Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain
Phase: NA
Conditions: Bone Marrow Cancer, Leukemia, Lymphoma, Multiple Myeloma, Hematologic Cancer
Sponsor: Thomas Jefferson University

Improving Patient Experience During BMBA 
 
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THOMAS JEFFERSON UNIVERSITY 
Sidney Kimmel Cancer Center 
 
Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): 
Do interventions decrease distress and pain. 
 
Principal Investigator: 
Anne Delengowski 
Medical Oncology 
111 S. 11th St., Suite 3480 B 
Philadelphia, PA 19107 
(215) 955-7098 
Co-Investigator(s): 
Patricia Galanis 
Medical Oncology 
925 Chestnut St, 4th Floor 
Philadelphia, PA 19107 
(856) 397-8646 
 
Lisa Kearns 
Medical Oncology 
925 Chestnut St, Suite 420A 
Philadelphia, PA 19107 
(267) 432-3681 
 
Michelle Lasota 
Sidney Kimmel Cancer Center 
RCC Division/Department of Medical Oncology 
925 Chestnut St, 4th Floor 
(267) 438-6652 
 
Katie Teets 
Medical Oncology 
925 Chestnut St, Suite 420A 
Philadelphia, PA 19107 
(267) 581-7762 
 
Victoria Gulick 
IS&T 
833 Chestnut St, Suite 1000 
(215) 503-3224 
Statistician: 
Tingting Zhan 
Division of Biostatistics 
Department of Pharmacology and Experimental Therapeutics 
(215) 955-3788 
Protocol IDs: 
JeffTrial # 18448 
PRC # pending 
IRB Control # 21G.1035 
 
 

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Version Number: 
Version Date: 
1.0 
9 June 2021 
1.1 
13 July 2021 
 
 
 
 
 
 
 
CONFIDENTIAL 
This document is confidential and the property of THOMAS JEFFERSON UNIVERSITY. 
No part of it may be transmitted, reproduced, published, or used by other persons 
without prior written authorization from the study sponsor. 
 
 
 

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Signature Page ............................................................................................................................. 7 
Statement of Compliance ............................................................................................................. 7 
List of Abbreviations ..................................................................................................................... 8 
Study Summary ............................................................................................................................ 9 
1 
Introduction .......................................................................................................................... 11 
1.1 Background Information .................................................................................................. 11 
1.2 Rationale for the Proposed Study ................................................................................... 12 
1.3 Potential Risks and Benefits ........................................................................................... 13 
1.3.1 
Potential Risks ........................................................................................................ 13 
1.3.2 
Benefits ................................................................................................................... 13 
2 
Study Objectives .................................................................................................................. 13 
2.1 Objectives ....................................................................................................................... 13 
2.1.1 
Primary .................................................................................................................... 13 
2.1.2 
Secondary ............................................................................................................... 13 
2.2 Endpoints/Outcome Measures ....................................................................................... 14 
2.2.1 
Primary .................................................................................................................... 14 
2.2.2 
Secondary ............................................................................................................... 14 
3 
Study Design ........................................................................................................................ 14 
3.1 Characteristics ................................................................................................................ 14 
3.2 Number of Participants ................................................................................................... 14 
3.3 Duration of Therapy ........................................................................................................ 14 
3.4 Treatment Assignment Procedures ................................................................................ 14 
3.4.1 
Randomization Procedures .................................................................................... 14 
3.5 Study Timeline ................................................................................................................ 14 
4 
Study Enrollment and Withdrawal ........................................................................................ 15 
4.1 Eligibility Criteria ............................................................................................................. 15 

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4.1.1 
Inclusion Criteria ..................................................................................................... 15 
4.1.2 
Exclusion Criteria .................................................................................................... 15 
4.2 Gender/Minority/Pediatric Inclusion for Research .......................................................... 15 
4.3 Strategies for Recruitment and Retention ....................................................................... 15 
4.4 Participant Withdrawal .................................................................................................... 16 
4.4.1 
Reasons for Withdrawal .......................................................................................... 16 
4.4.2 
Handling of Participant Withdrawals and Participant Discontinuation of Study 
Intervention .......................................................................................................................... 16 
4.5 Premature Termination or Suspension of Study ............................................................. 16 
5 
Study Intervention ................................................................................................................ 16 
5.1 Study Product ................................................................................................................. 17 
6 
Study Schedule .................................................................................................................... 17 
6.1 Pretreatment Period/Screening ...................................................................................... 17 
6.2 Enrollment/Baseline ........................................................................................................ 17 
6.3 Treatment Period ............................................................................................................ 18 
6.4 Withdrawal Visit/Discontinuation of Therapy .................................................................. 18 
7 
Study Procedures and Evaluations ...................................................................................... 18 
7.1 Study Procedures/Evaluations ........................................................................................ 18 
8 
Evaluation of Safety ............................................................................................................. 19 
8.1 Specification of Safety Parameters ................................................................................. 19 
8.1.1 
Unanticipated Problems .......................................................................................... 19 
8.1.2 
Adverse Events ....................................................................................................... 19 
8.1.3 
Serious Adverse Events ......................................................................................... 19 
8.2 Safety Assessment and Follow-Up ................................................................................. 20 
8.3 Recording Adverse Events ............................................................................................. 20 
8.3.1 
Relationship to Study Intervention .......................................................................... 20 
8.3.2 
Expectedness ......................................................................................................... 20 

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8.3.3 
Severity of Event ..................................................................................................... 21 
8.3.4 
Intervention ............................................................................................................. 21 
8.4 Safety Reporting ............................................................................................................. 21 
8.4.1 
Reporting to IRB ..................................................................................................... 21 
8.4.2 
Reporting to SKCC DSMC ...................................................................................... 22 
8.4.3 
Reporting to Funding Sponsor ................................................................................ 23 
8.4.4 
Reporting of Pregnancy .......................................................................................... 23 
8.5 Halting Rules .................................................................................................................. 23 
9 
Study Oversight ................................................................................................................... 23 
10 
Clinical Site Monitoring and Auditing .............................................................................. 23 
11 
Statistical Considerations ............................................................................................... 23 
11.1 
Study Hypotheses ....................................................................................................... 23 
11.2 
Analysis Plans ............................................................................................................ 24 
11.3 
Sample Size Considerations ....................................................................................... 24 
11.3.1 Accrual Estimates ................................................................................................... 25 
11.4 
Evaluation of Safety .................................................................................................... 25 
12 
Source Documents and Access to Source Data/Documents ......................................... 25 
13 
Quality Control and Quality Assurance ........................................................................... 25 
14 
Ethics/Protection of Human Participants ........................................................................ 26 
14.1 
Ethical Standard ......................................................................................................... 26 
14.2 
Institutional Review Board .......................................................................................... 26 
14.3 
Informed Consent Process ......................................................................................... 26 
14.4 
Exclusion of Women, Minorities, and Children (Special Populations) ........................ 26 
14.5 
Participant Confidentiality ........................................................................................... 27 
15 
Data Handling and Record Keeping ............................................................................... 27 
15.1 
Data Management Responsibilities ............................................................................ 27 

