Development and Pilot Testing of a Hybrid In Person and mHealth Coping Skills Training Intervention for Symptom Management and Daily Steps in Stem Cell Transplant Patients
Phase: NA
Conditions: Stem Cell Transplant
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell 
Transplant Patients 
 
NCT03859765 
 
May 23, 2022 

Purpose of the Study
Our group developed a mHealth pain coping skills training program for HCT patients and 
found in a small pilot trial (R21) that improved pain coping led to increased daily activity and 
reduced physical disability. However, fatigue and distress were also barriers to physical 
activity. We propose to develop a novel mHealth behavioral intervention to enable 
HCT patients to effectively cope with symptoms to improve their ability to engage in 
physical activity that can improve physical disability. Our interdisciplinary team 
(psychiatry, hematology/oncology, occupational therapy) will develop a hybrid in-person and 
mHealth HCT Coping Skills Training for Symptom Management and Daily Steps (HCT 
Symptoms and Steps) intervention protocol. HCT Symptoms and Steps will provide patients 
with coping skills training and activity coaching sessions to enhance their ability to cope with 
symptoms that interfere with activity. HCT Symptoms and Steps will be developed by 
experts in symptom management, members of the HCT medical team, and with extensive 
input from HCT patients. Innovative features to be considered include: initial in-person 
sessions with subsequent sessions via video-conferencing at home; a mobile application 
and wireless activity trackers to capture symptoms and activity data for real-time 
personalized feedback; cognitive behavioral strategies to decrease the impact of symptoms 
– pain, fatigue, distress – that most interfere with activity.
Aim 1: Develop the HCT Symptoms and Steps protocol for HCT patients. Development will 
consist of 5 focus groups with HCT patients (n=6/group), a focus group with HCT providers 
(N=6), and user testing with 10 HCT patients. H1: This process will develop a feasible and 
acceptable protocol for HCT patients with pain, fatigue, and distress. 
Aim 2: Use a small randomized controlled trial (N=40) to examine feasibility and 
acceptability of the developed HCT Symptoms and Steps protocol. Feasibility will be 
assessed via (a) study accrual, (b) protocol adherence, and (c) retention. H2: Feasibility will 
be determined by accrual (N=40/12 months), >80% adherence to the protocol, and <20% 
attrition. Acceptability will be demonstrated by 80% of participants reporting intervention 
satisfaction.
Aim 3: Examine outcome patterns suggesting the efficacy of the HCT Symptoms and Steps 
protocol for improving physical disability and other outcomes compared to an HCT 
Education group. H3: Between-group effect sizes will be used to evaluate patterns 
suggesting intervention efficacy on measures of physical disability (self-report, 6-min walk 
test), pain, fatigue, distress, physical activity (daily steps), and self-efficacy for symptom 
management.
Confirmed hypotheses would provide the first demonstration of the feasibility, acceptability, 
and positive impact of a hybrid in-person and mHealth coping skills training and activity 
coaching intervention that reduces physical disability by concurrently and synergistically 
decreasing symptom burden and increasing physical activity. This project has the potential 
to lead to future research (R01) that can redesign existing modes of behavioral intervention 
delivery, improve continuity and coordination of care, and ultimately enhance patient 
outcomes. 
Background & Significance
Should support the scientific aims of the research

