Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
Phase: NA
Conditions: Colorectal Cancer
Sponsor: NYU Langone Health

 
 
Official Title: 
Colorectal cancer screening through proactive outreach and navigation 
in federally qualified health care center in Brooklyn 
NCT Number: 
NCT05646355 
Study Number: 
 
 s22-00730 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
November 5, 2022 
 
 

CLINICAL STUDY PROTOCOL 
 
 
Colorectal cancer screening through 
proactive outreach and navigation in 
federally qualified health care center in 
Brooklyn 
 
Principal Investigator 
Aasma Shaukat 
Study Number 
s22-00730 
Protocol Version 
5 November 2022 
 
 
 
 
 
 
 
 
 
 

Study Number: 22-00730 
5 November 2022 
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Study Personnel 
Principal Investigator 
Aasma Shaukat 
NYU Langone Health & NYU Grossman School of Medicine 
Division of Gastroenterology & Hepatology 
Email: Aasma.Shaukat@nyulangone.org 
Address: 240 E 38th St, 23rd Floor, New York, NY 10016 
Phone: 929-458-5502  
Sub-Investigators 
Oliver Stewart 
NYU Grossman School of Medicine 
Graduate Medical Education 
Email: Oliver.Stewart@nyulangone.org 
Address: 462 1st Ave, 4th Floor, New York, NY 10016 
Phone: 561-847-1614 
Research Coordinators 
Jennifer Stromberg 
NYU Langone Health & NYU Grossman School of Medicine 
Division of Gastroenterology & Hepatology 
Email: Jennifer.Stromberg@nyulangone.org 
Address: 240 E 38th St, 23rd Floor, New York, NY 10016 
Phone: 612-747-9205 
 
Jessica Rauch 
NYU Langone Health & NYU Grossman School of Medicine 
Division of Gastroenterology & Hepatology 
Email: Jessica.Rauch@nyulangone.org 
Address: 240 E 38th St, 23rd Floor, New York, NY 10016 
Phone: 415-939-0214 
 
Ashley Augustin 
NYU Langone Health & NYU Grossman School of Medicine 
Division of Gastroenterology & Hepatology 
Email: Ashely.Augustin@nyulangone.org 
Address: 240 E 38th St, 23rd Floor, New York, NY 10016 
Phone: 516-506-1608 
Biostatistician 
Chan Wang 
NYU Langone Health 
Population Health 
Email: Chan.Wang@nhyulangone.org 
Address: 180 Madison Ave, 2nd Floor, New York, NY 10016 
Phone:  
 
 
 
 

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SYNOPSIS 
Study Purpose 
The purpose of our study is to assess the effectiveness and acceptability of a proactive 
screening outreach program on colorectal cancer screening rates for eligible patients at the 
Flatbush Family Health Center. 
Primary Objective 
The primary objective is to compare the effectiveness of a strategy of proactive invitation 
(eligibility assessment followed by a mailed invitation program and navigation) vs. standard-
care colorectal cancer screening at the Flatbush Family Health Center. 
Secondary Objectives  
The secondary objective is to identify potential barriers and facilitators to the implementation 
of a proactive outreach colorectal cancer screening program by performing quantitative 
surveys and qualitative interviews of randomly selected sample of providers and patients. 
General Design Description 
Randomized, controlled, non-blinded study  
Study Date Range and Duration 
The estimated duration for the study is approximately one year from the start of the 
intervention period (anticipated November 2022 – November 2023, depending on all 
approvals and other factors outside of the control of the study team). 
Number of Study Sites 
There is 1 study site for this project: Flatbush Family Health Center at NYU Langone 
Primary Outcome Variables 
The primary outcome variable is completion of initial fecal immunochemical test (FIT) or 
colonoscopy at 6 months. 
Secondary and Exploratory Outcome Variables  
Secondary outcome variables include: 
1) Completion of colonoscopy for individuals with a positive fecal immunochemical test at 6 
months. 
2) Determination of factors associated with non-adherence to initial fecal immunochemical 
testing or colonoscopy, and to completion of colonoscopy for those with positive FIT. 
 