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15.2 
Data Capture Methods ................................................................................................ 27 
15.3 
Types of Data ............................................................................................................. 27 
15.4 
Study Records Retention ............................................................................................ 27 
15.5 
Protocol Deviations ..................................................................................................... 28 
16 
Study Finances ............................................................................................................... 28 
16.1 
Funding Source .......................................................................................................... 28 
16.2 
Conflict of Interest ....................................................................................................... 28 
16.3 
Participant Stipends or Payments ............................................................................... 28 
17 
Publication and Data Sharing Policy ............................................................................... 28 
18 
Literature References ..................................................................................................... 29 
Appendices ................................................................................................................................. 32 
APPENDIX A: SCHEDULE OF EVENTS ................................................................................... 33 
APPENDIX B: PATIENT SURVEY ............................................................................................. 34 
 

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Signature Page 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
Principal Investigator: 
Signed: 
 
Date:  
Name: 
Anne Delengowski 
Title:  
Director Oncology Nursing Education, Oncology Clinical Nurse Specialist 
Statement of Compliance 
This study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), and Thomas Jefferson University research 
policies 
 
 
 

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List of Abbreviations 
AE 
Adverse Event/Adverse Experience 
BMBA 
Bone marrow biopsy aspiration 
CFR 
Code of Federal Regulations 
Co-I 
Co-Investigator 
CTCAE 
Common Terminology Criteria for Adverse Events 
DSMC 
Data and Safety Monitoring Committee 
DSMP 
Data and Safety Monitoring Plan 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
N 
Number (typically refers to participants) 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PRC 
Protocol Review Committee 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SKCC 
Sidney Kimmel Cancer Center 
TJU 
Thomas Jefferson University 
UAP 
Unanticipated Problem 
VR 
Virtual reality 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Summary 
 
Title: 
Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do 
interventions decrease distress and pain. 
Précis: 
Patients undergoing a bone marrow biopsy aspiration (BMBA) will 
trial possible interventions to decrease their distress and pain, as 
suggested by a previous patient survey conducted with this 
population. The study will assess both pre-intervention and post-
intervention distress scores and a post-intervention pain score. 
Patient satisfaction will also be assessed to determine overall 
patient experience. Each intervention will be compared to a control 
group to validate if one or both interventions are valuable to offer to 
patients in the future. 
Objectives: 
Primary: Trial VR and environmental interventions to determine if 
either result in a reduction in patient distress during BMBA. 
 
Secondary: Determine if either intervention results in decreased pain 
or improved satisfaction scores. 
Population: 
Young adult to geriatric patients with hematologic malignancies of 
varying health statuses and demographic groups 
Most patients have hematological cancers, including leukemia, 
lymphoma, and multiple myeloma. 
Phase: 
N/A 
Number of Sites: 
TJU 
Description of 
Intervention: 
Two interventions will be trialed. The first intervention is virtual 
reality (VR) guided mediation. Patients will be provided with 
wireless VR headsets that contain a guided meditation application. 
The application allows users to select their preferred music, visual 
setting, and a topic for meditation.  
The second intervention is environmental changes. A nature 
themed wall mural decal will be installed in the BMBA room and the 
in-room computer will play music from Pandora. A selection of 
suggested stations will be provided, with the option for outside 
selections.  
Study Duration: 
10 months  
 

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Participant 
Participation 
Duration: 
Approximately 45 minutes, the duration of a normal BMBA visit, 
including procedure 
Estimated Time to 
Complete 
Enrollment: 
6 months 
 
Schematic of Study Design: 
Phase I 
Prior to  
Enrollment 
 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Pre-procedure  
 
 
Visit 1 
Pre-procedure 
 
 
Visit 1 
Procedure 
 
Visit 1 
Post-procedure 
 
 
 
 
 
 
 
 
Total 30: Obtain informed consent. Screen potential subjects by inclusion and 
exclusion criteria. 
Administer pre-procedure questionnaire. 
Evaluate baseline vital signs, including heart rate, blood pressure, and respiratory 
rate.  
Evaluate post-procedure vital signs. 
Administer post-procedure questionnaire. 
BMBA procedure, per standard of care. 
Randomize 
Control 1 
Intervention 
1 
Provide instructions on how to use 
VR intervention.  
Wait in procedure room as standard. 

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Phase II 
Prior to  
Enrollment 
 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Pre-procedure  
 
 
Visit 1 
Pre-procedure 
 
 
Visit 1 
Procedure 
 
Visit 1 
Post-procedure 
 
 
1 Introduction 
1.1 
Background Information 
Bone marrow biopsies are frequent occurrences for hematological cancer patients. 
These procedures are a source of anxiety for many patients. Current literature suggests 
a wide variety of changes that can be employed to reduce stress and improve patient 
experience, including: room décor changes1, 2, 3, 4 some including nature inspired 
imagery,3, 5, 6 music for relaxation during procedure,7, 8, 9, 10 guided meditation,11, 12 virtual 
reality (VR) distraction therapy,13, 14, 15, 16, 17, 18 etc. These changes have the potential to 
decrease patient stress both prior to procedures9, 19 and during them.16  
In a human-centered design survey conducted by this team in December 2019, patients 
were asked about their pain and anxiety relating to BMBA procedures, as well as their 
thoughts on possible interventions. A large majority (72%, n=16) of patients believed 
that the addition of music to their treatment would improve their experience. Other 
options were also considered including virtual reality (26%, n=5) and guided meditation 
Total 30: Obtain informed consent. Screen potential subjects by inclusion and 
exclusion criteria. 
Administer pre-procedure questionnaire. 
Evaluate baseline vital signs, including heart rate, blood pressure, and respiratory 
rate.  
Evaluate post-procedure vital signs. 
Administer post-procedure questionnaire. 
BMBA procedure, per standard of care. 
Randomize 
Control 2 
Intervention 
2 
Allow selection of preferred music 
station.  
Wait in procedure room as standard. 

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(30%, n=6). Though fewer patients expressed interest in these interventions, only 8% 
(n=2) had previously experienced guided meditation and none of the patients surveyed 
had any experience with VR. For this reason investigators will trial two interventions with 
patients to determine if one or both are effective at improving the patient experience. 
The overall goal of the study is to identify an intervention–or both interventions–as a 
potential offering for patients during BMBA procedures to improve their overall 
experience. 
1.2 
Rationale for the Proposed Study 
Human-centered design puts “the user at the core of the design process” and allows 
spaces to be adapted to actual desired needs rather than perceived needs.20,21 The 
interventions being trialed were selected with the target patient population as part of the 
conversation.  
Intervention 1 provides patients with a guided meditation experience through a VR 
headset. Existing literature shows that guided imagery increases patient comfort and 
that meditation can substantially improve “psychological function, mental health, and 
[quality of life]” for cancer patients.22 VR has also been shown to be an “effective 
distraction intervention for managing pain and anxiety among breast cancer patients,”23 
during lumbar punctures13 and for patients with chronic pain.15, 18 Participants will be 
introduced to the Oculus Go VR headset while waiting in the procedure room prior to 
their procedure. They will use the headset for approximately 10 minutes, or until their 
provider arrives for their procedure. The provider will prepare the patient for their BMBA 
procedure, and then allow them to continue using their VR headset and chosen guided 
meditation during the procedure, for approximately 20 minutes. Oculus guidelines 
suggest new users take breaks every 30 minutes or as needed while adjusting to the 
technology.24 Participant usage should fit within this suggested timeframe.  
Intervention 2 provides patients with changes to their procedure room environment. 
Natural environments have a positive influence on human perceptions of stress25 and 
allow for greater recovery from mental fatigue.26 Furthermore, natural interior design, 
including soundscape,2 can have restorative properties for patients.1, 4 In particular, 
music therapy improves “anxiety and depression symptoms presented by patients with 
cancer,”27 has been associated with lower pain scores for palliative care patients,28 and 
been used for anti-anxiety interventions for outpatient procedures,10 including BMBA.8 
For this intervention, participants will be able to select their preferred type of music for 
the duration of their time in the procedure room, including while waiting before their 
procedure. They will be provided with a list of suggested music types, based on the 
previous patient survey’s results, but will also have the option to select outside the list 
based on their preference. 
Our hypothesis is that patients undergoing bone marrow biopsy and aspiration (BMBA) 
who receive distraction techniques (room décor, music, and virtual reality) will have 
lower levels of distress and pain than patients who receive only the standard of practice 
care. Additionally, these patients will have higher levels of satisfaction with their overall 
experience. This study aims to evaluate pre-procedure and post-procedure distress and 

