A Colorectal Cancer Educational Intervention in the Latino Community Assessing the Feasibility of Recruitment & Retention Via a Church-Based Approach: Identification of Novel Barriers to Cancer Clinical Trial Enrollment
Phase: NA
Conditions: Colorectal Cancer, Rectal Cancer, Colon Cancer, Colon Rectal Cancer, Rectal Neoplasms, Colon Adenocarcinoma, Hereditary Nonpolyposis Colon Cancer
Sponsor: University of North Carolina, Chapel Hill

Study Protocol 
 
A Colorectal Cancer Educational Intervention in the Latino Community Assessing 
the Feasibility of Recruitment & Retention via a Church-Based Approach: 
Identification of Novel Barriers to Cancer Clinical Trial Enrollment 
 
 
 
NCT number NCT06426927 
Document Date 11/21/2024 
 

PROTOCOL TEMPLATE: INTERVENTIONAL STUDY 
 
 
Complete Title: A Colorectal Cancer Educational Intervention in the Latino Community Assessing the 
Feasibility of Recruitment & Retention via a Church-Based Approach: Identification of Novel Barriers to Cancer 
Clinical Trial Enrollment 
 
 
 
 
Short Title: PeLear CCC: Proyecto Latino Contra Cáncer Colorrectal 
Drug or Device Name(s): N/A 
FDA IND/IDE (if applicable): N/A 
Sponsor: José G. Guillem 
Protocol Date: 21 November 2024 
Amendment 1 Date: 
Amendment 2 Date:  
Amendment 3 Date: 
Amendment 4 Date:  
 
 
 
 
 
 
 
Sponsor: José G. Guillem 
Sponsor Name: José G. Guillem 
Address: 101 Manning Drive 
City, State, Zip: Chapel Hill, North Carolina, 27514 
Country: United States of America 
Study Principal Investigator (if multicenter study with  UNC PI responsible): José G. Guillem 
Office Address: 101 Manning Drive 
City, ST, ZIP: Chapel Hill, North Carolina, 27514 
Phone 919-966-8436 
email: jose_guillem@med.unc.edu 
 
 

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PROTOCOL TITLE:  
A Colorectal Cancer Educational Intervention in the Latino Community Assessing the 
Feasibility of Recruitment & Retention via a Church-Based Approach: Identification of 
Novel Barriers to Cancer Clinical Trial Enrollment 
Short Title:  
PeLear CCC: Proyecto Latino Contra Cáncer Colorrectal  
Lead Investigator: 
Jose G. Guillem, M.D., M.P.H, M.B.A., 
 University of North Carolina at Chapel Hill 
Version Date: November 21, 2024 
 
I confirm that I have read this protocol and understand it.    
Principal Investigator Name:  
 
 
 
 
 
 
 
 
Principal Investigator Signature:  
 
 
 
 
 
 
 
Date:   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS .......................................................................................................... 4 
PROTOCOL SYNOPSIS .......................................................................................................................................................................................... 5 
BACKGROUND AND RATIONALE ......................................................................................................................................................................... 8 
1 
STUDY OBJECTIVES .......................................................................................................................................................................... 11 
2 
INVESTIGATIONAL PLAN ................................................................................................................................................................. 11 
3 
STUDY PROCEDURES ....................................................................................................................................................................... 12 
4 
STUDY EVALUATIONS AND MEASUREMENTS ................................................................................................................................ 13 
5               STATISTICAL CONSIDERATIONS ...................................................................................................................................................... 14 
6 
STUDY INTERVENTION (DEVICE, DRUG, OR OTHER INTERVENTION) ............................................................................................ 16 
7               STUDY INTERVENTION ADMINISTRATION...................................................................................................................................... 16 
8           SAFETY MANAGEMENT ................................................................................................................................................................... 16 
9           DATA COLLECTION AND MANAGEMENT ........................................................................................................................................ 17 
10           RECRUITMENT STRATEGY ................................................................................................................................................................ 19 
11           CONSENT PROCESS .......................................................................................................................................................................... 19 
12           PLANS FOR PUBLICATION ................................................................................................................................................................ 19 
13           REFERENCES ..................................................................................................................................................................................... 19 
APPENDIX .................................................................................................................................................................... 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 4 of 23 
 
