Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients
Phase: PHASE1
Conditions: Colorectal Carcinoma
Sponsor: Roswell Park Cancer Institute

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TITLE: Increasing Access and Developing Predictors for Colorectal Cancer Screening for 
Minority and Medicaid Clients
Roswell Park Cancer Institute
Study Number:
Initial Date:
Amendment 1:
Principal Investigator:
I 63518   NCT04607291
March 1, 2018
March 25, 2019
Deborah O Erwin, PhD 
Roswell Park Cancer Institute 
Elm and Carlton Street 
Buffalo, New York 14263
716-845-2927
Deborah.erwin@roswellpark.org
Sponsor: NIH/NCI SBIR/STTR
 Confidentiality Statement
Any and all information presented in this document shall be treated as confidential and 
shall remain the exclusive property of the party(ies) mentioned above. The use of such 
confidential information must be restricted to the recipient for the agreed purpose and 
must not be disclosed, published, or otherwise communicated to any unauthorized persons, 
for any reason, in any form whatsoever without the prior written consent of the party(ies) 
above.
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TABLE OF CONTENTS
1
Synopsis .................................................................................................................................................................3
2
Background ............................................................................................................................................................3
3
Rationale ................................................................................................................................................................3
4
Objectives...............................................................................................................................................................5
5
Methodology ..........................................................................................................................................................5
6
Target Accrual and Study Duration .......................................................................................................................9
7
Subject Selection....................................................................................................................................................9
7.1
Inclusion Criteria.........................................................................................................................................10
7.2
Exclusion Criteria........................................................................................................................................10
7.3
Inclusion of Women and Minorities............................................................................................................10
8
Statistical Analysis Methodology ........................................................................................................................10
9
Informed Consent.................................................................................................................................................11
10
Subject Confidentiality and Data Security...........................................................................................................14
11
References............................................................................................................................................................16
12
Appendices...........................................................................................................................................................18
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1
SYNOPSIS
African Americans have 22% higher incidence and 49% higher death rates from colorectal 
cancer (CRC) than any other ethnic/racial group. Similarly, lower socioeconomic status (SES) is 
also associated with higher CRC incidence and mortality. Both of these groups are 
overrepresented in Medicaid populations. Screening colonoscopy is the “gold standard” for cost-
effective cancer prevention and control and several fecal tests (e.g., FIT) are reliable 
alternatives. However, Medicaid clients have much lower screening rates causing large “gaps in 
care” – contributing to higher CRC morbidity and mortality—and are major challenges for health 
insurance companies and clinical practices which are negatively impacted by the lower quality 
metrics and reduced financial benefits that result from lower screening rates. Improving CRC 
screening rates is therefore a strategic priority for both health care providers and insurers. The 
mission of Witness CARES, LLC, is to improve people’s lives by facilitating use of health care. 
The goal of this Phase I STTR proposal is to test the feasibility of providing specialized services 
(i.e., WC Services) to increase CRC screening for Medicaid clients and thereby improve metrics 
for our health insurance (YourCare and clinical practice (Mercy Comprehensive Care Center) 
customers.  Based on prior research and experience, we will conduct a small pilot effectiveness 
study combining a broad range of services to educate, activate and navigate these “gaps in 
care” clients for a broader market (not just a single facility or patients with screening referrals) in 
order to test the feasibility for future commercialization. In addition, we will evaluate these clients 
to develop a predictive algorithm for assessing likelihood of CRC screening outcome. We 
propose the following specific aims: Aim 1: Test the feasibility of WC Services to achieve CRC 
screening for non-adherent Medicaid clients. Milestone 1a: Achieve colonoscopy by a minimum 
of 60 out of 200 (> 30%) patients contacted. Milestone 1b: Achieve CRC stool screening for 70 
of the 140 colonoscopy non-adherent clients. Milestone 1c: WC Services will be revised to 
produce a new prototype to test in a Phase II based on feasibility findings. Aim 2: Develop an 
algorithm for predicting CRC screening outcomes following intervention services. Milestone 2a. 
Develop models based on existing R01 data to predict intent and CRC screening behaviors.  
Milestone 2b. Revise this R01 model incorporating new measures collected prospectively with 
80% of clients contacted (n=160) to identify variations for likelihood of stool test v. colonoscopy 
completion. Milestone 3 will be the Phase I report of these findings. Successful completion of 
these aims are expected to show the acceptability and feasibility of WC Services to improve 
CRC screening rates for Medicaid patients and develop assessment tool(s) that enable us to 
evaluate this product in a randomized controlled trial in a Phase II study with a special emphasis 
on reducing CRC disparities in minority and lower income populations.  
2
BACKGROUND
Colorectal cancer (CRC) is the second leading cause of cancer deaths in the U.S.1 African 
Americans have 22% higher incidence and 49% higher death rates from CRC than any other 
ethnic/racial group.1 Similarly, lower socioeconomic status (SES) is also associated with higher 
CRC incidence and mortality.2 Both of these groups are overrepresented in Medicaid 
populations.3 Amongst screening options for average-risk individuals, both stool tests (e.g., fecal 
immunochemical-FIT or DNA-mtsDNA/Cologuard®) and colonoscopy are deemed effective;4 
with colonoscopy being the most effective at reducing CRC incidence.5,6 Adherence to CRC 
screening guidelines is poor for African American and low SES groups,7 even for insured 
individuals. In New York State (NYS), over 80% of CRC screening non-adherent individuals are 
insured.  Lack of screening in insured adults is a “gap in care” that poses significant challenges 
for insurers, including reduced quality metrics (i.e., Medicare Star and Healthcare Effectiveness 
Data & Information Set - HEDIS® scores) which negatively impacts financial bonus payments to 
these companies. Increased CRC screening is a high value product in the health care market as 
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well as addressing cancer disparities. 