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pain scores, and post-procedure satisfaction ratings to determine if one or both of the 
selected interventions are valuable to employ in-clinic for the entire patient population.  
1.3 
Potential Risks and Benefits 
1.3.1 
Potential Risks 
Potential risks vary based on intervention arm.  
Intervention 1: Virtual reality may cause symptoms associated with motion sickness, 
including nausea, dizziness, disorientation, and vertigo.29 Mild eyestrain or headaches 
may also occur.  
Intervention 2: There are no known risks associated with music therapy or décor 
changes. 
Participants in all study arms will undergo a BMBA procedure as part of their standard 
care. Potential risks of bone marrow biopsies are bruising and pain at the biopsy site, 
discomfort at the site during or post-procedure, prolonged bleeding, and infection. 
1.3.2 
Benefits 
Potential benefits include improved patient satisfaction, reduction of acute pain 
perception, decreased distress around BMBA, and overall improvement in patient 
experience.  
2 Study Objectives 
2.1 
Objectives 
2.1.1 
Primary 
To assess patient distress scores related to BMBA procedures.  
The primary outcome will be reported on a scale of 0-10, based on the National 
Comprehensive Cancer Network (NCCN) Distress Thermometer. This scale is 
standardly used with oncology patients to determine their distress levels—distress 
refers to “an unpleasant experience of a mental, physical, social, or spiritual nature. It 
can affect the way you think, feel, or act. Distress may make it harder to cope with 
having cancer, its symptoms, or its treatment.”30 
2.1.2 
Secondary 
To assess patient pain scores related to their BMBA procedure. This will be measured 
through the 0-10 Numeric Pain Intensity Scale  
To assess patient satisfaction with their procedure. This will be assessed through a 
patient satisfaction survey including Likert-type questions.  

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2.2 
Endpoints/Outcome Measures 
Primary outcomes will be assessed via the patient questionnaires. All endpoints are 
measured pre- and post-procedure at Visit 1. 
2.2.1 
Primary 
The primary endpoint of patients’ distress levels towards BMBA procedures are the 
responses to Question 13 and 16 of the survey (Appendix B).  
2.2.2 
Secondary 
The secondary endpoint of patients’ pain scores during BMBA procedures are the 
responses to Question 12 and 17 of the post-procedure survey. 
The secondary endpoint of patients’ satisfaction levels towards their BMBA procedures 
is the response to Questions 18 of the post-procedure survey. 
3 Study Design 
3.1 
Characteristics 
Trial of interventions to improve patient experience during BMBA procedures at 
outpatient oncology office.  
3.2 
Number of Participants 
60 total patients will be enrolled in the study. For Phase I, 15 patients will enroll in 
Intervention 1 and 15 patients will enroll in the control arm. For Phase II, 15 patients will 
enroll in Intervention 2 and 15 patients will enroll in the control arm. 
3.3 
Duration of Therapy 
Approximately 20-30 minutes of a 45-minute visit. No follow-up visit will occur. 
3.4 
Treatment Assignment Procedures 
3.4.1 
Randomization Procedures 
We will adopt a permuted block randomization schedule for both Phase I and II. Study 
staff will utilize a sealed envelope system provided by the Biostatistics department. 
3.5 
Study Timeline 
Patients will be enrolled on a rolling basis as they are scheduled for their BMBA 
procedures. We anticipate enrolling 2-3 patients per week, resulting in a 6-month 
timeline to achieve 60 participants. Both primary and study completion dates will 
conclude at the end of the enrollment period.  

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4 Study Enrollment and Withdrawal 
Pregnant women are not commonly a part of the BMBA patient population, but there is no 
reason to exclude their participation so pregnancy will not be included in the exclusion criteria.  
4.1 
Eligibility Criteria 
4.1.1 
Inclusion Criteria 
Individuals must meet all of the following inclusion criteria in order to be eligible to 
participate in the study: 
• Provide signed and dated informed consent form 
• Willing to comply with all study procedures 
• Over 18 years of age 
• Prior history of at least 1 (one) BMBA at Jefferson outpatient oncology office 
within the past 2 (two) years 
• Visiting the Jefferson outpatient oncology office for a BMBA procedure during the 
study duration 
4.1.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation 
in this study: 
• Inability to read questions in English 
• Inability to answer questions autonomously 
• History of vertigo 
• Legal blindness in both eyes 
• Severe or profound hearing loss, or deafness 
4.2 
Gender/Minority/Pediatric Inclusion for Research  
Pediatric patients are not included in this study as they are not treated at the outpatient 
medical oncology office at 925 Chestnut St where it is being conducted. All adult 
patients, regardless of gender or minority will be included.  
4.3 
Strategies for Recruitment and Retention 
Participants will be recruited from patients already attending the outpatient medical 
oncology office at 925 Chestnut for BMBA procedures. Study staff will review the BMBA 
schedule a week prior to procedures and call patients who fit the inclusion criteria to 

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inform them about the study. This will include a discussion of the goals of the study, 
expectations for participation, and a general overview of the consent process.  
Participation is for a one-time session and retention will not be necessary.  
4.4 
Participant Withdrawal 
4.4.1 
Reasons for Withdrawal 
Participants are free to withdraw from participation in the study at any time upon 
request. 
An investigator may terminate a study participant’s participation in the study if: 
• Any clinical adverse event (AE), laboratory abnormality, or other medical 
condition or situation occurs such that continued participation in the study would 
not be in the best interest of the participant. 
• The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation. 
4.4.2 
Handling of Participant Withdrawals and Participant Discontinuation of 
Study Intervention 
Any participant who experiences an AE and discontinues participation will be asked to 
provide details about their experience. They may also be asked to complete the post-
procedure survey, if deemed appropriate by study staff. 
4.5 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, 
will be provided by the suspending or terminating party to the investigators, funding 
agency and regulatory authorities. If the study is prematurely terminated or suspended, 
the principal investigator will promptly inform the IRB and will provide the reason(s) for 
the termination or suspension.  
Circumstances that may warrant termination include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants. 
• Insufficient adherence to protocol requirements. 
• Data that is not sufficiently complete and/or evaluable.  
• Determination of futility. 
5 Study Intervention 

