LIVE-R Life: Liver Cancer Education
Phase: NA
Conditions: Liver Cancer
Sponsor: Fox Chase Cancer Center

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
1
Protocol Title
LIVE-R Life: Liver Cancer Education
Principal Investigator:
Shannon M. Lynch, Ph.D., M.P.H., Fox Chase Cancer Center
Funding Source:
Pennsylvania Department of Health - 100082483
Initial Version Date: 7/26/2019
Amendment #
8
Version date:
4/20/2021

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
2
Table of Contents
Section
                    Page
1.0
Introduction...................................................................................................................................3
2.0
Objectives/Aims ...........................................................................................................................4
3.0
Background/Rationale................................................................................................................4
4.0
Study Design.................................................................................................................................6
5.0
Data Management........................................................................................................................9
6.0
Risks to Participants.................................................................................................................10
7.0
Potential Benefits to Participants..........................................................................................11
8.0
Provisions to Maintain the Confidentiality of Data............................................................11
9.0
Costs to Participants ................................................................................................................12
10.0
Consent Process........................................................................................................................12
11.0
Off-Study Criteria.......................................................................................................................12
12.0
Drugs and Devices ....................................................................................................................12
13.0
Multi-Site Research Study.......................................................................................................12
14.0
Statistical Analysis....................................................................................................................12
15.0
Data Safety Monitoring Plan ...................................................................................................13
16.0
Adverse Events ..........................................................................................................................13
17.0
Quality Assurance Procedures and Participant Confidentiality....................................13
18.0
Participant Informed Consent ................................................................................................13
19.0
Appendices .................................................................................................................................13
20.0
References...................................................................................................................................13

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
3
1.0 Introduction
    Incidence and mortality rates in liver cancer are on the rise in the U.S[1].  By 2030, liver 
cancer is expected to exceed breast cancer as the second leading cause of cancer death in the 
U.S[2].  Up to 30% of liver cancer cases are attributed to Hepatitis B (HBV) and/or Hepatitis C 
(HCV) viral infection, though the fraction of liver cancer cases in African American and Asian 
patients attributed to chronic HBV or HCV is much higher, closer to 40%-50%[3].  In Caucasians 
and Hispanics, HCV infection is considered a second leading cause of liver cancer, behind only 
diabetes and obesity[4].  In the State of Pennsylvania, racial trends in liver cancer, HBV, and 
HCV are similar to those in the U.S[5].  In the Temple University Health System, which serves 
primarily African American and other minority groups, incidence rates of liver cancer are the 
highest of any cancer site.
     Liver cancer incidence rates could be significantly lowered by reducing rates of HCV and 
HBV infections[6].  Treatments with high cure rates exist for HCV, and HBV can be prevented 
through vaccination[7].  Further, HCV and HBV infection are often contracted through risk 
behaviors (i.e., sexual activity, drug use, unsanitary tattoo/nail salon practices) that could be 
modified through educational interventions and policies.  However, rates of both liver cancer 
and HCV continue to rapidly increase, suggesting that available, evidence-based interventions 
are not reaching the most vulnerable, high risk populations.  There is a disconnect between 
translation of findings from discovery into population impact, and the disproportionate rates of 
HBV, HCV, and liver cancer across racial groups suggest health inequities contribute to the 
growing burden of liver disease in this country.  
     In this study, we propose to bridge the gap between evidence and action and combat rising 
liver cancer rates attributed to Hepatitis B and C infection in Philadelphia by identifying 
neighborhoods with higher than expected rates of liver cancer and related risk factors and 
administering an educational intervention in those communities, working with existing 
community partners at Fox Chase Cancer Center.  In this proposal, we will generate new 
methods for identifying smaller communities or geographic areas (at the census tract level) in 
need of liver-cancer related interventions.  This is an improvement over existing studies that 
focus mostly on single risk factors for disease and targeting counties, which are often too large 
to implement public health programs[8].  By dually considering area-level measures of disparity 
(i.e. race/ethnicity, immigration, poverty, etc. from the U.S. Census) WITH the distribution/co-
occurrence of liver cancer, HBV, and HCV, we hope to also shed light on disparities in liver 
cancer.  We hypothesize that communities carrying the greatest burden of liver disease (liver 
cancer/HCV/HBV) AND health disparities, if targeted, could lead to the greatest declines in liver 
cancer over time.  Further, community partners that work with the Fox Chase Office of 
Community Outreach requesting cancer education sessions via our Community Speaker’s 
Bureau for their community programs will be approached with this new liver cancer initiative. We 
will begin with partner sites identified via geocoding as well as regions where we need to 
establish new partnerships.  Partners will be informed of the project, its objectives and if 
interested, we will deliver the educational session about person-level liver cancer risk factors 
and how to reduce liver cancer risk, as well as some background on liver cancer rates and 
neighborhood research.  We will then administer pre-post tests to participants to test 
knowledge, attitudes, and intentions, and will disseminate liver cancer brochures from the 
American Liver Cancer Foundation to relevant community groups.  The use of surveillance data 
and the application of geospatial analytics to guide interventions that benefit populations more 
efficiently is a strategy that defines precision public health[9]. 
   