Background & Significance 
Hematopoietic stem cell transplant (HCT) is an aggressive treatment for life-threatening 
cancers. HCT has led to improved prognosis and survival, but 70-80% of HCT patients 
experience significant physical disability, which is exacerbated by persistent symptoms.1,2 P
ain, fatigue, and psychological distress are among the most prevalent and debilitating 
symptoms for HCT patients. Higher pain, fatigue, and distress in HCT patients are 
associated with greater physical disability and difficulty adhering to physical activity 
guidelines.1,3-11 Research shows HCT patients experience a significant increase in physical 
disability as their pain, fatigue, and distress increase.1,2 This physical disability along with 
their symptom burden interferes with patients’ ability to engage in recommended physical 
activity that can improve disability, symptoms, and other important health outcomes. 
Perhaps paradoxically, physical activity is the most common way to reduce physical 
disability. Physical activity is a part of standard care guidelines following transplant; HCT 
patients are instructed to engage in 30 minutes of daily activity or 2700 steps.12 Research 
shows that physical activity leads to reduced disability and other important health outcomes, 
including reduced symptom severity and increased psychological functioning.9,13-18 Increasi
ng evidence shows physical activity is safe and feasible for HCT patients, can alleviate 
symptoms and side effects of treatment, and can improve quality of life and potentially 
survival.19-23  
Despite the recommendations and its many benefits, HCT patients report difficulty engaging 
in physical activity. Pain, fatigue, and distress are major barriers to physical activity.2,19,24 H
CT patients report increased severity of symptoms when they attempt to follow activity 
guidelines; thus, symptoms either limit their activity or stop it completely.19 Low levels of 
activity exacerbate disability, and can result in impaired cardiorespiratory fitness and 
decreased mobility, strength, and endurance.18,23 Low levels of activity also increase 
patients’ risk for chronic diseases and may ultimately negatively impact survival.18,23 Teachi
ng HCT patients to cope with symptoms and engage in activity is critical to helping them 
increase activity and reduce disability.  
Cognitive behavioral coping skills training interventions are an efficacious treatment for 
cancer-related symptoms. Traditional analgesic and other medications for pain and 
symptom management have limitations, particularly in HCT patients. Some analgesics and 
corticosteroids are contraindicated25 and others can only be given orally. Importantly, 
medications often do not fully relieve pain, fatigue, and distress, and patients report 
significant side effects.26 Cognitive and behavioral factors play an important role in patients’ 
ability to cope with symptoms and engage in physical activity.27-29 HCT patients with 
persistent symptoms are likely to have low confidence in their ability to control their 
symptoms (i.e., self-efficacy for symptom management). HCT patients in our past work who 
have low self-efficacy for managing symptoms are more likely to experience problems with 
symptoms, adherence to activity recommendations, and physical disability.30,31 Work in 
other patients with persistent symptoms has found cognitive behavioral coping skills training 
protocols are efficacious in reducing symptom severity and improving self-efficacy for 
symptom management, physical activity and physical disability.32-36 However, the 
application of these protocols to HCT patients is limited by in person sessions, delivery of 
sessions in a medical center setting, and/or lack of tailoring to HCT patients’ specific needs.3
7,38  
Physical disability and persistent symptoms (pain, fatigue, distress) complicate an already 
challenging recovery course.8,39 HCT patients spend pre- and post-transplant days as 

inpatients, have weeks of intensive outpatient care, and then return home often many miles 
from the hospital. HCT patients return home with compromised immune functioning, low 
vigor, and restriction on normal activities (e.g., driving, cooking, yard work, church) that 
could increase infection risk or compromise safety. HCT patients report feeling socially 
isolated and disconnected from their medical team. HCT patients experience these 
challenges during a critical time of transition from hospitalization to home. Mobile health 
(mHealth) technologies can improve and extend intervention strategies during this time of 
transition. A protocol that uses mHealth technology for delivery may be particularly 
beneficial for HCT patients as it allows the medical team to provide care to the patient in his
/her home. The patient remains connected to the medical team during an important time of 
transition, which can increase continuity of care and access to treatment, and decrease 
patient burden.  
We aim to develop and test a combined coping skills training and activity coaching 
protocol that: first, is feasible and acceptable, and second, improves physical 
disability, as well as pain, fatigue, distress, and physical activity in HCT patients. We 
have used the NIH Treatment Development Stage Model40 to inform the research activities 
and design. This study focuses on development (i.e., focus groups, user testing) and a 
small pilot trial (Stage I), with emphasis on the mHealth component and mobile app. Data 
gathered from research activities will inform protocol modification and study results will be 
used to prepare for Stage II (efficacy trial). As described in Preliminary Studies, the 
proposed interdisciplinary research team is uniquely positioned to develop and test a coping 
skills training for symptom management and activity coaching protocol. 
We propose a novel intervention protocol that uses a hybrid in-person and mHealth 
intervention delivery model. The use of mHealth technology to deliver the proposed 
intervention is likely to be more effective than traditional interventions delivered in-person 
only, improving patient access to the intervention by decreasing burden. The NIH recently 
stated that the future of patient care should use a hybrid model of face-to-face contact 
integrated with remote strategies to provide balance between technology and the “human 
touch.” The proposed innovative intervention addresses these recommendations (i.e., in-
person and mHealth strategies). We have piloted hybrid work and the proposed project is a 
natural extension as we increase face-to-face contact, increase mHealth technology, and 
address shortcomings of the previous protocol (we now address pain, fatigue and distress, 
and incorporate activity coaching). Our past protocol included 1 in-person session at the 
hospital between patient and therapist, which led to development of a successful working 
relationship and integration of the intervention with the patient’s medical care.31 Then, once 
the patient returned home, 5 sessions were conducted via video-conferencing. This bridge 
between hospitalization and home maintained continuity of care. This work demonstrated 
that a mixed delivery modality fostered a strong patient-therapist relationship that likely 
increased feasibility, acceptability, and efficacy of the intervention.31 Further, our experience 
with mHealth technology suggests video-conferencing is human touch as it mirrors in-
person sessions and is interactive and personal. Traditional coping skills training 
interventions have been delivered almost exclusively in-person in major medical centers. 
For HCT patients, travel is burdensome due to significant symptom burden and strict activity 
restrictions. Distance from medical centers is a concern for several communities in the US 
and mHealth interventions can increase access to care. An intervention that begins in-
person immediately following transplant and continues via mHealth technology increases 
access by reducing travel barriers for a cancer population that experiences significant 
burden.  
*Due to COVID-19, we propose a 
 amendment. Session 1-3 will now be conducted 
temporary
via telephone or video-conferencing, the same way as the approved session 4-7. 
Design & Procedures