Disparities and low screening rates exist primarily because of a host of structural (e.g., 
access, transportation) and individual barriers (e.g., fear, negative affective associations, daily 
life issues) experienced by lower income and minority patients that are generally beyond the 
scope of clinical practices and health insurance companies to address. Approaches to address 
these barriers have been proven effective by our team and others for various screening services 
but have not been tested as a marketable commodity. These proven methods include the use of 
patient navigation,8,9 culturally appropriate education,10,11 and community-based participatory 
processes.12,13 However, navigation services are not reimbursable expenses for clinical 
providers, require specialized expertise and access to multiple ancillary services (e.g., 
transportation). Health insurers have experimented with monetary incentives, reminders and 
incentivizing health providers, but these approaches are limited and do not address the basic 
structural and individual barriers influencing behaviors. But if proven to reduce “gaps in care”—
insurance companies will outsource and pay for these services (e.g., see Letters; and National 
Witness Project (NWP) in Facilities and Resources).  Effective programs offering multi-level 
services to optimize screening for non-adherent clients are not readily available for insurers or 
clinicians to adopt or purchase. Witness CARES, LLC proposes to remedy this gap by offering a 
full-service resource for educating, activating and navigating clients to screening for insurance 
companies (e.g.,YourCare, see Letter) and for primary care clinics (e.g., Mercy Comprehensive 
Care Center, see Letter).  Moreover, although there is an extensive body of work examining 
decision-making predictors of successful CRC screening,14,15 there are not easily implementable 
tools for predicting compliance in real time, or to assess for which clients at-home stool testing 
versus colonoscopy screening is likely to be most achievable. This STTR Phase I study 
provides an opportunity for Witness CARES, LLC to explore the feasibility of providing these 
services to Medicaid clientele to satisfy the screening expectations of  insurers  and primary 
care providers (Aim 1), and the feasibility of developing a predictive tool(s) (Aim 2) for 
determining which screening test is most appropriate for clientele. 
Specialized Interventions. Our team has developed and implemented effective, 
specialized interventions for over 20 years to reach, educate, activate and navigate African 
American and low SES clients into cancer screening.16,17 For example, patient navigation by lay 
navigators (Consultant, Jandorf) increased adherence to screening colonoscopy to 66.4% 
among urban minority pateints18 at a cost of only $29/patient screened. Our sister, not-for-profit, 
The National Witness Project (NWP) (See Facilities and Resources), has provided specialized 
services to health insurance companies in western New York (WNY) on a contractual basis (> 
$600K) for over three years, screening over 3000 women with mammograms and Pap tests, 
and demonstrating a potential market for CRC screening navigational services. Witness 
CARES, LLC needs to conduct this Phase I study to determine if we can create a similar group 
of services and assessments specialized for increasing CRC screening based on findngs about 
behavioral constructs impacting CRC screening behaviors from our R01 CA171935 study.19,20 If 
proven feasible in this Phase I study, this will be a novel set of services to offer health insurance 
companies and their clinical practices, with the added innovative technology  of an algorithm for 
predicting screening preferences for this Medicaid population. This would be an important 
service for over 835,000 African American men and women, and 104,752 additional Medicaid 
clients between the ages of 50 and 79 who have not had a timely colonoscopy and/or other 
fecal testing for CRC screening in New York State.1,21,22 Achieving the aims of this STTR 
feasibility study, Witness CARES, LLC has a significant opportunity to develop a feasible 
prototype for WC Services to improve CRC screening by Medicaid clients and initiate the 
development of predictive measures to determine the most acceptable CRC screening test. 
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3
RATIONALE
The National Witness Project (NWP), has provided specialized services to health insurance 
companies in western New York (WNY) on a contractual basis for over three years, screening 
over 3000 women with mammograms and Pap tests, and demonstrating a potential market for 
CRC screening navigational services. Witness CARES, LLC needs to conduct this Phase I 
study to determine if we can create a similar group of services and assessments specialized for 
increasing CRC screening based on findngs about behavioral constructs impacting CRC 
screening behaviors from our R01 CA171935 study.19,20 If proven feasible in this Phase I study, 
this will be a novel set of services to offer health insurance companies and their clinical 
practices, with the added innovative technology  of an algorithm for predicting screening 
preferences for this Medicaid population. This would be an important service for over 835,000 
African American men and women, and 104,752 additional Medicaid clients between the ages 
of 50 and 79 who have not had a timely colonoscopy and/or other fecal testing for CRC 
screening in New York State.1,21,22 Achieving the aims of this STTR feasibility study, Witness 
CARES, LLC has a significant opportunity to develop a feasible prototype for WC Services to 
improve CRC screening by
4
OBJECTIVES
The goal of this Phase I application is to prove the feasibility and small scale pilot efficacy of WC 
Services to increase CRC screening. We propose the following specific aims:
Specific Aim 1: Test the feasibility of WC Services to achieve CRC screening for non-adherent 
Medicaid clients. Milestone 1a: Achieve colonoscopy by a minimum of 60 out of 200 (> 30%) 
patients contacted. Milestone 1b: Achieve CRC stool screening for 70 of the 140 colonoscopy 
non-adherent clients. Milestone 1c: WC Services will be revised to produce a new prototype to 
test in a Phase II based on findings. 
Specific Aim 2: Develop an algorithm for predicting CRC screening outcomes following 
intervention services. Milestone 2a. Develop models based on existing R01 data to predict 
intent and CRC screening behaviors.  Milestone 2b. Revise this R01 model incorporating new 
measures collected prospectively with 80% of clients contacted (n=160) to identify variations for 
likelihood of stool test v. colonoscopy completion. 