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5.1 
Study Product  
The Phase I intervention is virtual reality (VR) guided mediation. Patients will be 
provided with a wireless VR headset that contains a guided meditation application. The 
application allows users to select their preferred music, visual setting, and a topic for 
meditation. Patients who are enrolled to this study group will receive instructions on how 
to use the VR device prior to the procedure. 
The Phase II intervention involves environmental changes. A nature-themed wall mural 
decal will be installed in the BMBA procedure room, and the in-room computer will play 
music from Pandora. A selection of suggested stations will be provided, with the option 
for outside selections if desired. 
6 Study Schedule  
6.1 
Pretreatment Period/Screening 
Screening (Day -7 to -1) 
• During the week prior to a patient’s scheduled procedure, study staff will call 
patients to remind them of their appointment and determine their interest in 
participating in the study.  
• Based on the scheduling, staff will know if participants meet the eligibility criteria 
“Prior history of at least 1 (one) BMBA at Jefferson outpatient oncology office 
within the past 2 (two) years.” No other eligibility criteria will be evaluated at this 
time.  
• Information about the consent process will be provided to the patient if desired, 
but the formal informed consent form will be completely reviewed and signed on 
the day of the procedure in a private room prior to entering the procedure room. 
6.2 
Enrollment/Baseline 
Enrollment/Baseline (Visit 1, Day 1) 
• Obtain and document consent from participant on study consent form. Consent 
interview will be conducted in a private room separate from the procedure room.  
• Verify inclusion/exclusion criteria. 
• Randomize patient to Control or Intervention arm via sealed envelope.  
• Administer pre-procedure survey which includes: 
o Demographic information and focused medical history.  
o Assessment of current distress level (0-10 scale). 

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• Escort patient to procedure room. 
• Obtain baseline vital signs: heart rate, blood pressure, respiratory rate.  
• If randomized to an intervention group, provide intervention-specific instructions. 
o For Intervention 1, patients will be instructed on how to put on and use the 
VR headset and how to select their preferred guided meditation.  
o For Intervention 2, patients will be provided with Pandora music station 
options or allowed to select their own option.  
6.3 
Treatment Period 
Visit 1, Day 1 
• Confirm patient is comfortable proceeding with assigned intervention during 
BMBA procedure. 
• Standard of care BMBA procedure.  
• Assess post-procedure vital signs: heart rate, blood pressure, respiratory rate.  
• Administer post-procedure questionnaire, which includes: 
o Assessment of current distress level (0-10 scale). 
o 0-10 Numeric Pain Intensity scale. 
o Patient satisfaction questions. 
6.4 
Withdrawal Visit/Discontinuation of Therapy 
If a participant withdraws early or terminates participation, they will be requested to 
complete the post-procedure questionnaire, if deemed appropriate by study staff. 
7 Study Procedures and Evaluations 
7.1 
Study Procedures/Evaluations 
• Medical History: 
o Pre-procedure questionnaire will obtain diagnosis requiring BMBA, 
general reasons for receiving medical care, and history of previous BMBA 
procedures. 
• Physical examination: 
o Vital signs, including heart rate, blood pressure, and respiratory rate.  

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8 Evaluation of Safety 
8.1 
Specification of Safety Parameters 
8.1.1 
Unanticipated Problems 
Unanticipated problems (UAPs) include, in general, any incident, experience, or 
outcome that meets the following criteria: 
• unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; 
UAPs are considered to pose risk to participants or others when they suggest that the 
research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
8.1.2 
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
participant, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the participant’s 
participation in the research, whether or not considered related to the participant’s 
participation in the research. 
Potential adverse events include fainting or lightheadedness during or post-procedure, 
bruising resulting from needle insertion, prolonged bleeding at biopsy site, discomfort at 
the site during or post-procedure, infection, dizziness, nausea, disorientation, and 
vertigo. 
8.1.3 
Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
• Results in death 
• Is life-threatening (places the participant at immediate risk of death from the 
event as it occurred) 
• Is disabling or incapacitating 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect  
• An important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 

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medical judgment, the event may jeopardize the participant or may require 
intervention to prevent one of the outcomes listed in this definition. 
Potential SAEs include anaphylactic reaction after lidocaine or analgesic administration, 
post-biopsy bleeding, and severe infection.  
8.2 
Safety Assessment and Follow-Up 
The PI will follow adverse events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day 
of study participation. Events will be followed for outcome information until resolution or 
stabilization. 
8.3 
Recording Adverse Events 
The following subsections detail what information must be documented for each 
adverse event occurring during the time period specified in Section 8.2 Safety 
Assessment and Follow-Up.  
8.3.1 
Relationship to Study Intervention 
The relationship to study intervention or study participation must be assessed and 
documented for all adverse events. Evaluation of relatedness must consider etiologies 
such as natural history of the underlying disease, concurrent illness, concomitant 
therapy, study-related procedures, accidents, and other external factors.  
The following guidelines are used to assess relationship of an event to study 
intervention: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event 
onset. 
b. An alternate etiology has been established. 
8.3.2 
Expectedness 
The PI is responsible for determining whether an AE is expected or unexpected. An AE 
will be considered unexpected if the nature, severity, or frequency of the event is not 

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consistent with the risk information previously described for the intervention. Risk 
information to assess expectedness can be obtained from published medical literature, 
the protocol, or the informed consent document. 
8.3.3 
Severity of Event 
Adverse events will be graded for severity according to the Common Terminology 
Criteria for Adverse Events (CTCAE) version 5.0.  
8.3.4 
Intervention 
Any intervention implemented to treat the adverse event must be documented for all 
adverse events. 
8.4 
Safety Reporting  
8.4.1 
Reporting to IRB 
8.4.1.1 Unanticipated Problems 
All incidents or events that meet criteria for unanticipated problems (UAPs) as defined in 
Section 8.1.1 Unanticipated Problems require the creation and completion of an 
unanticipated problem report form (OHR-20).  
UAPs that pose risk to participants or others, and that are not AEs, will be submitted to 
the IRB on an OHR-20 form via the eazUP system within 10 working days of the 
investigator becoming aware of the event.  
UAPs that do not pose risk to participants or others will be submitted to the IRB at the 
next continuing review.  
8.4.1.2 Adverse Events  
Grade 1 AEs will be reported to the IRB at continuing review.  
Grade 2 AEs will be reported to the IRB at the time of continuing review.  
8.4.1.3 Serious Adverse Events  
SAEs will be reported to the IRB on OHR-10 forms via the electronic reporting system 
(eSAEy) according to the required time frames described below. 
Grade 3-4 AEs that are unexpected and deemed to be at least possibly related to the 
study will be reported to the IRB within 2 working days of knowledge of the event. 
Grade 3-4 AEs that are deemed unrelated to the study will be reported to the IRB within 
5 working days.  
Grade 5 AEs will be reported to the IRB within one working day of knowledge of the 
event. 