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
4
2.0 Objectives/Aims
Aim 1 (Similar to currently approved IRB #17-9031):  Conduct a geographic scan of liver 
cancer and related risk factors (age, race/ethnicity) for the entire State of PA by census tract in 
order to dually identify neighborhoods in Philadelphia with greater disease/disparity burdens 
than expected compared to the State and to inform where liver cancer-related educational 
interventions may be most needed. Hypothesis:  Enhanced spatial tools/metrics (that couple 
disease rates & area-level measures of disparity) will inform resource allocation through more 
precise identification/targeting of communities in need.
Aim 2:  To identify and/or establish community partnerships in “high-risk” areas to collaborate 
with, delivering and evaluating educational sessions.
Impact:  Our focus on geospatial, area level risk factors will provide novel insights into liver 
cancer disparities.  We take an innovative precision public health approach where the 
successful primary and secondary prevention of liver cancer could be monitored in areas 
selected for intervention in future studies.  
3.0 Background/Rationale
A. Precision Public Health Approach in Liver Cancer.  As outlined in currently approved IRB 
17-9031, the use of data to guide interventions that benefit populations more efficiently is a 
strategy referred to as precision public health.  Precision public health requires primary 
surveillance data, rapid application of 
sophisticated analytics to track the 
geospatial distribution of disease, and the 
capacity to act on this information in the 
form of interventions. In this proposal, we 
plan to use surveillance data from the 
Pennsylvania (PA) Cancer registry, the PA 
and Philadelphia Infectious Disease 
HBV/HCV registries and the U.S. Census 
in order to identify fewer and smaller 
geographic areas that are carrying the 
greatest disease burden of liver cancer, as 
well as a high burden of determinants of 
health disparities.  We will create new 
combinations of disease metrics and 
summary scores for determinants of 
disparity in order to estimate the 
disease/disparity burden in each census 
tract in Pennsylvania.  In an attempt to maximize limited resources, our goal is to select the 
fewest number of “in need” areas, where existing educational and screening interventions are 
likely to have the greatest impact on decreasing liver cancer rates. 
B. Liver Cancer Statistics.  The incidence rates of liver cancer have tripled over the past three 
decades. Due to a very poor prognosis, liver cancer is the fifth most common cause of cancer 
death in the United States. Hepatocellular carcinoma (HCC) is the major histological subtype, 
accounting for up to 80% of all cases[10].  In Pennsylvania, the incidence and mortality rates of 
liver cancer have been climbing each year since 2003.  In our catchment area, incidence rates 
of liver cancer are the highest of any cancer site in the Philadelphia area.  Thus, the burden of 
liver cancer needs to be addressed.

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
5
C. Liver Cancer and Hepatitis.  Risk factors for liver cancer are largely understood, with up to 
70% of liver cancer cases being attributed to modifiable factors, including drug/alcohol use, 
obesity, diabetes, and viral infection with Hepatitis B/C[4].   Despite these risk factors being 
largely addressable through early detection, vaccination, treatment, and lifestyle interventions, 
liver cancer continues to rise in the U.S., particularly in minority populations) [4].  Hepatitis B 
and C account for 32% of liver cancer cases in the U.S.  In African American and Asian 
populations, HBV and HCV account for 40-50% of liver cancer cases, whereas in Hispanics and 
Caucasians, HBV and HCV account for closer to 20% of cases.  In a study of Philadelphia 
residents between 2003-2012, individuals with HCV and HBV accounted for close to 40% of all 
liver cancer diagnoses.  Further, HCV-infected patients were also 2.8 times more likely to have 
liver cancer detected before age 65 and to have an earlier age of death than individuals without 
HCV.  For Philadelphia males and non-Hispanic blacks, HCV was more common and more 
often associated with liver cancer diagnosis and death at a younger age.  For Asians in 
Philadelphia, HBV was more common and more often associated with liver cancer diagnosis 
and death.  Given the contribution of HCV and HBV to liver cancer in our area, widespread 
public health actions to prevent HCV and HBV infection could have a substantial effect on the 
burden of liver cancer in Philadelphia.  Thus, in this proposal, we focus on identifying 
geographic areas (census tracts) that carry the greatest burden of liver cancer, and will be 
creating an educational session to review risk factors for liver cancer and how to decrease risk.  
D. Disparities in Liver Cancer.  Beyond race/ethnicity, individual-level socioeconomic status 
(SES) (e.g., education, income, employment), as well as area-level SES conditions (i.e., 
neighborhood socioeconomic deprivation), are also believed to contribute to liver cancer[11].  
Liver cancer patients are more likely to live in deprived-socioeconomic conditions, and studies 
show that these area-level socioeconomic associations may result from the geographic 
distribution of individual risk factors associated with liver cancer, such as low educational 
attainment.  This is important because studies have shown differences in area-level 
determinants of disparity by race, i.e. African Americans living in neighborhoods with high 
poverty (but not areas with high unemployment) and Hispanics living in areas of low educational 
attainment have higher rates of liver disease.  Further, additional determinants of disparity 
(beyond race/ethnicity, education, income, employment) that are dually related to health 
outcomes and can provide useful information for intervention development, also warrant further 
study.  These determinants include immigration status, literacy, transportation, and housing 
(Table 1).  In this study, we more comprehensively evaluate determinants of disparity in liver 
cancer.  We do not plan to investigate associations between determinants of disparity and liver 
cancer, but will quantify the prevalence of determinants of disparity in small geographic areas 
(i.e. census tracts) and use that information to create an overall disparity metric or score.  This 
new disparity metric can be referenced and used to determine 1) which areas with high rates of 
liver disease (liver cancer, HCV, and/or HBV) also have a high disparity score (with the 
hypothesis that targeting fewer areas with higher disease and disparity scores will result in 
maximizing limited resources); 2) what determinants (i.e. education, employment, literacy, etc) 
are driving the low disparity score in each area, which can inform the type of 
intervention/intervention materials needed for designated high risk areas(i.e. where should 
Spanish educational interventions be offered, etc). 
E. Recommendations for the Primary and Secondary Prevention of Liver Cancer.  While 
recommendations for liver cancer do vary, the National Comprehensive Cancer Network panel 
recommends screening with ultrasound and alpha fetoprotein (AFP; a liver cancer blood 
biomarker) testing every 6 to 12 months for patients at risk for liver cancer.  At risk populations 
are defined as those with liver cirrhosis and hepatitis B.  Liver cirrhosis can be caused by HBV 

