Assessing the Effectiveness of a Community-Based Colorectal Cancer Screening Intervention
Phase: NA
Conditions: Colorectal Cancer Screening
Sponsor: University of Illinois at Chicago

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UI CAAN (Cancer Screening; Access; Awareness; Navigation) 
Assessing the Effectiveness of a Community-Based 
Colorectal Cancer Screening Intervention 
Version: 4 
October 21, 2019 
 
Principal Investigator: 
Karriem S. Watson, DHSc, MS, MPH 
Co-Director, Office of Community Engaged Research UI Cancer Center (OCERIS) 
Research Assistant. Professor, UIC School of Public Health, Community Health 
Sciences 
kswatson@uic.edu 
 
Co-Investigators: 
Vida Henderson, PhD, PharmD, MPH, MFA 
Research Scientist 
Research Assistant Professor 
vhende5@uic.edu  
 
Katherine Tossas-Milligan, PhD, MS 
Co-Director, Office of Community Engaged Research UI Cancer Center (OCERIS) 
ktossa2@uic.edu 
 
Robert A. Winn, MD 
Director, University of Illinois Cancer Center 
Associate Vice Chancellor for Community Based Practice, UI Health 
rwinn@uic.edu 
 
 
Study Location(s): 
University of Illinois at Chicago, including the University of Illinois Cancer Center and 
Mile Square Health Centers; Cut It Out Curt (a barber shop);  

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TABLE OF CONTENTS  
Page 
 
 
TABLE OF CONTENTS .................................................................................................... 2 
LIST OF ABBREVIATIONS .............................................................................................. 3 
1.0 
Project Summary/Abstract........................................................................... 4 
2.0 
Background/Scientific Rationale ................................................................. 5 
3.0 
Objectives/Aims ............................................................................................ 5 
4.1 
Eligibility ........................................................................................................ 6 
4.2 
Inclusion Criteria .......................................................................................... 6 
4.3 
Exclusion Criteria ......................................................................................... 7 
5.0 
Subject Recruitment and Enrollment .......................................................... 7 
6.1 
Study Design and Procedures ..................................................................... 9 
6.3 
Study Procedures ....................................................................................... 10 
7.1 
Expected Risks/Benefits  Potential Risks: ................................................ 12 
8.1 
Data Collection and Management Procedures ......................................... 12 
9.1 
Data Analysis .............................................................................................. 13 
10.1 
Quality Control and Quality Assurance .................................................... 14 
11.0 
Data and Safety Monitoring........................................................................ 14 
12.1 
Statistical Considerations .......................................................................... 15 
13.1 
Regulatory Requirements .......................................................................... 15 
13.3 
Subject Confidentiality ............................................................................... 15 
13.4 
Unanticipated Problems ............................................................................. 16 
14.0 
References .................................................................................................. 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
ACS 
American Cancer Society 
COE 
Community Outreach and Engagement 
CPC 
Cancer Prevention and Control Program 
CRC 
Colorectal Cancer 
DSMB 
Data and Safety Monitoring Board 
DSMP 
Data and Safety Monitoring Plan 
FITs 
Fecal immunochemical tests 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
LGBTQ 
Lesbian, Gay, Bisexual, Transgender, Queer 
MSHC 
Mile Square Health Center 
OCERIS 
Office of Community Engaged Research and Implementation 
Science 
OHRP 
Office of Human Research Protections 
OPRS 
Office for the Protection of Research Subjects 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
UIC 
University of Illinois at Chicago 
UICC 
University of Illinois Cancer Center 
UI CAAN 
Cancer Screening; Access; Awareness; Navigation 
USPSTF 
U.S. Preventive Services Task Force 

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1.0 
Project Summary/Abstract 
 
The UI CAAN (Cancer Screening; Access; Awareness; Navigation) Project is a 
community focused cancer education, prevention, screening and navigation program 
aimed at addressing the elevated burden of cancer among marginalized communities in 
the UI Cancer Center (UICC) catchment area. Cook County is populated by some of the 
most diverse racial/ethnic groups in the US; 2017 census data showed that almost 50% 
of the Cook County population is Hispanic/Latino (25%) and African American (24%). 
The top five cancers with the highest incidence rates in the UICC catchment area 
include Lung, Prostate, Colorectal (CRC), Breast and Cervical cancers. Within the UICC 
catchment, under-represented racial/ethnic minorities carry the greatest burden of 
cancer disparities, which is further impacted by social determinants of health. Cancer 
disparities in racial/ethnic minorities are further impacted by intersecting identities such 
as being a sexual and gender minority (LGBTQ) or by being differently abled. 
 