 

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Study Population 
The study population will be individuals aged 45-75 years old who receive medical care at a 
federally qualified health care center in Brooklyn, New York whom are either due or overdue 
for colorectal cancer screening. 
Number of Participants 
There will be a total of 100 participants in the study, 50 of whom will be randomized to 
receive proactive screening outreach and 50 of whom will be randomized to receive usual 
care.  
Study Flow Chart  
  
QTR 
1 
QTR 
2 
QTR 
3 
QTR 
4 
QTR 
5 
QTR 
6 
Develop tailored invitation and other study 
letters; develop process for FIT mailings 
and returns; Work with FHC to establish 
process for training staff; IT support for 
obtaining list of screen eligible individuals 
and electronic data capture; Develop 
Protocol; Develop qualitative interview 
guides; Set up database for data entry in 
REDCap; IRB approvals 
X X   
  
  
  
  
  
 
Perform the screening program at FHC 
  
  
X X X  
X 
  
  
 
Study accuracy of organized screening 
program and logistical aspects 
  
  
  
  
 
X  X 
  
 
Perform physician and patient qualitative 
interviews 
  
  
  
  
 
X  X 
 X 
 
Collect data on screening rates and perform 
analyses as planned and dissemination 
  
  
  
  
  
  
 
X 
X 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS 
Abbreviation  
Explanation 
CRC 
Colorectal Cancer 
EMR 
Electronic Medical Records system 
FHC  
Family Health Center  
FIT 
Fecal immunochemical test 
 
 

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Table of Contents 
SYNOPSIS ...................................................................................................................................... 3 
ABBREVIATIONS ........................................................................................................................ 5 
1 - Statement of Compliance........................................................................................................... 9 
1.1 Statement of Compliance ...................................................................................................... 9 
2 - Background .............................................................................................................................. 10 
2.1 Background ......................................................................................................................... 10 
3 - Rationale/Significance ............................................................................................................. 11 
3.1 Problem Statement .............................................................................................................. 11 
3.2 Purpose of Study/Potential Impact ...................................................................................... 11 
3.3 Potential Risks and Benefits ................................................................................................ 11 
3.3.1 Potential Risks .............................................................................................................. 11 
3.3.2 Potential Benefits .......................................................................................................... 12 
4 - Study Objectives ...................................................................................................................... 13 
4.1 Hypothesis ........................................................................................................................... 13 
4.2 Primary Objective ............................................................................................................... 13 
4.3 Secondary Objectives .......................................................................................................... 13 
5 - Study Design............................................................................................................................ 14 
5.1 General Design Description ................................................................................................ 14 
5.1.1 Study Date Range and Duration ................................................................................... 14 
5.1.2 Number of Study Sites .................................................................................................. 14 
5.2 Outcome Variables .............................................................................................................. 14 
5.2.1 Primary Outcome Variables ......................................................................................... 14 
5.2.2 Secondary and Exploratory Outcome Variables .......................................................... 14 
5.3 Study Population ................................................................................................................. 15 
5.3.1 Number of Participants ................................................................................................. 15 
5.3.2 Inclusion Criteria  ......................................................................................................... 15 
5.3.3 Exclusion Criteria ......................................................................................................... 15 
5.3.4 Vulnerable Populations ................................................................................................. 15 
6 – Methods................................................................................................................................... 16 
6.1 Intervention ......................................................................................................................... 16 
6.1.1 Description of Intervention ........................................................................................... 16 
6.1.2 Method of Assignment/Randomization ........................................................................ 17 

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6.1.3 Selection of Instruments/Outcome Measures ............................................................... 17 
6.1.4 Intervention Administration ......................................................................................... 17 
6.1.5 Reaction Management .................................................................................................. 18 
6.2 Assessments ........................................................................................................................ 18 
6.2.1 Efficacy ......................................................................................................................... 18 
6.2.2 Adverse Events Definition and Reporting .................................................................... 18 
6.3 Study Procedures ................................................................................................................. 18 
6.3.1 Study Schedule ............................................................................................................. 18 
6.3.2 Informed Consent ......................................................................................................... 18 
6.3.3 Screening ...................................................................................................................... 19 
6.3.4 Recruitment, Enrollment and Retention ....................................................................... 19 
6.3.5 Study Visits .................................................................................................................. 20 
6.3.6 End of Study and Follow Up ........................................................................................ 20 
6.3.7 Removal of Subjects ..................................................................................................... 20 
6.4 Statistical Method ................................................................................................................ 21 
6.4.1 Statistical Design .......................................................................................................... 21 
6.4.2 Sample Size Considerations ......................................................................................... 21 
6.4.3 Planned Analyses .......................................................................................................... 21 
6.4.3.1 Primary Analyses ....................................................................................................... 21 
6.4.3.2 Secondary Objectives Analyses................................................................................. 21 
6.4.3.3 Analysis of Subject Characteristics ........................................................................... 21 
7 – Study Administration .............................................................................................................. 22 
7.1 Ethical Considerations: Informed Consent and HIPAA Authorization .............................. 22 
7.2 Institutional Review Board (IRB) Review .......................................................................... 22 
7.3 Subject Privacy, Confidentiality & Data Management ....................................................... 22 
7.4 Deviations/Unanticipated Problems .................................................................................... 22 
7.5 Data Collection .................................................................................................................... 22 
7.6 Data Quality Assurance ....................................................................................................... 23 
7.7 Study Records ..................................................................................................................... 23 
7.8 Access to Source ................................................................................................................. 23 
7.9 Data Storage / Security ........................................................................................................ 23 
7.10 Retention of Records ......................................................................................................... 23 
7.11 Future Use of Stored Data ................................................................................................. 23 
7.12 Study Monitoring .............................................................................................................. 24 

