Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients
Phase: NA
Conditions: Lung Cancer, Cholangiocarcinoma, Pancreatic Cancer, Liver Cancer
Sponsor: Hackensack Meridian Health

 
Hackensack Meridian Integrative Health & Medicine 
 
“The human body has been designed to resist an infinite number of changes and attacks 
brought about by its environment. The secret of good health lies in successful  
adjustment to changing stresses on the body.” 
– Harry J. Johnson 
 
Title of study:  Personal Resilience Empowerment Program (PREP) in the perioperative setting of 
surgically treated cancer patients  
PI:  
Ronald Matteotti, MD 
Sub-Is:  Thomas L Bauer, MD  
Marie Feiter, BSN, RN, Hospital & Care Transformation Integration Manager 
Lori Knutson, BSN, RN, HNB-BC, Corporate Administrative Director  
David C Leopold, MD 
Jessica DiNapoli, PA-C 
Jillian Cassidy, PA-C 
Sarina Molinari, PA-C 
Sara Scheller, BSN, RN, CPN, CCRN, NBC-HWC Integrative Health Coach 
Marjorie Catone, BSN, RN, CCRN- CSC, Integrative Health Coach 
Kathleen Welshman, RN-BC, BA, NBC-HWC Integrative Health Coach 
 
Protocol Development and Support:  
Elli Gourna Paleoudis, PhD  
 
 
 
 
 
Patricia Greenberg, MS, Biostatistician   
 
 
 
 
 
 
Version:  June 19, 2018 
 

2 
 
Table of Contents 
1. 
Introduction to the Personal Resilience Empowerment Program (PREP) at Hackensack Meridian 
Integrative Health & Medicine ...................................................................................................................... 4 
2. 
Introduction to the PREP project .......................................................................................................... 4 
3. 
Study Purpose and Objectives .............................................................................................................. 5 
3.1. 
Purpose of the study ..................................................................................................................... 5 
3.2. 
Primary and Secondary objectives ................................................................................................ 5 
3.3 Primary and Secondary Endpoints ...................................................................................................... 5 
4. 
Study Participants ................................................................................................................................. 6 
4.1. 
Study population ........................................................................................................................... 6 
4.2. 
Number of participants ................................................................................................................. 6 
4.3. 
Selection Criteria ........................................................................................................................... 6 
5. 
Study Design.......................................................................................................................................... 7 
5.1. 
Study Overview ............................................................................................................................. 7 
5.2. 
Study Duration .............................................................................................................................. 8 
5.3. 
Study Sites ..................................................................................................................................... 8 
5.4. 
Study visits / sessions .................................................................................................................... 8 
5.4.1. 
Research Eligibility ................................................................................................................ 8 
5.4.2. 
First session ........................................................................................................................... 9 
5.4.3. 
Second session ...................................................................................................................... 9 
5.4.4. 
Third session ....................................................................................................................... 10 
5.4.5. 
Fourth session ..................................................................................................................... 10 
5.4.5. 
Fifth session ........................................................................................................................ 10 
5.4.6. 
Follow-up ............................................................................................................................ 10 
6. 
Methods .............................................................................................................................................. 11 
6.1. 
Survey .......................................................................................................................................... 11 
6.1.1. 
Survey Construction ............................................................................................................ 11 
6.1.2. 
Survey Administration ......................................................................................................... 11 
6.2. 
Statistical Design ......................................................................................................................... 11 
6.2.1 Sample Size ................................................................................................................................ 11 
6.2.2 Planned Analyses ....................................................................................................................... 11 
6.2.3 Data Relevance .......................................................................................................................... 12 
6.2.4 Data Coding ................................................................................................................................ 12 

3 
 
6.2.5 Data Analysis Tools .................................................................................................................... 13 
7. 
Ethical Considerations ......................................................................................................................... 14 
7.1. 
Institutional Review Board (IRB) Review .................................................................................... 14 
7.2. 
Data Management ...................................................................................................................... 14 
7.3. 
Informed consent ........................................................................................................................ 14 
7.4. 
Confidentiality ............................................................................................................................. 14 
Appendix 1 – ECOG Performance Status .................................................................................................... 16 
Appendix 2 – Handout and Script for Session No 2 .................................................................................... 17 
Appendix 3 – Script for Session No 3 .......................................................................................................... 20 
Appendix 4 – Script for Session No 4 .......................................................................................................... 22 
Appendix 5 – Script for Session No 5 .......................................................................................................... 24 
 
 
 

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1. Introduction to the Personal Resilience Empowerment Program 
(PREP) at Hackensack Meridian Integrative Health & Medicine  
 
The Personal Resilience Empowerment Program (PREP) at Hackensack Meridian Integrative Health & 
Medicine is designed to assist patients in preparing for a planned hospital admission for a surgery or 
procedure. The program offers classes  and personal sessions where the patient, with the  support of an 
Integrative Health Coach (Registered Nurse), is introduced to new life skills that will help him or her 
during their hospital experience and beyond in everyday life.  
Using evidence-based tools derived from our Five Pillars of Health & Well-Being (Sleep, Activity, 
Purpose, Nutrition, and Resilience), the patient learns how to:  
■ Acquire mind-body skills to assist in stress management 
■ Learn to thrive by building resilience  
■ Feel empowered to manage their own health 
■ Gain self-care skills to decrease anxiety, pain, and nausea naturally 
■ Control the stress response and trigger the relaxation response to promote well-being 
■ Discover what foods fuel the body in preparation for healing, during recovery, and overall health 
The goal is for the patient to leave the coaching sessions feeling empowered to use new tools to elicit 
the relaxation response or build on resiliency practices they may already use.  
The program is led by integrative health coaches/registered nurses who will help to facilitate and 
motivate the patient to make positive choices for overall health and wellness. They educate and support 
group members to achieve their goals through lifestyle and behavior adjustments. Health coaching 
brings together several disciplines including sleep, activity, purpose, nutrition, resilience. There is no 
cost for the class. 
2. Introduction to the PREP project 
 