Abbreviations and Definitions of Terms 
 
Abbreviation 
Definition 
NCTraCS 
North Carolina Clinical and Translational Science Institute 
US 
United States 
CRC 
Colorectal Cancer 
CCT 
Cancer Clinical Trial 
STM 
Saint Thomas More  
LCRB 
Latine Community Review Board 
CHW 
Community Health Workers 
IRB 
Institutional Review Board 
PHI 
Private Health Information 
RCMU 
Research Coordination & Management Unit 
UNC 
University of North Carolina 
PI 
Primary Investigator 
RIS 
Research Information Sheet 
CTS 
Clinical Translational Science 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
  
Study Title 
A Colorectal Cancer Educational Intervention in the Latino 
Community Assessing the Feasibility of Recruitment & Retention via 
a Church-Based Approach: Identification of Novel Barriers to Cancer 
Clinical Trial Enrollment 
Funder 
NCTraCS  
Clinical Phase 
N/A 
Study Rationale 
Cancer is the leading cause of death in the US Latino community, 
with CRC accounting for 10% of overall Latino mortality. Although 
Latino individuals are among the largest and fastest growing 
communities of color in the US, currently comprising 18.7%, their 
representation in CCTs remains low. This is of concern because: 1) 
advances arising from trials with limited Latino representation may 
not be applicable to the Latino population, and 2) decreased Latino 
participation in CCTs may delay Latino access to novel therapies. We 
believe that low cancer-specific health knowledge may be impacting 
Latino representation and willingness to participate in CCTs and can 
be addressed through culturally and linguistically appropriate 
community-based educational interventions. Since Latino CCT 
underrepresentation is likely to be a multifaceted phenomenon with 
potential contributing barriers at the physician-, healthcare system-, 
and patient-level, understanding the multiple driving forces and 
barriers is essential to identifying potential targets for improvement 
and addressing our CTS roadblock of Latino underrepresentation in 
CCTs.  
Study Objective(s) 
1. To identify novel Latino-perceived barriers to participation in 
CCTs. 
2. To assess the impact that CRC educational videos in Spanish 
have on participants’ CRC knowledge. 
3. To assess the potential relationship between an increase in 
health knowledge of a specific cancer via educational videos 
in Spanish and willingness to participate in CCTs.  
Test Article 
The intervention in this study entails three CRC educational videos 
in Spanish. 
Study Design 
 
To achieve our goals, Spanish speaking Latino individuals will be 
recruited to participate in an educational intervention that will take 
place at STM Church. On Study Day 1, participants will be given the 
CRC Knowledge Survey in Spanish before watching three CRC 
educational videos. After watching the videos, participants will be 
given the Post Video CRC Knowledge Survey. After 30 +/- 7 days, 
participants will be asked to return to the Church for Study Day 2 in 
order to complete the 30 Day Follow Up CRC Knowledge Survey, 

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consisting of the original survey plus an open-ended question 
regarding barriers to participation in CCTs. Subsequently, 20 
participants will be invited to participate in one-on-one qualitative 
interviews aimed at gaining further insight on Latino-perceived 
barriers to CCT participation. (Study Day 3) 
Subject Population 
Key Criteria for Inclusion 
and Exclusion: 
Participants should: 
1. Self-identify as Hispanic/Latino. 
2. Be Spanish speakers. 
3. Be 18 years or older. 
Participants will be excluded if they: 
1. Do not identify as Hispanic/Latino. 
2. Are not Spanish speakers. 
3. Are younger than 18 years old. 
Number Of Participants  
 
60  
Study Duration 
Every participant’s involvement will require at least two and a half 
hours over a 4-month period (two hours to take the CRC Knowledge 
Survey, watch the videos and take the Post Video CRC Knowledge 
Survey and thirty minutes to complete the 30 Day Follow Up CRC 
Knowledge Survey). Participants willing to take part in a qualitative 
one-on-one interview will be asked to participate for an additional 
hour, totaling three and a half hours over a 6-month period. The 
entire study is expected to last 12 months. 
Study Phases 
A. Educational Video 
i. 
Screening 
ii. Study Intervention 
iii. Follow-Up 
B. Identification of 
Barriers 
Preventing Latinos 
from participating 
in CCTs  
                              
A. Educational Video: 
(i) Screening: Spanish speaking attendees at STM Church will be 
screened for study eligibility.  
(ii) Intervention (Study Day 1): Consented participants will complete 
the CRC Knowledge Survey, watch three CRC educational videos and 
complete the Post Video CRC Knowledge Survey. Both surveys will 
be administered on paper form. 
(ii) Follow up (Study Day 2): In order to assess retention of 
knowledge, participants will return to STM Church 30 +/- 7 days 
after Study Day 1 to complete the 30 Day Follow Up CRC Knowledge 
Survey on paper form. 
B. Identification of Barriers for Latino Participation in CCTs: 
(Study Day 3): 20 of the participants will be asked to participate in a 
qualitative one-on-one interview aimed at identifying barriers 
preventing Latinos from participating in CCTs. 
Efficacy Evaluations 
Participants’ knowledge on CRC symptoms, risk factors, and general 
CRC facts will be assessed using questions from the “Bowel Cancer 
Awareness Measure” and from the “Colorectal Cancer Screening 
Decision Quality Instrument (CRC-DQI)”. 

