Measuring Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome (MDS)
Conditions: Myelodysplastic Syndromes
Sponsor: Thomas Jefferson University

Activity Tracking in MDS Patients 
 
Version 1.0 
Protocol IRB#21D.214 
 
February 11 2021
 
 
Based on SKCC Interventional Protocol Template v.20170209 
page 1 of 34 
THOMAS JEFFERSON UNIVERSITY 
Sidney Kimmel Cancer Center 
 
Measuring Physical Activity in Transfusion Dependent Patients with Myelodysplastic 
Syndrome (MDS) 
 
Principal Investigator: 
Lindsay Wilde, MD 
Medical Oncology 
925 Chestnut Street Suite 420A 
Philadelphia, PA 19107 
215-955-8874 
Co-Investigator(s): 
Kuang-Yi Wen, PhD (non-consenting) 
Margaret Kasner, MD MSCE 
Neil Palmisiano, MD 
Gina Keiffer, MD 
Kaitlin Rancani, CRNP 
Kathryn Yingling, CRNP 
Statistician: 
Benjamin Leiby, PhD 
Division of Biostatistics 
1015 Chestnut St. Suite 520 
Funding Sponsor: 
Insert the name of primary funding institution 
Insert address 
Insert phone number 
IND/IDE Holder: 
N/A 
IND/IDE Number: 
N/A 
Study Product: 
Fitbit Inspire HR 
Protocol IDs: 
JeffTrial # 16333 
PRC # 2020-145 
IRB Control # 21D.214 
NCT04969367 
 
Version Number: 
Version Date: 
1.0 
2/11/2021 
 
 
 
 
 
 
 
 

Activity Tracking in MDS Patients 
 
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Protocol IRB#21D.214 
 
February 11 2021
 
 
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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. 
 

Activity Tracking in MDS Patients 
 
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Table of Contents  
 
Signature Page .......................................................................................................................... 7 
Statement of Compliance ........................................................................................................... 7 
List of Abbreviations ................................................................................................................... 8 
Study Summary ........................................................................................................................10 
1 
Introduction .........................................................................................................................13 
1.1 
Background Information ..............................................................................................13 
1.2 
Rationale for the Proposed Study ...............................................................................13 
1.3 
Potential Risks and Benefits .......................................................................................14 
1.3.1 Potential Risks.........................................................................................................14 
1.3.2 Benefits ...................................................................................................................14 
1.4 
Objectives ...................................................................................................................14 
1.4.1 Primary ....................................................................................................................14 
1.4.2 Secondary ...............................................................................................................14 
1.5 
Endpoints/Outcome Measures ....................................................................................14 
1.5.1 Primary ....................................................................................................................14 
1.5.2 Secondary ...............................................................................................................15 
2 
Study Design ......................................................................................................................15 
3 
Study Enrollment and Withdrawal .......................................................................................15 
3.1 
Eligibility Criteria .........................................................................................................15 
3.1.1 Inclusion Criteria ......................................................................................................15 
 
Have access to Bluetooth LE and internet connection for syncing.  ................................16 
3.1.2 Exclusion Criteria ....................................................................................................16 
3.2 
Strategies for Recruitment and Retention ...................................................................16 
3.3 
Participant Withdrawal ................................................................................................16 
3.3.1 Reasons for Withdrawal ..........................................................................................16 

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3.3.2 Handling of Participant Withdrawals and Participant Discontinuation of Study 
Intervention .........................................................................................................................17 
3.4 
Premature Termination or Suspension of Study ..........................................................17 
4 
Study Intervention ...............................................................................................................17 
4.1 
Study Product .............................................................................................................17 
4.2 
Study Product Description ...........................................................................................17 
4.2.1 Acquisition ...............................................................................................................17 
4.3 
Study Product Accountability ......................................................................................17 
4.4 
Assessing Participant Compliance with Study Product Administration ........................18 
4.5 
Concomitant Medications/Treatments .........................................................................18 
4.6 
Dietary Restrictions .....................................................................................................18 
5 
Study Schedule ..................................................................................................................18 
5.1 
Screening ...................................................................................................................18 
5.2 
Enrollment/Baseline ....................................................................................................19 
5.3 
Treatment Period ........................................................................................................19 
5.4 
End of Treatment Study Procedures ...........................................................................19 
5.5 
Withdrawal Visit/Discontinuation of Therapy ...............................................................20 
No end of study procedures will be required if a patient withdraws or participation is 
terminated early. ....................................................................................................................20 
6 
Study Procedures and Evaluations .....................................................................................20 
6.1 
Study Procedures/Evaluations ....................................................................................20 
6.2 
Laboratory Procedures/Evaluations ............................................................................20 
6.2.1 Clinical Laboratory Evaluations ...............................................................................20 
7 
Evaluation of Safety ............................................................................................................20 
7.1 
Specification of Safety Parameters .............................................................................20 
7.1.1 Unanticipated Problems ..........................................................................................20 
7.2 
Safety Reporting .........................................................................................................21 