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
6
and HCV infections.  Screening tests for HCV and HBV involve blood test screening for HCV 
and HBV antibodies.  For those diagnosed with HCV, curative treatment is recommended.  One 
problem is the majority of HBV/HCV carriers do not know they are infected.  Thus, they can 
unknowingly spread the virus (through risk behaviors such as unsanitary needle use).  Further, 
those with chronic HCV and/or HBV infection are often diagnosed with advanced liver disease 
(cirrhosis) and/or advanced liver cancer.  Patients diagnosed with early stage liver cancer 
survive more than 5 years.  However, the majority of liver cancer cases are diagnosed with 
advanced stage liver cancer where the average survival is less than one year.  Given the 
contribution of HBV and HCV to liver cancer incidence, interventions that provide education 
about hepatitis, who is at risk, and how it is contracted, will likely have an impact on liver cancer 
incidence and mortality rates.  The complex interactions of risk behaviors, differences in disease 
rates by race/ethnicity, and the impact of social environment on liver cancer suggests that 
community-based approaches to identifying high risk areas and high risk individuals within those 
areas, is warranted.  We will discuss recommendations and reduction of risk behaviors in our 
educational session.  
F. Innovation. This is the first study to apply a precision public health approach to address the 
growing burden of liver cancer and to engage community partners in this process.    
4.0 Study Design
In line with the Precision Medicine Initiative, we propose to utilize data from existing resources, 
to inform liver cancer prevention using cross-sectional data for the liver cancer geospatial 
analysis. Intervention materials include the development of an educational module addressing 
risk factors, symptoms, diagnosis and treatment.  The sessions will incorporate both didactic 
and interactive modalities.  The educational module includes a slide presentation, and will be 
accompanied by an educational brochure that participants can take home. The information 
included in the educational brochure reinforces the information presented in the slide show. 
Prior to each session, a pre-test will be administered to establish a baseline of knowledge and 
to collect demographic information.  Following the education session, we will administer a post-
test to evaluate the initial impact and assess participants’ interest and impact of neighborhood 
health.   
4.1 Recruitment and Eligibility. Eligible participants will self-identify at scheduled community 
events with identified community partners.  They will be able to read and understand English or 
Spanish, and be 18 years or older. Participants must also be Philadelphia residents, or receive 
healthcare at a community partner site that is located in Philadelphia. Additional demographic 
data such as age and racial/ethnic background will be collected on the pre-survey. 
Recruitment of participants during the COVID-19 pandemic will be adjusted to adhere to stay-at-
home and social distancing orders. These adjustments will include working with community 
partner sites to assist with the promotion of the liver study via a recruitment flyer to assist with 
identification of potential participants. Individuals interested in participating will contact FCCC 
staff directly at the number provided on the flyer or provide the partner with permission for us to 
contact them. We may also contact participants from a previous study that gave us permission 
to contact them about future research opportunities (IRB #17-8005). Per our protocol, staff will 
identify themselves and let them know why we are calling and how we obtained their name. 
Former study participants who are being re-contacted will be reminded that they gave us 
permission during previous study participation.

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
7
The ongoing COVID-19 pandemic has negatively impacted the research team’s ability to recruit 
via standard methods originally proposed due the “stay-at-home” orders.  Therefore, the team 
would like to explore the following two approaches to facilitate recruitment efforts:
1.
 Collaboratively working with Temple Physicians Inc., an existing partner, we have 
drafted an invitation letter to their patients promoting the study and requesting that 
interested individuals, contact the research team.  No direct patient recruitment will 
be employed.
a.
The TPI practices have been identified and categorized according to the 
priority methodology presented. 
2.
With the approval of a Fox Chase Cancer Center Facebook Community Outreach 
page, we will utilize passive recruitment practices to promote the study, utilizing the 
approved recruitment flyer, to invite interested participants to contact the research 
team member listed on the recruitment flyer[12]. 
a.
The Community Outreach FB sites intended audience is FCCC Community 
Outreach partners and their networks;
b.
No direct targeting of individuals will be administered.  Interested participants 
will call the research team listed on the approved recruitment flyer or may 
click a link provided in the Facebook post to be taken to an opt-in survey in 
REDCap. The opt-in survey responses are only accessible by the study team;
c.
No individual’s personal data will be collected via FB;
d.
No individual’s online activity will be collected and retained by the 
investigators;
e.
Online communications will be monitored to ensure no PHI is divulged.  
f.
Comments posted regarding participation will be allowed as long as no 
specific information that might jeopardize the study is posted i.e. responses to 
questions;
g.
Online communications will be monitored by the Outreach team (Zambon, 
González, Ortiz).  Any negative comments or PHI will be blocked from public 
view.  All negative comments will be collected and if appropriate, will be 
reported to the IRB.
We believe these additional strategies will expand our reach, potentially benefitting our 
recruitment efforts. While the FB approach may garner a broader audience that our priority 
areas, we will continue to utilize the eligibility criteria stated, remaining focused on Philadelphia 
County.  We will monitor and assess the overall impact of our new approaches as part of the 
data analysis and manuscript development.
 
