Development of Avatar-based Intervention to Support Patients Undergoing Reduced-Intensity Allogenic Stem Cell Transplantation
Phase: NA
Conditions: Hematopoietic Cell Transplantation
Sponsor: Dana-Farber Cancer Institute

PROTOCOL TITLE: Development and Piloting an Avatar-based Intervention to 
Support Patients Undergoing Stem Cell Transplantation
PRINCIPAL INVESTIGATOR (PI) 
Gregory Abel, MD MPH
Dana-Farber Cancer Institute, Department of Medical Oncology
450 Brookline Avenue, Boston, MA 02215
Phone: 617-632-1906
gregory_abel@dfci.harvard.edu
CO-INVESTIGATOR:
Amar Harry Kelkar, MD
Dana-Farber Cancer Institute, Department of Medical Oncology
450 Brookline Avenue, Boston, MA 02215
Phone: 857-215-6105
amarh_kelkar@dfci.harvard.edu
VERSION NUMBER: V1.1
DATE:    8/24/2022

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
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Table of Contents
1.0
Objectives ................................................................................................................3
2.0 Background....................................................................................................................3
3.0
Inclusion and Exclusion Criteria .............................................................................9
4.0 Study-Wide Number of Subjects.................................................................................10
5.0 Study-Wide Recruitment Methods ..............................................................................10
6.0 Study Timelines...........................................................................................................11
7.0  Study Endpoints..........................................................................................................11
8.0
Procedures Involved ..............................................................................................11
9.0
Data and Specimen Banking..................................................................................15
11.0
Withdrawal of Subjects..........................................................................................18
12.0
Risks to Subjects....................................................................................................19
12.0
Potential Benefits to Subjects ................................................................................19
13.0
Community-Based Participatory Research............................................................20
14.0
Sharing of Results with Subjects ...........................................................................20
15.0
Setting....................................................................................................................20
16.0
Resources Available ..............................................................................................20
17.0
Prior Approvals......................................................................................................20
18.0
Recruitment Methods.............................................................................................20
19.0
Local Number of Subjects .....................................................................................21
20.0
Provisions to Protect the Privacy Interests of Subjects .........................................21
21.0
Compensation for Research-Related Injury...........................................................21
22.0
Economic Burden to Subjects................................................................................21
23.0
Consent Process.....................................................................................................21
24.0
Process to Document Consent in Writing..............................................................22
25.0
Drugs or Devices ...................................................................................................22
26.0
Appendices – Attached Separately in Individual Files..........................................22
Appendix A: Post-Pilot Survey .........................................................................................25

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
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1.0 Objectives  
1.1 Aim 1: Modify care.coach, an existing inpatient bedside digital relational 
agent to enhance the well-being, safety, and outcomes of patients 
undergoing hematopoietic cell transplantation (HCT). We will convene a 
focus group consisting of HCT nurse navigators, inpatient HCT nurses, and 
HCT physicians and extenders to determine appropriate modifications to the 
care.coach health coaching protocols and technology setup for the inpatient 
HCT setting, including development of educational modules that will be 
provided to patients undergoing HCT. 
1.2 Aim 2: Iteratively pilot the modified avatar agent in three cohorts of six 
patients each. We will assess the feasibility of the patient education and 
relational functions of the digital avatar.  
2.0  Background
2.1 Among patients who undergo reduced intensity conditioning stem cell       
transplantation (RIC), relatively lengthy inpatient stays are routine for pre-
HCT conditioning and receipt of donor cells. As those who receive this type 
of transplant tend to be older (60 to 75) and/or have baseline comorbidities, 
the inpatient stay can be difficult. Indeed, in-house delirium is one of the most 
frequent and distressing complications, even though it is typically a treatable, 
reversible syndrome.   
The incidence of delirium in cancer patients undergoing myeloablative HCT is 
about 50%, and the presence of delirium at any point during hospitalization 
after transplantation has been shown to be highly predictive of mortality (odds 
ratio = 14).1 Also, the medications and side effects that accompany RIC HCT 
place this population at high risk for falls, and sustained low platelet counts 
following transplant exacerbate risk of death in the event of a fall.2 Many risk 
factors for falls among HCT patients correspond to risk factors for delirium 
and preventing delirium in cancer patients can also prevent falls.3Moreover, 
HCT often experience stress, anxiety, anger, depression, insomnia and 
loneliness, with the percentage of depressed patients increasing more than 
two-fold after 2 weeks of isolation. Among HCT patients, research has shown 
that loneliness during hospital stay is negatively associated with overall 
quality of life six months after transplant, reducing both social and functional 
well-being, increasing difficulty of managing disease symptoms six months 
after transplant, and increasing ratio of neutrophil to monocyte counts 30 days 
after transplant (an indicator of poorer survival rate).4
Inpatient non-pharmacological interventions that have been implemented to 
improve the quality of life (QOL) of pediatric and adult HCT patients include 
psychoeducational, exercise, and mindfulness interventions, all of which hold 

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
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potential to outcomes during patients’ hospital stay. In a multimodal study, 
individualized psychoeducation was provided to HCT patients 5 days a week 
alongside other interventions; patients showed an improvement for a variety 
of symptoms.5-7 Individualized and supervised exercises routines, such as 
daily dynamic exercises, stretching exercises, resistance training and 
progressive relaxation training, have been implemented and well received in 
both pediatric and adult HSCT settings.6,7 Mindfulness mediation (MM) 
practices can be easily provided to patients and have the potential to relieve 
patient distress.5 Although sleep interventions have been implemented in a 
wide variety of inpatient populations, they have not specifically been studied 
in the inpatient HCT population.8 Since different sleep interventions may 
better serve some populations more than others, it is unclear which sleep 
interventions may be the most beneficial to HSCT patients.8
Indeed, a combination of psychoeducational, exercise, sleep, and mindfulness 
interventions could be applied in HCT patient settings simultaneously with the 
goal to improve patient QOL and to potentially improve patient outcomes. 
Moreover, for RIC HCT, post-HCT changes in lifestyle are complex, 
including nutrition, hydration, transplant medications, home disinfection, 
socialization, and others. For this population, the Health Belief Model5,  and 
Prochaska’s Transtheoretical model of change6 would argue that patients who 
are hospitalized and waiting for their HCT to occur would be highly motivated 
to learn about these items being in the “groundwork for change/take action” 
phase while admitted.  
care.coach™ provides a care support and health coaching platform in which a 
patient-facing interface is a digital relational agent, appearing on a tablet 
device as a dog or cat avatar to enable a non-judgmental, positive emotional 
connection for inpatients during their stay. Each avatar is controlled directly 
by a 24x7, world-wide team of trained humans known as “health advocates,” 
who are background checked, psychometrically screened, and receive 
specialized training (non-medical). Each health advocate can cost-effectively 
monitor and engage 12 or more patients sequentially (2 simultaneously) 
through audio/visual feeds from the patient’s device and send text commands 
which are converted into the avatar’s voice through a speech synthesis engine. 
The health advocates are guided by a software-driven expert system 
embedded into their work interface, which implements evidence-based 
clinical protocols to support patient self-management and care coordination. 
Pace University conducted a clinical pilot of the care.coach technology in 
2016 at Jamaica Hospital Medical Center with 95 hospitalized 
(medical/surgical) older adults at high falls or delirium risk.9 Mean age was 
76.5 years, with 55% female, 46% African-American, and 44% speaking 
English as a second language.9 Typical length of stay was 3-6 days. On 
average, the avatars performed 71.3 observational check-ins, 61 minutes of 