Describe the study, providing detail regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Study Overview. We will develop and test an in-person and mHealth HCT Coping Skills 
Training for Symptom Management and Daily Steps (HCT Symptoms and Steps) 
intervention protocol. To do this, we will develop a mobile app, conduct focus groups, 
complete user testing, and conduct a small RCT to examine feasibility, acceptability, and 
outcome patterns suggesting intervention efficacy. 
 
Methodological Features. This protocol has several important methodological features. 
First, we will combine symptom management and activity coaching to address the multiple 
recovery challenges faced by HCT patients. Second, we will use in-person and video-
conferencing sessions to bridge hospitalization and home. The initial HCT Symptoms and 
Steps coping skill (1) and activity coaching (2) sessions will be in-person in the hospital 
which provides several benefits including: integration of HCT Symptoms and Steps into 
patients’ medical care; facilitation of a relationship between therapist and patient; and, 
establishment of care that bridges hospitalization and home. All sessions following the initial 
in-person sessions will be delivered to the patient in his/her home through video-
conferencing. The use of video-conferencing (vs. in-person or phone) is likely to provide 
important advantages. A) HCT patients often live many miles from the hospital and are 
advised against extended travel thus video-conferencing will increase intervention access. 
B) Empirical work suggests educational and psychosocial content is better communicated 
through video-conferencing than by phone.41 C) Video-conferencing may enhance factors 
suggested by social cognitive theory to impact self-efficacy for symptom management: mast
ery, enhanced by practice/feedback in the home environment; vicarious learning, enhanced 
by therapist and video clip modeling; verbal encouragement, personalized to the patient’s 
home skills practice; and, observation of and addressing negative physiological and 
affective responses to skills use in the patient’s practice environment. Third, a mobile app 
will provide HCT Symptoms and Steps participants with accessible coping skill content 
(audio and video), data syncing of daily steps from their wireless activity tracker, daily 
assessment of symptoms and activity, and real-time personalized feedback (push 
notification) based on symptoms and steps. The mobile app will be accessible on study 
iPhones and/or personal tablets/smart phones. Fourth, we have incorporated an objective 
assessment of physical disability (6-min walk test). 
 
HCT Symptoms and Steps Intervention Mobile App Development. The study team 
(Kelleher, Somers, Sung) responsible for mobile app development have worked together for 
several years and will be ready to immediately begin app development in Year 1.30,31,42 We 
propose that the HCT Symptoms and Steps app include: 1) patient content on coping skills 
and physical activity (e.g., audio, skills demonstration videos), 2) syncing of wireless activity 
tracker data and transmitting in real-time to study staff, 3) coping skills use tracking, 4) daily 
symptoms assessment, 5) push notifications from the therapist (3x/week) that include 
reminders, encouragement, and real-time personalized feedback based on coping skills use 
and symptoms assessment, and 5) a link to the intervention video-conferencing application. 
We will use feedback from the focus groups and user testing (see below) to make revisions 
to the mobile app as indicated. Pattern Health (Durham, NC) is a digital health company 
specializing in patient-centered web and mobile products for clinical and medical research 

and health data tracking and analysis, with expertise working with wireless devices and 
improving patient engagement. Pattern Health has an established relationship with 
researchers at Duke and will be contracted for the development of a mobile app for use in 
the current study (see letter of support). The investigators have already been working with 
expert technicians at Pattern Health and will continue to work closely to design and develop 
the study app. 
 
Focus Groups/User Testing.  We will conduct focus groups and user testing to iteratively 
develop the HCT Symptoms and Steps protocol. Focus groups will be sequential allowing 
for the data from each group to iteratively update the protocol prior to the next group. In 
focus groups, patients will respond freely to verbal feedback based on the presentation and 
questioning, and provide written responses to assessments of needs, barriers, mobile app 
format preferences, and ratings of app and material helpfulness and ease of use. Focus 
groups will be audio-recorded. Focus group and user testing participants will be 40 patients 
who have undergone HCT and 6 healthcare providers from the Adult Blood and Marrow 
Transplant (ABMT) Clinic. 
 