Research Questions: a) Will Medicaid clientele, health insurers and physicians find WC 
Services usable and valuable for CRC screening? b) Will clients accept services and obtain 
colonoscopy or stool tests? c) Will current and/or new measures show predictive potential within 
Medicaid clientele for colonoscopy and/or stool tests? d) Will WC Services be able to increase 
screening enough to demonstrate potential for improving quality metrics for health insurance 
companies and primary care practices?  Answering these research questions and achieving 
these aims (Milestone 3: Phase I Report), position us for a larger randomized controlled 
evaluation in Phase II while addressing important CRC screening disparities for the community 
and health care system.
5
METHODOLOGY
Overview. This Phase I small pilot efficacy and feasibility application is built upon the combined 
passion, persistence, science, expertise and experience from the following: a) Research on 
navigation for CRC screening (R01 CA 120658, Jandorf, see Bio);25 b) Years of community-
based studies (Erwin, Johnson, Jandorf, see Bios)10,16,26 resulting in the National Witness 
Project® (NWP) not-for-profit; c) Ability of the NWP to garner contracts for services from health 
insurance companies and health care providers (see Facilities and Resources); d) Results from 
our R01 (CA171935, MPIs: Erwin, Kiviniemi, Jandorf, see Bios);19,20,23 and e) Training through 
the NCI SPRINT Supplement (Erwin, Johnson, see Bios).27 Based on this foundation, we now 
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are in a position to determine if we can combine this experience, data and expertise into a 
deliverable product (WC Services) that provides acceptable and appropriate services to non-
adherent Medicaid clients resulting in effective CRC screening rates to meet the various 
requirements of health insurers (i.e., YourCare), primary care practices (Mercy Comprehensive 
Care Center- MCCC) and gastrointestinal endoscopy providers. 
Product Concept. The proposed framework for services based on previous research19,28 is 
displayed in Figure 1. Encrypted lists of eligible clientele will be given to racially-concordant, 
call-center staff, including experienced navigators, according to established procedures by 
NWP. Scripts, based on Jandorf’s CRC screening protocol,  will be used by navigators and call-
center staff, including messaging and information that promotes positive affective associations 
with colonoscopy. From initial assessments and client responses, navigators will determine next 
steps following cues and flow 
chart experience (see Figure 1).  
Based on assessments in real 
time, navigators will offer to 
send appropriate materials, 
messages and videos to 
clientele electronically and or by 
mail as requested to assist with 
clients’ decision-making if they 
are not prepared for either 
colonoscopy or stool tests, and 
will be followed up by phone 
within two weeks. For clients 
desiring colonoscopy, navigators will assess client capacity to obtain this screening (e.g., Rx, GI 
doctor, scheduling appointment, prep materials and process, transportation, escort) and offer 
assistance as needed. For clients desiring to use a stool test, navigators will facilitate FIT tests 
or mtsDNA (Medicare eligible only and Exact Sciences provide navigation). Telephone follow-up 
will be conducted on a prescribed schedule for clients planning to be screened. Including 
primary care clients (MCCC) as well as insurer clients (YourCare) gives us an opportunity to test 
the acceptability of WC Services for both customers and their clientele to determine variations in 
services, needs and outcomes for the two sources.  
 Phase I Goals, Timetable and Milestones: The goal of this Phase I STTR study is to 
determine the feasibility and small scale pilot efficacy of WC Services to increase CRC 
screening, determine appeal and satisfaction with services by clients and company partners, 
and based on client variables, predict the CRC screening test most acceptable and likely to be 
Table 2. Phase I Timeline, Tasks, 
Milestones
Ju
l
Aug
Se
p
Oct
No
v
Dec
*
Ja
n
Fe
b
Ma
r
Apr
May
Ju
n
1)Test ability to increase CRC screening
-Finalize WC Services process flow chart
-Conduct pilot for colonoscopy (Milestone 
1a)
-Conduct pilot for stool screens (Milestone 
1b)
-Conduct satisfaction & prediction surveys
-Produce prototype for RCT (Milestone 1c)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
2) Develop algorithm for predicting CRC
-Analyze R01 variables (Milestone 2a)
-Assess new measures with clients
-Analyze new variables for new Screening 
Engagement Model (Milestone 2b)
-Prepare Phase I Report (Milestone 3)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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successfully completed.  Table 2 presents the timeline (*Dec. is not an ineffective month for 
scheduling screenings based on our experiences, so we resume the pilot in Jan.)
Study Team: Dr. Deborah Erwin (RPCI subcontract) and Ms. Detric Johnson will manage the 
science and WC Services activities, respectfully, as MPIs.  The WC Services to Medicaid clients 
will be conducted by experienced team members contracted from the NWP (see Budget 
Justification). The pilot efficacy study benefits from the expertise of assembled colleagues Drs. 
Kris Attwood (Statistician), Marc Kiviniemi (Consultant) and Ms. Jandorf (Consultant). The entire 
process and especially the feasibility assessments will be reviewed under the guidance of a 
five-member advisory board designed to offer expertise and counsel regarding 1) Technology 
transfer and potential commercialization issues (RPCI, Dr. Emmerling); 2) Needs and concerns 
of the health insurance industry (YourCare, Ms. O’Donnell); 3) Needs and concerns of primary 
care clinical practices (MCCC, Ms. O’Hara/Gomlak); and 4) Science and clinical issues of 
colonoscopy and CRC screening (RPCI, Dr. Bain).  