UI CAAN advances health equity by addressing barriers to care; mobilizing community 
assets and partners; coordinating comprehensive prevention; screening and navigating 
patients to healthcare services and resources; and engaging community members as a 
vital part of the health care workforce. By employing community health workers and 
navigators from communities that are most impacted by cancer inequities, the UI CAAN 
addresses community inequities from an asset-based model. Creating a cancer 
screening/navigation workforce representative of the diversity of the UICC communities 
also addresses workforce needs of underserved communities. The overall goal of this 
project is to evaluate the feasibility of conducting community-based colorectal cancer 
screening in an urban environment. We will study the efficacy of the community-
based intervention on improving CRC screening rates. A controlled trial will be 
conducted to achieve these objectives. Additionally, we will characterize factors that 
inhibit and/or facilitate colorectal cancer screening among people in the UICC catchment 
area. 

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2.0 
Background/Scientific Rationale 
 
Population health can be improved by implementing effective screening programs for 
CRC. CRC is the second-leading cause of cancer death in the United States. The 
USPSTF recommends screening for CRC starting at age 50 years and continuing until 
age 75 years. The American Cancer Society (ACS) recommends screening starting at 
age 45. Fecal immunochemical tests (FITs), which identify intact human hemoglobin in 
stool, are FDA approved tests for detecting CRC (Lin et al. 2016). Screening strategies 
that employ annual screening with FIT have been shown to reduce CRC deaths (Lin et 
al. 
2016). A 2015 community health needs assessment in the South Shore area 
(http://www.southshorehospital.com/wp-content/uploads/2014/07/Community-Health- 
Needs-Assessment-2013.pdf) showed that CRC deaths are an area of opportunity for 
health improvement in the South Shore community area. 
 
The CRC screening process is complex, particularly for those that screen positive and 
require diagnostic evaluation, treatment, and/or repeat screening following an abnormal 
test. Furthermore, screening for CRC is not a one-time activity and instead requires 
annual screening to be most effective. The UI Cancer Center Community Outreach and 
Engagement (COE) program is housed within the Office of Community Engaged 
Research and Implementation Science (OCERIS) of the UI Cancer Center. OCERIS is 
the community engagement and health disparities research arm of the Community 
Outreach and Engagement Program of the UI Cancer Center’s Cancer Prevention and 
Control Program (CPC). Established in 2014, OCERIS has led the mission of the UI 
Cancer Center to ensure the community is at the center of research, screening, 
prevention, and supporting the training of a diverse and inclusive biomedical and 
population health workforce. Mission: The mission of OCERIS is to lead the UI Cancer 
Center in integrating the community in everything it does through fostering community 
based screening, prevention, education, building community-academic partnerships, to 
conduct transdisciplinary research, training and education to reduce the burden of cancer 
health disparities and inequities. 
 
This study is a direct results of OCERIS’ involvement in ongoing community based 
screening and navigation programs, and will go beyond quality improvement in 
screening to extend to answer the important research questions about engagement 
within a healthcare system and lack of follow-up. 
 
3.0 
Objectives/Aims 
 
We propose to address the multiple determinants of health that impact CRC screening 
in the South Shore community in the UI Cancer Center’s catchment area by conducting 
a quasi-experimental intervention to test the effectiveness of FIT tests dispensed by 
community stakeholders (community-dispensed) versus FIT tests dispensed using 
standard of care procedures by a clinic (clinic-dispensed) on FIT test return rates. This 

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study will follow ACS guidelines for FIT testing, with the South Shore community area 
assigned to the intervention group (community-dispensed). CRC screening within the Mile 
Square Englewood Health Center, using standard of care, will serve as our control group to 
use for comparison (clinic-dispensed). The intervention will include a multifaceted approach 
to health education and community engagement focused on CRC led by a team of trusted 
health champions (community leaders, a barber, a hair salon, and community health 
workers) in the South Shore community area. We specifically propose to investigate the 
following three specific aims to be achieved over the three-year project period: 
 
Aim 1: To assess the feasibility and efficacy of the community-based CRC screening 
intervention in increasing CRC screening rates; 
 
Aim 2: To evaluate individual-level knowledge related to CRC 
screening and risk factors; 
 
Aim 3: To characterize individual -level facilitators and barriers to engaging in 
CRC screening and related diagnostic tests and treatment when applicable. 
 