The PREP at Hackensack Meridian Integrative Health & Medicine was designed in Legacy Meridian to 
assist all selected patients with upcoming hospitalization. For the “Personal Resilience Empowerment 
Program (PREP) in the perioperative setting of surgically treated cancer patients”, hereafter “the Project 
or PREP”, the Hackensack Meridian Integrative Health & Medicine is designing a new pilot program to 
focus on the needs of oncology patients.   
All patients diagnosed with cancer that will undergo a scheduled surgical (Hepato-Biliary, and Thoracic) 
procedure in Hackensack Meridian Health and specifically in the Jersey Shore University Medical Center, 
will be eligible to participate (for more details please see eligibility criteria, section 4).  
Overall, this pilot project will include 5 coaching sessions and an introductory session/visit that will take 
place on the physician’s office. The initial  physician visit will focus on patient eligibility, introduction to 

5 
 
the Project, informed consent and a pre-intervention survey and will be conducted by  the principal 
investigator or one of the sub-investigators listed above. The following 5 sessions will be conducted by 
one of the integrative health coaches/registered nurses (for details please see section 5). A post-
intervention survey will be completed during the final session and repeated at one month, and at 3 
months from the final session.  
The goal of this project is to investigate whether using the PREP as an intervention in patients diagnosed 
with cancer would result in improving various metrics including improvements to resilience, sleep, 
activity, purpose, nutrition, empowerment to manage one’s own health and well-being, decrease in pain 
medication use and more rapid return to previous functional status according to Eastern Cooperative 
Oncology Group (ECOG).  
3. Study Purpose and Objectives 
 
3.1. 
Purpose of the study   
This is a pilot study designed to assess the effectiveness of the Personal Resilience Empowerment 
Program (PREP) in supporting surgical oncology patients before, during and after their hospitalization.  
 
3.2. 
Primary objectives  
The primary objective of this project is to determine if an increase in knowledge and awareness through 
coaching sessions improves quality of life by empowering the person to manage one’s own health in the 
application of skills related to our 5 pillars of Health and Wellbeing. (sleep, activity, purpose, nutrition, 
resilience) in oncology patients. 
 
3.3. 
Primary and Secondary Endpoints   
Measurements of health related quality of life, sleep, activity, purpose, nutrition, resilience and  
empowerment to manage one’s own health and well-being  at 1 month and 3 months from final session. 
Also pain, use of pain medication and return to work-more rapid return to previous pre-operative 
functional status according to ECOG.  In addition, record the number of times (if any) that nurse coaches 
are called for support outside of the protocol.   
 
 
 

6 
 
4. Study Participants  
 
4.1. 
Study population 
All patients who will undergo a scheduled surgical, thoracic (lung), hepato-biliary (cholangiocarcinoma, 
pancreatic, liver) procedure in Hackensack Meridian Health at Jersey Shore University Medical Center 
that meet the inclusion criteria will be invited to participate in this project. 
Initial contact with potential participants will take place at each surgeon’s office and every surgeon 
listed as investigator/sub-investigator in this protocol will present the study to his/her patients and will 
consent them.  
 
4.2. 
Number of participants 
This project is a pilot to assess the effectiveness of the PREP to support oncology patients before, during 
and after their hospitalization  
Five to six new patients are seen on a weekly basis in the physician practices. We plan to run this project 
for 3 months, therefore taking into consideration patients’ willingness to participate and complete all 
sessions and the number of potential losses during follow-up, we estimate that we will include 30-40 
patients but no more than 50 patients.  
4.3. 
Selection Criteria  
Inclusion Criteria 
1. 18 years of age and older 
2. Patients diagnosed with cancer of the thoracic (lung), hepatobiliary system 
(cholangiocarcinoma, pancreatic, liver)   that will undergo a scheduled surgical procedure at 
Jersey Shore University Medical Center.  
3. Able to understand and sign the informed consent form  
4. Willingness to participate in the study and comply with protocol requirements 
Exclusion Criteria 
1. < 18 years of age  
2. Unable to provide consent 
3. Unable to participate at the discretion of the PI based on the ECOG survey (if ECOG >1). See 
section 5 and appendix 1 for details.   
4. Non- English speaking patients1.   
5. Opioid use for non-malignant pain for greater than 7 days 6 Terminal or Stage 4 cancer. 
                                                          
1 Participants will be limited to English-Speaking patients only for this pilot phase as current resources do not allow 
the support of foreign speaking patients.  

7 
 
5. Study Design  
5.1. 
Study Overview 
This is a pilot study designed to assess the effectiveness of the PREP in supporting surgical oncology 
patients before, during, and after their hospitalization.   
The project includes 5 sessions with a RN Health Coach. The overview of the study is summarized in 
table 1 below. The initial pre-operative physician visit will focus on patient eligibility, introduction to the 
Project, informed consent and a pre-intervention survey and will be conducted by oncology surgeon or 
physician assistant. The remaining sessions will be conducted by one of the integrative health 
coaches/registered nurses. A post-intervention survey will be completed during the final session.  
In addition to the basic demographics being collected, the following clinical information will also be 
collected for every patient across multiple time points: AJCC cancer stage, occurrence of chronic pain (if 
applicable), pain level (using a scale 0-10), pain medication usage (yes/ no), pain medication type used 
(prescription or over the counter), and pain medication dosage and frequency for each pain medicine 
listed (where applicable).  
The goal of this project is to investigate whether using the PREP as an intervention in patients diagnosed 
with cancer would result in improving various metrics including improvements to health related quality 
of life, sleep, activity, purpose, nutrition, resilience, and empowerment to manage one’s own health and 
well-being, decrease in pain medication use and more rapid return to previous functional status. 
For details about each session and what will be covered please see below (section 5.4.).  
For details on the study timeline, please see below.  
Table 1: Study schedule  
Study-
related 
activity  
# of 
session  
Type of session 
Procedure 
Timeline  
1 
- 
Eligibility visit  
Initial pre-operative visit at surgeon’s office to 
include: determination of patient eligibility, 
introduction into the study, informed consent, pre-
intervention survey 
Prior to surgery  
 
Pre-intervention survey  
2 
1 
In-person 
coaching 
Group PREP coaching class   
Introduction to 5 pillars of health & well-being 
 
Prior to surgery 
3 
2 
Over the phone 
coaching 
Review of the Basic Pillars and validating learned 
skills from group session.  
 