Aim 1: Test the feasibility of WC Services to achieve CRC screening for non-adherent 
Medicaid clients.  Based on previous experience and research (see Bios, Facilities), we 
hypothesize that we will be able to combine multi-level services to effectively assist > 65% of 
Medicaid clients from health insurer and clinical partners to obtain CRC screening in a 6-month 
trial during this Phase I. Achieving the milestones and benchmarks in Aim 1 will provide proof 
that we can improve screening metrics and meet the needs for our potential customers. 
Partners, Recruitment and Participants. Witness CARES, LLC has established relationships 
with Mercy Comprehensive Care Center (MCCC), a local primary care practice serving a high 
proportion of Medicaid patients, and YourCare Health Plan, a Medicaid Managed health 
insurance company serving Buffalo, NY (see Facilities and Resources) to conduct this Phase I 
study (see Letters), and we will rely upon our Scientific Advisory Board (see Letters) to guide 
the conduct of the study, assuring that we are meeting the needs of customers, providing 
optimal services for clients/patients and truly achieving our feasibility measures in this study to 
effectively move forward into Phase II. 
WC Services Flow Chart. To finalize details of the decision flow chart for contacting and 
providing services for CRC screening, Dr. Erwin and Ms. Johnson will work with the NWP 
navigators and call center staff to modify activity flow charts from current mammography 
screening, adding all details for CRC screening actions. We will also notify physicians including 
gastroenterologists and private and hospital colonoscopy facilities serving MCCC and YourCare 
patients that we are piloting new services for patients in the area, explain the services and 
obtain preferred colonoscopy prep instructions. MCCC and YourCare will assist with this 
process.
Pilot Study. Study participants will originate from MCCC and YourCare “gaps in care” lists of 
Medicaid/Medicare patients who are ages 50-75, have not had a stool test within 11 months, 
colonoscopy within 9 years and live in the Buffalo/Niagara Falls area. YourCare currently has a 
CRC gaps in care list of approximately 2500 clients and MCCC has 1599 patients for this study.  
From the NWP experience with insurers, we expect up to 48% of clients to be excluded (e.g., 
incorrect phone numbers, no longer insured, already screened).  Therefore, we anticipate 
having a working list of at least 1,968 clients from which to contact over the approximately 26-
week enrollment period (see Timeline Table 2). Based on prior experience with mammography 
screening for gaps in care clients, we know we can successfully contact > eight new clients per 
week (within the STTR budget) for a potential sample size of N=200 from the two sources 
(MCCC ~100 clients; YourCare~100 clients), which is expected to provide 80% power (at 
α=0.05) (see Analysis of Aim 2 below). (Also See Figure 2. Study Schema).
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Aim 2: Develop an 
algorithm for predicting 
CRC screening 
outcomes from 
intervention services. 
We hypothesize that we 
will be able to identify a 
set of predictive 
measures, applicable for 
Medicaid clients and 
feasibly implementable, 
that will allow us to 
effectively predict which 
clients would be most 
likely to “convert” from 
not intending to screen to 
intending to screen 
following the receipt of 
WC Services and which 
clients would be most likely to translate that intention to screen into actual engagement in 
specific screening behavior. 
Data Sources and Participants: Specific Aim 2 will rely on a two pronged approach. First, we will 
leverage a rich, existing data resource collected as part of our recently completed community 
trial R01 of the WitnessCARES intervention for CRC screening (See Measures Table in Human 
Subjects). The data available from this study includes pre-intervention measures on a variety of 
psychosocial determinants of screening behavior, relevant demographic characteristics, 
intentions to screen both before and after the intervention, and, for a subset of participants, a 6 
month follow-up report of actual screening behavior. The dataset contains 516 individuals who 
were: over age 50, self-identified as Black/African American, and either never screened or 
currently screening noncompliant. In addition to this secondary data analysis, we will collect and 
analyze new measures as a part of the methods described in Aim 1. 
Proposed Secondary Data Analysis (Milestone 2a). The dataset from the WitnessCARES 
intervention study will provide us the ability to develop an initial iteration of a predictive tool to 
effectively identify two types of potential clients: a) individuals who, if they receive the 
intervention, are most likely to change from not intending to screen for CRC to intending to 
screen for CRC; b) individuals who intend to screen following the intervention but do not 
successfully convert that intention to actual engagement in screening behavior. To do so, we 
will use the individual items in the psychosocial and demographic measures collected pre-
intervention to identify a subset of items that can successfully distinguish the types of potential 
clients described above. The analysis will proceed in 3 phases: variable reduction, screening 
intent model, and screening engagement model. Variable Reduction: Standard variable 
reduction techniques (such as principle components, missing values ratios, low variance filter, 
etc.) will be used to combine or exclude individual items (or sub-scales) for the candidate list of 
variables for model development. Screening Intent Model: Model development will proceed in 
two steps and will be based on available subjects. First, using a multivariable logistic regression 
model, main effects will be selected using a bootstrap backwards selection method (BBSM; 
alpha exit = 0.01). Second, potential two-way interactions between the selected main effects will 
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be identified using the BBSM (alpha exit = 0.001). The final model estimates for predicting 
screening engagement will be obtained using standard bootstrap methods. Screening 
Engagement Model: The model development will proceed as described for the screening 
intendent model, except only subjects intending to be screened will utilized. Model Performance: 
The screening intent and engagement models will produce predicted probabilities of intent and 
engagement based on subject characteristics. These probabilities are relatively subjective, so 
the Youden’s index criterion will be used to identify a cut-off for both models that identifies which 
clients should be identified as “intending to screen” and “screening engaged”. Model 
performance will be summarized using the receiver operating characteristic (ROC) curve and 
corresponding area under the ROC curve (AUC), and the sensitivity and specificity 
corresponding to the Youden’s index cut-offs. Alternative Approaches: Classification and 
Regression Tree (CART) or other machine learning methods may be employed for the 
development of a classification model. In the presence of multiple models, models will be 
ranked by the specified performance measures.