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Patients Undergoing Stem Cell Transplantation 
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engagement using 11.5 images or audio files, and 6.5 protocol-driven tasks 
per patient, per day, based on certain protocols derived from the Hospital 
Elder Life Program (HELP).9 Compared to randomized control patients with a 
daily nurse student visit (n=54), intervention patients with our bedside avatar 
(n=41) showed a significantly greater reduction in delirium score (CAM, 
p=0.003) and loneliness (UCLA-LS, p=0.008). The primary intervention unit 
had 0.9 falls per 1000-patient days during the 3-month study period, compared 
to 6.5 on the control unit (86% reduction in fall rate).9 University of 
Washington has published 3 peer-reviewed papers about how the avatars help 
reduce loneliness, increase social support through informational, affectionate, 
and positive social interaction mechanisms, and decrease depressive 
symptoms among older adults in the community, including those with mild 
cognitive impairment.10-12 Quality improvement projects with care.coach 
health plan customers have also reported high patient and provider 
satisfaction, and reduced anxiety based on GAD-7 surveys.10-12   
In summary, digital conversational agents provided to patients offer potential 
benefits to patients including a reduction in delirium, and this technology has 
not been offered to patients in HCT settings. We propose to pilot this 
technology after modifying it to include educational protocols tailored to the 
needs of RIC HCT patients additionally offering education in post-HCT home 
care. 
2.2  Draft care.coach Clinical Protocols: The following protocols will be 
developed into lessons that will be presented by the avatar.      
[1] Diet & Hydration 

Hydration reminder, question 
o
Importance of staying hydrated to maintain kidney health, 
drinking at least 2 liters of fluid per day with the goal of 2-3 liters 
per day ( aiming for non-caffeinated beverages)

Meal rating, enjoyment  

Permitted outside foods (during inpatient transplant)  
o
Beverages : canned sodas, juices, flavored drinks, nutritional 
supplements
o
Canned items: canned foods EXCEPT grapefruit, canned 
vegetables, canned soups and stews (portioned sized) 
o
Cookies, crackers, and snacks : all individually portioned 
packages cookies, crackers, and chips, individually packaged pies 
and cakes that are commercial, shelf-stable products 
o
Candy : individually wrapped hard candy and candy bars 
o
Frozen entrees: Only frozen entrees that are individual portion-
sized, remain frozen during transport to you, and have been 
cooked at BWH, either by room service or in the floor microwave 

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
Inquiry about (healthy) eating habits/plans, fruits & vegetables (at home 
after transplant)  
o
Vegetables: May eat fresh vegetables, raw or uncooked, as long as 
they are washed well EXCEPT FOR raw broccoli and cauliflower 
o
Frozen vegetables: May eat frozen vegetables, raw or uncooked, 
as long as they have been washed well EXCEPT FOR broccoli 
and cauliflower which must be cooked and cannot be eaten raw 
o
Canned vegetables: Can eat and do not have to be cleaned or 
cooked 
o
Vegetable drinks : May eat if they are pasteurized 
o
Fruits: Do not eat grapefruit or grapefruit juice, Seville oranges or 
marmalade made with Seville oranges 
o
Fresh Fruits: can eat fresh fruits as long as they are washed well 
EXCEPT fresh berries (must be cooked completely). No cracks or 
bruises 
o
Frozen fruits: May eat cooked or raw as long as they are washed 
well EXCEPT fresh berries (must be cooked completely). No 
cracks or bruises 
o
Dried Fruits: May eat dried fruits 
o
Canned Fruits: May eat, without washing or cooking 
o
Fruit Cups: Can eat fruit cups packaged and pasteurized at the 
factory. You do not have to wash or cook fruit cups packed at the 
factory. 
o
Fruit Drinks: Can drink fruit drinks if they are pasteurized 
o
DO NOT EAT HONEY 

Food Safety (at home after transplant)  
o
Reminder to check expiration dates before opening frozen or 
canned vegetables or vegetable juices 
o
Vegetable cans, boxes, and bags should have no rips, dents  
o
Wash bags, boxes, and cans before opening frozen or canned 
vegetables or vegetable juices 
o
Clean the can opener before using it 
o
Do not eat food prepared at friends’ or family’s houses. Do not 
eat out or eat takeout. 

Diabetes-related diet questions 
  [2] Physical Exercise [ambulation] 

Education about energy saving techniques, platelet precautions with 
activity and the overall importance of daily mobility to prevent 
fatigue/deconditioning 

Mobility assessment to determine levels (5) of ambulation, types of 
exercises (seated, standing, in bed)  

Otago exercises (home-based balance, strength exercises for older adults) 

Exercise arms, feet, hands, neck, hip, leg lifts, toe/calf raises 

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
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
Inquiry about ambulation, going for a walk, exercise for the day  
        [3] Orientation/confusion/delirium 

Focused attention questions 

Confusion assessment (CAM) questions 

Orientation questions 

Cognitive impairment (MoCA) questions 

5 senses countdown 
             [4] Non-pharmacological pain/anxiety management, 

Comfort level assessment/question(s) 

Evening meditation, guided imagery 

Simple breathing exercise, relaxation 
       [5] Sleep 

Encourage to go back to sleep if after 11PM 
             [6] Toileting/fall risk assessment 

Inquiry if need to use the bathroom (call nurse to assist if yes) 

Reminders – ambulatory device/assistive tech (cane, glasses, hearing aids), 
ask for assistance, do not rush, proper footwear, sleep in the center of the 
bed 

Falls check 

Tips for lowering your risk for falling 
o
Wear non-skid socks or supportive footwear
o
Taking time with positional changes 
o
Notifying staff if you have sudden onset of dizziness 
o
Ensuring there is adequate lighting before getting up 
        [7] Psychosocial Support & Staff communication. 