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Safety Evaluations 
N/A, this study imposes minimal risk. 
Statistical And Analytic 
Plan 
A. Identification of Barriers: The top 2 conceptual themes within 
each section of the interview (attitudes regarding general clinical 
trials, attitudes regarding CCTs, and perception of the 
Hispanic/Latino community) and the top 3 higher-level, holistic 
themes across the sections will be reported in terms of percentage 
of participants. 
B. Assessment of the potential impact of the educational videos in 
Spanish on CRC knowledge: Use of repeated measures ANOVA with 
appropriate follow-up contrasts to compare total number of correct 
responses within three time points (baseline vs post-video; baseline 
vs 30 +/- 7 days follow up; post-video vs 30 +/- 7 days follow-up) 
accounting for multiple observations within participants.  
C. Exploration of the potential relationship between an increase in 
health knowledge of a specific cancer via educational videos in 
Spanish and willingness to participate in CCTs: Since questionnaires 
will be completed pre- and post-video, we will explore, in a 
preliminary fashion, the association between watching the video (X) 
and willingness to participate in CCTs (Y) using repeated-
measures/mixed-effects logistic regression on the paired responses 
of participants. The mediating effect of Study Day 1 post-video 
health knowledge levels (M) on the relationship between X and Y 
(established in the preliminary step above) will be explored. Using a 
structural equation modeling approach, two mixed-effects 
generalized linear models will be carried out: one model uses both X 
and M to predict Y, while another uses only X to predict M. The two 
models will be compared and tested using the algorithm introduced 
by Imai and colleagues. The estimated average causal mediation 
effect (from X to Y, through M) will be tested using the 
bootstrapping method with 1,000 replications, and the proportion 
of the effect being mediated will be reported as the effect size. 
Lastly, in order to explore an adjusted approach, the same steps 
used for the mediation model will be replicated, while incorporating 
demographic variables as covariates.  
DATA AND SAFETY 
MONITORING PLAN 
Monitoring of quality data entry will be performed by our 
collaborators at the RCMU and members of the study team after 
the initial 5 registrants and then after every 10. The PI will be 
responsible for data monitoring. To minimize the risk of breach of 
confidentiality, all PHI will be stored in a password protected server 
accessible only by members of the study team. To minimize the risk 
of emotional distress, participants will be reassured that they will  
not have to answer any questions that make them feel 
uncomfortable and may stop completing the questionnaires at any 
point. 

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BACKGROUND AND RATIONALE 
 
1.1 
Introduction 
Cancer is the leading cause of death in the US Latino community, with CRC accounting for 10% of this 
overall mortality.1 Although Latino individuals are among the largest and fastest growing communities 
of color in the US, currently comprising 18.7%,2 their representation in CCTs remains low.3–5 This is of 
concern because: 1) advances arising from trials with limited Latino representation may not be 
applicable to the Latino population,6 and 2) decreased Latino participation in CCTs may delay Latino 
access to novel therapies. 
We believe that low cancer-specific health knowledge may be impacting Latino representation and 
willingness to participate in CCTs and that this can be addressed through culturally and linguistically 
appropriate community-based educational interventions.7,8  Since Latino CCT underrepresentation is 
likely to be a multifaceted phenomenon with potential contributing barriers at the physician-, 
healthcare system-, and patient-level, understanding the multiple driving forces and barriers is 
essential to identifying potential targets for improvement and addressing our CTS roadblock of Latino 
underrepresentation in CCTs.  
1.2 
Name and Description of Investigational Product or Intervention  
This study will assess the impact of three educational videos in Spanish on participants’ CRC knowledge 
and willingness to participate in CCTs.   
1.3 
Non-Clinical and Clinical Study Findings 
Potential benefits from participation in this study may include improvement in participants’ 
knowledge of CRC, a major healthcare problem for the Latino community. The pre- (CRC Knowledge 
Survey) and post-educational video (Post Video CRC Knowledge Survey) questionnaires will allow us to 
determine the impact of the educational videos on CRC knowledge and retainment as well as allow us 
to explore the potential relationship between an increase in knowledge on a specific cancer and 
willingness to participate in CCTs. The follow-up questionnaire (30 Day Follow Up CRC Knowledge 
Survey) will assess retention of information at 30 +/- 7 days. In addition, through the conduct of 
qualitative one-on-one interviews, Latino-perceived barriers to CCT participation may be identified. 
The study requires completion of three questionnaires and a potential one-on-one interview. It will be 
conducted in a familiar location (namely, STM Church), and we do not anticipate any adverse events. 
There is minimal risk of emotional distress from answering questions related to CRC. However, 