Within one week of visit #1.  
 
Scheduled surgical procedure  
4 
3 
In-person 
coaching 
Review of all the skills, focus on skills for support 
during the hospital stay.  
Within one week after surgery 
5 
4 
Over the phone 
coaching 
Follow-up after the surgery  reinforcing the new life-
skills   
Within one week from discharge  
6 
5 
In-person 
coaching 
Review of the skills, coaching for integration into 
everyday life.  
Within two weeks from discharge 
at post-operative visit 
 
Post-intervention survey 
7 
- 
Survey  
Follow-up survey (hard copy) 
One month after the surgery  
8 
- 
Survey  
 
Follow-up survey (hard copy) 
3 months after the surgery  

8 
 
5.2. 
Study Duration 
The expected study duration is three months. After informed consent, participants will fill out the pre-
intervention survey and   then they will attend five coaching sessions either in person or over the phone. 
Participants will fill the post-intervention survey during their last session. Two follow-up surveys will be 
sent to enrolled participants one month and three months after the last session.  
5.3. 
Study Sites 
This project will take place in:  
- 
Jersey Shore University Medical Center, 1945 Route 33, Neptune, NJ 07753 
- 
Riverview Medical Center, 1 Riverview Plaza, Red Bank, NJ 07701 
- 
Medical Arts Building , 1944 Route 33, , Neptune, NJ 07753 
- 
Integrative Health & Medicine, 16 Spring Street, Red Bank, NJ 07701 
 
5.4. 
Study visits / sessions  
As described earlier, this project will include one initial visit focusing on patient eligibility, study 
presentation and informed consent followed by 5 coaching sessions that will take place either in-person 
or over the phone.  
The initial visit will be conducted by one of the oncology surgeons listed as investigators in this protocol, 
while the coaching sessions will be conducted by one of the Nurse Health Coaches from Integrative 
Health & Medicine.  
Attendance and the duration of each session will be recorded in a Word document.  
5.4.1. Research Eligibility  
The research eligibility will take place in the office of each one of the surgeons listed in this protocol. 
Following consent based on research eligibility, all participants will complete the pre-intervention 
survey.  
More specifically, the surgeon will present the study using the script presented below.  
The Personal Resilience Empowerment Program (PREP) will assist you in preparing for your 
upcoming hospital admission. You will learn and practice skills that you can use beyond your 
surgery or procedure in your everyday life. We look at this health event as an opportunity to 
examine your lifestyle choices and build your awareness of the mind/body connection so you can 
become empowered to manage your own health. You will be contacted by telephone by a 
Registered Nurse (RN) health coach to schedule an in-person group coaching and telephone 
coaching session within one week of this consent. During the group session, you will be introduced 
to our five pillars of health and well-being: sleep, activity, purpose, nutrition and resilience. 
Following the group session and prior to your surgery, you will have a phone call with the nurse 
health coach. In this phone call, the RN health coach will reinforce our five pillars of health and 
well-being and discuss how you and the coach will partner throughout this process. In total, you 
will meet with the nurse health coach five times-first during a group coaching class, and then 
session 2 will be a phone coaching session within one week prior to your surgical admission, 
session 3 will be in person hospital coaching session, session 4 will be a phone coaching session 
within one week of discharge and the fifth session will be in person at your post-operative hospital 
visit . Our goal is to assist you in developing resilience skills that can help you bounce back and 

9 
 
assist you in managing stress, reducing potential pain and empowering you to improve your 
quality of life. 
Patients that are interested in taking part in the study will be then consented by the surgeon or another 
member of the study team and will be notified of the study procedures (upcoming 5 sessions). They will 
be asked to provide their contact details including their email and a contact number.  
To facilitate the information and engagement process, the surgeon will also provide enrolled patients 
with the “The Personal Resilience Empowerment Program (PREP) flyer”. 
At the end of the information process, the surgeon will notify patient that the Registered Nurse - Health 
Coach will contact them to schedule the initial group session within one week and telephone session to 
be completed prior to surgery. 
Finally, patients will be asked to fill the pre-intervention survey at the end of the session. Participants 
will be provided with hardcopies of the surveys and data collected will then be transferred to a database 
created specifically for this project in Excel.  
After the end of the research eligibility visit, the nurse coach will receive a spreadsheet of patients 
enrolled in the study by the physician office following consent  
5.4.2. First session 
The first session is a group coaching class prior to surgery. After an overall presentation of the program, 
the class will focus on introducing the 5 pillars of health and well-being: sleep, activity, purpose, 
nutrition and resilience. Several handouts will be provided for patients to take home and use between 
sessions. All handouts and the PowerPoint presentation for this session will be submitted to the IRB for 
approval.  
This is a 90 minute class held at Jersey Shore University Medical Center. During the group PREP class, 
participants will learn how to acquire mind-body skills to assist in stress management, learn to thrive by 
building resilience, feel empowered to manage their health, gain self-care skills to decrease anxiety, pain 
and nausea naturally, control the stress response and trigger the relaxation response to promote well-
being and discover what foods fuel the body in preparation for healing, during recovery and overall 
health. 
5.4.3. Second session 
The second session will take place over the phone.  
During the second session, the nurse coach after a quick overview of the group session will focus on the 
coaching needs of the patient at that time. The coach will address the readiness to change and will 
reinforce the skills taught in the group class. 
To facilitate the discussion and ensure consistency across patients, the nurse coach will use a script (see 
appendix 2).  
The call is expected to last approximately 30 minutes (but not more than 60 minutes). The total time of 
the session will be documented and recorded in the patient’s research file.  The nurse health coach will 
complete a health coach consult note in research file.  