Depression/mood question(s) 

Companionship/loneliness (FS/UCLA) question(s) 

Stress, worry, nervousness, anger question(s) 

“Fun facts”, patient education 

Establish urgent call criteria 

Interactive games 

Music, images, audiobooks 
              [8]  HCT Medication Resources 

Tacrolimus  

Sirolimus

Mycophenolate mofetil

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
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
Levofloxacin

Acyclovir

Atovaquone

Bactrim

Ursodiol
         [9] Catheter Care 

Preparation to flushing catheter 
o
Each lumen (small tube within your catheter) of central line 
catheter will need to be flushed once a day with 0.9% saline flush. 
The following steps can be used for either a PICC or a Hickman 
Central Line. 
o
MUST wash hands prior, may choose not to wear gloves  

Steps to flushing catheter, which are as follows: 
1. Clean your worktable with a disinfectant wipe 
2. Gather supplies 
a.
Catheter caps 
b. Alcohol wipes 
c.
Prefilled 10mL .9% saline flush 
d. Gloves (optional) 
e.
Alcohol cover (Curos) 
3. Wash hands well with soap and water OR use an alcohol-based 
hand sanitizer 
4. Dry your hand with a clean paper towel  
5. If you have been taught to or want to use gloves, put them on now 
6. Take the flush syringe from the package 
7. Hold the syringe up in the air with the plunger pointing to the 
floor 
8. Tape the syringe so that any air bubbles rise to the top 
9. Take off the syringe cap 
10. Push the plunger to the 10mL mark. This will take out any air and 
extra flush from the syringe. Some flush may drop out. 
11. Hold the syringe upright and do not let the syringe touch anything   
12. Do you have a green alcohol cover over your catheter cap OR do 
you NOT have a green alcohol cover over your catheter cap 
a.
IF YES: 
i. Remove the green alcohol cover only, do not reuse 
ii. Leave the catheter cap in place 
iii. Do not let the end of the catheter cap touch 
anything, including your body  
b. IF NO 
i. Open the alcohol wipe 
ii. Scrub the catheter cap with the alcohol wipe for at 
least 10 seconds 

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
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iii. Let it dry completely 
iv. Do not let the end of the catheter cap touch 
anything, including your body after it has been 
cleaned   
13. Hold the catheter cap 
14. Put in and screw the flush syringe onto the end of the catheter cap 
15. Open the clamp on the catheter 
16. Flush the line with the saline using a push pause method. The 
turbulence helps to keep your line clear. 
17. Firmly push 1cc then pause 
18. Continue to push 1cc and pause until the line is flushed with al 10 
ccs
a.
If it is hard to push the flush, check to make sure the 
clamp is open. If it was clamped, open the clamp 
b. If it is still hard to push, STOP. Do not push the flush. 
Close the clamp. Unscrew and remove the syringe. Call 
your doctor or Oncology Nurse Navigator.  
19. Do not use force to flush  
20. Be sure that the clamp is over wording “ clamp here” 
21. Clos ethe clamp on the catheter. You should here a click. 
22. Hold the catheter cap tightly and unscrew the syringe form the 
catheter. Be careful not to loosen the catheter cap form the 
catheter. 
23. Always check to be sure the catheter cap is on tight 
24. Put a new green alcohol cover over the catheter cap. 
25. Now flush all other lumens of the catheter. 
26. After you flush all of your lumens, throw your supplies away. 
3.0  Inclusion and Exclusion Criteria 
3.1 Aim 1: Screening and Eligibility     
We will convene one focus group with 8-10 participants who are DFCI/BWH 
HCT nurse navigators, inpatient HCT nurses, and HCT physicians and extenders 
(NP/PA). 
Eligibility for Aim 1:  

Inclusion Criteria 
o
Age 18+.
o
DFCI/HCC HCT nurse navigators, inpatient HCT nurses, 
and HCT physicians and extenders (NP/PA).
3.2 Aim 2: Screening and Eligibility  

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
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Potential patients will be identified and screened through provider referral as 
identified in the transplant team’s weekly (Friday afternoon) clinical meeting.  
Screening and recruitment will be conducted by a trained research assistants (RA) 
who will utilize HIPAA-compliant and DFCI IRB approved patient approach 
procedures. Potential patients will be approached and consented upon inpatient 
admission for RIC HCT. 
Eligibility for Aim 2: 

Inclusion Criteria:
o
Age 18+.
o
Admitted for reduced-intensity conditioning (RIC) 
allogeneic HCT (prior to day 0, generally day -7).

Exclusion Criteria: 
o
Deemed by clinical staff or RA to be unable to converse 
with an avatar, due to: 

Severe, uncorrectable hearing impairment and 
simultaneous severe, uncorrectable vision 
impairment.  

Severe speech impairment that precludes 
understanding by staff (and by extension, by the 
avatar). 

Not fluent in English.
4.0 Study-Wide Number of Subjects
Aim 1: This is a single-site study, located at Dana-Farber/BWH Cancer Center. 
We anticipate 8-10 participants for the focus group. 
Aim 2: This is a single-site study, located at Dana-Farber/BWH Cancer Center. 
We anticipate enrolling 3 cohorts of 6 patients for a total of 18 participants.  
 5.0 Study-Wide Recruitment Methods
Aim 1: Potential participants will be Dana-Farber/BWH Cancer Center staff. 
Department directories will be used to identify potential participants, who will be 
initially recruited by email and follow up contacts will be by phone and/or in 
person.