Page 9 of 23 
 
participants will be encouraged to not answer any questions that make them feel uncomfortable and 
to stop the questionnaires at any point. Participants will be asked to provide contact information in 
order to schedule interviews. Efforts are in place to minimize any potential breach of confidentiality. 
Overall, the potential risks from participating in our study are minimal while the knowledge to be 
gleamed, including Latino-specific barriers to CCT participation, will be significant.  
1.4 
Relevant Literature and Data 
Use of the Church-based Approach: Approximately 75% of Foreign- and 55% of US-born Latino identify 
as Christian, respectively9 and 74% of Latinos attend Church at least 1-2 times a month.10 As a 
testament to the important role that the Church plays in the Latino community, several interventions 
have been evaluated in the Church setting11–25 including: breast cancer prevention;16,17,19 diabetes 
mellitus;14,23,24 cancer screening promotion;13,15 physical exercise promotion;18,21 HIV stigma 
reduction;20 stroke prevention;22 organ donation promotion;25 and cardiovascular risk reduction.11,12 
With the exception of a recent study limited to Latino men,26 we are not aware of any Church-based 
educational interventions that have: 1) educated Latinos on CRC or 2) reported strategies for their 
recruitment and retention. We believe that our approach, if successful, may have broad applicability 
for the recruitment of other ethnic minority groups with high religious beliefs across a multitude of 
denominations (e.g. 68% of Asians attend Church at least 1-2/month10).  
Education of the general population/non-cancer afflicted individuals: Most CCT educational 
interventions target individuals afflicted with the disease.27–33 While only a handful target the non-
affected general population,34–37 this approach may be uniquely suited for recruitment of Latinos in 
CCTs since in the Latino community the decision to enroll in a CCT is likely to be multifactorial and 
heavily influenced by input from family members.38 In fact, a core value of Latino culture is familismo: 
“the concept of a broad network of familial support that extends beyond the nuclear family”.39 Since 
lack of family support may act as a barrier to Latino CCT participation,40,41 we believe that: (1) 
educating the general population and non-cancer afflicted Latino individuals and families will facilitate 
Latino CCT participation and (2) the Church setting, given the multiple familial generations attending 
mass, is a viable venue for educating the Latino general population. 
Education on a specific cancer & willingness to participate in CCTs: Unlike other studies aimed at 
increasing willingness to participate in CCTs solely through general education about CCTs, our study 
focuses primarily on education on a specific cancer.27–37,42 Since education on CRC has been shown to 

Page 10 of 23 
 
increase willingness to participate in CRC screening,43 we anticipate it could similarly increase 
willingness to participate in CCTs. This can be achieved by increasing awareness of CRC and its 
treatment options ultimately leading to improved decision-making.27 
Questionnaire: Knowledge on CRC and willingness to participate in CCTs will be assessed using 3 
subscales from 2 CRC knowledge questionnaires previously validated in English. Dr. Perreira and 
Jessica Grant from the Odum Institute combined the 3 subscales44–46 to form our Pilot Study 
Questionnaire. This Pilot Study Questionnaire has been translated into Spanish by Language Line 
Solutions, hired through the UNC Clinical Research Support Office (CRSO), and revised, using an 
iterative process with input from the LCRB, for linguistic and cultural relevance and accuracy. The 
resultant Pilot Study Questionnaire consists of 29 items that assess health knowledge levels and 1 that 
assesses willingness to participate in CCTs (30 total questions). General knowledge on CRC will be 
assessed using the prompted 9-item “Awareness of warning signs’’ (Yes/No) and the prompted 11-
item “Awareness of risk factors'' (5 point Likert agreement scale) subscales of the “Bowel/CRC Cancer 
Awareness Measure (Bowel/CRC CAM)”.45 Specific knowledge on CRC screening will be assessed using 
the 9-item “Knowledge on CRC screening” (mixed types of response options) subscale from the CRC 
Screening Decision Quality Instrument (CRC-DQI).46 Our outcome variable, willingness to participate in 
CCTs, will be assessed using a “Yes/No” item.28,36,42 Our Pilot Study Questionnaire is used in all three 
surveys, namely the CRC Knowledge Survey; Post Video CRC Knowledge Survey and 30 Day Follow Up 
CRC Knowledge Survey. Additionally, the CRC Knowledge Survey, administered pre-video, includes 
seventeen questions capturing demographic information (47 total questions), while the 30 Day Follow 
Up CRC Knowledge Survey contains in addition to the pilot study Questionnaire, an open-ended 
question aimed at capturing barriers preventing Latinos from participating in CCTs (31 total 
questions). 
Video: Previous studies demonstrate the superiority of a video-based approach compared to other 
educational tools in terms of knowledge acquisition and acceptance within the Latino 
population.42,43,47,48 Based upon strong recommendation from the UNC’s Audio and Video Production 
Team, we contracted DWALT Media, which has filmed videos for UNC Medical Center and worked 
with local churches, for the production of our Spanish educational videos. Filming occurred at UNC 
Medical Center and included animations, figures and 3D models. The videos will educate the 
participants on CRC symptoms, risk factors, screening and CRC facts. In addition, the third video will 
contain some information regarding CCTs. Since Latinos consider physicians a trustworthy source of 