4.1 
Eligibility 
Community Intervention Group/Arm 
Eligibility to participate in this community intervention will primarily be driven by 
location of residence and age, since screening CRC have established age 
criteria for screening initiation. A total of four community health navigators will 
be deployed in the South Shore community area. Each navigator will be 
trained to understand the eligibility criteria and determine subject eligibility. For 
those that consent to take the FIT kit and return it, the navigator will document 
the participants’ eligibility in the appropriate REDCap participant information 
form (attached). .  
 
Standard of Care Comparison Group/Control Arm 
Within the Mile Square Health Center system, lay navigators already work to do 
colorectal cancer screening in the Mile Square Health Center setting. It is 
standard of care for these navigators to engage patients in health education 
and awareness regarding the need for colorectal cancer screening. As such, 
each navigator is familiar with eligibility criteria for screening under standard of 
care. For the purposes of this study, we will use deidentified aggregate data 
from the CRC screening navigation program at the Mile Square Health Center 
in Englewood as a comparison group to evaluate the value of the community 
intervention relative to standard of care. As general practice, each navigator at 
MSHC keeps a running tally of the number of patients approached, deemed 
eligible, and who opt to participate in colorectal cancer screening during each 
day the navigator works in the health center setting. 
 
 
4.2 Inclusion Criteria 
• Male or female adults ages 45 to 74, who speak English and 
reside in or near the South Shore community area or utilize 

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the Mile Square Englewood Health Center. Must not have had 
CRC screening in the previous 12 months. 
 
4.3 Exclusion Criteria 
• Adults ages <45 or >74, those that do not speak English, do 
not reside in o r  n e a r  the South Shore community area, 
do not utilize the Mile Square Englewood Health Center, or 
have had CRC screening in the previous 12 months. 
 
Table 1. Inclusion and Exclusion Criteria 
Cancer 
Screening 
4.1 Inclusion Criteria 
4.2 Exclusion Criteria 
Colorectal 
Male or Female 
Age ≥45 and < 75 years 
Resides in or near the South Shore 
community area (within UI Health 
MSHC-South Shore Clinic Service 
Area) 
Utilizes the Mile Square Englewood 
Health Center 
Age <45 or >75 years 
Does not reside in or near the South 
Shore community area (within UI Health 
MSHC- South Shore Clinic Service Area) 
Does not utilize the Mile Square 
Englewood Health Center 
Does not speak English Has received 
CRC screening in past 12 months 
 
5.0 
Subject Recruitment and Enrollment 
 
Participants will have an opportunity to enroll in this project at multiple points as 
summarized in Table 2. We will enroll at least 600 men and women across a three-year 
period for CRC screening in the South Shore community area, and acquire deidentified 
aggregate comparison data for the men and women who engage in CRC screening in 
the Mile Square Englewood Health Center across the same three-year period. 
 
Community Intervention Group/Arm 
 
For the intervention arm, the team of community navigators will recruit participants from 
multiple venues. We will work with local business owners who are actively engaged in 
health advocacy and will use their local businesses as sites of participant recruitment 
(Cut It Out Curt, a barber shop and a hair salon (Location TBD)) to identify and inform 
eligible community members within or near the South Shore community area about 
CRC screening. These partners will post the attached CRC screening flyer, and engage 
with each potential participant to provide information and education about CRC 
screening using the attached script. If the participant is interested, the partner will inform 
one of our trained community navigators who will connect with the interested participant 
to  review the study information sheet and ask the participant to provide written consent 
to participate. Once the participant agrees to participate, the navigator will document the 
participant’s contact information, and assist the participant in obtaining and 
understanding how to use and return their FIT via mail. The navigator will also give the 
participant a short survey (attached) to complete. The FIT test, instructions, survey, and 
mailing envelope will be contained in a “FIT Kit,” a labeled plastic bag, that will be 

8 
 
dispensed to participant by the community navigator. The FIT and survey will be returned 
to the UICC via mail or dropped off at the barber or hair salon using a drop box (to be 
picked up regularly by research personnel), where it will be processed by key research 
personnel following the manufacturer’s instructions. Participants who receive their FIT 
from the barber or hair salon will be offered a $25 gift certificate to the barber or hair 
salon for use towards a future service. Each community navigator will keep a tally of the 
number of participants who are approached, eligible, and who decline to participate in 
screening for evaluation purposes. All potential participants will be informed that 
declining participation will not influence their ability to participate in any future activities 
at either business or with the UICC. 
 