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Patients Undergoing Stem Cell Transplantation 
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Aim 2: All eligible patients as defined in Section 3.0 will be met by a 
trained RA soon after inpatient admission. This RA will be responsible for 
obtaining informed consent, as outlined in Section 23.0. All participants 
will be entered into the Clinical Trials Management System (CTMS) 
OnCore per DF/HCC guidance as per DF/HCC Policy REGIST-101. 
6.0 Study Timelines
Aim 1: Prior to enrollment of the initial cohort of patients, we will convene a one-
time 60minute focus group led by Anna Revette PhD 
(annac_revette@dfci.harvard.edu), a Senior Research Scientist in qualitative 
research, to discuss perspectives and opinions on implementing care.coach 
technology for HCT patients including education domains to include, frequency 
of avatar interactions, and anticipated staff concerns. This analysis will inform 
changes to be applied to the avatar, including script adjustments, prior to 
introducing the technology to patients in Aim 2. 
Aim 2: We will complete the initial implementation of multiple HCT-related 
avatar changes across each of the categories in Section 2.2 and integrate them into 
an overall program schedule within 3 months. In the next 6 months, the HCT 
avatar program will then be piloted and iteratively improved through a phased, 
iterative user acceptance study with 3 consecutive cohorts of 6 RIC HCT patients 
each, receiving the avatar for up to 3 weeks per cohort (or patient discharge). 
After each cohort, user feedback will be gathered in the post-pilot survey (one 
week after disenrollment; see Appendix A), and protocol completion and patient-
avatar engagement data will be analyzed.
7.0  Study Endpoints 
7.1 Aim 1: Modifications to an avatar-based human-staffed artificial intelligence 
technology platform for use in an inpatient HCT setting, derived from thematic 
analyses of a focus group of DF/BWH Cancer Center HCT nurse navigators, 
inpatient HCT nurses, and HCT physicians and extenders (as described in Section 
8.4)
7.2 Aim 2: PRIMARY: Retention rate in protocol from enrollment to hospital 
discharge or three weeks (whichever comes first). SECONDARY: Patient 
satisfaction rate with avatar in the final cohort; rate of completion of 80% of the 
HCT educational modules; rate of completion of post-pilot survey.
8.0  Procedures Involved  
8.1 Design/Study Type  

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Aim 1: Focus group.
Aim 2: Single-arm feasibility pilot, with 3 cohorts of 6 patients (18 total). 
8.2 care.coach  
care.coach is a “human-in the-loop” conversational agent (avatar) used to interact 
and converse with patients through natural dialogue and text-to-speech software 
that is powered by a team of trained human staff, called health advocates. A 
summary of the platform is shown in Figure 1. Note that the Family Portal and 
Provider Portal depicted in this figure are features from the commercial 
care.coach device that will not be activated for the purposes of this study. These 
features provide patient-avatar interaction summaries to the providers and, if 
approved by the patient, to family members.
Figure 1. care.coach Avatar Platform
The care.coach patient-facing interface appears as a virtual animal avatar on a 
touch-screen handheld device. Patients interact with the avatar by speaking with it 
or tapping the avatar on the screen. This simple interface allows many users to be 
engaged effectively. The avatar has two states: awake and asleep. When the avatar 
is visually sleeping, the audiovisual (AV) stream is offline. To awaken the avatar 
on-demand, it must be tapped on the touchscreen device. When the avatar is 
visually awake, the care.coach staff-monitored AV stream will become active. 
Several times per day, the avatar will attempt to engage the patient spontaneously 
to provide key reminders, such as for hydration or activity, and initiate patient 
education modules. 
If a patient participant is not available, does not respond, or the participant 
requests privacy, the avatar will go back to sleep. Whenever the avatar is visually 
awake, care.coach staff members monitor the AV streams from the avatar device 
to hear, see and interpret what users are saying and what is happening in the 
environment. This enables the care.coach staff to speak to study participants 

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Patients Undergoing Stem Cell Transplantation 
13
appropriately and have genuinely natural, contextually relevant interactions and 
conversations. What the avatar says is guided by software protocols for 
consistency, speed, and automation, but is overseen and directly controlled 
(“supervised”) by care.coach staff to ensure that the avatar talks with patients in a 
sensible, appropriate, and empathic manner. In the case of an emergency when 
communicating with the avatar, the care.coach team will contact the unit 
coordinator (number will be provided at patient enrollment) and ask for the nurse 
assigned. A removable cover will be provided for the camera if patients desire at 
time of enrollment.  
Health advocates contribute to the system their human abilities for natural 
language processing and compassionate conversational responses to help each 
avatar build personal relationships. While health advocates are not clinicians, they 
have a minimum set of certifications (Section 8.3). 
Figure 2:  patient using the “tap to wake” feature on avatar
Additionally, the abilities are augmented through a software-driven system 
embedded into the work interface, which guides participants through modules that 
aim to mitigate falls and delirium, executing cognitive exercises. Modules have 
been reviewed by principal investigators and will be adapted to best serve patients 
who have undergone RIC HCT. An analysis of the focus group on Aim 1 will 
result in the re-review and further improvement of these modules. 
8.3 care.coach Health Advocate Training     
The health advocates who staff the avatar system must each complete the 
following screening mechanisms and training certifications (or their equivalents 
deemed by care.coach, as specific training courses and providers become 
outdated/available from time-to-time), through several online learning platforms, 
over the course of approximately 65 hours:
1.
care.coach psychometric, technical, skills-based, and face-to-face interview 
assessment

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Patients Undergoing Stem Cell Transplantation 
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2.
InfoCubic international background check
3.
Registered Nurses' Association of Ontario delirium, dementia and 
depression course
4.
National Institutes of Health privacy and ethics course for human subjects 
research
5.
MGB basic motivational interviewing class
6.
care.coach technology, patient support, information security, and job 
shadowing training
The qualification process is stringent, and the proportion of health advocate job 
applicants who successfully complete all the required certifications and are hired 
is only about 1%. For the proposed project, each health advocate will also attend a  
specific one-hour training about RIC HCT provided by Drs. Abel and Kelkar.
8.4 Study Procedures 
In Aim 1, a focus group consisting of focus group consisting of DF/BWH Cancer 
Center HCT nurse navigators, inpatient HCT nurses, and HCT physicians and 
extenders will he held to discuss the feasibility and benefits of implementing an 
avatar-based artificial intelligence system in an inpatient HCT setting (See 
Appendix B for draft script). The care.coach technology as described in Section 
8.2 will be presented to the focus group. Following this introduction, a guided 
discussion will be held discussing the feasibility and benefits of providing this 
technoloigy to HCT patients. Participants will receive $50 gift cards for 
participation. The findings of this focus group will further shape the development 
of educational scripts incorporated into the care.coach technology. 
In Aim 2, the care.coach device will be provided to a total of 18 patients (3 
cohorts of 6 patients) who fall within the eligibility requirements outlined in 
Section 3.2 and who consent to participating in the study. Participants will receive 
the device while admitted at the Brigham and Women’s Hospital for RIC HCT, 
and the device will be collected by study staff prior to discharge. 
8.5 Aim 2 Study Calendar   
Table 1. Study Calendar
Study Procedures
Baseline
Day 5 (± 2)
-1 to 0 days prior 
to discharge
One week after 
pilot ( + 5 days ) 
Informed Consent of participant
X
Demographic data: self-report and 
EHR review
X
Setting up avatar device
X
RA check in
X
X
Disenroll patients and retrieve avatar 
device from participants
X

