A Feasibility Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation
Phase: NA
Conditions: Lymphoma, Plasma Cell Myeloma
Sponsor: Emory University

Protocol Title:  A feasibility study of Chaplain-delivered compassion meditation for patients 
receiving stem cell transplantation. 
 
 
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PROTOCOL TITLE:   A feasibility study of Chaplain-delivered compassion meditation for 
patients receiving stem cell transplantation.  
 
Investigators: 
Rev. Caroline Peacock, LCSW, MDiv 
ACPE Certified Educator 
Board Certified Chaplain 
 
Erin Brauer, MPH, Emory 
Department of Family and Preventative Medicine 
 
Principal Investigator: 
Jenny Mascaro, Ph.D. 
Emory University, Department of Family and Preventative Medicine 
Atlanta, GA 30322 
Phone: 404-558-4461 
Fax: 404-727-2860 
Email: jmascar@emory.edu 
 
Principal Contact: 
Jennifer Mascaro 
 
Short Title: Chaplain Meditation HSCT 
 
Draft Date: September 27, 2021 
 
VERSION: 1 
FUNDING SOURCE: NIH- 5TK01AT010488 
 

Protocol Title:  A feasibility study of Chaplain-delivered compassion meditation for patients 
receiving stem cell transplantation. 
 
 
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REVISION HISTORY 
Revision # 
Version 
Date 
Summary of Changes 
3 
01/20/2022 
We will access patients’ information from the electronic 
medical record to determine eligibility and to get patients’ 
contact information.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A feasibility study of Chaplain-delivered compassion meditation for patients 
receiving stem cell transplantation. 
 
 
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Table of Contents 
 
1. Study Summary ........................................................................................................................... 4 
2. Objectives ..................................................................................... Error! Bookmark not defined. 
3. Background .................................................................................. Error! Bookmark not defined. 
4. Study Endpoints .......................................................................................................................... 7 
5. Study Intervention/Design .......................................................................................................... 7 
6. Procedures Involved.................................................................................................................... 7 
7. Study Timelines ........................................................................................................................... 8 
8. Inclusion and Exclusion Criteria ................................................... Error! Bookmark not defined. 
9. Population ..................................................................................... Error! Bookmark not defined. 
10. Local Number of Participants ..................................................... Error! Bookmark not defined. 
11. Recruitment Methods ................................................................ Error! Bookmark not defined. 
12. Withdrawal of Participants ........................................................ Error! Bookmark not defined. 
13. Risk to Participants .................................................................................................................... 9 
14. Potential Benefits to Participants .............................................. Error! Bookmark not defined. 
15. Compensation to Participants ................................................... Error! Bookmark not defined. 
16. Data Analysis, Management and Confidentiality ...................... Error! Bookmark not defined. 
17. Provisions to Monitor the Data to Ensure the Safety of Participants ...... Error! Bookmark not 
defined. 
18. Provisions to Protectd the Privacy Interest of Participants .................................................... 11 
19. Economic Burden to Participant ................................................ Error! Bookmark not defined. 
20. Informed Consent ................................................................................................................... 12 
21. HIPPA .......................................................................................... Error! Bookmark not defined. 
22. Setting  ....................................................................................... Error! Bookmark not defined. 
23. Resources Available……………………………………………………………………………………………………………13 
24. References…………………………………………………………………………………………………………………………14 
 
 
 
 
 

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1. Study Summary 
 
Study Title 
A feasibility study of Chaplain-delivered compassion 
meditation for patients receiving stem cell 
transplantation. 
Study Design 
The study will be an open-pilot trial of chaplain-
delivered CCSH to examine chaplain fidelity to CCSH.  
Primary Objective 
To examine the adoption, extent of implementation, 
and fidelity of chaplain-delivered CCSH.  
 