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All SAEs will be submitted to the IRB at continuing review, including those that were 
reported previously. 
8.4.2 
Reporting to SKCC DSMC 
All AEs and SAEs, safety and toxicity data, and any corrective actions will be submitted 
to the DSMC per the frequency described in the SKCC DSMP. The report to the SKCC 
DSMC will also include any unanticipated problems that in the opinion of the PI should 
be reported to the DSMC. 
For expedited reporting requirements, see table below:                                            
DSMC AE/SAE Reporting Requirements 
 

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8.4.3 
Reporting to Funding Sponsor 
Funding provided by the DAISY Foundation requires an interim report after patient 
enrollment is complete, anticipated as 6 months after start date. A final report of findings 
is due after data analysis is complete, no later than 1 year after the study start date.  
8.4.4 
Reporting of Pregnancy 
Pregnant women are not commonly a part of the BMBA patient population, and no 
participants will undergo pregnancy tests. As the study takes place for a single day, no 
ongoing reporting for pregnancy will be required.  
8.5 
Halting Rules 
Six or more patients experiencing Grade 4 and 5 AEs, as well as three or more patients 
experiencing SAEs, will prompt a temporary suspension of enrollment until a safety 
review can be convened.  
9 Study Oversight 
In addition to the PI’s responsibility for oversight, study oversight will be under the 
direction of the SKCC’s Data and Safety Monitoring Committee (DSMC). The SKCC 
DSMC operates in compliance with a Data and Safety Monitoring Plan (DSMP) that is 
approved by the NCI.  
10 Clinical Site Monitoring and Auditing 
Clinical site monitoring and auditing is conducted to ensure that the rights of human 
participants are protected, that the study is implemented in accordance with the protocol 
and/or other operating procedures, and that the quality and integrity of study data and 
data collection methods are maintained. Monitoring and auditing for this study will be 
performed in accordance with the SKCC’s Data and Safety Monitoring Plan (DSMP) 
developed by the SKCC Data and Safety Monitoring Committee (DSMC). The DSMP 
specifies the frequency of monitoring, monitoring procedures, the level of clinical site 
monitoring activities (e.g., the percentage of participant data to be reviewed), and the 
distribution of monitoring reports. Some monitoring activities may be performed 
remotely, while others will take place at the study site(s). Appropriate staff will conduct 
monitoring activities and provide reports of the findings and associated action items in 
accordance with the details described in the SKCC DSMP. 
11 Statistical Considerations  
11.1 Study Hypotheses 
Alternate hypothesis: Patients undergoing BMBA who receive distraction techniques 
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patients who receive only the standard of practice care. Additionally, these patients will 
have higher levels of satisfaction with their overall experience.  
Null hypothesis: Patients undergoing BMBA who receive distraction techniques will 
have no change in their level of distress and pain when compared to patients receiving 
the standard of practice care. Additionally, the satisfaction of these patients will be 
comparable to the satisfaction of patients receiving the standard of care.  
11.2 Analysis Plans 
Endpoints: All endpoints are measured pre- and post-procedure. 
The primary endpoints are 
1. Q13: a scale from 0-10, measuring pre-procedure patient distress, which will be 
treated as a numeric value in statistical analysis. 
2. Q16: a scale from 0-10, measuring post-procedure patient distress, which will be 
treated as a numeric value in statistical analysis  
The secondary endpoints are  
1. Q12: a scale from 0-10, measuring patient pain scores, which will be treated as a 
numeric value in statistical analysis 
2. Q17: a scale from 0-10, measuring post-procedure patient pain scores, which will 
be treated as a numeric value in statistical analysis  
3. Q18, which is on a 5-level Likert scale, measuring satisfaction. This endpoint 
focuses on the post-procedure response and does not have a pre-procedure 
comparison. 
Statistical Analysis:  Responses to the questionnaire before and after the procedure will 
be reported using summary statistics such as means, standard deviations and 
proportions. The numeric difference between post vs. pre responses of Q13, Q16, Q12 
and Q17 will be compared between Intervention 1 and Control in Phase I, and between 
Intervention 2 and Control in Phase II, using two-sample t-test. The post-responses of 
Q18 will be compared between the procedures in Phase I and Phase II using two-sided 
test for ordinal categorical variables. 
11.3 Sample Size Considerations 
We expect to enroll 15 patients for Intervention 1 and 15 patients for Control for Phase I, 
and 15 patients for Intervention 2 and 15 patients for Control for Phase II. For the 
primary endpoint of Q13 and Q16 in each of the two phases, the numeric difference of 
post- vs. pre- responses will be compared between Intervention and Control arms. This 
sample size will achieve 82.8% power to detect an effect size of 1.1 at 5% significance 
level using a two-sided two-sample equal-variance t-test. 

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11.3.1 Accrual Estimates 
30 patients will be accrued into each phase of the trial, resulting in 60 total patients 
enrolled. 
11.4 Evaluation of Safety 
Safety will be assessed on a per participant basis as each patient will only be tracked 
for one visit. There is no statistical analysis of safety planned. 
12 Source Documents and Access to Source Data/Documents 
Study staff will maintain appropriate medical and research records for this study, in 
compliance with ICH E6, and regulatory and institutional requirements for the protection 
of confidentiality of participant information. Study staff will permit authorized 
representatives of SKCC and regulatory agencies to examine (and when required by 
applicable law), to copy research records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress and data validity.  
Source data will be maintained via the electronic medical record (EMR) and the 
Qualtrics survey platform. The EMR will maintain recorded vital signs and Qualtrics will 
maintain all survey data, including demographics. Qualtrics is a HIPAA compliant 
platform. Survey responses will be accessible to the PI and one Co-I for review and 
analysis.  
Physical copies of the randomization envelopes, provided by the Biostatistics 
department, will also be retained for reference.  
13 Quality Control and Quality Assurance 
The PI, in conjunction with the research coordinator, Victoria Gulick, will provide training 
for all study staff on appropriate language for communicating with patients, proper 
implementation of interventions, and usage of Qualtrics survey software. This will 
include an introduction to the VR hardware and guided meditation software. All study 
staff will follow the same plan for onboarding patients to interventions to assure 
consistency in care.  
Source materials will be evaluated weekly, or as problems arise, to ensure data entry is 
maintained and information remains organized. The research coordinator will be 
responsible for addressing Qualtrics quality assurance issues. All other compliance will 
be assessed by the PI.  
 
 

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14 Ethics/Protection of Human Participants  
14.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6.  
14.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant 
materials will be submitted to the IRB for review and approval. Approval of both the 
protocol and the consent form must be obtained before any participant is enrolled. Any 
amendment to the protocol will require review and approval by the IRB before the 
changes are implemented in the study.  
14.3 Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to 
participants and their families, if applicable. An e-consent form describing in detail the 
study procedures and risks will be given to the participant via the REDCap HIPAA-
compliant platform. Consent forms will be IRB-approved, and the participant is required 
to read and review the e-document or have the e-document read to him, her, or them. 
Paper consent will be available at patient request. The investigator or designee will 
explain the research study to the participant and answer any questions that may arise. 
The participant will electronically sign the informed consent document prior to any 
study-related assessments or procedures.  
Participants will be given the opportunity to discuss the study with their surrogates or 
think about it prior to agreeing to participate. They may withdraw consent at any time 
throughout the course of the study. A copy of the signed informed consent document 
will be emailed to participants for their records. If a participant does not have an email or 
does not wish to provide one, they will instead receive a paper copy of their consent 
form.  
The rights and welfare of the participants will be protected by emphasizing to them that 
the quality of their clinical care will not be adversely affected if they decline to participate 
in this study. The consent process will be documented in the research record.  
14.4 Exclusion of Women, Minorities, and Children (Special Populations) 
Individuals of any gender, race, or ethnic background are eligible to participate. 
Individuals must be over 18 years of age as pediatric patients are not treated at the 