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Patients Undergoing Stem Cell Transplantation 
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9.0 Data and Specimen Banking
9.1 Data Collected by care.coach: Only meta-data will be collected through 
the avatar device. care.coach will be provided with a first-name, study-
assigned patient number, and in-hospital location for safety functions, but 
will not be provided with other PHI. Upon completion of the study, name 
and in-hospital location data will be decoupled from other data and 
destroyed by care-coach. Audiovisual streams are recorded for immediate 
language processing and understanding but will not be stored post-
processing. See Appendix C for care.coach security protocols.
9.2 Data Collected by Dana-Farber: No specimens will be collected or 
stored as part of this study. We will collect data on feasibility outcomes 
(retention, satisfaction, completion of modules) via post-pilot survey 
administered by the RA in person, at first follow up at Dana-Farber after 
discharge, or via telephone (Appendix A). Components of post-pilot 
survey questions on technology usability (Q1-19) were adapted from a 
published system usability scale.13 Questions on self-efficacy (Q20-28) 
were directly adapted from the General Self-Efficacy Scale.14 The 
remaining questions were newly developed for this study. Data will also 
be collected on patient demographics, transplant characteristics (type of 
transplant, donor characteristics, conditioning, GVHD prophylaxis, 
antibiotic prophylaxis, status of prior infectious diseases), and transplant 
outcomes (incidence and severity of GVHD, other infectious and non-
infectious complications, relapse, survival). PHI will be stored with these 
data to allow for monitoring of long-term outcomes. Data will be stored on 
a secure server at DFCI up to 5 years from completion of the last study 
conducted as part of this project (dependent on whether we proceed to the 
Phase 2 study). One year after completion of the study, long-term 
analyses, and publication of deidentified findings, all PHI will be 
destroyed.
9.3 Data Storage: No specimens will be stored.
Post-pilot survey
X

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
16
9.4 Data Sharing: Aggregated de-identified post-protocol survey data will be 
shared with care.coach; care.coach meta-data will not be shared with 
DFCI.  
10.0
Data Management and Confidentiality  
10.1 Data Analysis: 
Aim 1: This will be a qualitative study, consisting of a focus group of 8-10 
subjects consisting of DF/BWH Cancer Center HCT nurse navigators, 
inpatient HCT nurses, and HCT physicians and extenders. The objective 
of Aim 1 is to use this focus group to identify key educational topics of 
interest, frequency of check-ins with the study patients, transplant 
treatment groups most likely to benefit from the avatar, timing of avatar 
device delivery, length of time with the avatar, and other potential uses for 
the avatar. After enrollment (as described in Section 5.0 ), we will 
undertake the focus group using a semi-structured guide (Appendix C), in 
which we will present each topic and ask for feedback. The focus group 
will be conducted either virtually using videoconference software or on-
site at DFCI depending on the current state of the pandemic at the time of 
the focus group. The session will last approximately 60 minutes, will be 
audio-recorded, and will be transcribed verbatim. The interview guide will 
be further developed by the investigators, and we will consult the Dana-
Farber/Harvard Cancer Center (DF/HCC) Survey and Data Management 
Core for help in reviewing our final guide (although we will run the focus 
groups ourselves). We will explore the themes listed in the Table in 
Appendix C, which have been developed based on areas of highest need in 
our transplant program to improve patient experience and outcomes. We 
will request feedback from the group about the utility of different 
transplant education topics, frequency of interruptions, and other potential 
uses of the avatar and recommendations for modifications to improve 
usability, feasibility, and utility of the avatar. In addition to soliciting 
feedback from all participants, we will perform in-depth explorations of 
components of the avatar functions for which each type of participant is 
considered a topical expert. For example, we will seek advice on optimal 
timing and frequency of patient interruptions from bedside transplant 
nurses who are most closely involved in direct patient care and are most 
familiar with patient needs and attention spans. The investigators will 
analyze all transcribed interviews through an interactive approach using 
framework analysis.15 Using techniques we have refined in prior work,16,17 
two team members will review transcripts independently using an 
electronic research journal (NVivo 12 Pro) to create a coding matrix, after 
which they will compare results until reliability and interpretive 
consistency of coding is established (80% agreement). We will keep a 
thorough audit trail that will allow for other team members to carefully 
review and confirm that conclusions clearly flow from the coding, thus 
enhancing interpretive rigor and credibility. The study team will integrate 

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
17
findings from the focus group into the functions of the avatar to optimize 
the device functions for our patients.
Aim 2: We will enroll 18 patients in a single-arm pilot/feasibility study 
testing the care.coach avatar. The goal of the study is to determine if the 
avatar achieves the prespecified usability and feasibility outcome goals. 
As is common for HCT studies,18 the following covariates will be 
collected for each enrolled patient from hospital records and analyzed in 
conjunction with survey data collected by study RAs, with the support of 
the consulting biostatistician: incidence of delirium, falls, falls with injury, 
and sitter utilization, length of stay, use of benzodiazepines and sedatives, 
fluid “ins/outs” and meal fractions from nursing notes, in-hospital weights, 
neutrophil and platelet counts at fixed durations post-transplant, and 
incidence and severity of transplant-related complications including graft 
failure, graft-versus-host disease (GVHD), thrombotic microangiopathies 
(TMA), venous thrombosis, hemorrhage, acute infections and viral 
reactivations, idiopathic pneumonia syndromes, vaso-occlusive disease 
(VOD), cytokine release syndrome, mucositis, engraftment syndromes, 
and posterior reversible encephalopathy syndrome (PRES). Demographic 
variables between groups, including age, gender, education, and 
race/ethnicity collected upon enrollment will be compared to confirm 
equivalency and randomization. Primary and secondary usability and 
feasibility outcomes are summarized in Table 1. Each metric will be 
analyzed using paired t-tests to compare between groups and analysis of 
covariance to adjust for possible differences in demographics or initial 
assessments (baseline) between groups. Binary measures will entail chi-
squared comparisons of proportions between groups. All data will be 
analyzed using the Statistical Package for Social Sciences software (SPSS, 
Inc. Chicago, IL). Statistical significance will be defined as p ≤ 0.05.
Table 2. Usability and Feasibility Outcomes
Usability and Feasibility Outcomes
Estimated 
Percentage 
Usability or 
Feasibility 
Determine the feasibility of retaining 18 patients in the protocol 
from enrollment to hospital discharge or three weeks (whichever 
comes first).
66%
Determine the patient satisfaction rate in the final cohort.
80%
Determine the rate of completion of the HCT educational 
modules.
75%
Determine the rate of completion of the post-pilot survey within 
one week of discharge.
90%