10 
 
5.4.4. Third session 
The third session will be an in-person hospital visit with the nurse health coach and will occur 3-5 days 
following the surgical procedure. The session will last 15-30 minutes (but not more than 60 minutes).  
During the session, the nurse coach will re-introduce the skills and he/she will practice those skills with 
the patient. To facilitate the discussion and ensure consistency across patients, the nurse coach will use 
a script (see appendix 3). The nurse health coach will encourage and empower the patient to use these 
skills throughout the remainder of the stay and beyond. Coach will offer additional support as 
appropriate.  
In the end of the session, the nurse will remind the patient that they will receive a telephone call after 
discharge to schedule the fourth session over the phone. The patient will also be offered the 
opportunity to call the nurse-coach if they feel like they need additional support at any time throughout 
this program.  
5.4.5. Fourth session 
The health coach will be notified of the patients discharge date from the surgeon’s office and the health 
coach will contact the patient to schedule a telephone coaching session within one week of the 
discharge. To facilitate the discussion and ensure consistency across patients, the nurse coach will use a 
script (see appendix 4).  
The fourth session will be over the phone and will last approximately 15-30 minutes (but not more than 
60 minutes).During the session, the nurse-coach will focus on the skills and will encourage and empower 
the patient that these can be used for relaxation, stress management and to build and sustain resilience 
beyond the hospital experience. Coach will offer additional support as appropriate.  
5.4.5. Fifth session  
Session 5 will be in-person and will take place the same day as the follow-up doctor’s appointment and 
will last 15-30 minutes (but not more than 60 minutes). 
The nurse-coach will conclude the program, remind patient of the techniques learned and will also 
encourage and empower the patient that these are life skills that can be used for relaxation, stress 
management and to build and sustain resilience. Coach will offer additional support as appropriate after 
the end of the study. To facilitate the discussion and ensure consistency across patients, the nurse coach 
will use a script (see appendix 5). 
In the end of the final session, the patient will be asked to complete a hard copy of the exit survey (post-
intervention).  
5.4.6. Follow-up 
Patients will be sent a hard copy of the follow-up  survey to the address  they have provided at one and 
three months after discharge.  
 
 
 

11 
 
6. Methods  
6.1. 
Survey 
All surveys used were created for this project. The majority of the questions are influenced by questions 
found in validated tools such as the CDC Quality of Life tool and have been adjusted to reflect the needs 
of oncology patients.  
6.1.1. Survey Construction  
All instruments are novel and were developed solely for this project. Questions were developed through 
consultation with the investigator team, subject matter experts, and relevant literature. 
6.1.2. Survey Administration 
The surveys will be administered during the initial visit and at the last coaching session. Two more 
follow-up surveys will be sent to participants at one and three months after discharge. Participants will 
be provided with hardcopies of the surveys and data collected will then be transferred to a database 
created specifically for this project in Excel. 
6.2. 
Statistical Design 
The proposed study will be a descriptive case-series of thoracic and hepatobiliary oncology patients who 
are scheduled to undergo surgical intervention at Jersey Shore University Medical Center, a hospital in 
the Hackensack Meridian Health Network, that will be enrolled in the Personal Resilience Empowerment 
Program (PREP). 
6.2.1 Sample Size 
The sample size proposed for this study is as many patients as can be recruited by the end of March 
2018 or a maximum of 50 patients, whichever occurs first.  Given that this is a pilot study for the PREP 
initiative at Hackensack Meridian Health there is no existing data with which to calculate a precise 
sample size that would be needed to provide statistical power.  Therefore, we relied heavily upon the 
number of patients who could be approached during the study consent timeframe, with consideration 
for both potential drop-out and loss to follow-up, as well as the challenge of consenting patients in the 
first place, to determine the potential sample size. 
6.2.2 Planned Analyses 
6.2.2.1 Interim Analysis 
Due to the nature of the study design, there is no interim analysis planned. 
6.2.2.2 Analysis Methods  
Continuous measures and outcomes will first be summarized using minimum, maximum, mean, 
standard deviation, median, and interquartile range, while categorical and ordinal measures will first be 
summarized using frequencies and percentages. For any patient measure that can be described as a 
time to an event, the median time will be estimated using the Kaplan-Meier procedure with the 
standard error being estimated by the Greenwood formula. 
In order to detect significant changes in the longitudinal repeated measurements from the pre- and 
post-intervention patient survey, McNemar or Stewart-Maxwell tests will be used for categorical 
measures while Wilcoxon Signed Rank Tests will be used for ordinal measures. Any continuous measures 