Secondary Objective(s) 
The second goal is to make refinements as necessary. 
Research 
Intervention(s)/Interactions 
Compassion Centered Spiritual Health (CCSH) 
Study Population 
The study participants for this aim will be (1) 
Chaplains who have already completed the formal 
educational course as part of their residency training 
and willingly volunteer to participate. There will be 
no exclusion criteria and no consequence to the 
chaplains for refusing to volunteer.  (2) The patients 
they see during consultation are also part of the 
study population. 
Sample Size 
6-8 chaplains 
50 stem cell patients 
Study Duration for 
individual participants 
8 months  
Study Specific 
Abbreviations/ Definitions  
Compassion Centered Spiritual Health (CCSH) 
Hematopoietic stem cell transplant (HSCT) 
Funding Source (if any) 
NIH- 5TK01AT010488 
EPEX#- 62568 
 
 

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2. Objectives 
To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-
delivered CCSH. 
3. Background 
Based on a wealth of research demonstrating the associations between physical health and 
psychosocial well-being, modern health care in the United States is characterized by an 
increasingly patient-centered model of care that places a premium on the holistic treatment of 
the patient as a physical, psychosocial, and spiritual whole. Hospital chaplains play a vital role in 
delivering emotional and spiritual care to a broad range of both religious and non-religious 
patients for a wide variety of stressors, and extensive research indicates that spiritual consults 
impact patient outcomes and satisfaction. However, there is remarkably little research on the 
“active ingredients” of chaplaincy spiritual care, and a subsequent lack of standardization and 
best-practice guidelines informing chaplain training and chaplain spiritual consulting. CCSH ® 
(Compassion-Centered Spiritual Health) is a secularized compassion meditation program 
adapted from the Tibetan Buddhist mind training (lojong) tradition, and it may be an ideal 
addendum to both chaplain training programs and to the spiritual care consults provided by 
Emory University hospital chaplains to approximately 100,000 patients each year. 
Importance of integrative treatment for depression and quality of life (QOL) in cancer. In 
2016, more than 15.5 million Americans were cancer survivors, and that number is projected to 
grow to more than 20 million in 2026.1 Epidemiological studies find that survivors of almost all 
types of cancer have significantly poorer mental health2 and health-related QOL3 than people 
without cancer. At one year after diagnosis, the prevalence of depression in cancer survivors is 
estimated to range between 8-24% compared to the 4-7% in the general population.4-6 The 
rates of depression among cancer patients actively undergoing treatment is higher, closer to 
32%,7-9 and an astounding 73% of cancer patients with depression do not receive any treatment 
for this very debilitating symptom.10 Both depression and QOL levels during and after cancer 
treatment predict mortality, independent of, and sometimes better than,11 clinical variables of 
disease.12,13 Effective evidence-based interventions to improve psychosocial well-being and 
long-term QOL for cancer survivors are imperative to advancing cancer care.14-16   
Hematopoietic stem cell transplant (HSCT) is among the most physically and mentally 
arduous cancer treatments. Due to chemotherapy-induced toxicity and early post-transplant 
medical complications, HSCT patients experience a multitude of acute physical symptoms that 
negatively impact their QOL and psychosocial well-being.17-19 This array of symptoms occurs 
concomitant with requisite physical isolation, as the average hospitalization for transplantation 
is 2-3 weeks.20 While rates of emotional distress and physical limitations are acutely elevated in 
the 100 days following transplant,21,22 the majority of survivors don’t regain high levels of 

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physical function until nearly 5 years out of treatment.23 Moreover, socio-emotional symptoms 
are difficult to remediate, and long-term medical uncertainty and fear of relapse leave the 
majority of survivors with lingering emotional distress23,24 and restricted social function.21,25 Of 
note, the deleterious psychosocial symptoms that accompany HSCT also affect mortality, likely 
due, in part, to elevated levels of beta-adrenergically induced pro-inflammatory processing that 
is seen with depression,26,27 fatigue,28,29 and with reduced QOL for patients with blood 
cancers.30 Depressed HSCT patients have a three-fold increased risk of dying within 1 year after 
transplantation,31 and a recent clinical trial found that administration of a serotonin reuptake 
inhibitor (sertraline) reduced engraftment time for patients with depression and/or anxiety.32 
Together, these findings suggest that intervening on the emotional and social symptoms during 
HSCT may reduce depression and improve QOL, which is so critical for well-being and survival.  
Compassion meditation can be an eminently feasible adjunctive intervention for depression 
and QOL. The Society for Integrative Oncology highly recommends (grade A) meditation as an 
adjunctive intervention for anxiety and depression and for improving QOL for patients during 
and after cancer treatment.33,34 Mindfulness-based approaches have received the most 
research attention and appear to be particularly promising, with a 0.44 (Hedges’ g) effect on 
symptoms of depression for adult cancer patients and survivors, estimated from 22 randomized 
controlled trials (n = 1,403).35 A small but emerging body of research indicates that compassion-
based compassion practices reduce anxiety and depressive rumination among cancer 
survivors.36-39 Our ultimate goal in this research is to test whether CCSH (Compassion-Centered 
Spiritual Health) a secular meditation program that includes mindfulness and compassion 
practices, can be delivered at the bedside by chaplains to reduce depression and increase QOL. 
Previous work from our group and others has found that CCSH is beneficial: CCSH increases 
hope40 and reduces symptoms of depression in healthy populations41,42 and attenuates the pro-
inflammatory response to psychosocial stress.43,44 In breast cancer survivors, CCSH reduced 
depression and psychological stress associated with the fear of cancer recurrence.37,38  
Scientific Premise:  CCSH is a secularized, research-based mindfulness and compassion 
meditation program designed to expand and strengthen compassion for self and others. 
Practices include training in attentional stability and increased emotional awareness, as well as 
targeted reflections to appreciate one’s relationship with self and others. By centering the 
mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an 
inclusive and more accurate understanding of others, CCSH reduces the sympathetic response 
to psychosocial stress and thus reduces beta-adrenergic induction of inflammatory 
processing.43,44 
 