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
18
10.2 Sample Size:
Aim 1: Aim 1. We selected a focus group size of 8-10 subjects. As per 
Krueger and Casey’s “Focus groups: A practical guide for applied 
research,” the ideal size of a focus group is 8-10 subjects because 
participants in a smaller focus group may feel pressure to talk more than 
they would otherwise, while larger focus groups will limit detail of 
participants’ responses who may feel pressure to share airtime.19
Aim 2: A sample size of 18 patients was selected to achieve three goals. 
First, we estimated 162 RIC transplants per year over the past three years, 
with approximately 33% (54 patients) being performed inpatient, and 
estimated that approximately 33% could be enrolled, resulting in an 
achievable pilot sample size of 18 patients. Second, we ensured that the 
“rule of 10” for binary outcomes, wherein at least 10 participants per arm 
allows for reliable estimates in pilot studies (10 total in a single arm pilot, 
such as ours), was met.20 Third, we wanted to ensure that there were 
sufficient patients in three smaller cohorts to allow for an iterative process 
of improving the technology over the course of the pilot study, as per the 
guidance from the NIH SBIR process. With six patients per cohort, we 
should be able to achieve sufficient data for assessing usability.21
10.3 Milestones and Success Criteria:     
PRIMARY: Retention rate in protocol from enrollment to hospital 
discharge or three weeks (whichever comes first) of over 66%. 
SECONDARY: Patient satisfaction rate with avatar in the final cohort of 
80%; rate of completion of 80% of the HCT educational modules of 75%; 
rate of completion of post- pilot survey within 1 week of discharge of 
90%.  
10.4 Risk Mitigation and Alternative Strategies: After each group of 5 we 
will assess patient feedback and modify the avatar program; this iterative 
design will allow for rapid protocol improvements to be deployed to new 
patients in subsequent cohorts to move towards achieving the success 
criteria above. In case outcomes are disappointing during the first cohort, 
we may switch to a more frequent iteration rate, in conjunction with the 
advice of our consulting biostatistician.
11.0
Withdrawal of Subjects
Subjects are able to withdraw from the study at any point. They will be 
given study team contact information to withdraw after agreeing to 
participate and will be able to terminate their participation in the focus 
group or interview at any point. Their demographic information will not 
be used at that point; for focus group participants, it will not be possible to 
remove their data from the audio transcription; for individual interviewees, 

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
19
their interview data will be deleted. Subject withdrawal reason(s) will be 
attempted to be obtained. In certain situations, such as severe 
encephalopathy or critical illness, patients may be withdrawn from the 
trial by the investigators due to inability to utilize and interact with the 
digital avatar device.
12.0
Risks to Subjects
12.1 Anticipated Risks   
Aim 1: Anticipated risks to participants include the potential risk of 
compromise of participant confidentiality due to use of video conferencing 
groups. For the focus group associated risks, the study team will explain to 
participants the procedures that will be employed to ensure privacy and 
confidentiality, and situations such as the focus group discussions where 
these are not entirely possible. Procedures that will be taken to ensure 
confidentiality include de-identifying all the data collected from the focus 
group and storing in a password encoded database.     
Aim 2: Anticipated risks to participants include the potential risk of 
compromise of participant confidentiality and loss of confidentiality of 
their data collected by the DFCI investigators. Psychological risks include 
embarrassment and stigmatization if there is inadvertent disclosure of 
confidential information, and distress due to losing a friendship with the 
avatar at the end of the hospital stay. While it is very common to develop a 
friendship with the avatar and ending such a relationship is generally a 
negative experience, due to the context of the relatively short-term 
hospital stay, it is expected that patients will overall be happy to be 
discharged and they will not be led to believe that the avatar will be with 
them for the long-term.
12.2 Unanticipated Risks

Any unanticipated event will be reported to the OHRS. All human subjects 
will be informed of their right to stop participation at any time. Subjects 
will be notified of their right not to answer any questions or choosing to no 
longer participate. If a participant experiences distress, they can contact 
Dr. Gregory Abel at gregory_abel@dfci.harvard.edu or 617-632-1906 or 
Dr. Amar Kelkar at amarh_kelkar@dfci.harvard.edu. 
12.0
Potential Benefits to Subjects  
Aim 1: There is no direct benefit expected for participants except for the $50 gift 
card.

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
20
Aim 2: Participants may potentially benefit from participating in the study by 
being exposed to educational modules pertaining to their care as well as receiving 
psychosocial support via the avatar. Participants in the third cohort will receive a 
$20 Dana-Farber gift card for completion of at least 4 out of 7 educational 
modules presented by the device to assess the impact of this potential benefit 
when planning the subsequent randomized trial.
13.0
Community-Based Participatory Research
Not applicable. 
14.0
Sharing of Results with Subjects
Given constraints on study resources and the exploratory nature of the study, we 
do not plan to disseminate study findings or individual results directly to 
participants; however, participants will hopefully be able to view publications that 
arise from this study in oncology journals.
15.0
Setting 
Aim 1: Participants will be selected and recruited purposively via recruitment 
emails. The focus group will be held over a secured Zoom conference call to 
abide by social distancing guidelines outlined by the CDC during the COVID-19 
pandemic. 
Aim 2: Potentially eligible patients identified in weekly transplant sign-out round 
meetings will be approached and those who consent will be given the device at 
the time of their admission for RIC HCT at Brigham and Women’s Hospital. 
16.0
Resources Available 
DFCI: Drs. Abel and Dr. Kelkar both have experience with care delivery research. 
The study will be supported by our research assistants Isabella Kallassy and 
Dillon Clancy. 
17.0
Prior Approvals 
Aim 1: We will request a waiver documentation of informed consent, although all 
elements of informed consent will be included in the focus group script. 
(Appendix B).
Aim 2: N/A.
18.0
Recruitment Methods 
 