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7.13 Data Monitoring Plan ........................................................................................................ 24 
7.13 Study Modification ............................................................................................................ 24 
7.14 Study Discontinuation ....................................................................................................... 24 
7.15 Study Completion .............................................................................................................. 24 
7.16 Conflict of Interest Management Plan .............................................................................. 24 
7.17 Funding Source ................................................................................................................. 24 
REFERENCES ............................................................................................................................. 25 
 
 
 

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1 - Statement of Compliance 
1.1 Statement of Compliance 
This document is a protocol for a human research study. The purpose of this protocol is to ensure 
that this study is to be conducted according to the Common Rule at 45CFR46 (human subjects) 
and other applicable government regulations and Institutional research policies and procedures. 
 
 

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2 - Background 
2.1 Background 
Colorectal Cancer (CRC) is the third most common cancer in men and women and the second 
leading cause of cancer related death7. Screening for CRC reduces CRC incidence and mortality, 
and is recommended for average risk men and women between the ages of 45 and 75 by the US 
Preventive Services Task Force guidelines; which were updated recently to include 45-49 year 
olds, an additional 20 million individuals in the US1. In New York State, CRC screening rates 
are over 70%2 but only 48-52% in Brooklyn family health centers (FHC) that provide free and 
subsidized health services to underrepresented minorities. Currently, invitations to screen are 
offered only when a patient is seen by his or her provider. Consequently, many eligible 
individuals, particularly 45-55 year olds who do not regularly access healthcare are under-
screened. 
 
 

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3 - Rationale/Significance 
3.1 Problem Statement 
CRC screening rates are 72% in New York State2 but 48-55% in the federally qualified health 
center where we anticipate performing the study. Hence, there is an unmet need to organize and 
implement CRC screening using multilevel interventions to improve screening rates.  
The current model for CRC screening is far from optimal and poses many barriers at the patient, 
provider and systems level. At the patient level: the current model requires an in-person or 
telehealth visit, which poses barriers through difficulty accessing transportation, time 
commitments and financial barriers. Furthermore, men and women aged 45-55 (on the younger 
end of the screening spectrum) may not have a primary care provider or seek routine medical 
care. Many individuals may not know they are eligible for CRC screening or the benefits of CRC 
screening. At the provider level, barriers include lack of up to date information and a lack of time 
to address CRC screening in a short clinic visit with many pressing urgent medical needs. The 
alternative method of screening we are proposing, an organized program of proactive invitation, 
has two main components: 1) identification of screen eligible individuals using health records 
from the clinic; and 2) a proactive invitation program, with (a) mailed invitation, (b) a package 
of materials so patients can complete a fecal immunochemical test (FIT) from their homes (i.e., 
FIT kit), and (c) instructions on how to schedule colonoscopy if they prefer this to completing 
the FIT. From a public health perspective, an outreach screening program is more likely to reach 
all individuals eligible for screening.     
              
Multiple trials have reported higher screening rates with proactive invitation through outreach 
efforts and programmatic approaches, compared to usual care3,4.  Kaiser Permanente Northern 
and Southern California implemented proactive outreach screening in 2008, based primarily on 
annual FIT.  Their reported rates of CRC screening are one of the highest in the country, at 
81%5,6.  In their recent publication, they reported that 323,349 health plan members were reached 
through the program. Completion rates for screening improved from 48% to 86% over 4 rounds 
of implementing the outreach screening process. The program detected 80% of patients 
diagnosed with stage I colon cancer within 1 year of screening6.      
              
3.2 Purpose of Study/Potential Impact 
Disparities exist in the CRC screening rates in the Brooklyn family health centers compared to 
New York State at large, likely driven primarily by social determinants of health. The purpose of 
this study is to establish the effectiveness of a proactive CRC screening outreach approach on 
improving CRC screening rates in an underserved population. We will also gather data regarding 
patient and provider perception of feasibility and overall experience with the proactive outreach 
program in order to better inform future screening implementation efforts. Ultimately, the 
broader goal is to decrease patient morbidity and mortality from CRC through improved 
screening rates. 
 
3.3 Potential Risks and Benefits 
3.3.1 Potential Risks 

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Potential risks of the study include psychological harm associated with potential false-positive 
results on FIT screening or rare adverse reactions to routine colonoscopy screening which may 
include bleeding, bowel perforation, or adverse reactions to anesthesia during colonoscopy. 
 