This protocol is registered on clinicaltrials.gov, and eligible individuals who reach out to the 
study contact (Sorice) listed on the study profile will also be recruited. 
Participants recruited during the COVID-19 pandemic will also be asked if they have reliable 
telephone access and if they have access to a computer; due to suspension of in-person 
recruitment, the study will be conducted over the telephone and/or via Zoom or a similar 
platform.

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
8
4.2 Aim 1 Methods: Conduct a geographic scan of liver disease rates and determinants of 
disparity
A. Study Population.  As part of IRB 17-9031, we will use Registry data from the 
Pennsylvania (PA) State Liver Cancer Registry.  This data has about 18,000 incident liver 
cancer cases (primarily Hepatocellular Carcinoma cases) diagnosed from 2003-2015 from the 
cancer registry. For each patient in the registry, we will geocode or request existing geocodes at 
the census tract level to represent the neighborhood in which they live.  We will exclude cases 
missing geocodes, address information or with P.O. Box addresses.  
     B. Area-level Determinants of Disparity.  As part of IRB 17-9031, area level determinants 
of disparity were selected from Year 2010 U.S. Census and the 2010-2015 American 
Community Survey.  In this analysis, we focus primarily on race/ethnic breakdown by 
neighborhood (i.e. % non-Hispanic Black; %Hispanic).  We also collected information on the 
estimated total population of each census tract, gender breakdowns and reported age ranges 
within each census tract to allow for stratification/adjustment.  Area-level determinants of 
Disparity from the U.S. Census data were linked at the census tract level to the PA State 
Cancer Registry.
C. Database Linkage and Geocodes. Geocoding of liver cancer data was completed a part of 
IRB 17-9031. Geocoding is the process of assigning latitude and longitude to a point, based on 
street addresses, city, state and ZIP code. Geocodes are defined here in terms of Federal 
Information Processing Standard (FIPS codes) and will link each case to the geographic area in 
which they live.  These codes include unique identifiers for each state (two digits), each county 
(3 digits), and each census tract (6-digits) in the U.S.  On average, there are approximately 
4,000 residents located in a single census tract; as such, census codes can serve as unique 
identifiers for census tract-level neighborhood characteristics[13], and household information is 
not easily identifiable[13].  Patient addresses, including street address, city, state, and ZIP code, 
are needed to create geocodes and assign individual patients to a census tract. The 
Pennsylvania Cancer Registry and Pennsylvania Department of Health have provided patient 
address for geocoding.     As part of IRB 17-9031, we implemented additional protections for our 
geocoded study populations by employing a “false coordinate system” to decouple household 
addresses from individual personal data attributes.  That is, we have mapped the data in such a 
way that the true geographic location is not stored in the GIS software.  For instance, the actual 
position of an address might be described by the coordinates: -125.652, 24.229.  The statistical 
tools within GIS enable us to very simply alter the true coordinate values by adding or 
subtracting a fixed value to all the X and Y geographic coordinates in the dataset. We intend to 
employ a “minimum-maximum false coordinate range” of  values 1-8 — to ensure that the 
confidentiality of the study participants’ household addresses are, not in any way, compromised.  
Further, for areas or census tracts with a minimal number of patients (i.e. <6 patients), we 
employed geographic aggregation techniques and small area estimations to further protect 
confidentiality[14].  Once geocodes were created from PA Cancer Registry data, patient 
address information were removed and destroyed, as only geocoded, de-identified data was 
kept and used for analysis.  
    D. Liver Disease Definitions.  Incidence rates of hepatocellular cancer(HCC) and early 
(Stage 1/2) versus late stage (Stage 3/4) HCC.
4.3 Aim 2 Methods: Identification of Community Partners and Development of Education 
Session