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7.2.1 Reporting to IRB ......................................................................................................21 
8 
Study Oversight ..................................................................................................................22 
9 
Statistical Considerations ...................................................................................................22 
9.1 
Analysis Plans ............................................................................................................22 
9.2 
Sample Size Considerations .......................................................................................22 
10 
Source Documents and Access to Source Data/Documents ..........................................22 
11 
Quality Control and Quality Assurance ...........................................................................24 
12 
Ethics/Protection of Human Participants .........................................................................24 
12.1 
Ethical Standard .........................................................................................................24 
12.2 
Institutional Review Board ...........................................................................................24 
12.3 
Informed Consent Process ..........................................................................................24 
12.4 
Exclusion of Women, Minorities, and Children (Special Populations) ..........................25 
12.5 
Participant Confidentiality............................................................................................25 
13 
Data Handling and Record Keeping ...............................................................................25 
13.1 
Data Management Responsibilities .............................................................................25 
13.2 
Data Capture Methods ................................................................................................26 
13.3 
Types of Data .............................................................................................................26 
13.4 
Study Records Retention ............................................................................................26 
13.5 
Protocol Deviations .....................................................................................................26 
14 
Study Finances ...............................................................................................................26 
14.1 
Funding Source ..........................................................................................................26 
14.2 
Conflict of Interest .......................................................................................................27 
14.3 
Participant Stipends or Payments ...............................................................................27 
15 
Publication and Data Sharing Policy ...............................................................................27 
16 
Literature References .....................................................................................................28 
Appendices ...............................................................................................................................30 
APPENDIX A: SCHEDULE OF EVENTS ..................................................................................31 

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Activity Tracking in MDS Patients 
 
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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: 2/11/21 
Name: 
Lindsay Wilde, MD 
Title:  
Assistant Professor 
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 
CBC 
Adverse Event/Adverse Experience 
Complete Blood Count 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
CTCAE 
Common Terminology Criteria for Adverse Events 
DSMC 
Data and Safety Monitoring Committee 
DSMP 
ECOG 
FACT-An 
Data and Safety Monitoring Plan 
Eastern Cooperative Oncology Group 
The Functional Assessment of Cancer Therapy-Anemia 
FDA 
Food and Drug Administration 
FWA 
Federal wide Assurance 
GCP 
Good Clinical Practice 
GWAS 
Genome-Wide Association Studies 
HIPAA 
HRQoL 
Health Insurance Portability and Accountability Act 
Health-Related Quality of Life 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
MDS 
Institutional Review Board 
Myelodysplastic Syndrome 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PRC 
Protocol Review Committee 
QA 
Quality Assurance 
QC 
RBC 
Quality Control 
Red Blood Cell 

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SAE 
Serious Adverse Event/Serious Adverse Experience 
SDS 
Safety Data Sheet (formerly MSDS; Material Safety Data Sheet) 
SKCC 
Sidney Kimmel Cancer Center 
SOP 
Standard Operating Procedure 
TJU 
Thomas Jefferson University 
UAP 
Unanticipated Problem 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Summary 
 
Title: 
Measuring Physical Activity in Transfusion Dependent Patients 
with Myelodysplastic Syndrome (MDS) 
Précis: 
This will be a single-arm, prospective, observational study that 
will collect data on daily step count, heart rate, and anemia-
related symptoms in patients with red blood cell transfusion 
dependent MDS.  Patients will be provided with a wearable 
activity monitor, which will be used to monitor daily step 
count and heart rate.  Devices will be paired with a centralized 
data aggregation platform which will automatically collect and 
store data. Anemia-related symptom and quality of life data will 
be assessed using the FACT-An questionnaire at baseline 
and then twice a week during the study period. Feasibility will 
be measured by accrual rate, Fitbit compliance rate and study 
completion rate. Acceptability will be measured by a 
satisfaction survey and a brief interview at the end of 3-month 
study.    
 
Objectives: 
 
 
Primary:  
• To assess the feasibility and patient acceptability of 
using a Fitbit to monitor daily step count and heart rate. 
 
Secondary:  
• To graph changes in daily step count, average daily 
resting heart rate, Fact-An score (assessed before and 
one day after each transfusion), and hemoglobin level. 
Population: 
Red blood cell transfusion dependent patients with MDS 
Phase: 
Pilot Study 
Number of Sites: 
1 site (TJUH) 
Description of 
Intervention: 
Patients will be given an activity tracker to wear continuously 
for 90 days   
Study Duration: 
12 months 

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Participant 
Participation 
Duration: 
90 days 
Estimated Time to 
Complete 
Enrollment: 
9 months 

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Schematic of Study Design: 
 
Prior to/At  
Enrollment 
 
 
Baseline/ 
Enrollment 
 
 
 
Routine 
Care 
 
 
 
Twice a  
week 
 
 
 
 
Study Completion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screen potential participant by inclusion and exclusion criteria; obtain informed 
consent; obtain history, document.  
Perform baseline assessments. Provide patient with Fitbit wearable device. 
Instruct patient on device utilization. Administer baseline FACT-An questionnaire 
Obtain twice weekly CBCs and receive transfusions per standard of care.  
Complete FACT-An questionnaire.  Assess adherence with device. 
 