In addition to  recruitment efforts in the barber shop and beauty salon, our community 
navigators who are trained on the study protocol will attend community events in the 
South Shore and surrounding communities such as the annual African Festival of The 
Arts (https://www.aihusa.org/african-fesitval-of-the-arts) where UICC hosts an 
informational table each year. These navigators will use the attached CRC screening 
flyer, and engage with each potential participant to provide information and education 
about CRC screening using the attached script. If the participant is interested, the 
navigator will review the study information sheet and ask the participant to provide 
written consent to participate. Once the participant agrees to participate, the navigator 
will document the participant’s contact information, and assist the participant in 
obtaining and understanding how to use and return their FIT. The navigator will also 
give the participant a short survey (attached) to complete. The FIT and survey will be 
returned to the UICC via mail or dropped off at the barber or hair salon using a drop 
box, where it will be processed following the manufacturer’s instructions. Any positive 
FIT will be promptly reported (within 48 hours) to the MSHC clinical navigator, who will 
follow standard practices to register the participant as a patient, and navigate the 
participant through standard medical care if clinical follow-up is needed due to a 
positive screening and need for a diagnostic examination within the MSHC System. 
Participants who receive their FIT from a community navigator outside of the barber or 
hail salon setting will be offered a $25 incentive (Walgreens store gift card or cash) to 
be paid upon receipt of the FIT to UICC. Each navigator will keep a tally of the number 
of participants who are approached, eligible, and who decline to participate in 
screening for evaluation purposes. 
 
Standard of Care Comparison Group/Control Arm 
 
For the standard of care control arm, we will obtain deidentified aggregate data from the 
Mile Square Englewood patients that are approached following standard practice 
utilizing clinic schedules, walk-ins, etc. to identify potentially eligible participants for CRC 
screening during the intervention period. This aggregate data will include the number 
approached, the number eligible, the number that  take and return the FIT kit, and the 
number of FITs returned. Among those that return the FIT, aggregate data will be 
provided detailing the proportion of positive FITs, the proportion of positive FIT 
participants who return for diagnostic services, and the proportion of detected cancers.  
 
Table 2. Subject Enrollment Plan 

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Screening 
Target 
Community-Based (Intervention Arm) 
Colorectal 
• Community navigators will work with local businesses (barber shop, 
hair salon) to identify and screen eligible community members within 
or near the South Shore community area. The navigator will engage 
with each potential participant using the attached script. If the 
participant is interested, the navigator will document the participant’s 
contact information, and assist the participant in obtaining and 
returning their FIT. 
• Community navigators will attend community events to post the 
informational flyer and provide education about CRC to community 
members. At these events, they will identify and screen eligible 
community members within or near the South Shore community 
area. The navigator will engage with each potential participant 
using the attached script. If the participant is interested, the 
navigator will document the participant’s contact information, and 
assist the participant in obtaining and returning their FIT. 
Screening 
Target 
• Standard of Care Clinic-Based Comparision Group (Control 
Arm) 
Colorectal 
• These procedures are a detailed summary of the existing lay 
navigation program at MSHC. These procedures are unrelated to our 
research, except to demonstrate how the existing navigation program 
from which we will obtain deidentified data works. 
• Lay clinic navigator use clinic schedules and walk-ins to identify and 
screen eligible participants within the Englewood MSHC. The 
navigator engages with each potential participant using standard 
scripted language. For interested patients, the navigator documents 
interest and FIT dispensing as appropriate, and assists the patient in 
obtaining and returning their FIT. 
• Lay clinic navigators attend community events as normally 
scheduled to provide community-based health education and 
referral to the MSHC. At these events, they identify and screen 
eligible community members within the Englewood community area.  
 