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
9
A. Identification of Community Partners. Working with long-standing community partners, the 
Office of Community Outreach (OCO) will isolate those located within the “high-risk” 
communities identified via geo-spatial analysis.  Community sites may include community-
based, faith-based, academic, primary care community practices or non-government 
organizations. Once we have worked with a set of identified partner sites, we will seek to 
establish additional partnership to expand our reach.  
Historically, OCO networks with community partners to offer our education sessions via our 
community speaker’s bureau.  The sessions are generally one-hour long and are offered at no 
cost.  For the purposes of this study, we will inform the partner sites that this education session 
is part of a pilot research project we are conducting to determine the community’s 
understanding of the liver cancer burden in the region and to assess their interest in community 
health.  Based on this conversation, the partner will inform us of their interest in participating. 
B. Education Session. The intervention consists of a PowerPoint presentation (See Appendix 
B), an educational brochure, and a pre/post test (Appendix C).  An OCO trained health educator 
will provide delivery of the session; didactic and interactive modalities will be employed to 
engage participants.  This includes sharing liver cancer anatomical models and encouraging 
participants to ask questions during the Q/A period.   
The module will provide participants with a general overview of cancer and will then provide liver 
cancer specific information.  Included in the module is risk factors, symptoms, screening, and 
diagnosis and treatment information.  The PowerPoint presentation will be accompanied by an 
educational brochure for participants to take home with them. Following the liver cancer 
information, the health educator will provide an overview of neighborhood health and what this 
project aspires to yield from our approach.
The PowerPoint liver module is written at a 7.3 grade level and has been vetted for accuracy by 
clinician Minhhuyen Nguyen, MD at Fox Chase Cancer Center.  Behavioral Scientists, Shannon 
Lynch, Ph.D., Jennifer Reese, Ph.D. and OCO Sr. Director Evelyn Gonzalez have developed 
the pre/post tests.  The final versions has been reviewed by the director of health 
communications, Stephanie Raivitch for plain language review.  Once approved by IRB, OCO 
will proceed with translation of the documents into Spanish, using the TUHS approved 
vendor(s). 
Because in-person education sessions cannot be held during the COVID-19 pandemic, the 
educational slides will be converted to a set of handouts that will be sent to the participant 
(along with the educational brochure). The educational intervention materials will be sent via US 
mail to participants who do not have reliable internet access, and those who prefer to view the 
materials online will be offered the choice of having them emailed or texted, or viewing them on 
Zoom. The health educator will call the participant to review the educational materials over the 
telephone (or Zoom). By default, the intervention will be conducted over the telephone and only 
participants who indicate that they are comfortable utilizing a web platform will be offered the 
intervention over Zoom (or a similar program). Zoom instructions will be given over the 
telephone at the time of the intervention to those who opt to receive the intervention online. For 
analysis purposes, intervention delivery method (pre-COVID in-person/telephone/online) will be 
tracked, as well as the timing of the intervention relative to consent and baseline (immediate 
administration, i.e., at time of consent and baseline vs. delayed administration, i.e., after 
materials are mailed to the participant after consent and baseline).

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
10
4.4 Study Procedures
A. Recruitment and Informed Consent. The Office of Community Outreach (OCO) has a 
history of working with multiple community organizations, offering free bilingual education via 
our community speakers bureau.  During our education sessions, community partners 
coordinate logistics, promote our programs and invite community members to participate.  
Recruitment of study participants will occur working through these long-standing community 
partners.  Partner sites will promote the study and invite participants to a session to learn more. 
A recruitment flyer may be used at some sites to advertise the study.
Recruitment efforts will be concentrated in census tracts with the greatest need for intervention, 
i.e., census tracts identified as high-risk due to socioeconomic factors linked to liver cancer 
(e.g., % non-Hispanic Black, household stability) and high rates of liver cancer. If no current 
partners are located in these high-risk census tracts, potential new partners will be identified by 
searching for community centers, federally qualified health centers, etc. 
Individuals who attend the session will be informed about the scope of the study and invited to 
formally participate by the study team.  Individuals interested in participating will be consented 
by health educator Rosa Ortiz, project manager Allison Zambon, or Co-PI Evelyn González prior 
to completing the pre-intervention survey.  Persons not interested will be thanked for their time 
and excused. We anticipate recruiting between 50-100 participants, depending on the number 
of participating community partners and the number of education session completed. Education 
sessions may be conducted on a one-on-one basis or in a group, depending on the number of 
interested individuals present at any given session. Individuals who refuse to participate or who 
withdraw from the project will be treated without prejudice.
Due to the COVID-19 pandemic, in-person recruitment efforts conducted by OCO has ceased. 
During pandemic-related closures, all study-related activities will be conducted over the phone, 
online, and through US mail. Recruitment will be conducted over the telephone, and informed 
consent will be obtained verbally (also over the telephone). Once informed consent is obtained, 
an oral consent document will be sent via US mail to the participant.
B. Study Survey
Once eligibility has been confirmed, informed consent has been obtained, participants will fill out 
a sign-in sheet that includes their street address. If the participant agrees to be contacted about 
this or future research after their participation, they will also be asked to write their telephone 
number on this form. Because the sign-in sheet contains identifiable information, it will be kept 
separate from survey data and will be linked by a study ID assigned to the participant after 
consent. The street address data will be geocoded for neighborhood analysis. Telephone 
numbers will be stored in a secure database. Once geocodes are created from the street 
addresses, hard copies of the sign-in sheets will be destroyed. After the sign-in sheet is collected, 
the study survey will be administered. Once approved, the English survey will be translated into 
Spanish language. Once translated, a modification will be submitted.  
The study “pre” survey will be administered post informed consent process and prior to the 
educational intervention by OCO health educators (field staff).  Upon completion of the 
educational module, a posttest survey will be administered.  All survey data will be entered in the 
RedCap database.  