Page 11 of 23 
 
medical information,49 our PI, a member of the STM Latino community, will present some of the 
educational material.  
1 
STUDY OBJECTIVES 
1.4 
Primary Objective 
The Primary Objective of this study is to identify novel Latino-perceived barriers to participation in CCTs. 
1.5 
Secondary Objectives 
1. Assess the impact that CRC educational videos in Spanish may have on participants’ CRC 
knowledge.  
2. Assess the potential relationship between an increase in health knowledge of a specific cancer 
via educational videos in Spanish and willingness to participate in CCTs.  
 
2 
INVESTIGATIONAL PLAN  
2.1 
Study Design 
Type of Design: Single-arm intervention study 
Brief Overview of Study Phases: Following completion of the Hispanic Masses at STM Church on 
Saturday and Sunday, attendees will be approached by members of our study team and CHWs. They 
will be screened for their eligibility to participate in our study through an Intake Form which they will 
be able to complete either in-person while they are at the Church, or through the project website. 
Those deemed eligible will be prompted to complete the RIS online, in-person, or via the phone. Those 
that complete the RIS and enroll in the study will be scheduled to come to STM Church on future Study 
Days. During Study Day 1, participants will complete the CRC Knowledge Survey, watch three CRC 
educational videos in Spanish and then complete the Post Video CRC Knowledge Survey. On Study Day 
2 (30 +/- 7 days after their participation in Study Day 1), participants will return to STM Church in order 
to complete the 30 Day Follow Up CRC Knowledge Survey. Subsequently, on Study Day 3, 20 of the 60 
participants will participate in a one-on-one qualitative interview aimed at identifying barriers 
preventing Latinos from participating in CCTs.  
 
 

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2.2 
Study Duration, Enrollment and Number of Participants 
Participant commitment will consist of at least two and a half hours over a 4-month period (two hours 
to take the CRC Knowledge Survey, watch the videos and take the Post Video CRC Knowledge Survey 
and thirty minutes to complete the 30 Day Follow Up CRC Knowledge Survey). Participants willing to 
take part in a qualitative one-on-one interview will commit an additional hour, totaling three and a half 
hours over a 6-month period. The entire study is expected to last 12 months. We intend to enroll a 
total of 60 participants. However, in order to recruit the necessary 20 for the qualitative interview, we 
may need to enroll more than 60 since not everyone participating in Study Days 1 and 2 will choose to 
participate in Study Day 3. 
2.3 
Study Population 
Participants should:  
(1) Self-identify as Hispanic/Latino. 
(2) Be Spanish speakers. 
(3) Be 18 years or older. 
Participants will be excluded if they: 
(1) Do not identify as Hispanic/Latino. 
(2) Are not Spanish speakers. 
(3) Are younger than 18 years.  
 
3 
STUDY PROCEDURES  
3.1 
Screening/Baseline Visit procedures 
Interested participants will be asked to complete an Intake Form in Spanish which captures name and 
contact information as well as determines study eligibility as listed above. Those deemed eligible will 
be prompted to complete the RIS. In addition to in-person recruitment, interested participants will 
have the opportunity to complete the Intake Form using our study website, which will be readily 
accessible via a QR code found on the Study Flyer.  
 