12 
 
will be compared using either a paired T-Test or a Wilcoxon Signed Rank Test depending on the outcome 
of the Shapiro-Wilk test of normality. 
In addition, a cancer stage stratified analysis is currently planned. The normality of each continuous 
measure will first be tested using the Shapiro-Wilk test.  Given that the variable can be considered 
normally distributed, either a T-test or an ANOVA test will be used to compare the continuous measure 
between the stage groups, dependent upon how many stages are represented in the patient sample.  
However, if the measure cannot be considered normally distributed, then the Wilcoxon rank sum test or 
Kruskal-Wallis test will be used instead.  For all categorical variables, we will first consider using the 
Pearson’s Chi-Square test.  However, if any expected frequency within the contingency table is less than 
5 then the Fisher’s exact test will be used.  For any ordinal variables with more than 2 potential 
outcomes the Wilcoxon rank sum test or Kruskal-Wallis test will be used. 
A two-sided p-value will be reported for each test result using a potential Type 1 error of α = 0.05.  Any 
p-value shown to be less than α will be considered statistically significant.  As necessary, graphical 
representations of results will be provided. 
6.2.3 Data Relevance 
The data elements being collected are both clinical and patient self-reported measures.  The clinical 
aspects that are proposed will allow the study team to better ascertain the patients’ health condition 
pre-operatively and post-operatively during the most critical timeframes for preparation and recovery, 
respectively.  These pieces of information are vital in being able to describe the study population and 
understand the clinical experience of the participants. Whereas the self-reported measures that are 
proposed for collection, via surveys, will provide the study team with more of an understanding of the 
patients’ awareness of the effects of the 5 Pillars (Activity, Nutrition, Sleep, Purpose, and Resilience), as 
well as their feelings towards making changes in their life based on the PREP coaching process.  
Additionally, the follow-up surveys will allow the team to gain information from the patient on how they 
are recovering as well as how they can improve PREP for future patient participants. 
6.2.4 Data Coding 
6.2.4.1 Data De-identification  
All study data will be de-identified prior to analysis by assigning a unique and generic study identifier to 
each patient upon enrollment into the study.  This assigned number will not contain or be linked to any 
personal health identifiers (PHI). A coded list containing the matching information between the generic 
study identifier and the true identity of the patient will be kept on a Hackensack Meridian Health 
password protected network computer and will not be shared with the study biostatistician or anyone 
else performing data analyses.    
6.2.4.1 Data Element Coding  
All clinical study data will be recorded as it is written in the patient chart, lab test report, or pathology 
report.  However, we may later create or recode measures that indicate the presence or the lack of 
presence of something specific pre- or post-operatively as 0 (not present) and 1 (present). This could 
include the presence of certain comorbidities that may affect the coaching process or surgical outcomes. 
For coaching follow-up notes and survey data, the responses that are requested from the patient are 
largely from a 0 – 5 Likert Scale (with some written explanation) and will be coded as such. For any 

13 
 
questions that elicit an affirmative response (i.e.: yes) or a negative response (i.e.: no) the measures will 
also be coded as a 0 or 1. 
6.2.5 Data Analysis Tools 
Data collection and storage will be performed using Microsoft Work and Microsoft Excel. All documents 
will be saved in password protected computers only accessible to the study team.  
Statistical analysis will be performed using: 
1. 
SAS software Version 9.4 of the SAS System for Windows (SAS Institute Inc. [2012], Cary NC, 
USA. URL www.SAS.com ) 
2. 
R language for statistical computing (R Core Team [2017].  R: A language and environment for 
statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL http://www.R-
project.org/ ) 
 
 

14 
 
7. Ethical Considerations 
 
The study will be conducted according to the International Conference on Harmonization (ICH), Good 
Clinical Practice (GCP), the Declaration of Helsinki, Institutional Review Boards (IRB) and in accordance 
with the U.S. Code of Federal Regulations on Protection of Human Rights (21 CFR 50). 
7.1. 
Institutional Review Board (IRB) Review 
The final study protocol, surveys and collection tool will be approved by the Institutional Review Board 
(IRB) at Jersey Shore University Medical Center. Approval will be received in writing before initiation of 
the study.  
Any changes to the study design will be formally documented in protocol amendments and approved by 
the IRB prior to implementation.  
7.2. 
Data Management  
All data will be stored on a Hackensack password protected computer only accessible by the investigator 
team.  
Jersey Shore UMC password protected computers are only accessible by the P.I. and/or research staff.  
Data collected will be maintained securely with limited access. Records will be retained in accordance 
with regulatory, organizational and sponsor requirements, but no less than six (6) years following the 
completion of the research.  Disposal of records will be done in such a manner that no identifying 
information can be linked to research data. 
7.3. 
Informed consent 
A signed informed consent shall be obtained from each participant prior to entering the study. The 
informed consent forms provides information and explanations of the aims, methods, anticipated 
benefits and potential hazards of the study.  
Before any protocol-specific screening procedures are administered, information will be given to all 
potential participants during the study introduction taking place in the first session.   
The acquisition of informed consent will be documented in the participant’s record and the informed 
consent form will be signed and personally dated by the participant and by the person who conducted 
the informed consent discussion. The original signed form will be retained in the Investigator Site File 
and a copy of the original will be provided to the participant prior to participation in the study.  
The participants will be informed that they may withdraw from the study at any time without prejudice 
and compilation of that person’s data will cease as of the date of his/her written request for withdrawal.   
 
7.4. 
Confidentiality 
The patient charts, collected data and all analysis of the data will adhere to HIPAA & institutional patient 
confidentiality requirements.  

15 
 
More specifically, a coding system will be used for which a unique identifier (study number) will be 
assigned to each name and contact details.  Each participant whose data is collected will be assigned a 
unique study number. Only the study number will be included in the data collection tool, data analysis 
tools, and potential publications. The list with the direct identifiers (for the purposes of linking data with 
the surveys and keeping track of the devices) will also be stored in a secured server in the Jersey Shore 
University Medical Center, Center for Integrative Medicine, in a separate file.  
Analytical datasets will be stored on secure servers that also limit access to the investigator team. 
Should results of the study be published or reported, individual names or other identifying information 
will not be used. 
 
 

16 
 
Appendix 1 – ECOG Performance Status 
 
Developed by the Eastern Cooperative Oncology Group, Robert L. Comis, MD, Group Chair.* 
 
GRADE 
ECOG PERFORMANCE STATUS 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature, e.g., light house work, office work 
2 
Ambulatory and capable of all selfcare but unable to carry out any work activities; up and 
about more than 50% of waking hours 
3 
Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 
4 
Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 
5 
Dead 
 
*Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology 
Group. Am J Clin Oncol. 1982;5:649-655. 
 