Randomized Controlled Trial. We will use a small RCT to assess the feasibility, 
acceptability, and outcome patterns suggesting efficacy of a HCT Coping Skills Training for 
Symptom Management and Daily Steps (HCT Symptoms and Steps) protocol. This study 
will be conducted in the ABMT Clinic with 40 HCT patients. Following consent (consent 
process detailed below), participants will be randomly assigned in equal allocation to one of 
two conditions: 1) HCT Symptoms and Steps or 2) HCT Education. HCT Symptoms and 
Steps will provide patients with cognitive behavioral coping skills training and activity 
coaching sessions to enhance their ability to manage symptoms that interfere with activity. 
All participants will receive a wireless activity tracker (Fitbit) to track steps; Fitbits will not be 
returned, participants will keep their Fitbit. All participants who do not have a smart phone 
will be lent one (iPhone) equipped with Internet access to access the mHealth features: 
video-conferencing, coping skill content, activity tracker syncing, daily symptoms 
assessment, and personalized feedback (via push notification) based on symptom and step 
data. HCT Education will only have access to activity tracker syncing and daily symptoms 
assessment. HCT education participants will be encouraged to download the Transplant (HCT) 
Guidelines mobile app that is free of charge. The Transplant Guidelines app is developed by the 
National Marrow Donor Program and designed for HCT patients with a focus on treatment 
guidelines for patients before and after transplant. The Transplant Guidelines App provides 
recommended annual check-up guidelines and timing and contains helpful information, 
checklists and reminders for patients who have had a blood or marrow transplant. App content 
also includes cancer education, information about health and well-being, cancer treatment 
guidelines specific to HCT patients, and what to expect at follow-up visits. App features allow 
participants to use a GvHD symptom checker to help identify early signs of GvHD and make 
notes, e-mail guidelines and symptom checker results to self, and set reminders for 
appointments, medications, and exercise. All participants will complete 2 assessments: pre-
treatment and post-treatment. We will recruit 10 patients per quarter (3-4/month) to complete 
the recruitment goal of 40. Participants will receive $20 for completing each assessment. Th
erapist Training. Coping skills training sessions will be delivered by a doctoral level 
psychologist with experience delivering cognitive behavioral interventions. Activity coaching 
sessions will be delivered by an OT with expertise working with HCT patients. Treatment 
strategies will be taught through didactic instruction, audio-/video-recorded illustration of 
techniques, and role-play. Procedures to Ensure Consistency of Treatment. To ensure 
consistency with the intervention protocol: 1) therapists will follow a treatment manual, 2) 
weekly supervision will occur, 3) sessions will be audio-recorded and reviewed during 
supervision and feedback provided, and 4) ratings of treatment adherence and competence 
will be conducted.  

For individuals who already have a smartphone, they will use their own device. For participants 
who can use their own phones, the following steps will be taken to ensure the phones are 
secured: 1) We will enable encryption on the device and verify that data protection is enabled, 
set “require passcode” to immediately, and enable erase data to “automatically erase the 
device” after 10 failed passcode attempts. 2) We will set Auto-Lock. 
For participants who have their own smart phone with a Fitbit app installed/personal Fitbit 
account already created, we will loan them a study phone for the purposes of study participation 
to access their study Fitbit account which will not include any personal identifiers. This measure 
is taken for these individuals as another layer of security.
*Due to COVID-19, we propose a 
 amendment. Participants will now be screened 
temporary
and must have a smartphone to be eligible. We will be temporarily suspending giving 
participants smartphones and FitBits. 
Selection of Subjects
 