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1 Introduction 
1.1 
Background Information 
The myelodysplastic syndromes (MDS) are clonal blood cancers characterized by 
ineffective blood cell maturation, peripheral blood cytopenias, and risk of progression to 
acute myeloid leukemia (AML). Effective treatments for MDS are lacking, and the overall 
prognosis is poor. Every year there are ~15,000-20,000 new cases of MDS in the US, 
with an incidence that increases very significantly after age 65 1. A TriNetX database 
query shows that at least 275 patients with MDS were seen in the Jefferson Health 
Network in the past 12 months. The SKCC has identified MDS as a catchment area 
priority and an enterprise-wide effort is underway to harmonize care and increase access 
to high impact clinical trials.   
The majority of patients with MDS are anemic at diagnosis and become dependent on 
red blood cell (RBC) transfusions to maintain the hemoglobin at a level that is adequate 
for oxygen delivery2. Frequent RBC transfusions are associated with iron overload, 
transfusion reactions, alloantibody development, infection, and decreased healthcare 
related quality of life (HRQoL) 3-5. In addition, RBC transfusions significantly increase the 
cost of care, with one study estimating a >$30,000 increase in annual cost for MDS 
patients who are RBC transfusion-dependent compared to those who are not 6-8.  
The decision to transfuse RBCs in a patient with MDS is often guided by pre-determined 
hemoglobin threshold levels and modified based on patient symptoms and comorbidities 
4. However, data to support these threshold levels in MDS are scarce. In addition, neither 
the objective clinical benefit nor the patient-reported symptom improvement associated 
with transfusion practices based on these hemoglobin threshold levels have been well 
described. Patient reported outcome (PRO) measures for anemia, such as The 
Functional Assessment of Cancer Therapy-Anemia (FACT-An), exist, but have not been 
widely adopted in the care of transfusion dependent patients with MDS9. Therefore, the 
development of a reliable composite decision support tool that includes objective 
measurements of patient activity, hemoglobin levels, and PRO to guide RBC transfusion 
practices in patients with MDS would represent a significant advancement.  
1.2 
Rationale for the Proposed Study 
Wearable activity trackers, such as Fitbit, Apple Watch, and Garmin, have gained 
mainstream popularity and are capable of collecting physiologic data like step count and 
heart rate. Incorporating activity tracker data into oncology clinical trials has been shown 
to be feasible (measured by device compliance), well tolerated (based on patient survey 
data), and effective in providing detailed information about patient activity patients with 
breast, prostate, or endometrial cancer 10-13. However, published studies of activity 
tracker monitoring in MDS patients are lacking. 

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The primary objective of this pilot study is to test the feasibility and acceptability of using 
a wearable activity tracker to monitor transfusion dependent MDS patients seen in the 
SKCC Leukemia/MDS clinic in Center City Philadelphia. In addition, we will generate 
preliminary data regarding daily step count, average daily resting heart rate, anemia 
related symptoms, and hemoglobin level.  The hypothesis of this study is that patients will 
be able to comply with device utilization and will find this technology to be an acceptable 
addition to their care.  Ultimately, our goal is to utilize activity tracker data, either alone or 
in combination with hemoglobin level and/or FACT-An score, to develop a more 
personalized approach for RBC transfusion in patients with MDS.   
 
1.3 
Potential Risks and Benefits 
1.3.1 
Potential Risks 
The potential risks associated with this study are minimal.   
1.3.2 
Benefits 
The benefits of this research study include the acquisition of knowledge about the 
feasibility of activity tracker use in MDS patients and the correlation between activity 
level and anemia. Participants will also benefit from the receipt of an activity tracker that 
they will be able to keep after the study concludes.  Although study participants cannot 
be guaranteed that they will further benefit from the study, the information gained may 
benefit cancer patients in the future. 
Study Objectives 
1.4 
Objectives 
1.4.1 
Primary 
• 
To assess the feasibility and patient acceptability of using a Fitbit to monitor daily 
step count and heart rate. 
1.4.2 
Secondary 
• 
To graph changes in daily step count, average daily resting heart rate, Fact-An 
score (assessed twice a week), and hemoglobin level. 
1.5 
Endpoints/Outcome Measures 
1.5.1 
Primary 
• Feasibility will be measured by accrual rate, compliance with the device (80% of 
the 90-day intervention time), and retention rate.  

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• Acceptability will be measured by a short survey and interview addressing 
participant satisfaction.   
1.5.2 
Secondary 
• Daily step count 
• Average daily resting heart rate 
• Fact-An score (assessed twice a week) 
• Hemoglobin level measured by CBC twice a week 
2 Study Design 
This is a single arm, prospective, observational pilot study that will collecting data on 
daily step count, heart rate, and anemia related symptoms. The study population will 
include RBC transfusion dependent MDS patients who are ambulatory and in the 
outpatient setting. Patients will be given a wearable activity monitor and instructed to 
wear it continuously for 90 days. Baseline FACT-An questionnaire will be obtained to 
assess anemia related symptom data. Patients will have their CBC checked two times 
weekly and a FACT-An questionnaire will be administered twice a week (either on paper 
or electronically, based on patient preference). Activity data will be automatically 
collected from the Fitbit and stored using a centralized data aggregation platform. We 
will aim to collect data on 21 patients, with an estimated enrollment period of 9 months. 
3 Study Enrollment and Withdrawal 
3.1 
Eligibility Criteria 
3.1.1 
Inclusion Criteria 
Individuals must meet all of the following inclusion criteria in order to be eligible to 
participate in the study: 
• Confirmed pathologic diagnosis of MDS  
• Requiring ≥2 blood transfusions in the past month if previously diagnosed or 
hemoglobin ≤8g/dL if newly diagnosed 
• Age ≥ 18 
• ECOG performance status of 0 to 2 
• Ambulatory (use of a walking aid, such as a cane or rollator, is acceptable) 
• Able to give informed consent 
• Willing to comply with all study procedures and available for the duration of the 
study 
• Able to read and/or understand English 