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
21
Aim 1: HCT nurse navigators, inpatient HCT nurses, and HCT physicians and 
extenders will be selected and recruited purposively via recruitment emails 
Aim 2: We will use weekly transplant sign-out meetings to identify 
potentially eligible patients. Communication with all potential participants 
will contain all the elements of informed consent and potential participants 
will also be made aware that the study team will keep personal identifiers 
confidential by removing identifying information from interview 
transcripts. Patient information will be kept in a database that is password 
protected and utilized only at DFCI. This will ensure that ineligible 
patients are not contacted and will limit the number of non-participants 
affected. 
19.0
Local Number of Subjects  
Aim 1: 8-10 participants for the focus group. 
Aim 2: 3 cohorts of 6 patients for a total of 18 participants.  
20.0
Provisions to Protect the Privacy Interests of Subjects
Subjects' demographic data will be deidentified, as described above, and contact 
information will be stored on a secured database on a password-protected 
computer accessible only to DFCI study team personnel. Participants will be 
informed of the steps taken to secure their data privacy during the consent 
process.
21.0
Compensation for Research-Related Injury
This research involves minimal risk to subjects; therefore, this is not applicable. 
22.0
 Economic Burden to Subjects   
We anticipate no additional costs to subjects for enrollment in this study. 
23.0
Consent Process 
Those unable to consent for themselves are not involved in this research. 
Informed consent will be required for all participants. 
Aim 1: As this Aim is minimal risk and involves no procedures for which written 
documentation of consent is normally required outside of the research context, we 
request that written documentation of consent be waived. Oral consent language is 
included in all recruitment communications with participants (see appendices). 
The PI will be present at each focus group and interview to obtain oral consent. 

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
22
Participants will be shown the script on the video conference screen, which 
includes all elements of informed consent (Appendix B). Participants will be 
asked to verbally confirm their consent at the time of the meeting. This verbal 
confirmation will serve as documentation of consent. We request that written 
documentation of consent be waived.  
Aim 2: Informed consent will be required for all participants in the study. The RA 
will document consent with the participant’s wet-ink signature. All participants 
will receive a copy of the completed consent form for their records. 
24.0
Process to Document Consent in Writing  
25.1. Aim 1: This research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is 
normally required outside of the research context. As such, we request that the 
IRB waive the requirement to obtain written documentation of consent. During all 
participant contacts, all the required elements of informed consent will be 
included, as are outlined in the Appendices.  
25.2. Aim 2: We will be obtaining written consent for this study per SOP: 
Informed Consent Process (CON-100). Once a potentially eligible subject is 
admitted, the RA will approach the subject. If the subject is interested, the RA 
will document consent with the participant’s wet-ink signature. The RA will 
consent the first 6 patients under the supervision of either Dr. Kelkar or Dr. Abel. 
25.0
Drugs or Devices
N/A. 
26.0
Appendices – Attached Separately in Individual Files 
A: Post-Pilot Survey Draft
B: Focus Group Script Draft
C: Security Details

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
23
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1.
Laino C: Delirium Often Misdiagnosed in Stem Cell Transplant Patients, 
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2.
Ueki S, Ikegame K, Kozawa M, et al: Risk Analysis of Falls in Patients 
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3.
Pautex S, Herrmann FR, Zulian GB: Factors associated with falls in 
patients with cancer hospitalized for palliative care. Journal of palliative medicine 
11:878-884, 2008
4.
Mosher CE, Lepore SJ, Wu L, et al: Social correlates of distress following 
hematopoietic stem cell transplantation: Exploring the role of loneliness and cognitive 
processing. Journal of health psychology 17:1022-1032, 2012
5.
Bauer-Wu S, Sullivan AM, Rosenbaum E, et al: Facing the Challenges of 
Hematopoietic Stem Cell Transplantation With Mindfulness Meditation: A Pilot Study. 
Integrative Cancer Therapies 7:62-69, 2008
6.
Bogg TFT, Broderick C, Shaw P, et al: Feasibility of an inpatient exercise 
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Jarden M, Nelausen K, Hovgaard D, et al: The Effect of a Multimodal 
Intervention on Treatment-Related Symptoms in Patients Undergoing Hematopoietic 
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8.
Tamrat R, Huynh-Le M-P, Goyal M: Non-Pharmacologic Interventions to 
Improve the Sleep of Hospitalized Patients: A Systematic Review. Journal of General 
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Bott N, Wexler S, Drury L, et al: A Protocol-Driven, Bedside Digital 
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Machesney D, Wexler SS, Chen T, et al: Gerontechnology Companion: 
Virutal pets for dementia patients, IEEE, pp 1-3
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Demiris G, Thompson HJ, Lazar A, et al: Evaluation of a Digital 
Companion for Older Adults with Mild Cognitive Impairment. AMIA ... Annual 
Symposium proceedings 2016:496-503, 2016
12.
Chi N-C, Sparks O, Lin S-Y, et al: Pilot testing a digital pet avatar for 
older adults. Geriatric nursing (New York) 38:542-547, 2017
13.
Brooke J: SUS - A quick and dirty usability scale, 
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Schwarzer R, Jerusalem M: Generalized Self-Efficacy Scale, in J. 
Weinman SW, & M. Johnston (ed): Measures in health psychology: A user’s portfolio. 
Windsor, UK, NFER-NELSON, 1995, pp 35-37
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Pope C, Ziebland S, Mays N: Qualitative research in health care. 
Analysing qualitative data. Bmj 320:114-6, 2000
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Odejide OO, Salas Coronado DY, Watts CD, et al: End-of-Life Care for 
Blood Cancers: A Series of Focus Groups With Hematologic Oncologists. Journal of 
Oncology Practice 10:e396-e403, 2014

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Patients Undergoing Stem Cell Transplantation 
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17.
Henckel C, Revette A, Huntington SF, et al: Perspectives Regarding 
Hospice Services and Transfusion Access: Focus Groups With Blood Cancer Patients and 
Bereaved Caregivers. J Pain Symptom Manage 59:1195-1203.e4, 2020
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Rahul Banerjee; Amar Kelkar M: The Toxicities of Allogeneic 
Transplantation: What Fellows Need to Know, in Hematopoiesis (ed). 
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Krueger R, Casey M: Focus groups: A practical guide for applied research 
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van Belle G: Statistical Rules of Thumb (ed 2nd). New York, NY, John 
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impairment. Gerontechnology 20:1-15, 2020