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
11
Both the pre- and post-survey will contain measures of knowledge about liver risks and 
prevention, self-efficacy about talking to medical professionals about neighborhood risk, as well 
as demographic items (e.g. gender, race/ethnicity).  The post survey will include similar 
knowledge questions as well as additional questions specifically related to neighborhood health, 
including a program evaluation, outcome expectancies about learning about neighborhood 
health (i.e., the extent to which leaning about neighborhood health will be beneficial), and 
intentions to talk with clinicians about liver cancer, neighborhood health and liver cancer 
screening.  Primary outcomes include pre-post changes in knowledge about liver cancer, 
interest in learning about neighborhood health, outcome expectancies for learning about 
neighborhood health, and participant intentions for talking to their doctors about liver cancer 
risk.
During COVID-19 closures, the survey will be administered over the telephone. Mailing and 
street address will be collected during recruitment, so that informed consent copies and 
intervention materials can be mailed to the participant.
C. Follow-up of Participants
At this juncture, we do not anticipate active follow-up of participants. However, we will include 
an option on the consent form for patients to be re-contacted should we determine it necessary 
or if we have other research opportunities. 
5.0 Data Management
All study data released to Fox Chase Cancer Center (FCCC) will be kept in a study-specific, 
secure, password protected, REDCap database (which will be created by the FCCC Population 
Studies Facility or study team). REDCap (Research Electronic Data Capture; developed by 
Vanderbilt University in collaboration from a consortium of institutional partners) will be used for 
electronic data collection and study data management[15]. The REDCap system is a secure, 
web-based application that is flexible enough to be used for a wide variety of research studies. It 
offers intuitive interfaces for data entry and real time data validation. REDCap relies on a study-
specific data dictionary that will be defined by the research team. REDCap supports easy data 
manipulation with audit trails and reporting capabilities, including automated export to common 
statistical packages (SPSS, SAS, Stata, R). REDCap was developed around HIPAA-Security 
guidelines, and all web-based information transmissions are encrypted. REDCap currently 
supports 500+ academic/non-profit consortium partners on six continents and over 70,000 
research end-users (www.project-redcap.org). All data will be stored on a server maintained by 
the FCCC Information Systems and Technology Department in a secure data center. The server 
is backed up to tape on a daily basis and is protected from inappropriate outside access by 
commercial grade firewalls. 
Separate secure databases will be used to a) store information which could identify participants 
(e.g., name, local address, contact information, etc) and b) store geocoded de-identified data from 
regional/state/national data resources for subsequent data linkage. Select research staff will be 
given access to the study REDCap database. Only research staff involved in patient 
recruitment/geocoding will have access to information which could identify participants. Only 
geocoded de-identified data will be used/released for analysis.  Address information will be 
destroyed once geocoding is complete.  All data will be destroyed seven years after study closure.

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
12
6.0 Risks to Participants
     For this study, in Aim 1, we will be utilizing existing data resources under a currently 
approved IRB protocol #17-9031.  Only geocoded (census tract level), de-identified data will be 
used for analysis.  We will provide additional protections for our geocoded study populations as 
follows.  If we are provided patient addresses, we will employ a “false coordinate system” to 
decouple household addresses from individual personal data attributes.  That is, we will map the 
data in such a way that the true geographic location is not stored in the GIS software.  For 
instance, the actual position of an address might be described by the coordinates: -125.652, 
24.229 (see the illustration below).  The statistical tools within GIS enable us to very simply alter 
the true coordinate values by adding or subtracting a fixed value to all the X and Y geographic 
coordinates in the dataset. We intend to employ a “minimum-maximum false coordinate range” 
of  values 1-8 — to ensure that the confidentiality of the study participants’ household addresses 
are, not in any way, compromised.  Further, for areas or census tracts with a minimal number of 
patients (i.e. <6 patients), we will employ geographic aggregation and geomasking techniques 
to further protect confidentiality[14, 16] Given we are working with geocoded, de-identified 
registry data for analysis and employing patient protections during the collection, storage, and 
analysis of data, this study represents minimal risk to participants.
There is no physical risk to participants.  There is a however a small risk that participant(s) may 
feel uncomfortable answering some questions on the survey.   Participants will be informed of 
their options to not answer any question they are uncomfortable responding to.
The study team will make every effort to keep the information provided in the study confidential. 

All information gathered during this study will be kept in locked cabinets or in electronic 
databases that are password-protected.

The study team will delete your name and other information that might identify participants, 
whenever possible.
Additional Protections Against Risk. Fox Chase Cancer Center (FCCC) participates in the 
Collaborative Institutional Training Initiative (CITI) on-line education program. In order to 
participate in the conduct of research, all research personnel involved with human subjects 
research must complete the tutorials designated as applicable to their research role.  Test dates 
and results are on file with the FCCC Institutional Review Board Office and Human Subjects 
Protection Office.  Investigators/staff participating in this project will complete CITI training (and 
have evidence of current certification on-file). In addition, all research personnel will be in 
compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other 
federal/state regulations.
Every effort will be made to protect participants against risk. All participants, will be told that they 
do not have to answer any questions that they do not want to answer and that they have the right 
to withdraw from the project at any time. Data will be collected and maintained in a manner that 
will not jeopardize the integrity of the project, but more importantly the privacy and confidentiality 
of the participants.  
Study processes regarding to data entry, data management are outlined in Section 5.0.
Only persons directly involved with the project will have access to data identifying individuals.  No 
names will be stored on computer files for data analysis, and no individuals will be identified in 
the results of this project. Access to computer-stored information will require simultaneous 