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• Have access to an iPhone 4S or later, iPad 3 generation or later, Android 5.0 or 
later, or Windows 10 device.  
• Have access to Bluetooth LE and internet connection for syncing.  
3.1.2 Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation 
in this study: 
• Uncontrolled illness including, but not limited to, symptomatic congestive heart 
failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social 
situations that would limit compliance with study requirements 
3.2 
Strategies for Recruitment and Retention 
Participants will be recruited from the Department of Medical Oncology- Jefferson 
Health.  Advertisements will not be used to recruit patients for this study other than the 
Jefferson website. Patients who meet eligibility criteria will be invited by their physician 
to participate in the study. The study will be discussed with the patient and the patient’s 
questions will be answered to the patient’s satisfaction. Patients will be asked to read 
and comment/ask questions about the study and then sign the informed consent form 
before any study procedures take place. 
3.3 
Participant Withdrawal 
3.3.1 
Reasons for Withdrawal 
Participants are free to withdraw from participation in the study at any time upon request 
or dropped from the trial at the discretion of the investigator. 
An investigator may terminate a study participant’s participation in the study if: 
• The subject withdraws consent. 
• Investigator’s decision to withdraw the subject. 
• Noncompliance with trial procedure requirements. 
• Administrative reasons 
• 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. 

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3.3.2 
Handling of Participant Withdrawals and Participant Discontinuation of 
Study Intervention 
Replacement of participants who withdraw or discontinue early in the study will be 
allowed. 
3.4 
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 funding sponsor. 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.  
4 Study Intervention 
4.1 
Study Product  
Fitbit Inspire HR 
4.2 
Study Product Description 
The Fitbit Inspire HR is a band based fitness tracker with a 0.8 inch monochrome, 
OLED, touchscreen display. The battery life is approximately 5 days. It has the following 
sensors: 3-axis accelerometer, optical heart rate monitor, vibration monitor. It includes 
inactivity alerts. Its dimensions are 1.5 inches x 0.6 inches. The Fitbit is not intended to 
be used as a medical device. 
The Fitbit Inspire HR syncs automatically an wirelessly to 200+ leading iOS, Android, 
and Windows 10 devices using Bluetooth LE wireless technology.  It syncs with iPhone 
4S and later, iPad 3 generation and later, Android 5.0 and later, and Windows 10 
devices. Syncing requires Bluetooth LE and internet connection.  
4.2.1 
Acquisition 
The study product will be acquired directly from the manufacturer.   
4.3 
Study Product Accountability 

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The study product will be distributed to patients who meet the inclusion/exclusion 
criteria after enrollment. Each participant will receive one wearable device that will be 
paired with a centralized data aggregation platform to automatically collect and store 
data. After completion of the study, participants will be able to keep the wearable device 
they used in the study. 
4.4 
Assessing Participant Compliance with Study Product Administration 
Compliance with the wearable device will be assessed at each outpatient visit and using 
the centralized data aggregation platform. 
4.5 
Concomitant Medications/Treatments 
There are no restrictions on concomitant medications/treatments. 
4.6 
Dietary Restrictions 
There are no dietary restrictions for participants during the trial. 
5 Study Schedule  
5.1 
Screening 
Screening Visit (can occur up to 28 days prior to enrollment or on the same day 
as enrollment) 
The scope of the study will be explained to the patient prior to any screening during the 
informed consent. Patients should be asked to sign and date a Notice of Privacy 
Practice research authorization/HIPAA form and an IRB-approved statement of 
informed consent that meets the requirements of the Code of Federal Regulations 
(Federal Register Vol. 46, No. 17, January 27, 1981, part 50). During the screening 
period, subject eligibility will be determined according to the inclusion and exclusion 
criteria. The following assessments will be performed during this time: 
• Review medical history to determine eligibility based on exclusion/inclusion 
criteria. 
• Obtain informed consent from the potential participant. 
• Perform medical examination needed to determine eligibility 
• Record any current medications 
• Assess ECOG performance status 

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5.2 
Enrollment/Baseline 
Enrollment/Baseline Visit  
• Obtain/verify consent from participant on study consent form 
• Verify inclusion/exclusion criteria 
• Obtain demographic information, medical history, medication history, and social 
history 
• Perform and record physical examination 
• Assess ECOG Performance Status 
• Provide patient with Fitbit Inspire HR wearable activity monitoring device with 
instruction on proper usage/operation. 
• Ensure proper pairing and functionality with centralized data aggregation platform 
• Assess baseline anemia-related symptoms using FACT-An questionnaire. 
• Check baseline CBC 
5.3 
Treatment Period 
Two times per week 
• Check CBC 
• Administer Fact-An  
Office visits per standard of care (to be determined by the patient’s physician) 
• Record results of physical examination, vital signs 
• Assess any new medications 
• Assess ECOG performance status 
• Record participant’s compliance with wearing Fitbit Inspire HR device 
5.4 
End of Treatment Study Procedures 
Final Study Visit (Day 90) 
• Record results of physical examination, vital signs 
• Assess ECOG performance status 