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outpatient medical oncology office, at 925 Chestnut, where BMBA procedures are 
performed. 
14.5 Participant Confidentiality 
Participant confidentiality is strictly held in trust by the investigators and study staff. This 
confidentiality is extended to cover all study information relating to participants. To 
ensure this protection, participants will be assigned a study ID number. This number will 
be linked to their study arm enrollment and associated questionnaires.  
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence.  
15 Data Handling and Record Keeping 
The investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents must be completed in a neat, 
legible manner to ensure accurate interpretation of data. The investigators will maintain 
source documentation, including survey records on the Qualtrics platform. 
15.1 Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the PI. All source documents must be reviewed by the study 
team and data entry staff, who will ensure that they are accurate and complete. 
Unanticipated problems and adverse events must be reviewed by the PI.  
15.2 Data Capture Methods 
Survey data will be captured through a Qualtrics survey and analyzed through the 
Qualtrics software. This is password/login protected and recognized as a Jefferson 
preferred, HIPAA-compliant survey system. 
15.3 Types of Data 
Survey questions, including patient demographics, will be collected pre- and post-
procedure during Visit 1. Participant vital signs will be recorded as part of each patient’s 
EMR. All data to be used in analyses will be deidentified and maintained on internal 
secure data servers.  
A preliminary report will be generated following primary completion of Phase I. An 
additional report will be generated following primary completion of Phase II. The final 
report will look at data from both phases.  
An interim report is due to the funding sponsor, the DAISY Foundation, after enrollment 
is complete. A final report is due after all analysis is complete.  
15.4 Study Records Retention 

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Study records will be maintained for two years following study completion to allow for 
analysis and implementation into current processes. 
15.5 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical 
Practice, or Manual of Procedures requirements. The noncompliance may be on the 
part of the participant, the investigator, or study staff. As a result of deviations, 
corrective actions are to be developed by the study staff and implemented promptly. 
All deviations from the protocol must be addressed in study participant source 
documents and promptly reported to the IRB and other regulatory bodies according to 
their requirements.  
16 Study Finances 
16.1 Funding Source 
This study is financed through a grant from the DAISY Foundation.  
16.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the conflict 
reviewed by a properly constituted Conflict of Interest Committee with a Committee-sanctioned 
conflict management plan that has been reviewed and approved by the study sponsor prior to 
participation in this study. All Jefferson University Investigators will follow the TJU Conflicts of 
Interest Policy for Employees (107.03). 
16.3 Participant Stipends or Payments 
Participants will not receive payment for participation in the study. 
17 Publication and Data Sharing Policy 
Publications of results will be the shared responsibility of all Co-Investigators and the 
Principal Investigator. Primary results will be published as a group effort with the 
approval of all investigators. Secondary publications and presentations may be released 
by individual investigators with the approval of the other investigators. All 
secondary/tertiary publications and presentations must reference the original publication 
and cite other investigators’ work as applicable. 
 
 
 

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18 Literature References 
1. Schweitzer M, Gilpin L, Frampton S. Healing spaces: elements of environmental 
design that make an impact on health. J Altern Complement Med. 2004;10 Suppl 
1:71.  
2. Watts G, Khan A, Pheasant R. Influence of soundscape and interior design on 
anxiety and perceived tranquillity of patients in a healthcare setting. Applied 
Acoustics. 2016 Mar; 104:135-41.  
3. Ulrich RS. Effects of interior design on wellness: theory and recent scientific 
research. J Health Care Inter Des. 1991;3:97-109.  
4. Laursen J, Danielsen A, Rosenberg J. Effects of environmental design on patient 
outcome: a systematic review. HERD. 2014;7(4):108-19.  
5. Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy 
with nature sights and sounds reduces pain during flexible bronchoscopy: a 
complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8.  
6. Iyendo TO, Uwajeh PC, Ikenna ES. The therapeutic impacts of environmental 
design interventions on wellness in clinical settings: A narrative review. 
Complement Ther Clin Pract. 2016 Aug;24:174-88.  
7. Tsai HF, Chen YR, Chung MH, Liao YM, Chi MJ, Chang CC, et al. Effectiveness 
of music intervention in ameliorating cancer patients' anxiety, depression, pain, 
and fatigue: a meta-analysis. Cancer Nurs. 2014;37(6):35.  
8. Danhauer SC, Vishnevsky T, Campbell CR, McCoy TP, Tooze JA, Kanipe KN, et 
al. Music for patients with hematological malignancies undergoing bone marrow 
biopsy: a randomized controlled study of anxiety, perceived pain, and patient 
satisfaction. J Soc Integr Oncol. 2010;8(4):140-7.  
9. Thoma MV, Zemp M, Kreienbühl L, Hofer D, Schmidlin PR, Attin T, et al. Effects 
of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental 
Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505.  
10. Daniel E. Music used as anti-anxiety intervention for patients during outpatient 
procedures: A review of the literature. Complementary Therapies in Clinical 
Practice. 2015;22:21-3.  
11. Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled 
clinical trial: the effect of a mindfulness meditation-based stress reduction 
program on mood and symptoms of stress in cancer outpatients. Psychosom 
Med. 2000;62(5):613- 22.  

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12. Deng G, Cassileth BR. Integrative oncology: complementary therapies for pain, 
anxiety, and mood disturbance. CA Cancer J Clin. 2005;55(2):109-16.  
13. Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects of distraction using 
virtual reality glasses during lumbar punctures in adolescents with cancer. Oncol 
Nurs Forum. 2002 Jan-Feb;29(1):E15.  
14. Espinoza M, Baños RM, García-Palacios A, Cervera JM, Esquerdo G, Barrajón 
E, et al. Promotion of emotional wellbeing in oncology inpatients using VR. Stud 
Health Technol Inform. 2012;181:53-7.  
15. Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction 
technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 
Jun;17(6):346- 52.  
16. Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an 
Immersive Preoperative Virtual Reality Experience on Patient Reported 
Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 06;265(6):1068-73.  
17. Indovina P, Barone D, Gallo L, Chirico A, Pietro GD, Giordano A. Virtual Reality 
as a Distraction Intervention to Relieve Pain and Distress During Medical 
Procedures: A Comprehensive Literature Review. The Clinical Journal of Pain. 
2018 /09/01;34(9):858- 77.  
18. Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, et al. Virtual 
Reality for Management of Pain in Hospitalized Patients: Results of a Controlled 
Trial. JMIR Ment Health. 2017 Mar 29,;4(1):e9.  
19. Nanda U, Chanaud C, Nelson M, Zhu X, Bajema R, Jansen BH. Impact of visual 
art on patient behavior in the emergency department waiting room. J Emerg Med. 
2012 Jul;43(1):172-81.  
20. Harte R, Glynn L, Rodríguez-Molinero A, Baker PM, Scharf T, Quinlan LR, et al. 
A Human-Centered Design Methodology to Enhance the Usability, Human 
Factors, and User Experience of Connected Health Systems: A Three-Phase 
Methodology. JMIR Hum Factors. 2017 -3-16;4(1).  
21. Devlin AS, Andrade CC, Carvalho D. Qualities of Inpatient Hospital Rooms: 
Patients’ Perspectives. HERD. 2016 April 1;9(3):190-211.  
22. Satija A, Bhatnagar S. Complementary Therapies for Symptom Management in 
Cancer Patients. Indian J Palliat Care. 2017 Oct-Dec;23(4):468-479. doi: 
10.4103/IJPC.IJPC_100_17. PMID: 29123357; PMCID: PMC5661353. 
23. Mohammad EB, Ahmad M. Virtual reality as a distraction technique for pain and 
anxiety among patients with breast cancer: A randomized control trial. Palliative 
and Supportive Care. 2018;17(1):29-34. 