 

17 
 
Appendix 2 – Handout and Script for Session No 2 
 
Session 2- Phone call within one week prior to surgical admission with nurse health coach (at least 30, 
not more than 60 minutes) 
“Hi my name is ______ and I am a Registered Nurse Health Coach. We will partner throughout 
this process to help you bounce back and assist you in managing stress, reducing potential pain 
and empowering you to improve your quality of life. Today, in our second session, we will 
review the skills from the group class and I will provide you with support around the skills. In the 
class, you learned the five pillars of health and well-being that can support you to manage your 
upcoming surgery. These are life skills which you can apply during your upcoming hospital 
admission and beyond your hospital experience. To begin, let’s look at your pain, anxiety and 
well-being. How would you rate your pain right now from 0-10 with 0 being no pain and 10 
being the worst pain? How about your anxiety level from 0-10? If 0 is no anxiety and 10 is severe 
anxiety, how would you rate how you feel right now? How about your sense of well-being? 
From 0-10 with 0 meaning not well and 10 being well, what number would you rate yourself 
right now?  
We are now going to discuss the five pillars of health and well-being by looking at the Mind Body 
Spirt reference guide which you received at the PREP group coaching class. Let’s start by 
discussing your sleep which is essential for the body to heal, repair, and prepare for the next 
day. How are you sleeping? [Coach will offer support as appropriate]  
Our next pillar is activity. Activity is more than exercise; it includes your movement throughout 
the day. Movement is important for your body but it is also important for your mind. When you 
move, chemicals are released which improve your emotions and your brain function. What is 
your current activity level? Has your doctor given you any restrictions on your activity? [Coach 
will offer support as appropriate] 
Our third pillar is purpose. Purpose is where you find meaning in your life; it’s what gets you out 
of bed in the morning. When we are clear on our values, strengths and our sense of purpose, it 
can help serve as an anchor in tough times. Sometimes when we experience challenges such as 
a health event, it is a time where we re-examine our purpose. We can apply this to the purpose 
for your upcoming admission, or beyond to your greater life purpose. I would encourage you in 
the time before your surgery and in our future sessions to reflect on your purpose. [Coach will 
offer support as appropriate] 
 
Our fourth pillar, nutrition, is the fuel for our mind and body. You can refer to the food that 
increase and decrease inflammation sheet that was provided to you. How is your nutrition 
intake?   In general, foods like breads, pastas, dairy, processed meats, red meats, soy oil, corn 
oils, fast and fried food, and soft drinks and sugary beverages turn on inflammation in our body. 
Inflammation over time can lead to disease. The food choices you make now can help you in 
preparation for your wound healing and your body’s natural response to surgery. By choosing to 
eat things like nuts, avocados, spinach, tart cherries, pineapple, orange vegetables and fruit, and 

18 
 
turmeric, onion, ginger and garlic you can help your body to heal faster since these foods 
decrease inflammation and promote healing. [Coach will offer support as appropriate] 
 
The fifth pillar is resilience which is the ability to cope and bounce back in difficult times. How do 
you currently handle/manage your stress? [Coach will offer support as appropriate] To 
counteract your stress response, we are going to practice skills that can create balance in your 
body and mind. We are going to practice the 4-7-8 breathing technique which you learned in the 
group PREP class that will help relax you.  
 
The key to doing this exercise properly is to ensure that your exhalation is twice as long as your 
inhalation. Let’s take out the 4-7-8 breathing card now. [The nurse health coach will guide the 
patient through the following exercise]: 
1. Sit or lie comfortably with your back straight. 
2. Place the tip of your tongue against the ridge of tissue just behind your upper front teeth and 
keep it there throughout the entire exercise. 
3. Exhale completely through your mouth. 
4. Close your mouth lightly and inhale through your nose quietly to a count of 4. 
5. Hold your breath for a count of 7. 
6. Exhale audibly through your mouth for a count of 8. 
7. Repeat steps 4-6 three more times for a total of four breath cycles. 
8. Breathe normally and observe how your body feels. 
Try using this twice per day and any other time you want to relax your body and mind. You can 
use this if you are experiencing pain or anticipating pain. It may also help calm your mind prior 
to sleep. By focusing on your breath, you can allow your mind to settle down and rest.  
 
Next we will practice using the pressure point located on your inner forearm between the two tendons.  
Apply firm pressure to this area on the inside of your wrist to help with nausea and/or vomiting from: 
upset stomach, motion sickness, chemotherapy or after surgery due to the effects of anesthesia.  
  
 
 
Step 1: Find the point, three finger widths from base of wrist. 
 

19 
 
Step 2: Now feel the center of the two tendons with the index finger. Apply pressure with your pointer 
finger. It is common to feel a dull aching sensation at the point.  Stimulate this point with moderate to 
firm pressure with your fingertips in a circular motion and repeat the movement on each wrist for at 
least 30 seconds and up to 2 minutes. The treatment can be used as often as needed. Once you know 
the location of the point, some people find it is easier to use their thumb to apply the pressure. 
 
Make sure to ask your health care provider exactly how to use these mind-body techniques. 
 
Please remember our third session will be in-person in your hospital room midway during your hospital 
stay. At this time we will check in with your pain, anxiety and well-being and practice the skills we 
discussed in this call in addition to other coaching support you may need. Our fourth session will take 
place over the phone within one week of your discharge. I will call you once I’m notified that you have 
been discharged to schedule a phone coaching session within one week. At this session we will discuss 
the transition of the skills you learned and used in the hospital to your everyday life. I will check in again 
on your pain, anxiety and well-being and offer additional support as needed.  The final session will be in 
person at your first post-operative doctor visit. I will meet you in the office for a coaching session at this 
time to review the skills you have learned, and check in on your pain, anxiety and well-being. You will 
also be requested to complete a program evaluation and follow-up survey. If you feel like you need 
additional support at any time throughout this program, you can call me at ______________.  
 