List inclusion/exclusion criteria and how subjects will be identified.
1. Patients who have undergone hematopoietic stem cell transplant (HCT) due to an oncological disease (e.
g., leukemia, lymphoma, multiple myeloma) (up to N=30) from the Adult Blood and Marrow Transplant 
(ABMT) Clinic at Duke Cancer Institute will be recruited to participate in 5 focus groups (about 6 
participants in each group). Eligibility criteria include: 1) being at least 18 years old, 2) report clinical pain, 
fatigue, or psychological distress, at least 2/3 symptoms with 1 symptom rating at a 3 or greater on a 
scale from 0-10 and 1 symptom at any level, and 3) life expectancy at least 12 months. Exclusion criteria 
include: 1) cognitive impairment (e.g., dementia) recorded in the chart or suspected by healthcare 
provider, 2) presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric 
condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the 
medical chart, treating oncologist, or interactions with the medical/study staff, and 3) inability to converse 
in English. These focus groups are designed to facilitate development of a feasible and acceptable CST 
Step-Up intervention protocol by using rigorous qualitative (focus groups) and quantitative (self-report) 
methods.
2. Healthcare providers (about N=6) will participate in 1 focus group. Healthcare provider participants will 
include oncologists, oncology nurse practitioners, oncology physicians’ assistants, and oncology nurses. 
These focus groups are designed to facilitate development of a feasible and acceptable CST Step-Up 
intervention protocol by using rigorous qualitative (focus groups) methods.
 
3. Patients who have undergone hematopoietic stem cell transplant (HCT) due to an oncological disease (e.
g., leukemia, lymphoma, multiple myeloma) (up to N=10) from the Adult Blood and Marrow Transplant 
(ABMT) Clinic at Duke Cancer Institute will be recruited to participate in user testing of the developed CST 
Step-Up protocol. Eligibility criteria include: 1) being at least 18 years old, 2) report of clinical pain, 
fatigue, and psychological distress, and 3) life expectancy at least 12 months. Exclusion criteria include: 1) 
cognitive impairment (e.g., dementia) recorded in the chart or suspected by healthcare provider, 2) 
presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.
g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical 
chart, treating oncologist, or interactions with the medical/study staff, and 3) inability to converse in 
English. User testers will complete the developed CST Step-Up protocol and provide feedback following 
each session. The qualitative and quantitative data gathered from user testing will be used to refine the 
CST Step-Up intervention protocol.
 
Randomized Controlled Trial. We will use a small RCT to assess the feasibility, acceptability, and 
outcome patterns suggesting efficacy of the fully developed HCT Coping Skills Training for Symptom 
Management and Daily Steps (CST Step-Up) protocol. This study will be conducted in the Adult Blood and 
Marrow Transplant (ABMT) Clinic and involve 40 HCT patients. Inclusion criteria: 1) HCT due to oncological 
disease, 2) age 
18, 3) report clinical pain, fatigue, or psychological distress, at least 2/3 symptoms with 
>
1 symptom rating at a 3 or greater on a scale from 0-10 and 1 symptom at any level, 4) life expectancy 
1
>
2 months. Exclusion criteria include cognitive impairment (e.g., dementia), 2) presence of a severe 
psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent), 
and 3) inability to converse in English.

*Due to COVID-19, we propose a 
 amendment. This temporary amendment requires 
temporary
participants to own their own smartphone to be eligible for participation. 
Subject Recruitment and Compensation
Describe recruitment procedures, including who will introduce the study to potential subjects. Describe 
how you will ensure that subject selection is equitable and all relevant demographic groups have access 
to study participation (per 45 CFR 46.111(a) (3)). Include information about approximately how many 
DUHS subjects will be recruited. If subjects are to be compensated, provide specific prorated amounts 
to be provided for expenses such as travel and/or lost wages, and/or for inducement to participate.
Subject Recruitment and Compensation. Focus group and user testing participants will 
be 40 patients who have undergone HCT and have reported pain, fatigue, and distress post-
transplant in addition to 6 healthcare professionals (e.g., nurses, oncologists) who provide 
care to HCT patients. RCT participants will be 40 patients. The amount of time patients are h
ospitalized for their HCT varies based on the type of transplant they receive (e.g., 
autologous vs. allogeneic). Thus, patients who undergo an autologous transplant will be 
approached either pre- or post-transplant. Pre-transplant approach and consent will happen 
1 week to 1 month before a scheduled transplant and post-transplant approach and consent 
will happen up to 3-months post-transplant. Patients who undergo an allogeneic transplant 
will be approached within 1-month post-transplant.  
 
Drs. Kelleher (PI) and Somers (Co-I) will work closely with the study oncology physician 
champion (Dr. Anthony Sung [Co-I]) to facilitate recruitment of patient participants in their 
clinics. Drs. Kelleher and Somers (Co-I) have worked with the ABMT providers on past trials 
and successfully recruited cancer patients with pain, fatigue, and distress. 
 