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• Record participant’s compliance with wearing Fitbit Inspire HR device 
• Provide final instructions to participant 
5.5 
Withdrawal Visit/Discontinuation of Therapy 
No end of study procedures will be required if a patient withdraws or participation is 
terminated early.  
6 Study Procedures and Evaluations 
6.1 
Study Procedures/Evaluations 
The patient’s medical history will be obtained from the patient and his/her medical 
records. A complete list of current prescription medications will be obtained. A complete 
physical examination including vital signs (blood pressure, heart rate, respiratory rate, 
pulse oximetry, temperature) will be assessed. A CBC to assess hemoglobin will be 
collected twice per week during the enrollment period.  The CBC can be collected at 
TJUH or any other laboratory (Quest, LabCorp, or others).  If the CBC is collected 
outside of TJUH, results will be obtained from the outside lab.  Office visits will be 
scheduled per standard of care practices at the treating physician’s discretion. The 
decision to transfuse blood will be made by the treating physician per standard of care 
practice.  A FACT-An questionnaire will be used to assess anemia related symptoms 
and quality of life twice a week. The Fact-An will be completed either on paper or 
electronically (based on participant preference). The Fitbit device will capture daily step 
count and heart rate and the information will be stored in a centralized data aggregation 
platform. 
6.2 
Laboratory Procedures/Evaluations 
6.2.1 
Clinical Laboratory Evaluations 
A CBC to assess hemoglobin will be collected twice per week during the enrollment 
period.  The CBC can be collected at TJUH or any other laboratory (Quest, LabCorp, or 
others).  If the CBC is collected outside of TJUH, results will be obtained from the 
outside lab either electronically or on paper.   
7 Evaluation of Safety 
7.1 
Specification of Safety Parameters 
7.1.1 
Unanticipated Problems 

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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. 
7.2 
Safety Reporting  
7.2.1 
Reporting to IRB 
7.2.1.1 Unanticipated Problems 
All incidents or events that meet criteria for unanticipated problems (UAPs) as defined in 
Section 7.1.1 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.  
 

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8 Study Oversight 
The study PI is responsible for the study oversight. The PI will 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.  
9 Statistical Considerations  
9.1 
Analysis Plans 
Primary Analysis: The first aim of this study is to assess the feasibility of activity 
monitoring. This will be defined as usage of the Fitbit device for at least 80% of the 90 
days under observation. The overall study period compliance rate along with a one-
sided exact 95% confidence interval will be estimated. The device will be considered to 
have acceptable feasibility if the lower bound of the CI is above 0.6 or, equivalently, if at 
least 17/21 (81%) of participants are compliant for at least 70% of the days under 
observation. 
Accrual rate and retention rate for the study will also be calculated. 
Quantitatively, participants will complete the Client Satisfaction Quesionnaire-8 item 
version (CSQ-8), a validated measure that elicits the client’s perspective on the value of 
services received32. Qualitatively, we will interview each participant at the end of their 90-
day participation to understand their perceived barriers and facilitators of using Fitbit in 
their daily activities and elicit their feedback to refine future study design. Interviews will 
be digitally audio-recorded and transcribed verbatim. Transcripts will be analyzed with a 
pre-defined code book to summarize participant’s experience and comments.   
Exploratory Analyses: Descriptive statistics will be used to outline patient 
characteristics and report Fact-An results.  We will plot daily step count, average daily 
resting heart rate, hemoglobin levels, and Fact-An scores. We will use multivariate 
analyses to identify relationships between these variables and to determine if pre-
transfusion step count and/or heart rate predict post-transfusion FACT-An results. 
9.2 
Sample Size Considerations 
A sample size of 21 patients provides 80% power to reject the null hypotheses that the 
true compliance rate is less than or equal to 60% using a one-sided exact binomial tests 
of size 0.05 assuming the true rate is 85% or greater. 
10 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 

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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.  

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11 Quality Control and Quality Assurance 
Data obtained regarding activity level and compliance of study participants as measured 
by the wearable device stored in our central data aggregation platform will be correlated 
with hemoglobin level and FACT-An questionnaire results.  Documents to be reviewed 
to obtain this data include clinic notes, FACT-An questionnaire results, CBC results, and 
activity logs from our central data platform on a weekly basis by members of 
investigational team. Data will be evaluated in compliance with our protocol. Quality 
assurance and quality control issues will be addressed by the principal investigator.  
12 Ethics/Protection of Human Participants  
12.1 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.  
12.2 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.  
12.3 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. A consent form describing in detail the study 
procedures and risks will be given to the participant. Consent forms will be IRB-
approved, and the participant is required to read and review the document or have the 
document read to him or her. The investigator or designee will explain the research 
study to the participant and answer any questions that may arise. The participant will 
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 given to participants for their records. The rights and welfare of the 

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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 clinical or research record.  
12.4 Exclusion of Women, Minorities, and Children (Special Populations) 
Individuals must be ≥ 18 years of age to participate in the study. Individuals of any 
gender or racial/ethnic group may participate. 
12.5 Participant Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to any study information relating to participants. 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
The study monitor or other authorized representatives of the sponsor may inspect all 
study documents and records required to be maintained by the investigator, including 
but not limited to, medical records (office, clinic, or hospital) for the study participants. 
The clinical study site will permit access to such records. 
13 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 
adequate case histories of study participants, and source documentation. 
13.1 Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the investigator. All source documents and laboratory reports 
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 investigator or designee.  
The study protocol, documentation, data, and all other information generated will be held 
in strict confidence. No information concerning the study or the data will be released to 
any unauthorized third party without prior written approval of the sponsor. 