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
13
knowledge of the data format, computer language, file name, and password. We anticipate no 
significant risks
7.0 Potential Benefits to Participants
     There may or may not be direct benefits to the participants of this project.  The information 
learned from this project may benefit underserved populations in our Primary Service Area and 
will contribute to our efforts to better target prevention programs for liver disease and liver cancer. 
FCCC is committed to focusing its clinical and research enterprise on vulnerable populations.   
The proposed local data collection will provide new, potentially “actionable” information about risk 
behaviors, cancer knowledge/attitudes, cancer information access/usage, and cancer screening 
knowledge/access/usage across the various populations served by FCCC. Data/insights 
gathered from the large, at risk, minority population will be of crucial importance. The proposed 
project will also provide the Center with a deeper understanding of knowledge/attitudes about 
screening testing among the populations FCCC serves, which will in turn allow us to more 
effectively engage them in community-based, hypothesis-driven, research initiatives moving 
forward. 
The specific areas of health benefit to the populations served by FCCC will not be appreciated 
until the data are analyzed and strategies to align the Center’s research initiatives with the cancer 
burden in the catchment area Primary Service Area, optimize cancer prevention and control 
efforts, and increase inclusion of minorities in clinical research/trials and biobanking research 
have been implemented. Nonetheless, because the proposed study poses minimal risks to 
participants, the potential health benefits to the populations served will likely greatly outweigh any 
potential risks to participants.
8.0 Provisions to Maintain the Confidentiality of Data
    Research study staff and the FCCC Population Studies Facility will maintain project data in 
confidence according to the rules and regulations of FCCC, the ICR, the FCCC/TU IRB, and 
HIPAA requirements.  All information which could potentially identify participants will be 
maintained on a separate secured database. All paper files with identifiable information will be 
stored under lock and key at all times. All computer systems will be password-protected against 
intrusion; all network-based inter-site communications of confidential information will be 
encrypted.  
     An on-going computer virus protection program is available and utilized, maintained, and 
audited on all computers and pathways into the system, including good practice policies, 
screening of data files, executable software, diskettes, text macros, downloads, and other 
concerns as they arise. The redundant backups described above allow for quick restoration of 
data in the unlikely event that a security breach (or the more likely event of a hardware failure) 
occurs. Patient addresses will be removed from the dataset once geocoding is complete, and only 
geocoded, de-identified data will be used for analysis.  Identifiers will be stored separately from 
study data, and all identifiers and linkages will be destroyed 7 years after the completion of this 
study.
9.0 Costs to Participants
There is not cost associated with this project.  Neither community partners nor participants will 
incur any costs.  

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
14
10.0
Consent Process
Informed consent will be obtained from all participants prior to study participation. The informed 
consent form has been written at a 6.9 grade level and has been reviewed by the health 
communications director at Fox Chase.  The health educator will read aloud the consent to 
participants and participants will be given time to ask questions before they sign consent forms 
(or indicate verbal consent). Participants with email access will be offered the opportunity to be 
sent the verbal consent form via email so that they may read the form along with the recruiter during 
the consent process. Once the individual fully understands each element of the consent, including 
the purpose, requirements, risks, confidentiality, right to withdraw, and contact person, the individual 
will be asked to provide informed consent. Eligible participants will be given a copy of the consent 
form for their records (either a copy of their written consent or an oral consent form). Participants 
who consent in person will be given a copy of the consent form at the time of consent, and those 
who consent verbally over the telephone will be sent a copy of the consent form via U.S. Mail. 
Consents will be translated into Spanish and submitted as a modification in the event we plan to 
enroll Spanish-speaking participants. 
 
The informed consent process for both in-person and telephone verbal consent will be 
documented in detail, and research staff will date and sign the informed consent document. The 
original paper copy of the signed/countersigned document will stored in the participant’s file, as 
well as uploaded into the study REDCap database. 
11.0
Off-Study Criteria
Not applicable
12.0
Drugs and Devices
Not applicable
13.0
Multi-Site Research Study
Not applicable
14.0
Statistical Analysis
14.1 Spatial Analysis. The dataset for the geospatial analysis is de-identified, and geospatially 
aggregated to protect patient confidentiality[14].  Spatial analyses will be conducted by Fox 
Chase Cancer Center/Temple University using SatScan spatial scan statistics that empirically 
identify neighborhood clusters at the census tract level wither higher than expected rates of liver 
cancer [17], similar to existing protocol #17-9031. Mapping will be completed using ArcGIS 10.2 
software (www.esri.com).
14.2 Participant Self-Report Data. Demographics will be summarized using descriptive 
statistics. Statistical analysis for efficacy of the education sessions will include changes in 
knowledge, changes in self-efficacy, and intention. Mean differences will be calculated in self-
report outcome measures at pre- and post-survey, along with standard deviations and the effect 
size (mean difference/SD of the differences).  We will compare the pre-post differences using t-
tests or Wilcoxon tests, as appropriate.
 