 
 

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3.2 
Intervention/Treatment procedures 
Study Day 1: Consented participants come to STM Church. During Study Day 1, they will be asked to 
complete the CRC Knowledge Survey, watch three CRC educational videos in Spanish and subsequently 
complete the Post Video CRC Knowledge Survey in Spanish. Both surveys will be administered on paper 
form. 
3.3 
Follow- up procedures  
Study Day 2: The participants return to STM Church 30 +/- 7 days after their participation in Study Day 
1. During Study Day 2, they will complete the 30 Day Follow Up CRC Knowledge Survey on paper form. 
Study Day 3: A random subset of participants from Study Days 1 and 2 will be invited to participate in 
qualitative one-on-one interviews aimed at identifying barriers preventing Latinos from participating in 
CCTs. 
3.4 
Subject Completion/ Withdrawal procedures 
At the completion of Study Day 2, participants will receive a $100 gift card and a study T-shirt from 
either our research assistant or one of the volunteers, all of whom will be Tango trained and enlisted 
on the study’s IRB. Participants interested in participating in qualitative one-on-one interviews aimed 
at identifying barriers preventing Latinos from participating in CCTs will be invited to participate in 
Study Day 3. Following completion of Study Day 3, these participants will receive an additional $50 gift 
card for their participation in the qualitative one-on-one interviews. Participants choosing to withdraw 
from the study may do so at any point by notifying the PI via email.  
3.5 
Screen failure procedures 
At the beginning of each educational session, eligibility requirements (age ≥ 18 years of age; 
identifying as Hispanic/Latino and being Spanish speaker) will be confirmed for each registered 
individual. In the unlikely event that an ineligible individual had been registered, this will be noted and 
the involved parties reminded of the eligibility requirements and their inability to participate in the 
study.   
 
4 
STUDY EVALUATIONS AND MEASUREMENTS  
4.1 
Efficacy Evaluation  
To assess the impact of the CRC educational videos in Spanish on participant’s knowledge of CRC 
symptoms, risk factors, screening, and facts, this study will utilize questions obtained from 3 subscales 
from 2 questionnaires previously validated in English.  

Page 14 of 23 
 
1. Participants’ knowledge on CRC symptoms will be assessed using the “Knowledge of Warning 
Signs” questions from the “Bowel Cancer Awareness Measure”. Potential answers to these 
questions include “Yes”, “No” and “Don’t Know”. The overall score will range from 0 to 9 and it 
is anticipated that average scores will increase after the intervention. Higher scores imply 
greater knowledge of symptoms.  
2. Participant’s knowledge on CRC risk factors will be assessed using the “Knowledge of Risk 
Factors” questions from the “Bowel Cancer Awareness Measure”. This scale is measured using a 
Likert 1-5 scale with “1” corresponding to “Strongly Disagree” and “5” corresponding to 
“Strongly Agree”. The overall score will range from 11 to 55 and it is anticipated that the 
average scores will increase after the intervention. Higher scores imply greater knowledge of 
risk factors. 
3. Participant’s knowledge on CRC screening and general facts will be assessed using nine 
questions from the “Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI)”. The 
overall score will range from 0 to 9 and it is anticipated that average scores will increase after 
the intervention. Higher scores imply greater knowledge of general facts. 
STATISTICAL CONSIDERATIONS  
4.2 
Primary Endpoint 
Identify novel Latino-perceived barriers to participation in CCTs. 
4.3 
Secondary Endpoints 
The Secondary Endpoints of our study are to assess the association of:  
1. Educational videos on knowledge of CRC symptoms. 
2. Educational videos on knowledge of CRC risk factors. 
3. Educational videos on knowledge on CRC screening and facts. 
4. Watching the videos and willingness to participate in CCTs. 
4.4 
Methods 
Primary Endpoint: Twenty enrolled participants will participate in qualitative, semi-structured, one-on-
one interviews that will be performed in Spanish. The interviews will be recorded and transcribed. 
ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes within each 
section of the interview (attitudes regarding general clinical trials, attitudes regarding CCTs, and 
perception of the Hispanic/Latino community) and the top 3 higher-level, holistic themes across the 
sections will be reported in terms of percentage of participants. 