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Each participant will be assigned a unique identification number (ID) and this ID number 
will be the only identifying information on data form. A list linking ID numbers to names 
will be kept in a password-protected computer file accessible only to project staff. 
13.2 Data Capture Methods 
Data will be captured in multiple forms. Daily step count, compliance, and heart rate will 
be collected in an electronic format in a centralized data aggregation platform that is 
password protected. Data on hemoglobin and medical history will be collected from the 
electronic or paper medical record and transferred to an electronic database that is 
password protected. FACT-An questionnaire results will be obtained verbally via 
telephone and entered directly into the RedCap database. All data will be collected in an 
ongoing manner during the duration of the study. 
13.3 Types of Data 
Types of data that will be collected include: laboratory (hemoglobin), transfusion date, 
number of units of blood transfused, outcome measure data (FACT-An questionnaire, 
daily step count, average daily resting heart rate, and compliance with wearable 
device). Reports to monitor enrollment will occur on an ongoing biweekly basis by the 
study team. Plans for data analysis and interim and final study reports will occur 
immediately after completion of data collection. 
13.4 Study Records Retention 
Study documents will be retained for a minimum of 2 years.  These documents should 
be retained for a longer period, however, if required by local regulations. 
13.5 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.  
14 Study Finances 
14.1 Funding Source 
This study will be financed through the sponsorship of the Sidney Kimmel Cancer 
Center of TJUH. 

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14.2 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). 
14.3 Participant Stipends or Payments 
Participants will be able to keep the Fitbit wearable device they used for the study after 
completion of observation. They will also receive $40 via ClinCard as incentive for 
completing surveys. 
15 Publication and Data Sharing Policy 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a clinical trials registration policy as a condition for publication. The ICMJE 
defines a clinical trial as any research project that prospectively assigns human 
participants to intervention or concurrent comparison or control groups to study the 
cause-and-effect relationship between a medical intervention and a health outcome. 
Medical interventions include drugs, surgical procedures, devices, behavioral 
treatments, process-of-care changes, and the like. Health outcomes include any 
biomedical or health-related measures obtained in patients or participants, including 
pharmacokinetic measures and adverse events. The ICMJE policy requires that all 
clinical trials be registered in a public trials registry such as ClinicalTrials.gov, which is 
sponsored by the National Library of Medicine. Other biomedical journals are 
considering adopting similar policies. The ICMJE does not review specific studies to 
determine whether registration is necessary; instead, the committee recommends that 
researchers who have questions about the need to register err on the side of 
registration or consult the editorial office of the journal in which they wish to publish. 
U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or 
FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or 
designated principal investigator) register and report results of certain "applicable 
clinical trials."  

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16 Literature References 
 
 
1. 
Cogle CR: Incidence and Burden of the Myelodysplastic Syndromes. 
Current hematologic malignancy reports 10:272-281, 2015 
 
2. 
Mo A, McQuilten ZK, Wood EM, et al: Red cell transfusion thresholds in myelodysplastic 
syndromes: a clinician survey to inform future clinical trials. Internal Medicine Journal 47:695-698, 2017 
 
3. 
Platzbecker U, Hofbauer LC, Ehninger G, et al: The clinical, quality of life, and economic 
consequences of chronic anemia and transfusion support in patients with myelodysplastic syndromes. 
Leukemia Research 36:525-536, 2012 
 
4. 
Koutsavlis I: Transfusion Thresholds, Quality of Life, and Current Approaches in 
Myelodysplastic Syndromes. Anemia 2016:8494738-8494738, 2016 
 
5. 
J. PD, J. SS, Carolyn D, et al: Quality of life and use of red cell transfusion in patients with 
myelodysplastic syndromes. A systematic review. American Journal of Hematology 84:671-677, 2009 
 
6. 
Frytak JR, Henk HJ, De Castro CM, et al: Estimation of economic costs associated with 
transfusion dependence in adults with MDS. Current Medical Research and Opinion 25:1941-1951, 2009 
 
7. 
DeZern AE, Binder G, Rizvi S, et al: Patterns of treatment and costs associated with 
transfusion burden in patients with myelodysplastic syndromes. Leukemia & Lymphoma 58:2649-2656, 
2017 
 
8. 
Goldberg SL, Chen E, Sasane M, et al: Economic impact on US Medicare of a new 
diagnosis of myelodysplastic syndromes and the incremental costs associated with blood transfusion 
need. Transfusion 52:2131-2138, 2012 
 
9. 
Brandenburg NA, Yu R, Revicki DA: Reliability and Validity of the FACT-AN In Patients 
with Low or Int-1-Risk Myelodysplastic Syndromes with Deletion 5q. Blood 116:3827-3827, 2010 
 
10. 
Bennett AV, Reeve BB, Basch EM, et al: Evaluation of pedometry as a patient-centered 
outcome in patients undergoing hematopoietic cell transplant (HCT): a comparison of pedometry and 
patient reports of symptoms, health, and quality of life. Quality of Life Research 25:535-546, 2016 
 
11. 
Van Blarigan EL, Kenfield SA, Tantum L, et al: The Fitbit One Physical Activity Tracker in 
Men With Prostate Cancer: Validation Study. JMIR cancer 3:e5-e5, 2017 
 