In advance of implementation and evaluation of CCSH, here we will conduct a pre-
implementation study to evaluate the feasibility of chaplain-delivered CCSH for patients 
receiving stem cell transplantation. Systematic investigation of the fidelity of program 
implementation (FOI) of chaplain-delivered CCSH is required to establish methodological rigor. 
1) Incorporating evidence-based interventions requires rigorous evaluation of whether the 

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intervention is being implemented as intended, and whether its implementation varies 
depending on individual- or system-level factors. 2) Assessing FOI of chaplain-delivered CCSH 
will be essential for program improvement and refinement. 3) Quantifying FOI will be necessary 
for future studies evaluating the impact of CCSH on patient outcomes, as fidelity to intervention 
delivery directly informs conclusions that can be made about the effectiveness of the 
intervention [i.e., Does chaplain-delivered CCSH reduce depression?]. In general, counseling 
programs delivered with high fidelity report better outcomes than those of programs 
implemented with lower fidelity.45 4) Quantifying FOI will be imperative for any future 
mechanistic study aiming to identify the core components, or “active ingredients”, of CCSH that 
improve outcomes (i.e. How does chaplain-delivered CCSH reduce depression?). 
4. Study Endpoints 
The primary endpoints for this feasibility study are measuring fidelity to intervention delivery. 
As a secondary outcome, we will measure number of sessions completed. We will use an 
iterative theoretical framework for FOI proposed for mindfulness and yoga interventions46 to 
refine the fidelity coding manual.  
 
5. Study Intervention/Design  
This will be an open-pilot trial of chaplain-delivered CCSH to examine chaplain fidelity to CCSH.  
 
6. Procedures Involved 
Chaplains will be asked to volunteer to participate and be consented according to standard IRB-
approved protocols. We will enroll a convenience sample of 6-8 chaplains who have already 
completed the formal CCSH educational course. 
 
Jennifer (PI) will work with collaborators and CCSH experts to identify the core components of 
chaplain-delivered CCSH and to develop an objective fidelity-coding manual that we will use to 
evaluate the fidelity of chaplain-delivered CCSH for patients during HSCT. We will utilize FOI 
theoretical frameworks to identify structural components (the content that is delivered) and 
process components (the manner in which chaplains implement content).47  
 
1. Chaplains will deliver between four and eight 30-minute sessions (2-4/week) of CCSH to up to 
50 adult patients with multiple myeloma or lymphoma during their admission for HSCT. CCSH 
sessions will be delivered in the patient’s room. The number of sessions between four and eight 
will be determined based on patient availability, interest, and feasibility. Based on the 
interviews with staff, we will work within the cancer unit’s workflow to minimize any 
interference with medical care. Before the chaplain completes each session, we will administer 
the (<1 min) NCNN Distress Thermometer, a single-item distress thermometer that compares 
favorably with longer measures used to screen for distress. 
 
2. Chaplains will complete a post-visit fidelity checklist after each session to report which of the 
key intervention activities were completed.  
 