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24. www.oculus.com/warnings [Internet]. [cited 2021 Jun 9]. Available from: 
https://scontent-lga3-2.xx.fbcdn.net/v/t39.2365-
6/61202485_681924205599326_815470300731801600_n.pdf?_nc_cat=110&cc
b=1-3&_nc_sid=ad8a9d&_nc_ohc=LH67U4ajWOgAX9dyqzx&_nc_ht=scontent-
lga3-2.xx&oh=fa80d3890209a15de9868c732afc30a2&oe=60E83A69 
25. Stevenson MP, Schilhab T, Bentsen P. Attention restoration theory ii: A 
systematic review to clarify attention processes affected by exposure to natural 
environments. J. Toxicol. Environ. Health Part B. 2018; 21:227-268. 
26. Hartig T, Mang M, Evans GW. Restorative effects of natural environment 
experiences. Environ Behav. 1991;23:3-26. 
27. Li Y, Xing X, Shi X, Yan P, Chen Y, Li M, Zhang W, Li X, Yang K. The 
effectiveness of music therapy for patients with cancer: A systematic review and 
meta-analysis. J Advanced Nursing. 2020 May;76(5):1111-1123. 
28. Krishnaswamy P, Nair S. Effect of music therapy on pain and anxiety levels in 
cancer patients: a pilot study. Indian J Palliat Care. 2016 Jul-Sep;22(3):307-311. 
29. Lewis C, Griffin M. Human factors consideration in clinical applications of virtual 
reality. Studies in Health Technology and Informatics. 1997;44:35-56. 
30. National Comprehensive Cancer Network. NCCN Distress Thermometer and 
Problem List for Patients. 2020 Mar. Available from: 
https://www.nccn.org/docs/default-source/patient-
resources/nccn_distress_thermometer.pdf?sfvrsn=ef1df1a2_4 
 
 

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Appendices 
The following documents are officially affiliated with the protocol and will be submitted to the IRB 
as a part of the protocol. As such, changes to these items require a protocol amendment. 
Appendix A: Schedule of Events  
Appendix B: Patient Survey 
 
 
 

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APPENDIX A: SCHEDULE OF EVENTS 
Vital Signs – Heart rate, blood pressure, and respiratory rate. 
Procedures 
Screening  
(Day 1) 
Study Visit 1 
(Day 1) 
Premature 
Discontinuation 
Signed Consent Form 
X 
 
 
Assessment of Eligibility Criteria 
X 
 
 
Review of Medical History 
X 
 
 
Study Intervention 
 
X 
 
Physical 
Assessment 
Pre-procedure 
Vital Signs 
 
X 
 
Post-procedure 
Vital Signs 
 
X 
 
Assessment of Adverse Events 
 
(X) 
X 
Survey 
Distress 
Assessment 
 
X 
(X) 
Pain 
Assessment 
 
X 
(X) 
Satisfaction 
Questionnaire 
 
X 
(X) 
 
 
 
 
 
 
 
 

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APPENDIX B: PATIENT SURVEY 
Notes: Items Q1 and Q2 are for staff use only. Study staff will enter the patient’s ID number and 
randomized arm assignment before sharing the survey with patients. There will be no “back” 
button so patients will be unable to stumble upon this information accidentally. These items will 
be completed at the time of randomization. 
Q16 includes meta text (“${Q13/ChoiceGroup/SelectedChoices}”) that will show to participants 
as the choice they selected as part of Q13.  
Questions Q19 through Q23 will only be shown to participants in the relevant enrollment groups.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BMBA Pre- and Post-procedure Survey 
 
 
Start of Block: Study ID 
 
Q1 FOR STAFF: Enter Study ID number 
________________________________________________________________ 
 
 
 
Q2 Patient enrollment group 
o Control  
o Intervention 1  
o Intervention 2  
 
End of Block: Study ID 
 
Start of Block: Demographics 
 
Thank you for participating in this research study.   
    
The following questions help us understand your experience in comparison to other patients like 
you. Please complete them to the best of your ability.  
 
 
 

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Q3 What is your age? 
o 18-19 years old  
o 20-29 years old  
o 30-39 years old  
o 40-49 years old  
o 50-59 years old  
o 60-69 years old  
o 70-79 years old  
o 80 years or older  
o Prefer not to answer  
 
 
 

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Q4 What best describes your gender? (Select all that apply.) 
▢ 
Female  
▢ 
Male  
▢ 
Transgender  
▢ 
Non-binary / Gender variant  
▢ 
Not listed (please include if not listed) 
________________________________________________ 
▢ 
Prefer not to answer  
 
 
 
Q5 Are you of Hispanic, Latinx, or Spanish origin?  
o Yes  
o No  
o Prefer not to answer  
 
 
 

Improving Patient Experience During BMBA 
 
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Q6 Please specify your race. (Select all that apply.) 
▢ 
Asian  
▢ 
Black or African American  
▢ 
Native American  
▢ 
Pacific Islander  
▢ 
White  
▢ 
Other (please include if not listed) 
________________________________________________ 
▢ 
Prefer not to answer  
 
 
 

Improving Patient Experience During BMBA 
 
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Q7 What is the highest degree or level of school you have completed?  
o Some high school  
o High school graduate, diploma or equivalent (GED)  
o Some college  
o Associate degree  
o Bachelor's degree  
o Master's degree  
o Doctorate degree  
o Other (please include if not listed) 
________________________________________________ 
o Prefer not to answer  
 
End of Block: Demographics 
 
Start of Block: Background Health 
 

Improving Patient Experience During BMBA 
 
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Based on SKCC Interventional Protocol Template v.20170209 
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Q8 What diagnosis/diagnoses have required you to undergo one or more bone marrow biopsy? 
(Select all that apply.) 
▢ 
Aplastic Anemia  
▢ 
Leukemia  
▢ 
Lymphoma  
▢ 
Multiple Myeloma  
▢ 
Other (please include if not listed) 
________________________________________________ 
▢ 
Prefer not to answer  
 
 
 

Improving Patient Experience During BMBA 
 
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Q9 For what other medical conditions do you receive medical care? (Select all categories that 
apply.) 
▢ 
Blood or Vascular conditions (for example blood clots)  
▢ 
Bone or Muscle conditions (for example osteoporosis, arthritis)  
▢ 
Heart or Cardiovascular conditions (for example heart attack, heart disease)  
▢ 
Inflammation and immune conditions (for example Rheumatoid arthritis)  
▢ 
Kidney or Renal conditions (for example kidney disease)  
▢ 
Lung or Pulmonary conditions (for example asthma, COPD)  
▢ 
Mental health (for example anxiety, depression)  
▢ 
Nutrition, Exercise or Metabolic conditions (for example diabetes, obesity)  
▢ 
Stomach or Gastrointestinal conditions (for example Crohn's disease)  
▢ 
Other (please include if not listed) 
________________________________________________ 
▢ 
Prefer not to answer  
 
End of Block: Background Health 
 
Start of Block: BMBA History 
 

Improving Patient Experience During BMBA 
 
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Based on SKCC Interventional Protocol Template v.20170209 
page 42 of 52 
Please answer the following questions about your previous bone marrow biopsy visits.  
 