12. 
Hartman SJ, Nelson SH, Weiner LS: Patterns of Fitbit Use and Activity Levels Throughout 
a Physical Activity Intervention: Exploratory Analysis from a Randomized Controlled Trial. JMIR mHealth 
and uHealth 6:e29-e29, 2018 
 
13. 
Rossi A, Frechette L, Miller D, et al: Acceptability and feasibility of a Fitbit physical 
activity monitor for endometrial cancer survivors. Gynecologic Oncology 149:470-475, 2018 
 
14. 
Fenaux P, Haase D, Sanz GF, et al: Myelodysplastic syndromes: ESMO Clinical Practice 
Guidelines for diagnosis, treatment and follow-up†. Annals of Oncology 25:iii57-iii69, 2014 
 
15. 
Gupta P, LeRoy SC, Luikart SD, et al: Long-term blood product transfusion support for 
patients with myelodysplastic syndromes (MDS): cost analysis and complications. Leukemia Research 
23:953-959, 1999 
 
16. 
National Comprehensive Cancer Network, MDS (Version 2.2019) 
 
17. 
de Swart L, Smith A, Fenaux P, et al: Transfusion-Dependency Is the Most Important 
Prognostic Factor for Survival in 1000 Newly Diagnosed MDS Patients with Low- and Intermediate-1 Risk 
MDS in the European LeukemiaNet MDS Registry. Blood 118:2775-2775, 2011 
 
18. 
Harnan S, Ren S, Gomersall T, et al: Association between Transfusion Status and Overall 
Survival in Patients with Myelodysplastic Syndromes: A Systematic Literature Review and Meta-Analysis. 
Acta Haematologica 136:23-42, 2016 
 
19. 
Bryant AL, Drier SW, Lee S, et al: A systematic review of patient reported outcomes in 
phase II or III clinical trials of myelodysplastic syndromes and acute myeloid leukemia. Leukemia 
Research 70:106-116, 2018 

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20. 
Minton O, Stone P: A systematic review of the scales used for the measurement of 
cancer-related fatigue (CRF). Annals of Oncology 20:17-25, 2009 
 
21. 
Purswani JM, Ohri N, Champ C: Tracking steps in oncology: the time is now. Cancer 
management and research 10:2439-2447, 2018 
 
22. 
Datta SS, Ghosal N, Daruvala R, et al: How do clinicians rate patient's performance status 
using the ECOG performance scale? A mixed-methods exploration of variability in decision-making in 
oncology. Ecancermedicalscience 13:913-913, 2019 
 
23. 
Basch E: Patient-Reported Outcomes — Harnessing Patients’ Voices to Improve Clinical 
Care. New England Journal of Medicine 376:105-108, 2017 
 
24. 
Basch E, Deal AM, Dueck AC, et al: Overall survival results of a trial assessing patient-
reported outcomes for symptom monitoring during routine cancer treatment. JAMA 318:197-198, 2017 
 
25. 
Champ CE, Ohri N, Klement RJ, et al: Assessing Changes in the Activity Levels of Breast 
Cancer Patients During Radiation Therapy. Clinical Breast Cancer 18:e1-e6, 2018 
 
26. 
Dorion V, Lambert L, Frazzi A, et al: A Pilot Study in the Use of Activity Trackers for 
Assessing Response to Palliative Radiotherapy. Cureus 9:e1871-e1871, 2017 
 
27. 
Ohri N, Kabarriti R, Bodner WR, et al: Continuous Activity Monitoring During Concurrent 
Chemoradiotherapy. International journal of radiation oncology, biology, physics 97:1061-1065, 2017 
 
28. 
Hooke MC, Gilchrist L, Tanner L, et al: Use of a Fitness Tracker to Promote Physical 
Activity in Children With Acute Lymphoblastic Leukemia. Pediatric Blood & Cancer 63:684-689, 2016 
 
29. 
Rosenberg D, Kadokura EA, Bouldin ED, et al: Acceptability of Fitbit for physical activity 
tracking within clinical care among men with prostate cancer. AMIA ... Annual Symposium proceedings. 
AMIA Symposium 2016:1050-1059, 2017 
 
30. 
Hacker ED, Peters T, Patel P, et al: Steps to Enhance Early Recovery After Hematopoietic 
Stem Cell Transplantation: Lessons Learned From a Physical Activity Feasibility Study. Clinical Nurse 
Specialist 32:152-162, 2018 
 
31. 
Beg MS, Gupta A, Stewart T, et al: Promise of Wearable Physical Activity Monitors in 
Oncology Practice. Journal of Oncology Practice 13:82-89, 2017 
 
32. 
Attkisson CC, Greenfield T: The Client Satisfaction Questionnaire (CSQ) scales. Outcome 
assessment in clinical practice. Baltimore, MD: Williams & Wilkins:2-10, 1995 
 
 
 
 
 
 
 
 
 
 
 

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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 
 
 
 

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APPENDIX A: SCHEDULE OF EVENTS 
 
Procedures 
Screening2  
Enrollment/Baseline 
(Day 1) 
Subsequent Office Visits 
Twice a Week During 
Study Period3 
Study Completion 
Informed Consent 
X 
 
 
 
 
Assessment of Eligibility Criteria 
X 
X 
X 
 
 
Review of Medical History 
X 
X 
X 
 
X 
Review of Medications  
X 
X 
X 
 
X 
Document ECOG Performance Status 
X 
X 
 
 
X 
Administer Fact-An Questionnaire4 
 
X 
 
X 
 
Physical 
Examination 
Complete 
X 
 
 
 
 
Symptom-Directed 
 
X 
 
 
X 
Vital Signs 
 
X 
 
 
X 
Labs 
Hematology1 
X 
X 
 
X 
 
 
1. CBC or CBC with differential 
2. Screening may occur within the 28 days prior to enrollment or concurrently with the 
enrollment visit. 
3. CBC and Fact-An do not have to be completed on the same days 
4. Administered via telephone by study personnel 
 
 
 
 
 

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APPENDIX B: FACT-An Questionnaire 
Below is a list of statements that other people with your illness have said are important. Please 
circle or mark one number per line to indicate your response as it applies to the past 7 
days. 
 