Proposed Data Collection (Milestone 2b). For this secondary data analysis, as a part of the Aim 
1 methods described above, navigators will invite all clients contacted to complete assessment 
items via telephone.  Based on prior research and navigation experience, we know that clients 
are willing to complete health assessments and surveys of up to ~130 questions by phone if 
incentivized. This telephone assessment includes 118 self-report questions all of which have 
been used by the current team members with African American and Medicaid clients. However, 
we have never combined all of these items, and expect this to increase our capacity to identify 
impactful predictors.  Based on prior experience, we are adding a Patient Activation Measure 
(PAM),29-32 Process of Change (POC)33,34 for CRC screening and a 3-item unpublished, 
Navigator Subjective Assessment/Predictor (NSAP) by the navigator at the completion of the 
other questions (based on recent experiences by Jandorf and Erwin). A similar data analysis 
strategy will be applied here. The 118 items will be used to predict differentiation of screeners 
from non-screeners as well as, among screeners, those who chose FIT versus colonoscopy 
(COL). Together, these are expected to significantly increase our predictive capacity for 
colonoscopy outcomes. We anticipate (Milestone 2b) being able to complete the survey with at 
least 160 clients during this Phase I.     
6
TARGET ACCRUAL AND STUDY DURATION
From a list of approximately 2000 unscreened individuals from insurer and primary care patient 
lists (acquired through a Business Association Agreement), we will contact and enroll a 
maximum of 200 participants. Accrual is expected to take up to 2 years.
7
SUBJECT SELECTION
Recruitment and Informed Consent. Witness CARES, LLC staff members will work with our 
customer clients (YourCare and MCCC) to obtain Business Association Agreements in order to 
call, recruit and consent clients from their “gaps in care” lists.  Information sheets and oral 
consent over the phone will be used in order to conduct the telephone survey that collects 
information to contribute to the outcomes and predictor tool development.  The Business 
Agreements will provide coverage for offering the navigational services. 
The key elements of the informed consent procedure which will be explained to the participants 
are: 1) the research status of the study- particularly the survey; 2) the prospect of psychological 
risk and the provisions for it; 3) the lack of guarantee of benefit from participation in the survey, 
4) the confidentiality of subjects responses to all study measures; 5) the voluntary nature of the 
study; 6) the lack of consequences to medical care of the decision to consent or to refuse to 
participate in the survey (all participants will be offered CRC screening regardless of the 
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decision to complete the telephone survey); 7) the receipt of the gift card for participating in the 
survey interview, and 8) the freedom to withdraw from the study or to refuse to answer specific 
questions at any time. 
Before the survey is conducted, staff members will explain: 1) the nature and purpose of the 
research endeavor, 2) that participation in the research component is completely voluntary, and 
3) that data collected from participants will be confidential and assessed, evaluated and 
reported as aggregate data, as well as precautions taken in the storage of the data. The study 
staff member will verify that the women and men who wish to participate meet the study's 
eligibility criteria as described below. The staff member will solicit and respond to any and all 
inquiries. 
For the colonoscopy procedures, individual, hospital/facility/physician specific consents will be 
signed and this is beyond the scope or responsibility of Witness CARES, LLC or the study staff.
7.1
Inclusion Criteria
Witness CARES, LLC will develop and obtain business agreements with YourCare and Mercy 
Comprehensive Care Center (MCCC) as required by these businesses to allow them to provide 
lists of their clients who are ages 50 and over and are non-adherent to CRC screening over the 
past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years). The clients 
will be Medicaid or Medicaid/Medicare subscribers.  Uninsured patients may be included from 
MCCC, but will only be eligible for services to obtain FIT tests through the NYS Cancer Services 
Program. 
7.2
Exclusion Criteria
Any participants from the lists of gaps in care clients from insurance or primary care practices 
who report having had a colonoscopy in the past 9 years (or having positive findings such as 
polyps, 5 years) or having completed some type of fecal test for CRC will be excluded. 
Participants under 50 will be excluded unless they have been deemed high risk by their 
physician, and have a prescription for CRC screening. Participants symptomatic for CRC will be 
excluded from the study, but will be referred for follow-up and colonoscopy. 
7.3
Inclusion of Women and Minorities
The research outlined in this proposal will involve lower socioeconomic and African American 
clients as CRC screening is lowest in these groups. We will enroll up to 200 men and women in 
this study (including any race/ethnicity). We hope to enroll equal numbers of men and women. 
8
STATISTICAL ANALYSIS METHODOLOGY
AIM 1: Assessment and Evaluation. After Navigators have contacted and assessed client CRC 
screening needs by phone for providing WC Services, they will invite and consent clients to 
complete the study survey to collect prospective predictor assessment measures for which 
participants will be incentivized with a $20 retail gift card, a method we have found successful in 
previous studies. A process and system for contacting, monitoring and then assessing 
satisfaction of clients with services will be conducted based on current mammography services.  