 
6.1 
Study Design and Procedures 
 
6.2 Dimensions of the RE-AIM framework 
 
The overall aim of this study is to assess the feasibility and efficacy of the 
community-based CRC screening intervention in increasing CRC screening rates. We 
have designed this controlled trial in an effort to improve the quality of CRC 
screening that people receive and to assess whether or not implementing a 
community-based intervention where FIT tests are dispensed by community 
stakeholder will increase screening rates for CRC in specific community areas in 

10 
 
Chicago. If we find evidence supporting the efficacy of our intervention, that will 
demonstrate that community-based CRC screening interventions that actively involve 
community stakeholders in screening education and implementation may be a 
potential tool to improve health outcomes among the people that live in medically 
underserved communities. The RE-AIM framework will be used to evaluate both 
process and outcomes of the intervention program (Gaglio et al. 2013; Glasgow et al. 
1999; Glasgow et al. 2019). The RE-AIM framework has proven utility in assessing 
program impact. Through the RE-AIM Framework we will be able to assess Reach, 
Effectiveness, Adoption, Implementation and Maintenance. 
 
Data will be collected to evaluate our ability to “reach” targeted community members, 
hard to reach community members and the targeted number of participants. This is 
defined as the absolute number, proportion, and representativeness of individuals 
who are willing to participate in screening within our target community area. The 
clinical outcomes proposed through this project include improved screening of high 
risk populations for CRC screening and improved early detection of cancer through 
improved screening. To disseminate the findings to key stakeholders and community 
members, we will hold town hall forums to inform community members of findings 
from the project and produce infographics that clearly and succinctly communicate 
study findings. 
 
6.3 Study Procedures 
The expected flow of participants through the study is depicted in Figure 1.  
 

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Community Intervention Group/Arm 
 
For the intervention arm, community navigators will work with local businesses (barber 
shops, nail/hair salons, restaurants, etc.) to identify and screen eligible community 
members within the South Shore community area. In an effort to increase screening 
among the LGBTQ community, navigators will work with local entertainment venues to 
post the study flyer in order to provide information to patrons, and identify eligible 
participants for screening. The navigator will engage with each potential participant 
using the attached script. If the participant is interested, the navigator will review the 
study information sheet and ask the participant to provide written consent to participate. 
Once the participant agrees to participate, the navigator will collect contact information 
from the participant (see Participant Information Form), and provide the participant with 
a FIT, a short survey to complete and return with their FIT, and a postage paid 
envelope addressed for delivery to the UICC. The participant will also have the option 
to return the FIT at the barber or hair salon using a drop box. If the FIT is not returned 
within two weeks, the navigator will call the participant to remind them to return the FIT. 
 
FITs will be returned via mail directly to the UICC, where they will be processed 
following the manufacturer’s guidelines. Navigators will call back each participant to let 
them know about the results of their FIT using the attached script. If a participant 
screens positive, the participant will be informed by the navigator, who will direct the 
participant to the MSHC- South Shore Clinic, and connect the participant to the MSHC- 
South Shore clinical patient navigator. We will track the time between FIT dispensing 
and return, and the time between FIT processing and participant agreement to engage 
in diagnostic testing with the clinical navigator at MSHC as indicated (for those that 
screen positive). Once the FIT is returned, participation in the study will end. However, 
for those that have a positive/abnormal FIT, the community navigator will refer the 
person to MSHC for clinical follow-up. This is not part of the research, but to ensure a 
continuum of care among those that screen positive. The clinical navigator will follow 
the standard clinical flow and standard clinical care practices used at the MSHC- South 
Shore Clinic to schedule the participant for a diagnostic test, and any further procedures 
or treatments necessary. This will include, but is not limited to, helping the participant 
enroll in a health insurance program if the participant is uninsured, and/or obtaining a 
voucher to pay for the diagnostic/further screening examinations and tests. For CRC 
screening, we have partnered with administrative and clinical staff at the MSHC- South 
Shore clinic in the South Shore community area to facilitate this transition when needed.  
 