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3. To rigorously assess fidelity, the study team will collect audio recordings of all CCSH sessions. 
All sessions will be transcribed verbatim, and two CCSH experts will independently evaluate the 
extent to which chaplain residents deliver CCSH with fidelity in a random subset of 50% of the 
sessions. The audio transcripts will be secured on a password-protected Emory server for one 
year after transcription and will then be destroyed.  
 
4. After the chaplain completes each session, we will administer the (<1 min) NCNN Distress 
Thermometer, a single-item distress thermometer that compares favorably with longer 
measures used to screen for distress. We will also administer the (4 min) Scottish Patient 
Reported Outcome Measure (PROM)48. The PROM is an 18-item Likert-scale that assesses how 
a hospitalized patient felt about the Pastoral Care visit both during the consult and after it. 
Here, we will use the subscale that asks patients how they felt after the chaplain’s visit (5 
items). 
 
There will be no need for deception during the study.  
 
CCSH: Chaplain-delivered CCSH (description summarized and abridged from 109-page 
intervention manual): 
STAGE 1 Prepare the Care Responder (CR): Before engaging with the Care seeker (CS), if at all 
possible, the CR sets aside time to attune to their own motivation, attentional stability, and 
emotional state, using compassion training practice (CCSH) to do the following:  
- Connect with a personally nurturing moment  
- Stabilize attention/ ground in the body/ witness the nature of mental experience  
- Connect with the changing nature of suffering  
- Connect with the determination to emerge from internal sources of suffering  
- See others as the same as myself, fundamentally, in their desire to be free from distress or 
harm  
- Attune to the reality of interdependence and the affective response of gratitude  
- Generate warm-hearted attitude/altruistic love and the intent to share this inclusively 
- Deepen the intent to help all others be well and free from distress and discomfort 
-  Set the intention to stay mindful  
STAGE 2 Attune to Relationship with CS: Attune to self, attune to other, and discern sources of 
distress. 
- Communicate the role of the CR through the introduction, right away, so there is not 
confusion about the purpose of the consultation 
- Recall that caring for physical needs/immediate needs is sometimes primary 
- Identify, if any, faith tradition or belief system 
- Gauge trust, while also building trust 
- Sustain empathic balance  
- Sustain humility  
- Discern sources of distress: Examples: (CCSH module VI) Feeling unheard, disrespected, 
disconnected, or disparaged; (CCSH module F) Overwhelming anxiety or fear (open to 
connection); (CCSH module I) Overwhelming anxiety or fear (resistant to connection); (CCSH 

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module II) Over-identification with thoughts; fixation on one aspect of situation; (CCSH module 
III-a) Overly harsh self-judgment or self-criticism; toxic shame; (CCSH module III-b) Exaggerated 
expectations of being free from difficult emotions; (CCSH module III-c) Unrealistic expectations 
of predicting or controlling outcomes; (CCSH module III-d) Suffering is due to automatic or 
habitual mental interpretations of events; (CCSH module IV) Harsh blame or objectification of 
others V-a Feelings of isolation or disconnection, abandonment; (CCSH module V-b) Forgotten 
agency to hold another (or a group of others) with tenderness; (CCSH module VI) Disconnection 
from a sense of meaning or purpose in life 
STAGE 3 Access Compassion: Seeks to build on the CS’s own capacity to find and promote 
warm-heartedness, resilience, and wellbeing. The fundamental outcome of the Access 
Compassion stage is that the CS experiences heightened warmheartedness (tenderness, 
affection) – for self, or for others – which allows them to generate and sustain compassion in 
the face of difficult situations, struggles, and suffering. 
There are several types of cultivation that are constructive, and they are related to the 
foundational practice and the 6 modules of CCSH as follows, and as illustrated in the simplified 
diagram above.   
NURTURING MOMENT  
Foundational Practice: Resting in a Moment of Nurturance  
GROUNDING I. Stabilizing Attention / Clarifying Attention 
PRESENT MOMENT ATTUNMENT  
II. Resting the Mind in its Natural State 
BROADENING PERSPECTIVES (CULTIVATING SKILLS AND PERSPECTIVES)  
III. Cultivating Self-Compassion  
IV. Developing Impartiality toward Others  
V. Attuning to Interdependence; Cultivating Gratitude and Affection 
VI. Empathetic Concern and Engaged Compassion 
STAGE 4 Entrust the Care Seeker: As we prepare to bring closure to the visit, we are continuing 
to utilize the skills of attunement to the relationship in Stage 3. The CR is attuning to the desire 
to provide some relief from suffering for the CS while also sustaining the insight that the CS has 
many internal resources which they may have touched on together during the visit. The CR can 
also attune to the aspiration to have realistic expectations of what can occur in this closure 
moment. We aspire to “entrust” the CS with the tools they have begun to access during the 
conversation. By this, we mean that we give over agency to the CS to enact their own process 
of accessing compassion and wellbeing. 
 
