it a little better 
c. About the same 
d. Made it a little worse 
e. Made it a lot worse 
Overall, what was the effect of COVID on your emotional well‐being? 
a. Made it a lot better 
b. Made it a little better 
c. About the same 
d. Made it a little worse 
e. Made it a lot worse 
Overall, how much distress have you experienced related to COVID? 
1 
2 
3 
4 
5 
6 
7 
No Distress 
Extreme Distress 

117 
 
COVID-19 Caregiver Questions 
 
Please indicate if you have experienced any of the following during the COVID‐19 pandemic: 
a. You provided direct care to a family member with known or suspected COVID‐19 
b. You have contracted COVID 
c. A member of your household contracted COVID‐19 
d. You or your partner where considered essential personnel 
e. Your household living arrangements changed to protect others in your household from COVID‐19 
(caregiver) 
f. 
Loss or involuntary reduction of your employment income 
g. Loss or involuntary reduction of your partner’s employment income 
h. Loss of childcare or school closure 
i. 
You worked primarily from home 
j. 
You voluntarily reduced your work hours 
k. 
You are considering reducing your work hours 
l. 
Your partner worked primarily from home 
m. Your partner voluntarily reduced their work hours 
n. Your partner is considering reducing their work hours 
 
[BRANCH: If “yes” to child care/school closure, both questions below] 
Who is/was primarily responsible for providing childcare or schooling during this period? 
∙ You 
∙ Your spouse or partner 
∙ A sibling 
∙ Other family (e.g. grandparents, aunts/uncles) 
∙ A paid in‐home child care provider (e.g. nanny) 
∙ A child care facility located outside your home 
∙ Other 
 
Who in your family is/was responsible for performing day‐to‐day (non‐childcare) household tasks during 
this period (such as cleaning, cooking, laundry, etc.)? 
∙ I performed most or all of the household tasks 
∙ I performed slightly more household tasks than my significant other 
∙ My significant other and I shared the responsibility for performing household tasks evenly 
∙ My significant other performed slightly more household tasks than I do 
∙ My significant other performed most or all of the household tasks 
∙ Other family performed most household tasks 
∙ We employed outside help to aid with most household tasks 
 
 
 
To what extent did you find that COVID19 made it more difficult to get essential supplies including food, 
medicine, hygiene products, and healthcare? 

118 
 
f. 
Significantly more difficult than prior to COVID 
g. A little more difficult than prior to COVID 
h. About the same as prior to COVID 
i. 
A little easier than prior to COVID 
j. 
Significantly easier than prior to COVID 
Did a family member or close friend… 
e. Have symptoms of COVID‐19 
a. Fever 
b. Chills 
c. Shortness of breath 
d. New or worsening cough 
e. Sore throat 
f. 
Body aches 
g. Vomiting 
h. Diarrhea 
i. 
Loss of smell 
j. 
Loss of taste 
k. Other 
f. 
Have a confirmed COVID‐19 diagnosis 
g. Have a hospitalization for COVID 
h. Die from COVID 
If yes, what was the family member(s) and/or friend(s) relation? 
What was your relation to that family member or close friend? 
g. A brother or sister 
h. Your parents 
i. 
Your child 
j. 
A cousin 
k. An aunt/uncle 
l. 
A close friend 
Did you… 
e. Have any of the following symptoms of COVID‐19 
a. Fever 
b. Chills 
c. Shortness of breath 
d. New or worsening cough 
e. Sore throat 
f. 
Body aches 
g. Vomiting 
h. Diarrhea 
i. 
Loss of smell 
j. 
Loss of taste 
k. Other 

119 
 
f. 
Have a confirmed COVID diagnosis 
g. Have a hospitalization for COVID 
h. Have an ICU visit as a result of COVID 
If “Have a confirmed COVID diagnosis”, “hospitalization”, or “ICU visit” is selected: 
How many times did you get COVID? 
Did you receive any treatments for COVID? (Yes/No) 
If yes, please select the type of treatment(s) you received (check all that apply): 
Oral medication at home 
Infusion at a hospital or infusion center 
Other (please describe) 
Have you had a confirmed diagnosis of Long COVID? 
Yes 
No, but I suspect I have/had Long COVID 
No, never had Long COVID 
If “yes” or “suspected” to confirmed diagnosis of Long COVID: 
• 
Please select the following symptoms of Long COVID that you experienced: 
o Fatigue 
o Shortness of breath or difficulty breathing 
o Cough 
o Joint or muscle pain 
o Chest pain 
o Stomach pain 
o Difficulty thinking or concentrating (“brain fog”) 
o Sleep problems 
o Headache 
o Fast or pounding heartbeat (heart palpitations) 
o Loss of smell or taste 
o Depression or anxiety 
o Fever 
o Dizziness when you stand 
o Pins‐and‐needles feelings 
o Diarrhea 
o Rash 
o Changes in menstrual cycles 
o Worsened symptoms after physical or mental activities (“post‐exertional malaise”) 
Have you been vaccinated against COVID? (Y/N) 

120 
 
If yes: 
 
How many doses? 
Which brand(s) of the COVID vaccine did you receive? Select all that apply 
 
Pfizer 
 
Moderna 
 
Johnson & Johnson/Jassen 
 
Other (please specify) 
Was your loved one’s (patient’s) treatment changed or delay as a result of COVID? Yes/No 
If yes, please select all that apply 
d. Treatment delayed including chemotherapy, or radiation 
e. Imaging or scans delay 
f. 
Initial consult appointment delayed 
If yes, please select 
d. Patient/family wanted to reschedule 
e. Provider recommendation to reschedule 
f. 
Other; please specify  
 
If yes, do you feel the delay has or will negatively change the outcome of your loved one’s (patient’s) 
disease? 
e. Yes 
f. 
No 
g. Not sure 
h. Other; please explain  
 
Overall, what was the effect of COVID on your physical well‐being? 
f. 
Made it a lot better 
g. Made it a little better 
h. About the same 
i. 
Made it a little worse 
j. 
Made it a lot worse 
Overall, what was the effect of COVID on your emotional well‐being? 
f. 
Made it a lot better 
g. Made it a little better 
h. About the same 
i. 
Made it a little worse 
j. 
Made it a lot worse 
Overall, how much distress have you experienced related to COVID? 
1 
2 
3 
4 
5 
6 
7 
No Distress 
Extreme Distress 

121 
 
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