Standard of Care Comparison Group/Control Arm 
 
For the standard of care control arm, the lay patient navigator at Mile Square 
Englewood Health Center will provide deidentified aggregate data from the Mile Square 
Englewood patients that are approached following standard practice utilizing clinic 
schedules, walk-ins, etc. to identify potentially eligible participants for CRC screening 
during the intervention period. This aggregate data will include the number approached, 
the number eligible, the number that  take and return the FIT kit, and the number of FITs 
returned. Among those that return the FIT, aggregate data will be provided detailing the 

12 
 
proportion of positive FITs, the proportion of positive FIT participants who return for 
diagnostic services, and the proportion of detected cancer. 
 
For project evaluation purposes and to compare to the intervention arm, the deidentified 
aggregate data will include the number of participants who receive the FIT, return the 
FIT, screen positive, have a positive diagnostic, and receive a diagnosis. We will track 
the time between FIT dispensing and return, and the time between FIT processing and 
participant engagement in diagnostic testing as indicated (for those that screen positive).  
 
7.1 
Expected Risks/Benefits  
Potential Risks: 
• Participants who engage in colorectal cancer screening by completing and 
returning the FIT may require diagnostic testing to evaluate if they have 
colorectal cancer. Some of the participants identified for diagnostic testing 
may or may not have colorectal cancer. Engaging in subsequent diagnostic 
testing and/or receiving a cancer diagnosis may cause these participants to 
feel psychological discomfort. All diagnostic and subsequent testing (as 
necessary) will be conducted within the MSHC system under standard of 
care, which has resources and trained staff to answer questions that 
participants may have during this time. 
• Breach of confidentiality is another risk to individuals. To minimize the loss of 
confidentiality, the PHI collected for the participants will be kept on a 
password-protected UICC secure server network. No published data or public 
reports will have any identifiable information. 
• We do not foresee any other physical, psychological, social, or legal risks to 
subjects. 
Potential Benefits to Subjects and Society: 
• An individual may benefit from participation in this study by having an 
existing cancer identified and diagnosed and being navigated to a source 
of treatment. 
• Friends and family members of individual participants may benefit from 
increased awareness about colorectal cancer and the recommendations for 
screening. 
• The potential benefit to society is that this study could have important public 
health implications future community based screening programs of adults. 
The information learned from this evaluation may aid future intervention or 
prevention studies. 
 
8.1 
Data Collection and Management Procedures 
• Navigators will collect participant contact information for tracking and follow- 
up using REDCap. 
• Survey data will be collected via a paper survey, which will be entered into 
REDCap. Following data entry, paper copies will be destroyed. 
• All participant Protected Health Information (PHI), including contact 

13 
 
information, and full street address, unique participant ID numbers, 
demographic, the date a FIT was returned or diagnostic completed 
[colonoscopy]), navigation and follow-up data is stored on the University of 
UICC‘s password-protected secure server (K drive) in an encrypted Excel 
data entry workbook. Only the Principal Investigator (PI), Co-Investigators 
(Co-I), and key research personnel have access to the password-protected 
data entry workbook. 
• Data will be harmonized and cleaned prior to analyses by the statistical team 
at the UICC and stored on the UICC secured server.  All individual 
workstations at UIC that access data with PHI will be encrypted.  PIs will have 
access to all data collected. Overall data management will be overseen by the 
PI and Research team. 
9.1 
Data Analysis 
 
• Prior to any analyses, all data sources (tracking, demographic, and 
questionnaire) will be cleaned and linked using the participant unique study 
identifier. We will summarize the data using frequencies and percentages for 
categorical variables, and means and standard deviations for continuous 
variables. 
 
 
Aim 1: To assess the feasibility and efficacy of conducting a community-
based CRC screening intervention in increasing CRC screening rates. We 
aim to evaluate the feasibility and efficacy of conducting a community- based 
navigation program for colorectal cancer screening. In both arms of the study, we 
will examine the number of participants who were provided with health education 
about colorectal cancer, the number of FITs distributed, and the number of FITs 
returned. We will summarize the number of persons screened positive and 
negative, and determine the proportion of positive screening participants who 
are referred to clinical care overall, and at the Mile Square South Shore and 
Englewood sites through our community navigation program (intervention) and 
existing MSHC lay clinical navigation program. We will compare the FIT return 
rate and average return time at the South Shore and Englewood sites to 
determine if the rates and times are similar. We will also determine return rates 
and times for participants who screen positive and are navigated to return the 
MSHC for diagnostic testing, and make comparisons across the intervention and 
control arms.  
 