 
 
 
 
 

20 
 
Appendix 3 – Script for Session No 3 
 
Session 3 –In-person hospital visit with nurse health coach (at least 15 minutes, not more than 60 
minutes)  
“Hi, Mr. or Mrs. ______, I am ________, a Registered Nurse Health Coach . Let’s check in on how 
you’re doing and if you’ve used the techniques we discussed and practiced in the group PREP 
coaching class and over the phone. How would you rate your pain right now from 0-10 with 0 
being no pain and 10 being the worst pain? How about your anxiety level from 0-10? If 0 is no 
anxiety and 10 is severe anxiety, how would you rate how you feel right now? How about your 
sense of well-being? From 0-10 with 0 meaning not well and 10 being well, what number would 
you rate yourself right now? [Nurse Health coach will report findings to primary RN]. Let’s start 
by reviewing the 5 pillars of health and well-being. Sleep which is essential for the body to heal, 
repair, and prepare for the next day. How are you sleeping? [Coach will offer support as 
appropriate]  
Our next pillar is activity. What is your current activity level? Has your doctor given you any 
restrictions on your activity? [Coach will offer support as appropriate] 
Our third pillar is purpose. Did you create/are you using your purpose statement? [Coach will 
offer support as appropriate] 
 
Our fourth pillar, nutrition, is the fuel for our mind and body. How is your nutritional 
intake?[Coach will offer support as appropriate] 
 
The fifth pillar is resilience which is the ability to cope and bounce back in difficult times. How 
are you currently handling/managing your stress? [Coach will offer support as appropriate] 
Have you used the techniques we practiced prior to surgery? Which skill(s)? How often did you use it? 
Would you like to practice one of the skills now together?” *Coach will review skill(s) as patient self-
directs]. 
To counteract your stress response, we are going to practice skills that can create balance in 
your body and mind. We are going to practice the 4-7-8 breathing technique which you learned 
in the group PREP class that will help relax you.  
 
The key to doing this exercise properly is to ensure that your exhalation is twice as long as your 
inhalation. Let’s take out the 4-7-8 breathing card now. [The nurse health coach will guide the 
patient through the following exercise]: 
1. Sit or lie comfortably with your back straight. 
2. Place the tip of your tongue against the ridge of tissue just behind your upper front teeth and 
keep it there throughout the entire exercise. 
3. Exhale completely through your mouth. 
4. Close your mouth lightly and inhale through your nose quietly to a count of 4. 
5. Hold your breath for a count of 7. 

21 
 
6. Exhale audibly through your mouth for a count of 8. 
7. Repeat steps 4-6 three more times for a total of four breath cycles. 
8. Breathe normally and observe how your body feels. 
Try using this twice per day and any other time you want to relax your body and mind. You can 
use this if you are experiencing pain or anticipating pain. It may also help calm your mind prior 
to sleep. By focusing on your breath, you can allow your mind to settle down and rest.  
Next we will practice using the pressure point located on your inner forearm between the two tendons.  
Apply firm pressure to this area on the inside of your wrist to help with nausea and/or vomiting from: 
upset stomach, motion sickness, chemotherapy or after surgery due to the effects of anesthesia.  
  
 
 
Step 1: Find the point, three finger widths from base of wrist. 
 
Step 2: Now feel the center of the two tendons with the index finger. Apply pressure with your pointer 
finger. It is common to feel a dull aching sensation at the point.  Stimulate this point with moderate to 
firm pressure with your fingertips in a circular motion and repeat the movement on each wrist for at 
least 30 seconds and up to 2 minutes. The treatment can be used as often as needed. Once you know 
the location of the point, some people find it is easier to use their thumb to apply the pressure. 
 
Make sure to ask your health care provider exactly how to use these mind-body techniques. 
 [The nurse health coach will encourage and empower the patient to use these skills throughout the 
remainder of the stay and beyond. Coach will offer additional support as appropriate].  
You will receive a telephone call after discharge to schedule the fourth session with me over the phone. 
If you feel like you need additional support at any time throughout this program, you can call me at 
______________. 
 
 
 

22 
 
Appendix 4 – Script for Session No 4 
 
Session 4-Phone call within one week of discharge with nurse health coach (at least 15 minutes, not 
more than 60 minutes) 
“Hi, Mr. or Mrs. ______, I am ________, a Registered Nurse Health Coach. Let’s check in on how you’re 
doing and if you’ve used the techniques we discussed and practiced over the phone and in person. How 
would you rate your pain right now from 0-10 with 0 being no pain and 10 being the worst pain? How 
about your anxiety level from 0-10? If 0 is no anxiety and 10 is severe anxiety, how would you rate how 
you feel right now? How about your sense of well-being? From 0-10 with 0 meaning not well and 10 
being well, what number would you rate yourself right now?  Have you used the techniques we 
practiced since our last visit? Which skill(s)? How often did you use it? 
Let’s review again the 5 pillars of health and well-being. Sleep which is essential for the body to 
heal, repair, and prepare for the next day. How are you sleeping? [Coach will offer support as 
appropriate]  
Our next pillar is activity. What is your current activity level? Has your doctor given you any 
restrictions on your activity? [Coach will offer support as appropriate] 
Our third pillar is purpose. Did you create/are you using your purpose statement?  [Coach will 
offer support as appropriate] 
 
Our fourth pillar, nutrition, is the fuel for our mind and body. How is your nutrition? [Coach will 
offer support as appropriate] 
 
The fifth pillar is resilience which is the ability to cope and bounce back in difficult times. How 
are you currently handling/managing your stress? [Coach will offer support as appropriate] 
Let’s practice two of resilience techniques now again. Let’s start with the 4-7-8 breathing. As you may 
remember, the key to doing this exercise properly is to ensure that your exhalation is twice as long as 
your inhalation. [The nurse health coach will guide the patient through the following exercise]: 
1. Sit or lie comfortably with your back straight. 
2. Place the tip of your tongue against the ridge of tissue just behind your upper front teeth and 
keep it there throughout the entire exercise. 
3. Exhale completely through your mouth. 
4. Close your mouth lightly and inhale through your nose quietly to a count of 4. 
5. Hold your breath for a count of 7. 
6. Exhale audibly through your mouth for a count of 8. 
7. Repeat steps 4-6 three more times for a total of four breath cycles. 
8. Breathe normally and observe how your body feels. 
 By focusing on your breath, you can allow your mind to settle down and rest.  
The next skill we will practice is a pressure point located on your inner forearm between the two 
tendons.  