Witness CARES,LLC will be establishing a new and more comprehensive appointment 
scheduling monitoring system for this feasibility study to enhance measures currently used by 
NWP in order to improve the ability to track and document all CRC screening services and 
outcomes for future development. We currently have metrics for navigation and screening that 
will be revised for colonoscopy and stool test navigation and colonoscopy appointment 
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scheduling. We will use current tracking measures for accruals and outcomes and assess these 
weekly and monthly. We will closely monitor number of client contacts and time requirements to 
determine potential cost effectiveness and feasibility measures. Colonoscopy and FIT 
completion will be monitored and then validated by YourCare and MCCC. Basic frequencies 
and descriptive statistics will be used for this analysis.  We will compare outcomes from 
YourCare and MCCC clients. Upon completion of CRC screening, satisfaction surveys will be 
conducted by Call Center staff for at least 60% of clients in order to assess WC Services 
acceptability, merit and suggestions for revisions. If clients prefer, these satisfaction surveys can 
be sent via Survey Monkey and completed on Smartphones. The Call Center will also obtain 
brief satisfaction and assessment surveys from GI practices and Primary Care Physicians 
treating Medicaid clients referred through WC Services. 
 
Expected outcomes of Aim 1 will prove whether or not WC Services can achieve > 65% CRC 
screening of clients reached. Milestone 1a: Achieve colonoscopy by a minimum of 60 out of 
200 (> 30%) patients contacted. Milestone 1b: Achieve CRC stool screening for 70 of the 140 
colonoscopy non-adherent clients (50% of clients refusing/ineligible for colonoscopy). Beyond 
these milestones, additional feasibility benchmarks include:  a) Acceptance/satisfaction by 
clients per client satisfaction phone surveys; b) Acceptance/satisfaction by YourCare and 
MCCC per self-report and any screening metrics improvement; c) Navigation services, number 
of screening tests per week/month, hours spent for cost analysis; d) Acceptance/satisfaction by 
GI physicians and facilities per self-report, number and quality of bowel preps and no-shows; e) 
Process evaluation of all. Milestone 1c: WC Services will be revised based on outcomes and 
benchmark measures from Aim 1, to produce a new prototype to test in a larger randomized 
study in Phase II.   
AIM 2: Proposed Data Analysis (Milestone 2b). Update the Screening Engagement Model: 
Utilizing standard Bayesian methods, the data collected in Aim 1 from the (expected) n=160 
intent-to-screen clients will be used to: A) update the coefficients of the Screening Engagement 
Model; and B) determine whether PAM, POC and NSAP measures should be incorporated. The 
performance of the updated model will be assessed using the AUC, sensitively, and specificity 
(with 95% confidence intervals as appropriate). If the AUC of the resulting model is 0.8 (or 0.9), 
indicating reasonable performance, then the corresponding 95% confidence interval width would 
be 0.14 (or 0.10). FIT versus COL: Within the sub-set of subjects that were screened, measures 
will be compared between those who chose FIT versus COL using the Mann-Whitney U test. In 
Aim 1 we expect 60 COL and 70 FIT subjects, which provides 80% power (at α=0.05) to detect 
a 0.5 standard deviation difference. Additionally, a multi-variable logistic regression model may 
be considered to identify potential independent factors associated with screening choice.
Expected Outcomes. Milestone 2a: Develop models based on R01 data to predict intent and 
CRC screening behaviors. Milestone 2b: Revise this R01 model incorporating new measures 
collected prospectively with 80% of clients contacted (n=160) to identify variations for likelihood 
of FIT v. COL completion. From these analyses we will produce a new prototype of a Screening 
Engagement Model to test in a larger trial for a Phase II study. Milestone 3: Phase I Report will 
be prepared to include all Milestones and feasibility benchmarks.   
9
INFORMED CONSENT
Human Subjects Involvement and Characteristics. Witness CARES, LLC will develop and 
obtain business agreements with YourCare and Mercy Comprehensive Care Center (MCCC) as 
required by these businesses to allow them to provide lists of their clients who are ages 50 and 
over and are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 
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months or colonoscopy for over 9 years). The clients will be Medicaid or Medicaid/Medicare 
subscribers.  Uninsured patients may be included from MCCC, but will only be eligible for 
services to obtain FIT tests through the NYS Cancer Services Program. 
Once Witness CARES, LLC receives these lists they will do the following: 
1) Begin calling clients and explaining that they are working collaboratively with their 
insurer or clinic to provide additional services for clients needing CRC screening. This 
initial call will allow WC Services to determine working/accurate telephone numbers and 
confirm that clients have not obtained CRC screening.  We anticipate calling clients from 
the list (expected to be up to 2000 clients) until we successfully reach at least 200 
clients. Witness CARES, LLC will send insurer and health clinic the lists with results of 
non-working numbers, patients no longer at numbers, etc. 
2) Use an existing CRC navigation assessment to inquire about the client’s knowledge and 
understanding of CRC screening.  Depending on the results of this assessment, the 
navigator may a) determine some basic information about potential services the client 
will need to obtain screening (stool or colonoscopy), and establish a plan with the client 
to provide these services with a timeline; or b) send the client additional information by 
mail, email or text for a smart phone for the client to review, and establish a call-back 
appointment time. 
3) For clients planning to be screened, the navigators will begin the process of working 
through the services needed by the client (for either completion of the stool test) or the 
colonoscopy to include some or all of the following: a) delivery of a FIT or Cologuard test 
(dependent on Medicare coverage); b) telephone followup and assurances that stool test 
is completed, mailed and results are received; c) assistance to obtain the Rx for 
colonoscopy; d) determination of acceptable GI physician and screening location for 
colonoscopy; e) appointment for colonscopy is made; f)  education for and assistance 
with the prep materials and telephone followup for assurance that the materials are 
purchased (or we deliver them), the client understands the procedure; questions are 
answered; g) transportation plans are secured if needed, including escort or family 
member to accompany client; h) telephone followup the day before scheduled 
colonoscopy to assure prep is/will be completed; i) assistance as needed to transport the 
client for the colonoscopy appointment; j) telephone followup to assess client satisfaction 
with the procedure and understanding of results.     