Training Certification for chaplains to deliver CCSH: 
  Pre-requisite: Master’s level Theological degree and at least two units of CPE.  
  I. Engaged in the process of ACPE education (or) certified as an Educator with ACPE (or) in the 
process of certification (or) previously certified with one of its Strategic Partners. 
  II. Intensive 4-week CBCT course/CBCT Foundations course 
  III. Intensive 1-day course in CCSH delivery following intervention manual 
  IV. 4-hour in person follow-up training 
  V. Weekly follow-up group call booster sessions with practical reflections (2 months) 
 

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Certification is analogous to Standard (Level 1) CBCT Teacher certification 
  Pre-requisite: Complete CBCT Foundations course, 1 year meditation practice,7-day retreat 
  I. Retreat: CBCT Immersion (4 days) 
  II.  Retreat: Teaching Workshop (3 days) 
  III. Practicum: 8-week seminar, online with weekly meetings, readings, class planning, teaching 
  IV. Practicum: Final Workshop (2.5 days) 
  V. Supervised Co-Teaching (8-10 week course) 
 
 
The study participants who are patients will be experiencing a medical procedure that will be 
stressful in nature, but the research study is not inherently stressful.  On the contrary, the 
ultimate goal of this program of research is to alleviate some of the stress the patients are 
experiencing.  
 
7. Study Timelines 
Individual subject participation: approximately 8 months 
 
Chaplain study participants will deliver between four and eight 30-minute sessions (2-4/week) 
of CCSH to 30-50 adult patients with multiple myeloma or lymphoma during their admission for 
autologous HSCT. We expect recruitment will take up to 8 months.  
 
8. Inclusion and Exclusion Criteria 
Inclusion criteria:  
Patient Inclusion: 1) within 6 weeks of scheduled HSCT, 2) > 18 years of age, 3) speak and read 
English 
 
Chaplain Inclusion: Emory Healthcare Chaplain   
 
Exclusion Criteria:  
Chaplains: There will be no exclusion criteria and no consequence to the chaplains for refusing 
to volunteer 
 
Patient exclusion criteria: Neurologic or cognitive problems that preclude chaplain-delivered 
CCSH. 
 
 
9. Population 
We are not recruiting or enrolling participants from any vulnerable or special populations.   
 
Results of the research will be disseminated in peer reviewed journals and presentations.  
We will share the findings with study participants upon request.  
 

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10.  Local Number of Participants 
This is not a multi-site study.  
 
We will enroll a convenience sample of 6-8 chaplains. The 2018 entering class of chaplain 
residents is 47% male, and 88% non-white. We expect to enroll 50% women, and 50% non-
white chaplains.   
Chaplains will deliver eight 30-minute sessions (4/week) of CCSH up to 50 adult patients with 
multiple myeloma or lymphoma during their admission for autologous HSCT. Based on a 
previous pilot study of yoga with hospitalized HSCT patients49, we anticipate that 37% of the 
patients will be men, and 44% will be non-white. 
 
11. Recruitment Methods 
 
Chaplains will be asked to volunteer to participate via an in-person presentation of the research 
aims and be consented according to standard IRB-approved protocols. We will enroll a 
convenience sample of 6-8 chaplains who have already completed the formal educational 
course as part of their residency training and willingly volunteer to participate. There will be no 
exclusion criteria and no consequence to the chaplains for refusing to volunteer.   
Adult patients hospitalized for HSCT will be recruited by the study team on Emory campus to 
receive CCSH. Potential participants will be identified via: 
1. Collaboration with clinic staff – Our study team will receive an email from the clinic staff each 
time a new patient is identified. We will use the patients’ electronic medical record prior to 
their hospitalization in order to determine eligibility and to gather the contact information of 
those patients. Identifiers will be recorded to track contact. Identifiers include: patient name, 
email, address, and phone number. The study team will email new patients prior to 
hospitalization with a description of the study, the consent form, and a link to provide 
indication of interest and consent via Qualtrics.  
2. In-person recruitment by the research team. 
Patient eligibility will be determined by direct communication between the patient and the 
study team. Cognitive capacity will be determined if the person is confused, disoriented, unable 
to make a decision, unable to answer questions, or based on information obtained from family 
or other caregivers.  
 