Page 15 of 23 
 
Secondary Endpoint 1: Use of repeated measures ANOVA with appropriate follow-up contrasts to 
compare total number of correct responses within three time points (baseline vs post-video; baseline 
vs 30 +/- 7 days follow-up; post-video vs 30 +/- 7 days follow-up) accounting for multiple observations 
within participants. Knowledge pertaining to CRC symptoms will be assessed using the “Knowledge of 
Warning Signs” questions from the “Bowel Cancer Awareness Measure”. Potential answers include 
“Yes”, “No” and “Don’t Know”. The overall score will range from 0 to 9 and it is anticipated that 
average scores will increase after the intervention. Higher scores imply a greater knowledge of 
symptoms. 
Secondary Endpoint 2: Use of repeated measures ANOVA with appropriate follow-up contrasts to 
compare total number of correct responses within three time points (baseline vs post-video; baseline 
vs 30 +/- 7 days follow-up; post-video vs 30 +/- 7 days follow-up) accounting for multiple observations 
within participants. Knowledge pertaining to CRC risk factors will be assessed using the “Knowledge of 
Risk Factors” questions from the “Bowel Cancer Awareness Measure”. This scale is measured using a 
Likert 1-5 scale with “1” corresponding to “Strongly Disagree” and “5” corresponding to “Strongly 
Agree”. The overall score will range from 11 to 55 and it is anticipated that the average scores will 
increase after the intervention. Higher scores imply higher knowledge of risk factors. 
Secondary Endpoint 3: Use of repeated measures ANOVA with appropriate follow-up contrasts to 
compare total number of correct responses within three time points (baseline vs post-video; baseline 
vs 30 +/- 7 days follow-up; post-video vs 30 +/- 7 days follow-up) accounting for multiple observations 
within participants. Knowledge of CRC screening and general facts will be assessed using nine 
questions from the “Colorectal Cancer Decision Quality Instrument (CRC-DQI)”. The overall score will 
range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher 
scores imply greater knowledge of screening and facts. 
Secondary Endpoint 4: Since questionnaires will be completed pre and post video, we will explore, in a 
preliminary fashion, the association between watching the video (X) and willingness to participate in 
CCTs (Y) using repeated-measures/mixed-effects logistic regression on the paired responses of 
participants. The mediating effect of Study Day 1 post-video health knowledge levels (M) on the 
relationship between X and Y (established in the preliminary step above) will be explored. Using a 
structural equation modeling approach, two mixed-effects generalized linear models will be carried 
out: one model uses both X and M to predict Y, while another uses only X to predict M. The two 

Page 16 of 23 
 
models will be compared and tested using the algorithm introduced by Imai and colleagues50,51 The 
estimated average causal mediation effect (from X to Y, through M) will be tested using the 
bootstrapping method with 1,000 replications, and the proportion of the effect being mediated will be 
reported as the effect size. Lastly, in order to explore an adjusted approach, the same steps used for 
the mediation model will be replicated, while incorporating demographic variables as covariates.  
4.5 
Sample Size and Power 
A traditional “power analysis” is not directly applicable to the primary endpoint of the study which is 
qualitative in nature. Based on published methodologies to assess the adequate sample to reach 
“saturation”,52–54 we chose to invite 20 participants for qualitative interviews. 
For our quantitative, secondary endpoints, a traditional “power analysis” was performed. A total of 60 
participants will be recruited into the study. If in our study population the mean difference is 0.4, 
which as defined by Cohen is a small to medium difference, and the pre- to post- correlation is 0.5, 
then the power to reject the null hypothesis will be over 80%. If the differences in our study 
population are more extreme, our sample size will have even more power to reject the null hypothesis. 
 
5 
STUDY INTERVENTION (DEVICE, DRUG, OR OTHER INTERVENTION) 
The study intervention consists of three CRC educational videos in Spanish. The aim is to assess the 
potential impact of the intervention on participants’ CRC knowledge and willingness to participate in 
CCTs. 
 
6        STUDY INTERVENTION ADMINISTRATION  
This is a single arm study with consecutive enrollment of eligible participants as noted above. 
 
7. 
  SAFETY MANAGEMENT  
A possible inherit study risk for participants, although low, is a potential breach of confidentiality. To 
minimize this risk, all PHI and study data will be stored in password protected servers that only 
members of the study team will have access to. (e.g. secure drive on the UNC network, UNC 
SharePoint/OneDrive/Teams, REDCap). Intake information obtained on paper form will be initially 
stored in the file tote, transcribed into REDCap, and subsequently stored in a secure file cabinet in the 