There is also a risk of loss of confidentiality. To protect participant confidentiality, the records 
from the study will be kept private. Any published reports will not include any information that 
can be used to identify individuals. Research records will be stored securely and only the study 
team will have access to the records. The recordings from interviews will only be accessible to 
the study team and a professional transcription service. The transcriptions of the recordings will 
have all identifying information removed. The recordings will be destroyed at the end of the 
study. De-identified information from the interviews will be provided to Flatbush FHC for the 
purpose of improving their colorectal cancer screening program.  
 
3.3.2 Potential Benefits 
Potential benefits to subjects include improved access to CRC screening, earlier detection of 
CRC, and decreased morbidity and mortality associated with CRC. On a larger scale, potential 
benefits to society at large include further proof of concept of the efficacy of proactive outreach 
programs for increasing CRC screening rates amongst underserved populations. CRC is the third 
most common cancer in men and women as well as the second leading cause of cancer related 
death7. Given that CRC screening is associated with decreased morbidity and mortality, the 
benefits of improving screening rates far outweigh any potential risks associated with our study. 
 
 
 

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4 - Study Objectives 
4.1 Hypothesis 
We hypothesize that CRC screening rates will improve in underserved populations with the 
implementation of a proactive approach that incorporates a mailed outreach invitation to screen 
with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy 
completion if preferred or indicated by FIT test result. 
 
4.2 Primary Objective 
The primary objective is to compare the effectiveness of a strategy of proactive invitation 
(eligibility assessment followed by a mailed invitation program and navigation) vs. standard-care 
CRC screening at Flatbush Family Health. 
 
4.3 Secondary Objectives 
The secondary objective is to identify potential barriers and facilitators to the implementation of 
a proactive outreach CRC screening program by performing quantitative surveys and qualitative 
interviews of a randomly selected sample of providers and patients. These data can be used to 
inform further tailoring of an ongoing program of proactive CRC screening at this clinic, if 
shown to be feasible and effective. 
 
 

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5 - Study Design 
5.1 General Design Description 
Our study is a single-site randomized, compared effectiveness study. Patients randomized to the 
proactive outreach group will be blind to the presence of an alternative group assignment. 
Patients randomized to the usual care group will be blind to the presence of group assignment 
altogether. Group allocation will be concealed because all patients will be randomized at a single 
time point. To accurately assess whether this proactive approach is effective, real-world, 
unbiased behavior by the patients involved is vital. Intervention group patients will be informed 
that their data will be used for this research project via a study information sheet included with 
the initial FIT kit mailing. This sheet will clearly indicate that the CRC screening itself is 
standard of care screening for which they are due and not a research test. We are seeking a 
waiver of HIPAA authorization, a complete waiver of consent for the usual care group, and a 
waiver of documentation of written consent for the intervention group, including the subset of 
intervention patients who complete the post-intervention interview.  This subset will be verbally 
consented via telephone prior to completing the interview. 
 
The study team will operate mainly in the background, to facilitate mailings and reminders. All 
materials will be sent on behalf of the clinic, using the clinic’s usual stationery, and containing 
the electronic signature of the patient’s primary care physician, when applicable. The study team 
will be tracking the cost and effort involved to help the clinic determine the feasibility of long-
term implementation of a proactive screening program for CRC. 
 
5.1.1 Study Date Range and Duration 
The estimated duration for the study is approximately one year from the start of the intervention 
period (anticipated November 2022 – November 2023, depending on all approvals and other 
factors outside of the control of the study team).  
 
5.1.2 Number of Study Sites 
There is 1 study site for this project (Flatbush Family Health Center at NYU Langone). 
 
5.2 Outcome Variables 
Please see the following primary and secondary outcome variables below. 
 
5.2.1 Primary Outcome Variables 
The primary outcome variable is completion of initial fecal immunochemical test (FIT) or 
colonoscopy at 6 months. 
 
5.2.2 Secondary and Exploratory Outcome Variables  

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1) Completion of colonoscopy for individuals with a positive fecal immunochemical test at 6 
months. 
 
2) Determination of factors associated with non-adherence to initial fecal immunochemical 
testing or colonoscopy, and to completion of colonoscopy for those with positive FIT. 
 
5.3 Study Population 
Our study population includes men and women aged 45-75 who are patients in the Flatbush 
Family Health Center medical practice and are due or overdue for CRC screening. The patient 
population in the Flatbush FHC medical practice is an underserved population that currently has 
lower CRC screening rates compared to the average screening rate in New York State. Assessing 
the effectiveness of a proactive outreach CRC screening program is pivotal to develop strategies 
to increase CRC screening rate in underserved populations. 
 