 
PHYSICAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
GP1 
I have a lack of energy 
 
0 
1 
2 
3 
4 
GP2 
I have nausea  
0 
1 
2 
3 
4 
GP3 
Because of my physical condition, I have trouble meeting 
the needs of my family 
 
 
0 
 
1 
 
2 
 
3 
 
4 
GP4 
I have pain 
 
0 
1 
2 
3 
4 
GP5 
I am bothered by side effects of treatment 
 
0 
1 
2 
3 
4 
GP6 
I feel ill  
0 
1 
2 
3 
4 
GP7 
I am forced to spend time in bed 
 
0 
1 
2 
3 
4 
 
 
SOCIAL/FAMILY WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
GS1 
I feel close to my friends 
 
0 
1 
2 
3 
4 
GS2 
I get emotional support from my family 
 
0 
1 
2 
3 
4 
GS3 
I get support from my friends  
0 
1 
2 
3 
4 
GS4 
My family has accepted my illness 
 
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication about my illness
 
 
 
0 
 
1 
 
2 
 
3 
 
4 
GS6 
I feel close to my partner (or the person who is my main 
support) 
 
 
0 
 
1 
 
2 
 
3 
 
4 
Q1 
Regardless of your current level of sexual activity, please 
answer the following question. If you prefer not to answer 
it, please mark this box           and go to the next section. 
 
 
 
 
 
GS7 
I am satisfied with my sex life  
0 
1 
2 
3 
4 

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Please circle or mark one number per line to indicate your response as it applies to the 
past 7 days. 
 
EMOTIONAL WELL-BEING 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
GE1 
I feel sad 
 
0 
1 
2 
3 
4 
GE2 
I am satisfied with how I am coping with my illness  
0 
1 
2 
3 
4 
GE3 
I am losing hope in the fight against my illness 
 
0 
1 
2 
3 
4 
GE4 
I feel nervous  
0 
1 
2 
3 
4 
GE5 
I worry about dying 
 
0 
1 
2 
3 
4 
GE6 
I worry that my condition will get worse 
 
0 
1 
2 
3 
4 
 
 
FUNCTIONAL WELL-BEING 
 
Not 
at 
all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
 
GF1 
I am able to work (include work at home) 
 
0 
1 
2 
3 
4 
GF2 
My work (include work at home) is fulfilling  
0 
1 
2 
3 
4 
GF3 
I am able to enjoy life  
0 
1 
2 
3 
4 
GF4 
I have accepted my illness 
 
0 
1 
2 
3 
4 
GF5 
I am sleeping well 
 
0 
1 
2 
3 
4 
GF6 
I am enjoying the things I usually do for fun  
0 
1 
2 
3 
4 
GF7 
I am content with the quality of my life right now 
 
0 
1 
2 
3 
4 
 
 
 

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Please circle or mark one number per line to indicate your response as it applies to the 
past 7 days. 
 
ADDITIONAL CONCERNS 
 
Not 
at all 
A little 
bit 
Som
e-
what
Quite 
a bit 
Very 
much 
HI7 
I feel fatigued  
0 
1 
2 
3 
4 
HI12 
I feel weak all over 
 
0 
1 
2 
3 
4 
An1 
I feel listless (“washed out”)  
0 
1 
2 
3 
4 
An2 
I feel tired 
 
0 
1 
2 
3 
4 
An3 
I have trouble starting things because I am tired 
 
0 
1 
2 
3 
4 
An4 
I have trouble finishing things because I am tired 
 
0 
1 
2 
3 
4 
An5 
I have energy  
0 
1 
2 
3 
4 
An6 
I have trouble walking  
0 
1 
2 
3 
4 
An7 
I am able to do my usual activities 
 
0 
1 
2 
3 
4 
An8 
I need to sleep during the day 
 
0 
1 
2 
3 
4 
An9 
I feel lightheaded (dizzy) 
 
0 
1 
2 
3 
4 
An10 
I get headaches 
 
0 
1 
2 
3 
4 
B1 
I have been short of breath 
 
 
0 
1 
2 
3 
4 
An11 
I have pain in my chest 
 
0 
1 
2 
3 
4 
An12 
I am too tired to eat 
 
0 
1 
2 
3 
4 
BL4 
I am interested in sex  
0 
1 
2 
3 
4 
An13 
I am motivated to do my usual activities 
 
0 
1 
2 
3 
4 
An14 
I need help doing my usual activities  
0 
1 
2 
3 
4 
An15 
I am frustrated by being too tired to do the things I want to 
do 
 
 
0 
 
1 
 
2 
 
3 
 
4 
An16 
I have to limit my social activity because I am tired  
0 
1 
2 
3 
4