12. Withdrawal of Participants 
 

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The researchers will stop participation without participant consent if: 
• They believe it is in the patient’s best interest. 
• The patient objects to any future changes that may be made in the study plan. 
• The patient is no longer able or willing to receive CCSH. 
 
Participants are free to withdraw from the research at any time. If a participant requests 
withdrawal, the study team will request permission to use the acquired data and ask the reason 
for withdrawal.  
 
 
13. Risk to Participants 
Hematopoietic stem cell transplant (HSCT) is among the most physically and mentally arduous 
cancer treatments and patients experience a multitude of acute physical symptoms that 
negatively impact their QOL and psychosocial well-being.17-19 We do not have any reason to 
believe that CCSH will increase patients’ physical, psychological, social, legal, or economic risks. 
Patients may become upset during the CCSH interventions due to the nature of their treatment, 
diagnosis, and any emotional discomfort associated with thinking about their disease. However, 
CCSH has been widely used in usual care in the hospital for 12 months and the chaplains are 
trained in delivering this type of ‘talking therapy’. CCSH is widely associated with low levels of 
distress. 
 
Risks to confidentiality: The questionnaires that subjects will fill out as part of this study will 
contain personal information, and participants will have private pieces of audio recorded. We 
acknowledge that it could be embarrassing if this information were to become public or fall into 
the hands of someone not associated with the study. We will take the following steps to 
prevent this from happening: All information obtained from patients will be kept strictly 
confidential and will be de-identified and stored by a randomly assigned study number, such 
that these data will be anonymous at all times during data entry and analysis. The key used to 
link the study number with subject identification will be stored in a password protected, secure 
database accessible only to study researchers. The key will only be used in the case of study 
personnel needing to identify a subject and not for data analysis. In addition, all data, including 
personal identifiers (i.e., name, address, email contact details), will be maintained in secure 
password-protected electronic files stored on a secure computer system that can only be 
accessed by study researchers. Emory Spiritual Health supervisors and others in the spiritual 
health department (other than members of the research team) will not have access to the key 
nor will they receive any study data. 
 
 
14. Potential Benefits to Participants 
Hematopoietic stem cell transplant (HSCT) is associated with an array of negative symptoms 
that affect long-term QOL, and these symptoms occur during a requisite period of 

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hospitalization and physical isolation, as the average hospitalization for transplantation is 2-3 
weeks.20 Intervening on the emotional and social symptoms during HSCT may reduce 
depression and improve QOL, which is so critical for well-being and survival.  
Previous research from our group found that a single session of chaplain-delivered CCSH 
reduced depression and anxiety among hospitalized inpatients (paper in progress). Patients in 
this study may directly benefit from CCSH. Moreover, this feasibility study will establish the 
manualized protocol and intervention delivery process that can be further evaluated in future 
research.  
15. Compensation to Participants 
There is no financial compensation for participation. 
 
16. Data Analysis, Management and Confidentiality 
 
Statistical analysis  
 
Measuring and evaluating retention: Based on a large randomized trial of exercise and stress 
management programs for patients receiving blood and marrow transplant50, we expect that: 
• Benchmark 1: 29 (97%) patients enrolled in the study will complete at least one 
session of chaplain-delivered CCSH, based on the fact that 3% of patients 
enrolled in the larger trial did not receive an intervention).  
• Benchmark 2: We will lose 7 patients throughout the trial and thus have 
complete data from 23 patients (78.8%), based on the Day 100 completion 
percentage from the trial cited above (78.8%). 
We believe this is a conservative estimate because the 78.8% Day 100 completion rate reported 
in the previous study is approximately 2.5 month past our final time point for this aim. 
  