5.3.1 Number of Participants 
There will be a total of 100 participants in the study, 50 of whom will be randomized to receive 
proactive screening outreach and 50 of whom will be randomized to receive usual care. 
Approximately 7 patients from the intervention group are expected to complete a follow-up 
interview about their experience with the proactive program.  
 
5.3.2 Inclusion Criteria  
• Men and women aged 45-75 
• Receiving medical care at Flatbush FHC 
• Due or overdue for CRC screening 
 
5.3.3 Exclusion Criteria  
• Age younger than 45 years old or greater than 75 years old 
• Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 
years) 
• History of colorectal cancer, inflammatory bowel disease or colorectal polyps 
• No address or phone number on file 
• FIT test ordered within 6 months 
 
5.3.4 Vulnerable Populations   
We do not intend to target recruitment/enrollment of vulnerable subjects as defined by federal 
regulations or institutional policies.  
 

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6 – Methods  
6.1 Intervention 
6.1.1 Description of Intervention 
Our proposed intervention involves proactive outreach for CRC screening for patients receiving 
care at Flatbush FHC. More specifically, patients randomized to the proactive outreach group 
will receive a letter from their clinic (mailed by the study team) explaining colorectal cancer 
screening options (FIT vs colonoscopy) including a FIT kit with completion and return 
instructions. The letter will also include information for navigation to a screening colonoscopy 
instead of FIT testing, if deemed to be the patient's preference. A study information sheet will be 
included to inform the patient that their data will be used for this research study and explain that 
the screening by FIT is not a research procedure, but a standard of care screening test for which 
they are due or overdue. 
 
Approximately 10-14 days after mailing the FIT kit, patients who have not completed screening 
will receive a telephone call (with voice message left) and text message, querying whether the 
FIT kit was received and reminding the patient to complete the test or request a new kit, if 
needed.  
 
Finally, if the FIT kit has not been submitted after about two weeks from the reminder call/text 
message, the study team will mail a final letter to the patient on behalf of the clinic, reminding 
them to complete and return the FIT kit. 
 
If no FIT kit is returned after an additional three weeks, there will be a final note uploaded to the 
patient's chart alerting the patient's primary care physician to complete further action regarding 
CRC screening as indicated.  
 
Those patients with a positive FIT test result will be receive assistance with navigation to 
scheduling a colonoscopy by the study coordinator or appropriate clinic staff. Screening and 
diagnostic colonoscopy completion will be facilitated through phone calls to triage whether a 
colonoscopy can be scheduled over the phone or requires an in-person pre-colonoscopy visit. In 
addition, it will be facilitated through ensuring that bowel prep is mailed to the patient with 
instructions or is available for pick-up in clinic. Finally, bowel preparation instructions and 
appointment reminders will be performed via phone call, text or mail 5-7 days prior to 
colonoscopy.  
 
After the intervention period is over, patients in the intervention group will be invited to 
complete a qualitative interview with a trained member of the study staff, during which they will 
be asked about their personal experience with the proactive outreach screening program. An 
invitation letter will be mailed and non-responders will receive a follow-up phone call or text 
message to gauge interest in participating. Those who agree will be verbally consented over the 
phone prior to the interview.  
 

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Patients need not have completed the at-home screening to take part in the interview. Interviews 
will be audio recorded and professionally transcribed, with all identifiers scrubbed from the 
transcription. 
 
6.1.2 Method of Assignment/Randomization 
The study biostatistician will randomize 50 eligible patients to proactive outreach and 50 eligible 
patients to usual care, stratified by age and biological sex. Proactive outreach patients will be 
blind to the presence of an alternative group assignment and "usual care" patients will be 
unaware of group assignment altogether.  
 
6.1.3 Selection of Instruments/Outcome Measures 
The primary outcome measure is completion of initial fecal immunochemical test (FIT) or 
colonoscopy at 6 months. Both colonoscopy and fecal immunochemical tests are well-validated 
screening modalities for colorectal cancer that have been extensively studied throughout the 
years. 
 
6.1.4 Intervention Administration 
Please note:  all days listed beyond day 0 have a +5 day tolerance window. 
 
Day 0: Patients randomized to the proactive outreach group will be mailed letters explaining 
CRC screening options and a FIT kit with detailed instructions for collection and submission. 
 
Day 10-14: In the proactive outreach group, if a FIT kit has not been submitted by this time 
point, the patient will receive a call or voice message from our research team to ensure FIT kit 
was received and reminding the patient to complete and return it or request a new kit, if 
necessary. 
 
Day 28: If the FIT kit has not been submitted, the patient will receive a final letter reminding the 
patient to complete and return the FIT kit. 
 
Day 56:  For patients who have still not submitted a FIT kit or requested screening via 
colonoscopy, there will be a final note in the chart alerting the patient's primary care physician to 
complete further action regarding CRC screening as indicated. 
 