23 
 
Apply firm pressure to this area on the inside of your wrist to help with nausea and/or vomiting from: 
upset stomach, motion sickness, chemotherapy or after surgery due to the effects of anesthesia.  
  
 
 
Step 1: Find the point, three finger widths from base of wrist. 
 
Step 2: Now feel the center of the two tendons with the index finger. Apply pressure with your pointer 
finger. It is common to feel a dull aching sensation at the point.  Stimulate this point with moderate to 
firm pressure with your fingertips in a circular motion and repeat the movement on each wrist for at 
least 30 seconds and up to 2 minutes. The treatment can be used as often as needed. Once you know 
the location of the point, some people find it is easier to use their thumb to apply the pressure. 
 
Make sure to ask your health care provider exactly how to use these mind-body techniques. 
 
[The nurse health coach will encourage and empower the patient that these are skills that can be used 
for relaxation, stress management and to build and sustain resilience. Coach will offer additional support 
as appropriate] 
Our final session will be in person at your follow-up appointment with your surgeon. If you feel like you 
need additional support at any time throughout this program, you can call me at ______________.” 
 
 
 

24 
 
Appendix 5 – Script for Session No 5  
 
Session 5-In-person post-operative visit with nurse health coach at follow-up doctor’s appointment (at 
least 15 minutes, not more than 60 minutes) 
“Hi, Mr. or Mrs. ______, I am ________, a Registered Nurse Health Coach Let’s check in on how you’re 
doing and if you’ve used the techniques we discussed and practiced over the phone and in the hospital. 
How would you rate your pain right now from 0-10 with 0 being no pain and 10 being the worst pain? 
How about your anxiety level from 0-10? If 0 is no anxiety and 10 is severe anxiety, how would you rate 
how you feel right now? How about your sense of well-being? From 0-10 with 0 meaning not well and 
10 being well, what number would you rate yourself right now?  Have you used the techniques we 
practiced since our last visit? Which skill(s)? How often did you use it? 
Let’s review again the 5 pillars of health and well-being. Sleep which is essential for the body to 
heal, repair, and prepare for the next day. How are you sleeping? [Coach will offer support as 
appropriate]  
Our next pillar is activity. What is your current activity level? Has your doctor given you any 
restrictions on your activity? [Coach will offer support as appropriate] 
Our third pillar is purpose. Did you create/are you using your purpose statement?  [Coach will 
offer support as appropriate] 
 
Our fourth pillar, nutrition, is the fuel for our mind and body. How is your nutrition? [Coach will 
offer support as appropriate] 
 
The fifth pillar is resilience which is the ability to cope and bounce back in difficult times. How 
are you currently handling/managing your stress? [Coach will offer support as appropriate] 
Let’s practice two of those techniques now again. Let’s begin with the 4-7-8 breathing. As you may 
remember, the key to doing this exercise properly is to ensure that your exhalation is twice as long as 
your inhalation. [The nurse health coach will guide the patient through the following exercise]: 
1. Sit or lie comfortably with your back straight. 
2. Place the tip of your tongue against the ridge of tissue just behind your upper front teeth and 
keep it there throughout the entire exercise. 
3. Exhale completely through your mouth. 
4. Close your mouth lightly and inhale through your nose quietly to a count of 4. 
5. Hold your breath for a count of 7. 
6. Exhale audibly through your mouth for a count of 8. 
7. Repeat steps 4-6 three more times for a total of four breath cycles. 
8. Breathe normally and observe how your body feels. 
 By focusing on your breath, you can allow your mind to settle down and rest.  
The next skill we will practice is a pressure point located on your inner forearm between the two 
tendons.  

25 
 
Apply firm pressure to this area on the inside of your wrist to help with nausea and/or vomiting from: 
upset stomach, motion sickness, chemotherapy or after surgery due to the effects of anesthesia.  
  
 
 
Step 1: Find the point, three finger widths from base of wrist. 
 
Step 2: Now feel the center of the two tendons with the index finger. Apply pressure with your pointer 
finger. It is common to feel a dull aching sensation at the point.  Stimulate this point with moderate to 
firm pressure with your fingertips in a circular motion and repeat the movement on each wrist for at 
least 30 seconds and up to 2 minutes. The treatment can be used as often as needed. Once you know 
the location of the point, some people find it is easier to use their thumb to apply the pressure. 
 
Make sure to ask your health care provider exactly how to use these mind-body techniques. 
 
[The nurse health coach will encourage and empower the patient that these are skills that can be used 
for relaxation, stress management and to build and sustain resilience. Coach will offer additional support 
as appropriate].  
Would you like to continue to see a nurse health coach for further support to achieve your goals through 
lifestyle and behavior adjustments? [If so, patient will be referred for further support] 
Please complete the program evaluation and your final survey; we would appreciate your feedback. 
As discussed, you will also receive two brief surveys at the email you have provided. We will send you 
the survey after one and three months from the date you were discharged. Please take the time to fill 
them as your opinion is very important for us and the development of this program. ”