Patient participants will be recruited under a Waiver of Consent and HIPAA authorization. 
Dr. Sung and his team will provide the study team with the names and medical record 
number of all participants scheduled for transplant. Then, the study team will gather 
information from medical records to assess whether or not the patient meets study inclusion 
criteria (i.e., cancer diagnosis) and is at least 18 years old. The study team will also collect 
medical information related to transplant type and date to use to appropriately time 
recruitment. Other information gathered at this time will include cancer type, date of 
diagnosis, recurrence date, patient date of birth, sex, marital status, education, race, cancer 
stage, and height/weight. Once a potential study participant has been identified and they 
are within the study recruitment window, study staff will mail the patient a letter signed by 
the study PI and oncology physician champion (Anthony Sung, MD) informing them of the 
study and providing contact information to decline/opt out. We will attempt to meet potential 
participants at the transplant clinic to attempt recruitment, or by phone if we are unable to 
meet them in clinic (e.g., due to time constraints). 
 (e.
For patients approached by phone
g., due to time constraints in clinic), we will wait 3 days from mailing the study letter to allow 
time for the patient to receive the letter. When contacting by phone, the study team member 
will follow the IRB approved script to introduce and explain the study, describe study 
procedures, and assess the patient's interest and eligibility. If the patient is interested and 
eligible, the study team member will schedule a time to meet the patient in clinic or in the 
study team's research office to obtain written consent (Pain Prevention and Treatment 
Research Program, 2200 W. Main St., Ste. 340, Durham, NC 27705). For those 
, a member of the medical team known to the patient will first ask the 
approached in clinic
patient’s permission to have a member of the study team approach them. We will not be 
using cold-contact. Once permission is given, a member of the study team will approach the 
patient and describe the study procedures. If the patient remains interested, they will 

complete the written consent process prior to their participation in the study. A member of 
the study team will answer any questions that the potential participant may have. Once 
informed consent has been received, participants will be scheduled for a study appointment 
either to happen at that time or a time convenient for them in the future. A member of the 
study team will conduct the appointment. If a participant declines study participation at any 
point during these procedures, the information provided to the study team through the 
medical team or medical records will be immediately de-identified. At this first study 
appointment, the study team member will explain all study procedures and administer the 
baseline assessment.  
 
Compensation. User testing and RCT participants will receive $20 for completing each of 
the two study assessments (pre-treatment and post-treatment; total $40). All participants 
will continue to receive standard medical care from their medical team. No participant will be 
asked to change or decline any strategies for symptom management based on their 
participation in this study.  
*Due to COVID-19, we propose a 
 amendment. This temporary amendment 
temporary
suspends in-clinic approaches. Study staff will continue to mail out a letter, no cold-contact, and 
then will approach by telephone. Compensation procedures will remain the same. 
Consent Process
 
Complete the consent section in the iRIS Submission Form.
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
Not applicable.
Study Interventions
If not already presented in #4 above, describe study-related treatment or use of an investigational 
drug or biologic (with dosages), or device, or use of another form of intervention (i.e., either physical 
procedures or manipulation of the subject or the subject’s environment) for research purposes.
Study interventions presented in #4 above.
Risk/Benefit Assessment
Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant women, prisoners or cognitively impaired 
adults), what special precautions will be used to minimize risks to these subjects? Also identify what 
available alternatives the person has if he/she chooses not to participate in the study. Describe the 
possible benefits to the subject. What is the importance of the knowledge expected to result from the 
research?

Risk/Benefit Assessment 
Potential Risks. The primary risks of this study are those associated with confidentiality. 
There is some risk attendant to confidentiality of self-report data. Two password-protected 
databases will be used for this study to ensure confidentiality. First, a tracking database will 
be used for recruitment and follow-up. This data will house information related to tracking 
the participants in the study, such as phone numbers and addresses. No medically sensitive 
or outcome data will be stored in this database. This database will also track non-
participants (i.e., those who have declined participation) only to the barest minimum to 
ensure that they are not contacted again about participation. At the end of the study, all 
identifiable data of non-participants such as their names will be deleted. Tracking data on 
participants will be retained for the usual required period. Second, all study data will be 
stored in a separate password protected REDCap database without any personal 
identifiers. Data in this database will be derived from patients’ direct input into REDCap, 
which is an online survey system; data entered into this system is stored on a secure server 
housed behind the Duke Universtiy Medical Center (DUMC) firewall. Only a unique study 
identification number will link the electronic data to the study data file. The tracking data and 
study data will be stored in a file on a secure DUMC psychiatry server which can only be 
accessed by necessary members of the research team. Access to the Duke network 
requires a password protected, 128-bit encrypted virtual private network connection 
provided by Cisco systems. 
There are few risks linked to participating in in-clinic activity coaching sessions with an 
occupational therapist that center on daily steps. The activity coaching component of the 
intervention is being designed in part by hematology oncology providers and an 
occupational therapist who specializes in working with hematology oncology patients. 
Further, the activity coaching sessions will be led by a senior level occupational therapist at 
Duke University Hospital who holds a lymphedema therapist certification and specializes in 
working with hematopoietic stem cell transplant (HCT) patients pre- and post-transplant. 
The activity coaching component of the intervention is consistent with clinical 
recommendations for activity post-transplant and will be modified based on the patient 
participant’s level of functioning. We will obtain physician clearance for activity prior to 
initiating the intervention sessions. While we do not anticipate any adverse events, we have 
developed a protocol to protect against and track adverse events related to exercise injuries
/falls, lymphedema flares, hypotension or hypoglycemia, and cardiovascular events. 
 