Days 7-180: Patients with a positive FIT test result will receive assistance with navigation to 
scheduling a follow-up colonoscopy. If patients indicated that they prefer colonoscopy to FIT 
testing, they will also receive assistance with navigation to scheduling a colonoscopy. Assistance 
to scheduling a colonoscopy will include an initial phone call performed by our research 
coordinator or appropriate clinic staff to triage whether a colonoscopy can be scheduled over the 
phone or requires an in-person pre-colonoscopy visit. In addition, study staff will ensure bowel 
prep will either be mailed to the patient with instructions or made available to pick-up in clinic, 
depending on patient preference. Finally, bowel preparation instructions and appointment 

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reminders will be performed via phone call, text or mail 5-7 days prior to scheduled 
colonoscopy.  
 
6.1.5 Reaction Management 
Patients will be made aware in their testing instructions that the presence of a positive FIT test 
result does not confirm the presence of colorectal cancer. The patient will be able to follow-up 
with appropriate clinic staff, as well as with a gastroenterologist at the time of their colonoscopy 
in order to further answer any questions. 
 
6.2 Assessments 
6.2.1 Efficacy 
We will assess the efficacy of our intervention through a statistical analysis comparing the rates 
of completion of a FIT test or colonoscopy in the proactive outreach group compared to the usual 
care group. In addition, we will perform a statistical analysis comparing the rates of completion 
of a colonoscopy for individuals with a positive fecal immunochemical test at 6 months in the 
proactive outreach group compared to the usual care group.  
 
 
6.2.2 Adverse Events Definition and Reporting 
There are no anticipated adverse events with our proposed intervention. 
 
6.3 Study Procedures 
6.3.1 Study Schedule 
See section 6.1.4 for intervention schedule.  Data on control group CRC screening rates will be 
collected from clinic’s electronic medical records system (EMR) after the intervention period is 
over and prior to beginning data analysis. 
 
6.3.2 Informed Consent 
We are seeking a full waiver of informed consent and HIPAA authorization for the purpose of 
determining eligibility and group assignment. We are seeking a waiver of written documentation 
of consent for the intervention group and a full waiver of informed consent for the usual care 
group for the duration of the study. This research is minimal risk and involves the promotion of a 
recommended, standard-of-care, preventative health screening for which patients are due or 
overdue to undergo. By foregoing informed consent prior to mailing the FIT kit, we will avoid 
selection bias of enrolling individuals whom are particularly interested in receiving CRC 
screening or research, thus improving our study's external validity and more accurately 
measuring the potential efficacy of our intervention on the population at large. In short, the 
traditional consenting process would negatively impact the reliability of study outcomes.  
 
Additionally, providing information about the study prior to offering the proactive CRC 
screening to intervention patients may interfere with decision-making and the clinical care 

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process. The possible perception that CRC screening is research may negatively impact an 
individual’s behavior, attitudes towards such screening, or their willingness to undergo any type 
of screening in general, due to fear or other stigma associated with research. 
 
Providing information about the study to the standard-care (control) group could also influence 
decision-making regarding CRC screening and interfere with the clinical care process for these 
patients. 
 
The waiver of documentation of consent for the intervention group will include the subset of 
intervention patients who complete the qualitative interview. Information about the interview is 
included in the Study Information Sheet provided to all intervention patients in the initial FIT kit 
mailing. The study coordinators will verbally consent those patients who opt-in for the interview, 
using a study-specific NYU telephone consent script. 
 
6.3.3 Screening 
Screening for participant eligibility will be performed through the research team accessing 
patient charts through the Flatbush FHC’s EMR (Epic) and applying the inclusion and exclusion 
criteria previously stated.  
 
6.3.4 Recruitment, Enrollment and Retention 
Patients will be identified for inclusion in the study via accessing the Flatbush FHC EMR (Epic) 
and applying the inclusion and exclusion criteria previously mentioned. We will work with 
DataCore to obtain an initial list of eligible patients once, at the beginning of the study. The PI 
and study coordinators will be the only research staff with access to the list. The list will contain 
the following information about the eligible patients: MRN, full name, date of birth (or age), 
address, phone number(s), email addresses, biological sex, race, ethnicity, height/weight (or 
BMI), smoking status, and primary care physician’s name. Data for the patients that will not be 
included in the study will be deleted from the electronic list provided by DataCore at the end of 
the study. No information will be retained about these patients. 
 
After the mailed intervention process is complete, data regarding colorectal cancer screening will 
be obtained for the control group patients. This will include whether colonoscopy, FIT, or other 
screening tests for colorectal cancer were completed during the study period. Approved waiver 
of consent and HIPAA authorization for this patient group will allow this information to be 
collected directly from Epic by the study team. 
 