 
 
Measuring and evaluating adherence: While chaplains will intend to deliver 8 sessions of CCSH 
during HSCT, we may find that patients are too sick to receive all 8 sessions or that they drop 
out of the study prior to the completion of all 8. We may also find that chaplains do not deliver 
the intervention with fidelity during all 8 sessions. Adherence will be evaluated as the percent 
of sessions completed by patients and characterized as “low” (< 70%), “moderate” (70-80%) 
and “high” (> 80%) adherence. 
• Benchmark 1: We expect that all chaplain residents will achieve high levels of 
adherence.  
• Benchmark 2: We expect that 23 patients will begin the intervention, complete 
at least one session of CCSH and remain in the study until the end of HSCT (see 
retention benchmarks below), completing at least 75% (6 out of 8) CCSH 
sessions. 
 

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Data collection: We will collect audio recordings from all CCSH sessions conducted with 
enrolled participants. All sessions will be transcribed verbatim, and two CCSH experts will 
independently evaluate fidelity of implementation (FOI) in a random subset of 50% of the 
sessions. From the transcripts, coders will quantify 4 dimensions of fidelity according to a 
recent guide for FOI in meditation studies46:  
 
1) Accuracy (sometimes referred to as adherence but called accuracy here to avoid 
confusion with overall adherence): the extent to which the core elements of CCSH were 
implemented as intended. Accuracy will be evaluated as the percent of session components 
implemented by chaplains and characterized as “low” (< 70%), “moderate” (70-80%) and “high” 
(> 80%) accuracy. 
 
2) Dosage: quantified as the amount (percentage) of CBCT that patients receive. We will 
also characterize the modal number of sessions received as well as the range of sessions 
completed by all patients. From the range, we will create categories of “low”, “medium”, and 
“high” dosage that we will use as categorical groups in future studies. 
 
3) Quality: extent to which the chaplain delivered the content as intended. We will 
generate average competency ratings for each chaplain as well as overall average quality 
ratings.  
 
4) Responsiveness: the extent to which patients were engaged in each session, 
operationalized as “maximally,” “moderately”, or “minimally” enthusiastic and attentive during 
each. We will quantify the average patient engagement for all sessions, as well as the average 
responsiveness for each session (i.e., 1st – 8th).   
 
In addition, I will quantify Accuracy, Dosage, and Responsiveness from chaplain checklists that 
chaplains complete after each session.  
• Benchmark 1: We will be able to quantify FOI for all chaplain sessions and generate an 
average FOI for each chaplain 
• Benchmark 2: We expect all chaplains will deliver CCSH with high levels of fidelity. 
 
Audio files will be stored for one year after transcription is complete. All other data will be 
stored for at least 5 years as de-identified data and secured on a password protected Emory 
server. Only the IRB-approved study team will have access to the data. The PI (Mascaro) will be 
responsible for storage and maintenance and destruction of the data. 
 
 
17. Provisions to Monitor the Data to Ensure the Safety of Participants 
We do not believe the research involves more than minimal risk to participants. We will closely 
monitor all subjects’ responses and record conventional serious adverse events (SAEs) and 
unexpected and expected adverse events (AEs). For the purposes of study reporting, an SAE is 
any of the following events: 1. Death within 30 days of CCSH, 2. Suicidal ideation at any time 
during the study. When any of these events occur, the PI will report these events to the 

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receiving stem cell transplantation. 
 
 
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granting agency (NIH NCCIH). These events will also be reported to the IRB per local reporting 
requirements 
The PI has identified 3 independent scientists who are not related to the study who will serve 
on the Data and Safety Monitoring Committee (DSMC) for the conduct of this study. Prior to 
recruitment, the DSMC will review the protocol and monitoring plans. Following this, the DSMC 
will mainly monitor for adequate recruitment milestones and for the occurrence of adverse 
events related to participation in the study. 
 
Safety Review Plan Study progress and safety will be reviewed monthly and more frequently if 
needed. The PI will submit progress reports, including patient recruitment, retention/attrition, 
and AEs to the DSMC semi-annually. On an annual basis the DSMC will review pertinent aspects 
of the study to assess subject safety, compliance with the protocol, data collection, and risk-
benefit ratio. The PI will generate an Annual Report that will include (1) a list and summary of 
AEs; (2) whether AE rates are consistent with pre-study assumptions; (3) reason for dropouts 
from the study; (4) whether all participants met entry criteria; (5) whether continuation of the 
study is justified on the basis of that additional data are needed to accomplish the aims of the 
study; and (6) conditions whereby the study might be terminated prematurely. This report will 
be sent to the DSMC, Emory’s IRB, and to the funder (NIH NCCIH).  
 