The risks associated with this study are minimal and rare. During the assessments, 
participants will be asked to complete a walking test. The 6 minute walk test will be 
conducted in a hallway at the Duke ABMT Clinic or in a hallway in our research lab office 
space at the Pain Prevention and Treatment Research Program located in Erwin Square 
(2200 W. Main St., Ste. 340). Study staff (e.g., CRC, Occupational Therapist) will complete 
the 6 minute walk test. The 6 minute walk test is optional for participants; if a patient 
declines, we will not conduct the test. Further, we will check patients' blood pressure prior to 
conducting the 6 minute walk test and if any of the following contraindications are present, 
we will not conduct the test: (1) unstable angina during the previous month, (2) myocardial 
infarction during the previous month, (3) resting heart rate >120, (4) systolic blood pressure 
>180 mm Hg, (5) Diastolic blood pressure >100 mm Hg. There are some risks associated 
with the 6 minute walk test. During the 6 minute walk test, a participant may experience 
difficulty with breathing, shortness of breath, chest pains, dizziness, and/or light 
headedness. There is also the potential risk of a fall during the 6 minute walk. The study 
investigators, including the medical oncologist co-investigator, and the study team will take 
all precautions possible to avoid and minimize these risks (e.g., checking blood pressure 
and other contraindications prior to conducting test, making test optional). Should any of 
these occur, appropriate emergency care (e.g., 911) will be provided. A defibrillator is 

available at the ABMT Clinic, and so are nursing and other medically trained staff. Over the 
course of the intervention, participants will be asked to participate in in-person/in-clinic 
activity coaching sessions led by a certified, senior level occupational therapist and to 
continue this activity and skills practice on their own at home. While we do not anticipate 
any adverse events and the intervention is consistent with physical activity 
recommendations, participants may be at risk for adverse events related to physical activity 
such as injuries/falls, lymphedema flares, hypotension or hypoglycemia, and cardiovascular 
events. Again, we will obtain physician clearance for activity prior to initiating the 
intervention sessions and should any of these adverse events occur, appropriate 
emergency care (e.g., 911) will be provided. Overall, the benefits of the intervention 
outweigh the risks and the activity coaching component is consistent with recommendations 
from HCT oncology providers, occupational therapists specializing in HCT care, and 
national guidelines for HCT patients. 
 
Potential Benefits and Importance of Information to be Gained. This study has several 
potential benefits. First, hematopoietic stem cell transplant patients with pain, fatigue, and 
psychological distress who participate in the intervention may learn ways to enhance their 
symptom coping strategies and increase their physical activity. Intervention participants may 
experience significant decreases in symptom severity and physical disability as well as 
increases in physical and psychological functioning. Second, if the proposed HCT 
Symptoms and Steps protocol proves to be feasible, acceptable, and shows promise for 
efficacy, it could be applicable to a number of patient populations with a similarly high 
symptom burden who face challenges similar to hematopoietic stem cell transplant patients 
with pain, fatigue, and distress. Third, the proposed model of intervention delivery has the 
potential to be expanded to intervene on a number of other needs faced by patients with 
chronic illness (e.g., medication adherence, caregiver burden). The proposed intervention 
model has the potential to dramatically redesign existing modes of behavioral intervention 
delivery, improve continuity and coordination of care, and improve patient outcomes. 
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
There are no costs to the subject other than the time that is required to participate in the study.
Data Analysis & Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.
Data Analysis & Statistical Considerations 
Sample Size. Study goals are intervention protocol and mobile app development, feasibility, 
acceptability, and initial outcome patterns suggesting efficacy of a psychosocial 
intervention. We have used sample sizes from 15-40 to test feasibility, acceptability, and 
outcome patterns suggesting efficacy of a novel intervention or intervention delivery, 
successfully publishing these trials59,60 and using data to secure larger funding.  