The primary care physicians at Flatbush FHC have been notified that their intervention group 
patients will be contacted directly by the study team regarding this mailed CRC screening effort. 
All letters from the FHC (initial and final) will contain their electronic signature. These patients 
will receive the Study Information Sheet as part of the initial FIT kit mailing (first contact). If 
they decide to opt out, only de-identified data will be retained in REDCap for audits, summaries, 
and reporting purposes.  
 

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Subjects in the usual care group will not be approached or notified of their enrollment in the 
study.  
 
6.3.5 Study Visits 
There are no study visits associated with this protocol. Colonoscopy is also considered standard-
of-care CRC screening and is not a study procedure. The only potential visits, possibly facilitated 
by the study team, would be for patients opting to be screened via colonoscopy or navigating to 
diagnostic colonoscopy following a positive FIT test result. These non-study visits are detailed 
below. 
 
In person pre-colonoscopy screening visit (if applicable and if required, days 7-180): Patient will 
receive instruction from a certified R.N. or M.D. regarding colonoscopy preparation instructions, 
if not already provided by the colonoscopy provider. Estimated length of visit: 10-20 minutes 
 
Colonoscopy procedure visit (if applicable, days 7-180): Patient will have colonoscopy 
performed by certified gastroenterologist at the Brooklyn Family Health Center facility or 
another facility at which they have access for this procedure. 
 
6.3.6 End of Study and Follow Up 
Following the completion of the intervention period of the study, we will administer interviews 
to a subset of patients randomized to the proactive screening arm regarding barriers to 
completion of colorectal screening, perceived effectiveness of the proactive outreach screening 
program, and any unexpected adverse effects that the patient may have experienced. Patients 
receiving the intervention can participate in an interview regardless of whether or not they 
completed CRC screening. 
 
The interviews will be conducted by a member of the NYULH research staff trained in 
qualitative interviewing techniques and will occur either over the telephone or through HIPAA-
compliant WebEx sessions. The interviews will be audio recorded and transcribed, with any 
identifiers to be removed from the transcription records. The interviews will take about 15 
minutes to complete. Recording is required for participation. 
 
6.3.7 Removal of Subjects 
Given the nature of our proposed study and waiver of informed consent, participants in the usual 
care group will be unaware of their participation in this research study and thus will not actively 
withdraw from the study. Participants randomized to the intervention group may opt out of the 
screening program or refuse screening at any time. Instructions for how to opt out will be 
provided in the study information sheet included in the initial mailing. Once 50 of the eligible 
individuals are randomized to proactive screening and 50 to usual care, those selected to 
proactive screening will be mailed the FIT kit packet and this number will serve as our 
denominator for the remainder of the study.  
 

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At any point, if a patient initially randomized into the intervention group is found to no longer 
receive their medical care at Flatbush FHC or their address is deemed undeliverable by the 
United States Postal Service, they may be replaced at the discretion of the PI to ensure 50 
eligible patients receive the proactive intervention.  If this occurs, control group participants 
would be replaced based on the same criteria.  Replacements would be determined by the study 
biostatistician. 
 
6.4 Statistical Method 
6.4.1 Statistical Design 
The intent-to-screen principle will be utilized to analyze all participants for completion of the 
primary outcome variable of completion of colonoscopy or FIT testing screen at 6 months. The 
intent-to-screen principle will also be utilized to analyze all participants for completion of the 
secondary outcome variable of completion of colonoscopy in patients with a positive FIT test at 
6 months. Analysis will be conducted utilizing an independent two sample t-test. 
 
6.4.2 Sample Size Considerations 
Sample size selection (n = 100) for this pilot study was based on feasibility. 
 
6.4.3 Planned Analyses 
The intent-to-screen principle will be utilized to analyze all participants for completion of the 
primary outcome variable of completion of colonoscopy or FIT testing screen at 6 months. The 
intent-to-screen principle will also be utilized to analyze all participants for completion of the 
secondary outcome variable of completion of colonoscopy in patients with a positive FIT test at 
6 months. Analysis will be conducted utilizing an independent two sample t-test. 
 
6.4.3.1 Primary Analyses 
Analysis will be conducted utilizing an independent two sample t-test. 
 
6.4.3.2 Secondary Objectives Analyses 
Analysis will be conducted utilizing an independent two sample t-test. 
 
6.4.3.3 Analysis of Subject Characteristics 
We will summarize baseline and demographic characteristics utilizing standard descriptive 
summaries (means and standard deviations for continuous variables such as age and percentages 
for categorical variables gender).  
 
 

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7 – Study Administration 
7.1 Ethical Considerations: Informed Consent and HIPAA Authorization 
A waiver of informed consent (usual care group).  
 