This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention that will significantly impact the ability to evaluate the study 
endpoints; (3) any new information becomes available during the trial that necessitates 
stopping the trial; or (4) other situations occur that might warrant stopping the trial. 
 
 
18. Provisions to Protect the Privacy Interest of Participants 
Emory will keep any research records private to the extent that this is required by law.  
Whenever possible, a study number, rather than your name, will be used on study records.  
Your name and other identifying information will not appear when we present or publish the 
study results. 
Study records can be opened by court order.  They also may be provided in response to a 
subpoena or a request for the production of documents.  
 
19. Economic Burden to Participants 
Study participants will not incur or be responsible for costs because of participation in this 
research. 
 
 
20. Informed Consent   
 

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Yes, informed consent will be obtained from both chaplains and patients.  Chaplains will be 
asked to volunteer to participate and will be consented according to standard IRB-approved 
protocols. To avoid any sense of coercion, all chaplains will be contacted by researchers in 
private and they will be informed that their participation status will be unknown to all 
supervisors.  
 
For patients: To avoid any sense of coercion of the potential participant by the patient’s 
physician, an investigator/research assistant will be the recruiter for the study. The physician or 
nurses may refer a patient who satisfies the inclusion criteria to the recruiter, but he or she will 
not be the recruiter for the study. All recruited patients engage in a detailed informed consent 
before the study, prior to becoming a participant.  
 
To minimize burden on the patients and to reduce exposure to study staff, we will conduct 
informed consent online using a waiver of documented consent.  
 
  
 
Non-English-Speaking Participants   
 
N/A: all participants will be English-speaking because CCSH is delivered in English. 
 
Participants who are not yet adults (infants, children, teenagers)   
 N/A: we are not recruiting non-adults 
 
Cognitively Impaired Adults   
Patient ability to consent will be determined by direct communication between the patient and 
the study team. Cognitive capacity will be determined if the person is confused, disoriented, 
unable to make a decision, unable to answer questions, or based on information obtained from 
family or other caregivers.  
 
Adults Unable to Consent   
N/A: we will not obtain assent. 
 
Waiver or Alteration of Consent Process (consent will not be obtained, required information 
will not be disclosed, or the research involves deception) 
N/A: we will not use a waiver or alteration of the consent process. 
 
21. HIPAA 
We will not be recording identifiers from the medical record. 

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22. Setting 
The setting will be at Winship Cancer Institute at Emory Hospital.  
 
23. Resources Available 
It is expected that enrollment will take place from November 2021 through July 2022.  
To recruit patients for this study, we will engage with referring physicians in Emory’s Bone 
Marrow and Stem Cell Transplant Center. We will arrange to give a presentation at the Emory 
Huddle and/or the center’s grand rounds so that providers and staff are familiar with the study.  
Lost to follow-up: The funder (NCCIH) considers lost to follow-up as a research subject who was 
participating in the study at a certain point in time and subsequently missed two consecutive 
study visits and is unresponsive to study contact or is no longer participating in study activities. 
We base our calculations on a large randomized trial of exercise and stress management 
programs for patients receiving blood and marrow transplant50, in which the 120-day lost-to-
follow-up was 30.8%. Of 711 consented and randomized, the researchers received final surveys 
from 492 patients (69.2%): 5 (0.7%) did not undergo HCT, 21 (3.0%) did not receive the 
intervention, 37 (5.2%) died before Day 100, and 48 (6.8%) died between Day 100 and day 180.  
Based on these data, we expect that 97% patients enrolled in the study will complete at least 
one session of CCSH (based on the fact that 3% of patients enrolled in the larger trial withdrew 
prior to receiving an intervention). Based on the Day 100 completion percentage from that trial 
(78.8%), we expect that we will have complete data from 78.8% of enrolled patients. However, 
this is a conservative estimate, given that the 78.8% Day 100 completion rate reported in the 
previous study is approximately 2.5 month past our final time point for this aim.  
 
 
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receiving stem cell transplantation. 
 
 
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