Aim 1 Analyses. Focus groups will be audio-recorded and transcribed. Recordings and 
transcripts will be reviewed by Drs. Kelleher and Somers. These reviews will refine the 
discussion guide for the subsequent focus group. Data analyses will be based on a 
grounded theory approach,61 which has been used by Dr. Somers in development of other 
psychosocial interventions for patients with cancer. 
Aim 2 Analyses. Feasibility will be assessed by examining accrual, adherence, and 
attrition. Accrual will be indicated by meeting the recruitment goal of 40 participants in 12 
months. Descriptive statistics will be used to report the number of HCT patients screened 
and determine rates of non-eligibility and refusal. Adherence will be indicated by calculating 
the proportion successfully completing all intervention sessions within the HCT Symptoms 
and Steps arm and the proportion completing post-treatment assessments within each arm. 
80% completed intervention sessions and 80% completed assessments will serve as our 
feasibility benchmark. If less than 40% of participants complete all intervention sessions and 
assessments, HCT Symptoms and Steps will not be considered feasible. Attrition will be 
indicated by 80% of consented participants completing the study protocol (i.e., remain 
enrolled). Acceptability will be indicated by 80% of patients reporting satisfaction with HCT 
Symptoms and Steps (M=7) on the CSQ.
Aim 3 Analyses. Between-group effect sizes will be used to evaluate treatment effects on 
physical disability, as well as pain, fatigue, psychological distress, physical activity, and self-
efficacy for symptom management. Between-group effect sizes will provide an index of 
relative change for HCT Symptoms and Steps participants vs. HCT Education participants. 
Because small samples can differ on pretest scores, effect sizes will be calculated by first 
creating change scores for each person. The between-group effect size will then be 
calculated by subtracting the average HCT Education group change score from the average 
HCT Symptoms and Steps change score, and dividing this difference by the standard 
deviation of the pooled treatment/control group’s change score. This study is not designed 
to make conclusions about efficacy without further study.
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
Data & Safety Monitoring
This trial carries minimal risk. There are not physical or side effects involved in taking part in 
this study. The protocol does not use an investigational drug, procedure, or device. 
Regardless, all adverse events, serious and non-serious, will be fully documented in the 
appropriate adverse event form approved by the Duke University Medical Center IRB. For 
each event, the investigator will provide the onset, duration, intensity, treatment required, 
outcome, and action taken. Any serious or significant study-related adverse event, whether 
or not the investigational protocol has been administered, will be reported promptly to the 
IRB. All patients in the study will continue their usual care during the course of the study, 
thus their doctors will provide monitoring of the patients’ overall medical status. All research 
personnel who have direct contact with patients will be trained to observe and report any 

adverse events to the principal investigator. The principal investigator will report any 
adverse events to the institutional review board at Duke University and to the NIH. An 
adverse event is defined as any untoward medical occurrence during the clinical 
investigation that has a causal relationship to the study protocol. A serious adverse event is 
defined as any event which results in death, is immediately life threatening, results in 
persistent or significant disability/incapacity, patient hospitalization, or is serious for any 
other reason representing significant hazard. All adverse events will be reported to Duke’s 
IRB in real time. All data will be stored on a secure server with multiple backups created 
regularly. The data manager, Maggie Rogers, and the co-investigator, Tamara Somers, 
PhD, will monitor the data on a monthly basis.
All interactions with study participants will be under the direction of a Licensed Clinical 
Psychologist (Drs. Kelleher [PI] and Somers [Co-I]). Interventionists in this trial will have 
experience with distressed patients with chronic disease. They will be trained, specifically in 
the context of this trial, to monitor for any signs that participants are experiencing high levels 
of physical or emotional distress that need to be addressed outside the context of this trial. 
If this is determined to be the case, the PI will work directly with the participant to move 
forward in a way that is in the best interest of the patient. No participant will be kept in the 
trial if they are experiencing increased or extreme distress. Interventionists in this trial will 
be carefully trained to monitor participants’ psychologist status and report to the PI. Dr. 
Kelleher (PI) will be contacted when emotional distress is identified in a participant. Dr. 
Kelleher works directly with the Cancer Patient Support Program at Duke Cancer Institute 
as a practicing licensed clinical psychologist and as a supervisor to psychology trainees (i.
e., advanced graduate students, clinical psychology interns); she is integrated into the 
psychosocial care program at the cancer center and has experience referring cancer 
patients who are distressed to appropriate psychosocial or psychiatric care within this large 
team of mental health professionals. She will use the same resources when making 
referrals for distress participants in this study.
Privacy, Data Storage & Confidentiality
Complete the Privacy and Confidentiality section of the iRIS submission form.
Describe Role of External Personnel:
Not applicable.