4) For clients reluctant to be screened, or who do not complete stool tests or colonoscopy 
appointments, navigators will conduct additional follow-up and motivational interviewing 
to encourage completion.  After 3 attempts, the navigator will obtain permission from the 
client to mail them additional information and how to contact the navigator for future 
assistance, and then the client will be removed from the active list for navigation. 
5) All clients reached will be invited to complete a ~130-item survey (based on measures 
from our R01 CRC study plus two new measures – see Table 1) to obtain answers to 
questions that will be analyzed to study how to more accurately predict CRC screening 
compliance. Clients will be offered a $20 gift card as an incentive for completing this 
survey by the navigator over the phone. 
6) Following successful CRC screening (fecal test or colonoscopy), clients will be contacted 
by telephone to assess qualitative measures of satisfaction with the navigational 
services as well as the screening services received.  These findings will be used to 
refine and revise the WC Services.       
Sources of Materials. During the telephone calls, and specifically the survey assessment, 
survey data will include responses to questions on CRC knowledge, fear of colonoscopy, 
questions about CRC screening referrals (e.g. regular relationship with PCP physicians, having 
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had discussion or referral for CRC screening, personal experience or knowledge of individuals 
in the health care system), Process of Change, Patient Activation Measure and demographic 
(e.g. age, gender, education level, insurance status) and prior CRC screening (see Table 1). 
Educational materials will include printed brochures and evidence-based videos about CRC 
screening.   
Potential Risks.   There are no physical risks posed by this study.  The types of questions 
asked in the surveys and the types of information presented in the interventions are not different 
from those that might be asked or presented by a health care provider and thus do not pose 
greater than minimal risk. Although the chances of psychological distress are minimal, any 
psychological distress will be monitored by the staff and if appropriate, participants will be 
offered a referral to Psychology/Psychiatry Staff, if warranted.  Potential benefits include 
increased knowledge about colorectal cancer and screening as well as information about how to 
get screened and/or assistance and services to successfully complete screening.  Although we 
cannot guarantee that participants may benefit directly from study participation, especially those 
completing the survey alone, but those clients obtaining colonoscopy may prevent CRC cancer 
or find it earlier.  Study participants in our prior studies have reported they enjoyed providing 
researchers with greater knowledge of their experience in hopes of facilitating cancer prevention 
and in possibly benefiting others. Given the potential gains to participants the ratio of risk to 
benefits is quite low and reasonable.
2. ADEQUACY OF PROTECTION AGAINST RISKS
Recruitment and Informed Consent. Witness CARES, LLC staff members will work with our 
customer clients (YourCare and MCCC) to obtain and recruit clients from their “gaps in care” 
lists.  Information sheets and oral consent over the phone will be used for the telephone survey.  
The Business Agreements will provide coverage for offering the navigational services. 
Table 1. Study Measures 
R01 Measure for Milestones 2a & 
2b
Source
Reliability
Use in Previous Studies
Benefits/Barriers (Both FIT and 
Colonoscopy) 
Rawl et al 2001
αs > 0.65 
Rawl et al 2001
Janz et al 2007 & 2003; Madlensky et al 
2004; Menon et al 2003
Affective Associations with screening 
(including Fear of Colonoscopy)
Crites et al 1994; 
items selected based 
on pilot study above
αs > 0.88
Kiviniemi et al 2009;
Pilot study described 
above
Kiviniemi et al 2007 & 2009; Simons et al 
1998
Cognitive/Affective Risk Perceptions
Weinstein et al 1995; 
Zajac et al 2006
Single item measures
Moser et al 2007; Waters et al 2011;
Kiviniemi 2010 & 2009
Cancer Worry 
Lerman et al 1991
Lerman 1991
Screening Behavior/Intentions
Vernon et al 2004
Test-retest > 90%
Vernon et al 2008
Concordance > 0.80
Partin et al 2008
Emmons et al 2009; Janz et al 2007; 
Nelson et al 2004
Demographics (e.g.,SES, Insurance, 
PCP, PCP visits, screening referrals)
Erwin et al 2011; 
Jandorf et al 2010
Single item measure
Erwin et al 2011; Jandorf et al 2010
Prospective New Measures for Milestone 2b only
Patient Activation Measure®
Hibbard et al. 2005
Reliabiity coeffecients 
(with ethnic 
minorities) = >.70 
Alexander, Hearld and Mittler 2014; 
Serper et al. 2014; Greene, Hibbard 2012
Process of Change for CRC 
Screening
Manne et al. 2002
 CFI=0.785
Duhamel et al 2011
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The key elements of the informed consent procedure which will be explained to the participants 
are: 1) the research status of the study; 2) the prospect of psychological risk and the provisions 
for it; 3) the lack of guarantee of benefit from participation, 4) the confidentiality of subjects 
responses to all study measures; 5) the voluntary nature of the study; 6) the lack of 
consequences to medical care of the decision to consent or to refuse to participate; 7) the 
receipt of the gift card for participating, and 8) the freedom to withdraw from the study or to 
refuse to answer specific questions at any time. 
Before the survey is conducted, staff member will explain: 1) the nature and purpose of the 
research endeavor, 2) that participation in the research component is completely voluntary, and 
3) that data collected from participants will be confidential and assessed, evaluated and 
reported as aggregate data, as well as precautions taken in the storage of the data. The study 
staff member will verify that the women and men who wish to participate meet the study's 
eligibility criteria as described above. The staff member will solicit and respond to any and all 
inquiries. 
For the colonoscopy procedures, individual, hospital/facility/physician specific consents will be 
signed and this is beyond the scope or responsibility of Witness CARES, LLC or the study staff.