A waiver of written documentation of consent (intervention group) and HIPAA authorization (all 
participants) will be obtained for this study. Verbal consent via telephone will be obtained for 
intervention group participants who are willing to complete the post-intervention interview. 
 
7.2 Institutional Review Board (IRB) Review 
The protocol and all participant materials will be submitted to the IRB for approval. Any 
amendment to the protocol will be sent to the IRB for approval before the changes are 
implemented to the study. The IRB will be made aware of any reportable events and 
unanticipated problems.  
 
7.3 Subject Privacy, Confidentiality & Data Management 
The collection of personal patient information will be limited to the amount necessary to achieve 
the aims of the research, so that no unneeded sensitive information is being collected. Only study 
personnel as listed on the IRB will have access to study data. Patient identifiers that will 
temporarily be accessed/reviewed include name, medical record number, date of birth, phone 
number, address, height, weight, smoking status, and CRC screening history. Electronic study 
data will be stored on a securely managed (MCIT) network drive and in REDCap, with 
password-protected access limited to trained, authorized study personnel. It is not expected that 
paper documents will be generated in association with this study, however, any hard copy 
documents will be kept in a locked cabinet in the PI's office. Electronic data will be exported into 
excel file format (password protected) and utilized for data analysis. De-identified data will be 
sent to a biostatistician for statistical analysis. 
 
7.4 Deviations/Unanticipated Problems 
Any unanticipated problems will be reported promptly to the IRB (within one business day of 
discovery for serious adverse events), within 7 business days of discovery for all other 
unanticipated problems.  
 
7.5 Data Collection 
Data will be collected at the beginning the study during the initial eligibility screening process as 
well as ongoing throughout the intervention period in order to ascertain FIT testing and/or 
colonoscopy completion results. Data will only be accessed by trained, authorized study 
personnel. Data will be retained for the next 10 years for use in future studies following the 
completion of this pilot study.  
 

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7.6 Data Quality Assurance 
All research coordinators and study personnel will be trained by the primary investigator on both 
the intervention and data collection process. The study will be continuously monitored on a 
monthly basis by the study team. Standardized templates for proactive outreach letters will be 
utilized during the study. Statistical analysis will be performed by a professional biostatistician. 
 
7.7 Study Records 
Study records include subject medical records including FIT testing/colonoscopy results, 
outreach attempts and outcomes, and any survey results collected and interview transcripts.  
 
7.8 Access to Source 
Source documents will be obtained from the Flatbush Family Health Center’s electronic medical 
record (NYU Langone Health’s Epic system). All study personnel listed on the IRB will have 
access to the study documents. 
 
7.9 Data Storage / Security 
Electronic study data will be stored on a secure NYULH MCIT-managed network shared drive 
and in REDCap. All hard copy documents will be kept in a locked cabinet in the PI's office. 
Electronic data will be exported into excel file format (password protected) and utilized for data 
analysis. De-identified data will be sent to a biostatistician for statistical analysis. 
 
7.10 Retention of Records 
Study documents will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. These documents should be retained for a longer period, however, if 
required by local regulations. No records will be destroyed without the written consent of the 
sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained. 
 
7.11 Future Use of Stored Data  
 
Data will be maintained for 10 years following the pilot study in order to be utilized in future 
studies. Study data will be stored in REDCap and on a secure NYULH MCIT-managed network 
shared drive. Access to the dataset for any future research will require separate IRB approval. If 
any information is shared with external interested site(s), data set agreements with NYU 
LANGONE will be established. 
 
Transcripts from the patient interview audio recordings will be de-identified and will be used to 
tailor and improve possible future proactive CRC screening efforts. 
Study data may be used to inform future funding proposals. The purpose of other possible future 
research is unknown at this time. 

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7.12 Study Monitoring 
The principal investigator will monitor the study to ensure that it is completed in accordance 
with the protocol and that the data are valid. In order to ensure this, the study will be reviewed on 
a monthly basis by the principal investigator and study team. 
 
7.13 Data Monitoring Plan 
Our study involves minimal risk and thus does not require a data monitoring plan.  
 
7.13 Study Modification 
The study protocol will be updated with any study modifications and submitted to the IRB for 
approval. 
 
7.14 Study Discontinuation 
Given the benign nature of the study intervention, we do not foresee the study being discontinued 
for any reason. 
 
7.15 Study Completion 
The anticipated completion date of the study will be approximately one year after 
commencement of the intervention period. We will notify the IRB upon completion of the study. 
 
7.16 Conflict of Interest Management Plan 
There are no actual or perceived conflicts of interest for our study. 
 
7.17 Funding Source 
The study is funded by NCI (p20 SPORe pilot grant). 
 
 

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