 
 
Q10 When was your most recent bone marrow biopsy at Jefferson Health? 
o Less than one month ago  
o One to five months ago  
o Six months to one year ago  
o Greater than one year ago  
 
 
 
Q11 How many bone marrow biopsies have you had in the past two years? 
o One  
o Two or three  
o Four or five  
o Six or more  
 
 
 

Improving Patient Experience During BMBA 
 
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Q12 During your last bone marrow biopsy procedure experience, how would you rate your pain, 
on a scale of 0 to 10, with 0 being no pain and 10 being extreme pain? 
o 0  
o 1  
o 2  
o 3  
o 4  
o 5  
o 6  
o 7  
o 8  
o 9  
o 10  
 
End of Block: BMBA History 
 
Start of Block: Distress Assessment 
 
The following questions are about the distress you may feel about today's procedure. 
  
Distress is an unpleasant experience of a mental, physical, social, or spiritual nature. It can 
affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its 
symptoms, or its treatment. 

Improving Patient Experience During BMBA 
 
Version 1.1 
Protocol 21G.1035 
 
13 July 2021 
 
 
Based on SKCC Interventional Protocol Template v.20170209 
page 44 of 52 
    
  
 
 
 
Q13 On a scale of 0 to 10, with 0 being no distress and 10 being extreme distress, how much 
distress do you feel today?  
o 0  
o 1  
o 2  
o 3  
o 4  
o 5  
o 6  
o 7  
o 8  
o 9  
o 10  
 
 
 

Improving Patient Experience During BMBA 
 
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Q14 What part(s) of a bone marrow biopsy procedure make you feel distressed? (Select all 
that apply). 
▢ 
Being in a medical setting  
▢ 
Sitting and waiting before the provider comes in  
▢ 
Thinking about the pain I might feel  
▢ 
Worrying about the process of the procedure  
▢ 
Worrying about the results of the procedure  
▢ 
None of the above, I don't feel distress about bone marrow biopsies.  
▢ 
Other: ________________________________________________ 
 
 
 

Improving Patient Experience During BMBA 
 
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Based on SKCC Interventional Protocol Template v.20170209 
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Q15 How do you deal with feeling distressed about bone marrow biopsies? (Select all that 
apply.) 
▢ 
I bring a friend or relative with me to my appointments  
▢ 
I distract myself with my phone, a book, or a magazine  
▢ 
I listen to music  
▢ 
I practice breathing techniques or meditate  
▢ 
None of the above, I don't know how to handle my distress  
▢ 
None of the above, I don't feel distress about bone marrow biopsies.  
▢ 
Other (please elaborate) 
________________________________________________ 
 
End of Block: Distress Assessment 
 
Start of Block: Divider 
 
Thank you for completing this part of the survey. Please return the iPad to the study 
team member. You will complete the rest of the survey after your procedure.  
 
End of Block: Divider 
 
Start of Block: Post-procedure 
 
Post-procedure Questions 
 

Improving Patient Experience During BMBA 
 
Version 1.1 
Protocol 21G.1035 
 
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Based on SKCC Interventional Protocol Template v.20170209 
page 47 of 52 
 
 
Q16 At the start of your visit, you rated your distress as 
a ${Q13/ChoiceGroup/SelectedChoices} out of 10.  
  
On a scale of 0 to 10, with 0 being no distress and 10 being extreme distress, how much 
distress do you feel now? 
o 0  
o 1  
o 2  
o 3  
o 4  
o 5  
o 6  
o 7  
o 8  
o 9  
o 10  
 
 
 

Improving Patient Experience During BMBA 
 
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Protocol 21G.1035 
 
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Based on SKCC Interventional Protocol Template v.20170209 
page 48 of 52 
Q17 During your bone marrow biopsy procedure experience, how would you rate your pain, on 
a scale of 0 to 10, with 0 being no pain and 10 being extreme pain? 
o 0  
o 1  
o 2  
o 3  
o 4  
o 5  
o 6  
o 7  
o 8  
o 9  
o 10  
 
 
 

Improving Patient Experience During BMBA 
 
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Q18 Please rate your satisfaction with each of the following parts of your bone marrow biopsy 
experience.  
 
Extremely 
Dissatisfied 
Dissatisfied 
Neither 
Satisfied or 
Dissatisfied 
Satisfied 
Extremely 
Satisfied 
Time spent in 
the 
procedure 
room before 
the biopsy  
o  
o  
o  
o  
o  
Interactions 
with staff  
o  
o  
o  
o  
o  
Room decor  
o  
o  
o  
o  
o  
 
 
End of Block: Post-procedure 
 
Start of Block: Intervention Specific Questions 
Display This Question: 
If Patient enrollment group = Intervention 2 
 
As part of this study, you were provided with a selection of music and changes to your 
procedure room decor. These will be referred to as an "intervention" in the following questions. 
Please answer the following questions about your experience as it relates to this intervention.  
 
 
Display This Question: 
If Patient enrollment group = Intervention 1 
 
As part of this study, you were provided with a virtual reality (VR) headset and a selection of 
guided meditations. These will be referred to as an "intervention" in the following questions. 
Please answer the following questions about your experience as it relates to this intervention.  
 
 

Improving Patient Experience During BMBA 
 
Version 1.1 
Protocol 21G.1035 
 
13 July 2021 
 
 
Based on SKCC Interventional Protocol Template v.20170209 
page 50 of 52 
Display These * Questions: 
If Patient enrollment group is NOT “Control” 
 
*Q19 Because of this intervention, the distress I felt while waiting before the procedure was... 
o Significantly decreased  
o Slightly decreased  
o Neither increased or decreased  
o Slightly increased  
o Significantly increased  
o None of the above, I don't feel distress about this procedure.  
 
 
 
*Q20 Because of this intervention, the distress I felt after the procedure was... 
o Significantly decreased  
o Slightly decreased  
o Neither increased or decreased  
o Slightly increased  
o Significantly increased  
o None of the above, I don't feel distress about this procedure.  
 
 

Improving Patient Experience During BMBA 
 
Version 1.1 
Protocol 21G.1035 
 
13 July 2021 
 
 
Based on SKCC Interventional Protocol Template v.20170209 
page 51 of 52 
 
*Q21 Because of this intervention, the pain I felt during the procedure was... 
o Significantly decreased  
o Slightly decreased  
o Neither increased or decreased  
o Slightly increased  
o Significantly increased  
o None of the above, this procedure is not painful.  
 
 
 
*Q22 Please rate your overall satisfaction with your experience based on this intervention. 
o Extremely satisfied  
o Somewhat satisfied  
o Neither satisfied nor dissatisfied  
o Somewhat dissatisfied  
o Extremely dissatisfied  
 
 
 

Improving Patient Experience During BMBA 
 
Version 1.1 
Protocol 21G.1035 
 
13 July 2021 
 
 
Based on SKCC Interventional Protocol Template v.20170209 
page 52 of 52 
*Q23 If offered during a future bone marrow biopsy procedure, would you be interested in using 
this intervention again? Use this space to provide any additional feedback about your 
participation in this study or your bone marrow biopsy experience. 
o Yes, I am interested in using this intervention for future procedures.  
o No, I am not interested in using this intervention for future procedures.  
o I am undecided.  
 
 
Q24 Use this space to provide any additional feedback you may have about your participation in 
this study or your experience today. 
 
 
 
 
End of Block: Intervention Specific Questions