Protection Against Risk.  Oral consent will be received from participants prior to their 
completion of study questions for the telephone survey. These include questions on CRC 
knowledge, fear of colonoscopy, cancer worry, perceived risk, questions about regular 
relationship with physicians and having had discussion or referral for CRC screening), affective 
and cognitive associations with CRC and questions about demographics (e.g. age, gender, 
education level, insurance status) and prior CRC screening.  The data will be recorded on the 
phone and on a pen and paper survey form (to be developed into an electronic record).  The 
survey data will be identified with a coded ID in order to add CRC screening outcomes to the 
record for analysis. Reporting of the data is completely anonymous and de-identified. 
Participants may refuse to participate without penalty.  Participant records and responses are 
identified by an assigned identification code of the client and the client list will be kept locked 
and separated from the interview data. 
10 SUBJECT CONFIDENTIALITY AND DATA SECURITY
All study staff members will comply with federal regulations to ensure participant confidentiality 
is maintained. Information gathered from participants will be protected and kept in encrypted 
programs and locked file cabinets.  There will be no reference by name to any participant in any 
data capture for the surveys or satisfaction assessments.  All study records will be kept in a 
locked, secured cabinet in the study offices.  All data collected will be stored on password 
protected computers and encrypted USBs.  Data transfers among collaborators (clinics, 
insurers, RPCCC UB and Mt. Sinai and Witness CARES, LLC) will be done via encrypted files.  
All procedures will be monitored by the PIs.
3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND 
OTHERS
Potential benefits include learning about CRC screening, cancer risks, and cancer prevention 
efforts and receiving information and assistance to participate in screening activities. For 
participating in the additional survey participants will receive gift cards to local stores.
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4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
As stated in the text of this proposal, the proposed research aims to improve CRC screening in 
Medicaid and African American clients in the Buffalo area. Findings from this study are expected 
to contribute to the knowledge about the effectiveness of Witness CARES services to increase 
CRC screening. 
5. DATA SAFETY AND MONITORING PLAN 
The following plan addresses the four essential elements noted in NCI’s 2001 outline:  
“Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials Funded by the 
National Cancer Institute.”
1.  Monitoring the progress of trials and the safety of participants.
The proposed program is an educational and navigation to screening study and is low-risk.  This 
program will be submitted to the Roswell Park Comprehensive Cancer Center IRB as the IRB of 
record in order to establish exemption.   
Per Roswell Park IRB policies, all Roswell Park trials receive some form of data and safety 
monitoring.  Study investigators and clinical trials staff forward all adverse event reports to the 
Roswell Park Office of Clinical Research Services. On a monthly basis, the IRB reviews all 
adverse events for all clinical trials active at Roswell Park and makes recommendations to 
address concerns of patient safety. Roswell Park also has in place a rigorous compliance 
monitoring program that addresses the investigators’ adherence to the precise implementation 
of our IRB approved protocols. External adverse event reports (those that are reported to 
Roswell Park but take place on studies done outside of the institute) are reviewed on an annual 
basis, and more frequently if needed. 
While these activities have been a vital and important role for our clinical trials, the NIH 
guidelines require a more comprehensive and detailed data and safety monitoring plan. Thus, 
the Roswell Park Data and Safety Monitoring Plan has been developed to coordinate and 
provide oversight for data and safety monitoring for all therapeutic trials consistent with the 
National Institutes of Health Policy for Data and Safety Monitoring dated June 10, 1998, with 
further guidance issued on June 5, 2000. The National Cancer Institute issued a policy on June 
22, 1999 for data and safety monitoring of all trials with special emphasis on randomized phase 
III trials by Data and Safety Monitoring Boards [DSMB's].
Data and Safety Monitoring Board
The Data and Safety Monitoring Board (DSMB) meets at least quarterly to review the results of 
adverse event reporting, protocol deviations, protocol audits and the conduct of the study. Each 
Roswell Park study not otherwise overseen by an external DSMB is reviewed at least annually. 
The DSMB reports the analysis of their review to Sr. Vice President for Research and to the 
IRB.  To avoid conflicts of interest, members of the DSMB are not involved in the oversight of 
studies for which they serve as principal investigator or co-investigator / biostatistician.  
2.  Plans for assuring adherence with requirements regarding the reporting of 
adverse events (AEs).  
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All serious AEs (e.g., medical occurrences resulting in death) that occur during the study 
defined by the given protocol, regardless of the relation to the research, must be reported to the 
IRB by telephone, e-mail or FAX within 24 hours of the investigator’s awareness of the 
occurrence of the event. The MPIs will report SAEs to the Roswell Park IRB and will 
disseminate information to other agencies as necessary.  These initial reports are followed by a 
safety report which is a written account of a serious AE determined by a sponsor/investigator to 
be both related to the treatment under investigation and unexpected in nature.  Serious AEs will 
be summarized annually in the IRB application for continuation or termination of research.
All expected non-serious AEs that occur at a greater frequency or severity than anticipated and 
all unexpected non-serious AEs will be reported to the IRB within 15 working days of the 
investigator becoming aware of the event.  These AEs are also summarized annually in the IRB 
application for continuation or termination of the research.  
3.  Plans for assuring that any action resulting in a temporary or permanent 
suspension of an NCI funded clinical trial is reported to the NCI grant program 
director responsible for the grant.
Don Handley, Administrative Director of Research Subject Protection at Roswell Park 
Comprehensiv Cancer Center, will provide prompt written notification of any action resulting in a 
temporary or permanent suspension of this protocol to the NCI grant program director 
responsible for the grant.
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12 APPENDICES
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