Aim 2: To evaluate individual-level knowledge related to CRC screening 
and risk factors. We aim to assess knowledge related to CRC screening and 
risk factors as measured by our short survey that participants will return with their 
FIT. We will summarize the frequency and percentage of respondents who have 
had a prior CRC screening, in addition to the frequency and percentage of 
respondents who select the correct answers on knowledge questions. 
 
Aim 3: To characterize individual -level facilitators and barriers to engaging 
in CRC screening and related diagnostic tests and treatment when 

14 
 
applicable. We aim to evaluate facilitators and barriers people living in or near 
the South Shore communities experience related to CRC screening and related 
follow-up. We will summarize the respondent responses to survey questions about 
barriers and facilitators. 
 
10.1 Quality Control and Quality Assurance 
• 
The program evaluator (Jessica Madrigal) will monitoring the data entry in 
REDCap weekly, and follow up with the navigation team as appropriate for 
continued quality control and improvements. 
• 
The PIs will supervise and review the results of the FIT. 
 
11.0 Data and Safety Monitoring 
 
All participant information, including survey questionnaires and contact 
information will be kept secure with strict confidentiality. All key research 
personnel and clinical collaborators are or will be aware of HIPAA rules and 
will adhere to its policies when necessitated by science, before they initiate 
contact with participants. Risk of access to participant information will 
require simultaneous knowledge of data format, file name, password, and 
computer language. No individuals will be identified in any reports from the 
study. Confidentiality of participants will be protected in this project through 
assignment of a study identification number. Information linking the 
participant name and study ID number will be kept in a separate password-
protected computer file that has no data concerning survey or other study-
related data. Survey questionnaires, screening results, and details 
regarding engagement with the MSHC (among those with positive 
screening) will be coded and managed as separate files in a protected part 
of the computer network. Personal health identifying (PHI) information will 
be saved in XML files. De-identified survey questionnaire will be kept in 
standard statistical packages, including SSPS, SAS, or Stata. Data will be 
regularly backed up and securely stored. No information will be released 
that could lead to identification of any participating individual. All files will be 
encrypted/password-protected. We will log dates when the data are 
handled. We will have regular study team meetings to discuss data 
handling issues. Any breaches in confidentiality or privacy as well as any 
possible adverse effects that are unanticipated will be immediately reported 
to the UIC IRB for review and action. The study PIs will keep a log of the 
outcome of IRB decisions regarding these events and ensure study staff 
are aware of changes made as a result of IRB decisions. 
 
Adverse Event Monitoring and Reporting. Participants will be asked to 
report each adverse health event in person at study visits or via 
telephone/email to Dr. Watson or University of Illinois at Chicago 
Institutional Review Board (IRB). The investigative team will monitor 
adverse health events related to the study procedures, respectively. The PI 
and his team will consult and determine the severity and appropriate 

15 
 
response or action to the reported adverse health event. All serious 
unanticipated problems or serious adverse health events will be reported to 
the UIC IRB within 24 hours. Serious adverse health events are extremely 
unlikely to occur in this study; however, if such an event occurs, Dr. Watson 
will immediately inform the UIC Office for the Protection of Research 
Subjects and IRB within 24 hours. Any adverse event of a nature serious 
enough to warrant withdrawal from the study will also be reported to the 
UIC IRB in a timely manner. UIC Office for the Protection  of Research 
Subjects requires that all other problems (non-serious adverse events) be 
reported within five days of discovery and provide sufficient information to 
gauge severity and to complete the mandatory Office for the Protection of 
Research Subjects report form. UIC Office for the Protection of Research 
Subjects has procedures in place to review the report form, and the PI is 
notified if further review, changes to research protocol or consent form, or 
other action is required.  
 
12.1 Statistical Considerations 
• 
The primary aim of this project is to evaluate the feasibility and efficacy of a 
community- b a s e d  cancer screening intervention. The projected sample 
size will allow us to determine if the intervention is feasible, and we anticipate 
the sample size will be sufficient to make comparisons across the 
intervention and control arms of the study. The purpose of any analyses 
conducted is to understand the needs of the community being served and to 
inform future interventions in this area as they relate to cancer control and 
prevention. 
 