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
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Appendix A: Post-Pilot Survey
Hello,
Thank you for participating in this study evaluating the care.coach avatar.
My name is ***. We met when you were first enrolled in the study. As we mentioned in 
enrollment, I’m calling/stopping by to review a brief survey on your experience with the 
care.coach avatar.
We appreciate your time and help with this study!
CONTINUE

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
26
POST-PILOT SURVEY
Technology Usability
1. Regardless of prior choice, my ideal care.coach avatar is a:
a.
Dog
b. Cat
c.
Other Animal
d. Human
2. I find the avatar easy to use.
a.
Likert Scale (Strongly Agree to Strongly Disagree) (“on a scale of 1 to 5”)
3. What do you like best about the avatar?
a.
Write-in
4. What did you like least about the avatar?
a.
Write-in
5. I like the appearance of the avatar.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
6. I had difficulty waking the avatar.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
7. My conversation with the avatar was clear and understandable.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
8. I felt like I was speaking to a person while using the avatar.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
9. Roughly, what percentage of your (insert number) hospital days did you want to 
use the avatar?
a.
Scale of percentages (by 10% intervals)
10. The avatar interacted with me an appropriate number of times per day to 
encourage healthy habits such as eating, drinking, medications, and physical 
activity.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
11. Did you ever turn off or use the cover for the avatar?
a.
Yes/No
12. Did you feel like your privacy was impacted negatively by the presence of the 
avatar?
a.
Yes/No

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
27
13. I felt safer in the hospital because of the avatar.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
14. I would use the avatar again in the hospital.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
15. I would use the avatar at home after discharge if it were available.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
16. I would use the avatar before I was admitted to the hospital to prepare for my stay 
and treatment.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
17. Using the avatar was fun.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
18. Using the avatar was an enjoyable challenge.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
19. I would recommend the avatar to others.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
Self-Efficacy
20. I can always manage to solve difficult problems if I try hard enough
a.
Likert Scale (Strongly Agree to Strongly Disagree)
21. It is easy for me to stick to my aims and accomplish my goals.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
22. I am confident that I could deal efficiently with unexpected events.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
23. Thanks to my resourcefulness, I know how to handle unforeseen situations.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
24. I can solve most problems if I invest the necessary effort.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
25. I can remain calm when facing difficulties because I can rely on my coping 
abilities.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
26. When I am confronted with a problem, I can usually find several solutions.
a.
Likert Scale (Strongly Agree to Strongly Disagree)

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Patients Undergoing Stem Cell Transplantation 
28
27. If I am in trouble, I can usually think of a solution.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
28. I can usually handle whatever comes my way.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
Educational Modules
29. Since leaving the hospital after my transplant …
a.
I know the most common side effects of my transplant to watch out for.
i. Likert Scale (Strongly Agree to Strongly Disagree)
b. I feel comfortable with the dosage and timing of my transplant 
medications.
i. Likert Scale (Strongly Agree to Strongly Disagree)
c.
I feel comfortable recognizing situations where I might be at high risk for 
infections.
i. Likert Scale (Strongly Agree to Strongly Disagree)
d. I feel comfortable shopping for food that I can safely eat.
i. Likert Scale (Strongly Agree to Strongly Disagree)
e.
I feel comfortable with the protocols for cleaning my home.
i. Likert Scale (Strongly Agree to Strongly Disagree)
f.
I know the situations when I need to call my transplant team.
i. Likert Scale (Strongly Agree to Strongly Disagree)
Loneliness/Isolation
30. When did you choose to engage with the avatar? [select as many as appropriate]
a.
Never without prompting
b. Education
c.
Passing Time
d. Loneliness
e.
Anxiety
f.
Exercise
g. Other
31. I felt less bored/lonely/anxious in the hospital due to the avatar.
a.
Likert Scale (Strongly Agree to Strongly Disagree)
32. With which did the avatar help the most?
a.
Boredom/Loneliness/Anxiety

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Patients Undergoing Stem Cell Transplantation 
29
Artificial Intelligence
33. Did you feel respected when speaking to the avatar?
a.
Yes/No
34. Did you trust what the avatar was saying?
a.
Yes/No
35. Did you at times forget that you were talking to an avatar?
a.
Yes/No
36. Did that bother you?
a.
Yes/No
Thank you for taking the time to participate in our survey!

PROTOCOL TITLE: Development and Piloting of Avatar-based Intervention to Support 
Patients Undergoing Stem Cell Transplantation 
30
Appendix B: Focus Group Script Draft
Introduction and Welcome 
Welcome and thank you for taking the time to be part of this focus group session. We are
working on a study to determine appropriate modifications to care.coach, an avatar-based 
care  support platform, for the inpatient HCT setting. The information from this 
discussion will be used to develop educational modules that will be provided to patients 
undergoing HCT. 
This session is being audio recorded because we don’t want to miss any of your
comments. People often say very helpful things in these discussions, and we can’t write
fast enough to get them all down. You can introduce your name as you would like to be
called, but there will be no names attached to comments in our reports. We also ask each
of you to keep everything that is discussed today confidential. To prevent feedback and
distraction, we ask that each of you please turn off your cell phones so that the session is
not interrupted and, if you are not already in a quiet place, please move to one if you are
able. For recording purposes, it is best if we speak one at a time.
My role here, as the moderator, is to guide the discussion by asking questions and
listening. I will be asking you some questions that we have developed, and we are
interested in your thoughts. There are no wrong answers and we do not expect everyone
to agree, but rather it is important to know if people have differing points of view. Please
know, however, that you can skip any question you do not wish to answer. I will also
occasionally interrupt and move us to a new topic to keep us on time, thank you for your
understanding if this occurs. I will turn on the audio-recorder now. Let us begin the
discussion. 
Topics: [Moderator will ask questions that probe the following themes] 
1. Educational topics that should be incorporated into the avatar?
… Diet selection, exercise, medication use, common symptoms, when to call for 
help, catheter flushing, others?
2. Check-in frequency?
… At meal times only? Morning? Afternoon? Night? Total number of check-ins 
per day?
3. Which populations would most benefit? 
…Older patients? Younger? RIC? MAC? Specific regimens?
4. When should care.coach be given to patients?
…Before the transplant admission? On the date of admission for transplant? On 
the date of transplant? Several days after transplant? Other?
5. When should care.coach be taken back from the patient?
…On the date of transplant? Several days after transplant? At the time of 
discharge? At the time of completion of the educational modules? Other?
6. What other functions do you think this technology could be used for?