14.3 Power.  The sample size calculations are based on the primary outcomes for the pre-post 
evaluation of the education intervention. We assume a standard effect size of 0.3-0.4 on the 
primary outcomes (0.3-0.4 times the standard deviation of the pre-post changes for the 

Shannon Lynch
IRB# 19-1039
Liver Cancer Community Ed
15
measures). We therefore aim to accrue up to 100 patients (but no less than 50) to have 80% 
power to detect a standard effect of 0.3-0.4, with 5% two-sided type-I error.
14.4 Limitations.  Modifiable area unit problem (MAUP) will be evaluated and appropriate 
scale, aggregation, and cluster size will be considered for geospatial analysis.  
15.0
Data Safety Monitoring Plan
Not applicable
16.0
Adverse Events
Not applicable
17.0
Quality Assurance Procedures and Participant Confidentiality
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). To 
ensure confidentiality all records will be on encrypted, password-protected computers (See 
section 7).
Quality assurance procedures for administration of the educational intervention include 
completion of a fidelity checklist to ensure that health educators are reviewing the material in 
consistent and complete manner. Health educators will be asked to track whether any portion of 
the educational slides was not reviewed, and will document reasons for non-completion.
18.0
Participant Informed Consent
See Section 9.0.
19.0
Appendices
Appendix A:  Informed Consent Form
Appendix B:  PowerPoint Presentation and Educational Brochure
Appendix C:  Pre/Post-Test Survey
Appendix D:  Sign in Sheet
20.0
References
1.
Ryerson, A.B., et al., Annual Report to the Nation on the Status of Cancer, 1975-2012, 
featuring the increasing incidence of liver cancer. Cancer, 2016. 122(9): p. 1312-1337.
2.
Altekruse, S.F., Henley, S.J., Cucinell, J.E., McGlynn, K.A., Changing Hepatocellular 
Carcinoma Incidence and Liver Cancer Mortality Rates in the United States. Am J 
Gastroenterol, 2014. 109(4): p. 542-53.
3.
Wetzel, T.M., Graubard, B.I, Quraishi, S., Zeuzem, S., Davila, J.A., El-Serag, H.B., 
McGlynn, K.A. , Population-Attributable Fractions of Risk Factors for Hepatocellular 
Carcinoma in the United States. Am J Gastroenterol, 2013. 108(8): p. 1314-1321.
4.
Makarova-Rusher, O., Altekruse, S., McNeel T., Graubard, B.I., Greten, T., McGlynn, 
K.A., Population Attributable Fractions of Risk Factors for Hepatocellular Carcinoma in 
the United States. Cancer, 2015. 122(11): p. 1757-65.
5.
Statistics, P.D.o.H., Cancer Facts and Figures. 2016: Pittsburgh, PA.
6.
Singal, A.G., Pillai, A., Tiro,  J. , Early Detection, Curative Treatment, and Survival Rates 
for Hepatocellular Carcinoma Surveillance in Patients with Cirrhosis: A Meta-analysis. 
PLoS Me. PLoS Med, 2014. 11(4): p. e1001624. doi:10.1371/journal.pmed.1001624.
7.
NCCN, N.C.C.N., Hepatoceullar Carcinoma Clinical Practice Guidelines. 2017.

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Liver Cancer Community Ed
16
8.
Major, J.M., et al., Local geographic variation in chronic liver disease and hepatocellular 
carcinoma: contributions of socioeconomic deprivation, alcohol retail outlets, and 
lifestyle. Annals of Epidemiology, 2014. 24(2): p. 104-110.
9.
Dowell, S.F., Blazes, D., Desmond-Hellman, S., Four Steps to Precision Public Health. 
Nature, 2016. Comment(189-191).
10.
Perz, J.F., et al., The contributions of hepatitis B virus and hepatitis C virus infections to 
cirrhosis and primary liver cancer worldwide. Journal of Hepatology, 2006. 45(4): p. 529-
538.
11.
Nguyen, G.C. and P.J. Thuluvath, Racial disparity in liver disease: Biological, cultural, or 
socioeconomic factors. Hepatology, 2008. 47(3): p. 1058-1066.
12.
Gelinas, L., et al., Using Social Media as a Research Recruitment Tool: Ethical Issues 
and Recommendations. The American journal of bioethics : AJOB, 2017. 17(3): p. 3-14.
13.
Bureau, U.S.C., 2000 Census Technical Documentation for SF 3 Data. US Department 
of Commerce, 2007.
14.
Babcock, G., Aggregation without aggravation: determining spatial contiguity and joining 
geographic areas using hashing. . Proceedings of the Northeast SAS Users Group 
Conference, 2010. Available at: 
http://support.sas.com/resources/papers/proceedings10/223-2010.pdf.
15.
Harris, P.A., et al., Research electronic data capture (REDCap)--a metadata-driven 
methodology and workflow process for providing translational research informatics 
support. J Biomed Inform, 2009. 42(2): p. 377-81.
16.
Talbot, T. and G. LaSelva. Geographic Aggregation Tool, Version 1.31. 2010; July 
2010:[
17.
Sherman, R.L., et al., Applying Spatial Analysis Tools in Public Health: An Example 
Using SaTScan to Detect Geographic Targets for Colorectal Cancer Screening 
Interventions. Preventing Chronic Disease, 2014. 11: p. E41.