13.1 Regulatory Requirements 
 
13.2 Informed Consent 
 
This research presents no more than minimal risk of harm to the participants. Written 
informed consent will be obtained by the community navigator prior to dispensing the 
FIT in the community. During the recruitment process, the community navigator team 
members will describe the study and screen potentially eligible participants. The 
community navigator team will use the attached script and informed consent document 
to inform all potential participants of the study procedures. Interested participants will 
provide written documentation of consent if they decide to enroll in the study. In addition 
to training on health education and colorectal cancer screening content, informed 
consent training for the navigators will include consent simulations in which the trainee 
will read the consent script and respond to various questions about the purpose and 
procedures of the project. All navigators will practice explaining the study and obtaining 
informed consent with the study staff prior to engaging in recruitment and enrollment. All 
adult participants will provide written informed consent for participation.  
 
13.3 Subject Confidentiality 
 
As described in section 11.0, no protected health information will be stored with the 

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electronic datasets, and research datasets will be stored on a secure data server in the 
UI Cancer Center (maintained by the UIC College of Medicine IT department), 
accessible only by password, and backed up every night. For the purposes of 
enrollment and follow-up reminders for return of the FIT, some PHI will be collected, 
including name and address. This data is collected only because it is necessary to 
complete the research objectives.  This information will be entered into a secure 
REDCap database. Identifying information for the study participants will be kept 
separately from the analytic dataset and will only be accessed by the PIs. These 
precautions are expected to be completely effective in eliminating risks to 
confidentiality.  pIdentifiers will be kept separate from the study data. At the conclusion 
of the study, the research data with be stored without any PHI on a secure server in 
the UI Cancer Center (maintained by the UIC College of Medicine IT department). 
 
13.4 Unanticipated Problems 
 
Although unlikely, should any unanticipated problems or deviations from the protocol 
occur, the IRB will be promptly notified. When appropriate, the protocol would be 
amended to prevent further unanticipated problems or deviations from the protocol. 
 
14.0 References 
 
Gaglio B, Shoup JA, Glasgow RE. 2013. The re-aim framework: A systematic review of 
use over time. American journal of public health 103:e38-46. 
Glasgow RE, Vogt TM, Boles SM. 1999. Evaluating the public health impact of health 
promotion interventions: The re-aim framework. American journal of public health 
89:1322-1327. 
Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, et al. 2019. Re-aim 
planning and evaluation framework: Adapting to new science and practice with a 20- 
year review. Frontiers in public health 7:64. 
Kim JJ, Burger EA, Regan C, Sy S. 2018. U.S. Preventive services task force evidence 
syntheses, formerly systematic evidence reviews. In: Screening for cervical cancer in 
primary care: A decision analysis for the us preventive services task force. Rockville, 
MD:Agency for Healthcare Research and Quality (US). 
Lin JS, Piper MA, Perdue LA, Rutter C, Webber EM, O'Connor E, et al. 2016. U.S. 
Preventive services task force evidence syntheses, formerly systematic evidence 
reviews. In: Screening for colorectal cancer: A systematic review for the us preventive 
services task force. Rockville (MD):Agency for Healthcare Research and Quality (US). 
Siu AL. 2016. Screening for breast cancer: U.S. Preventive services task force 
recommendation statement. Annals of internal medicine 164:279-296. 
Steele CB, Townsend JS, Courtney-Long EA, Young M. 2017. Prevalence of cancer 
screening among adults with disabilities, united states, 2013. Preventing chronic 
disease 14:E09. 
U.S. Preventive Services Task Force. 2018. Final update summary: Cervical cancer: 
Screening. U.S. Preventive services task force. August 2018. Available: 
https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/c 

17 
 
ervical-cancer-screening2. 
U.S. Preventive Services Task Force. 2019. Final recommendation statement: Breast 
cancer: Screening. U.S. Preventive services task force. . Available: 
https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationState 
mentFinal/breast-cancer-screening1. 
US Preventive Services Task Force. 2008. Screening for colorectal cancer: U.S. 
Preventive services task force recommendation statement. Annals of internal medicine 
149:627-637. 
White A, Thompson TD, White MC, Sabatino SA, de Moor J, Doria-Rose PV, et al. 
2017. Cancer screening test use - united states, 2015. MMWR Morbidity and mortality 
weekly report 66:201-206.