Page 17 of 23 
 
PI’s academic office.  In addition, every participant will be assigned a unique deidentified study number 
that will be used during Study Days 1 and 2 (completion of questionnaires) as well as during Study Day 
3 (performance of qualitative one-on-one interview). In addition, there is minimal risk of emotional 
distress from answering questions related to CRC. Participants will be informed that they do not have 
to answer any questions that make them feel uncomfortable and may stop completing the 
questionnaires at any point.  
7.1. 
Adverse Events and Serious Adverse Event Collection and Reporting 
In case of a breach of confidentiality, the PI will immediately notify the IRB at UNC Chapel Hill. No 
serious adverse events are anticipated. However, any unanticipated problems will be reported to our 
IRB in a timely fashion.  
7.2. 
Entity Responsible for Monitoring 
 
The PI in collaboration with the RCMU will be responsible for data monitoring. 
7.3. 
Data Monitoring 
 Monitoring of data quality entry will be performed by our collaborators at RCMU and members of the 
study team after the initial 5 registrants and then after every 10. In order to assure accuracy in 
transcription of information from paper form to REDCap, a member of the study team other than the 
individual initially entering the data into REDCap, will confirm the accuracy of the entered data into 
REDCap by using the paper form to compare data on the initial 5 registrants. On subsequent data 
monitoring efforts (every 10 subsequent registrations), data entered into REDCap on 5 randomly 
selected registrants will be similarly evaluated for accuracy. 
 
8.  
DATA COLLECTION AND MANAGEMENT  
Every participant will be assigned a unique deidentified study number upon enrollment. When a 
participant arrives at STM Church and before they get seated, members of the study team will verify 
their name and DOB and subsequently enter their unique deidentified study number on their survey 
form.  
 At the beginning of Study Day 1, members of the study team will distribute paper surveys with 
deidentified study numbers to the corresponding participants pre- and post-video projection. In order 
to ensure privacy, adequate seating space between participant will be created. Upon completion of the 
surveys, members of the study team will perform a visual review of the survey to identify any quality 
control items such as illegible responses or stray marks across response bubbles. All completed surveys 

Page 18 of 23 
 
with a corresponding unique, deidentified study number will be placed into a portable file tote to 
assure privacy. Within 72 hours of collection, pre- and post-video survey responses for each participant 
will be uploaded to REDCap. Paper surveys will be stored in a secure file cabinet in the PI’s academic 
office. Similar procedures will be followed for the paper surveys collected during Study Day 2. 
On Study Day 3 (one-on-one qualitative interview), the audio of the interview will be recorded using a 
recording device and transcribed by GMR Transcription. ATLAS.ti software will be used for the analysis  
of the 20 deidentified transcripts. The deidentified transcripts will be stored in a secure file cabinet in 
the PI’s academic office. 
 
9.        RECRUITMENT STRATEGY 
Participants will be recruited in-person on the premises of STM Church. Members of the study team 
along with CHW from El Centro Hispano and UNC-Chapel Hill students that are members of the 
Carolina Latinx Center or Comprehensive Advanced Medical Program of Spanish (CAMPOS) will be 
present at STM every Saturday and Sunday for 3 months totaling an initial 24 recruitment attempts. 
During the in-person recruitment, Study Flyers will be handed out to Church attendees as they exit the 
mass. Interested individuals will complete the study Intake Form with the assistance of either a 
member of the study team or a CHW. Once eligibility for study participation has been determined, 
eligible individuals will have the option to enroll while on the premises of STM Church by completing 
the RIS with the assistance of eligible study team members or CHWs.  
In addition to in-person recruitment, interested participants will have the opportunity to enroll via our 
study website, which will be readily accessible via a QR code found on the Study Flyer. While on the 
study website, participants will be prompted to fill out the Intake Form, which captures demographics, 
preferred mode of communication (phone/text or email), contact information, and assesses eligibility.  
Eligible participants indicating that their preferred mode of communication is the phone will be 
contacted by our study Research Assistant who will walk them through the telephonic version of the 
RIS. If they indicate that their preferred mode of communication is email, our study Research Assistant 
will email them a link leading to the electronic version of the RIS.  
In order to facilitate our recruitment efforts, the Study Flyer along with the study QR will be posted on 
the STM Bulletin. In addition, the STM Deacon has agreed to make announcements following the 

Page 19 of 23 
 
Hispanic masses on Saturday and Sunday introducing the study and its importance to the Hispanic 
community.  
10. 
CONSENT PROCESS 
 
Eligible participants will have the option to consent by completing the RIS in three different scenarios: 
(1) in-person at STM Church; (2) online or (3) via the phone. Those that wish to complete the RIS form 
in-person will be guided by eligible members of the study team or El Centro Hispano CHWs. 
Participants completing the Intake Form online using the study website, will have the opportunity to 
indicate their preferred mode of communication. Eligible participants indicating the phone as their 
preferred mode of communication will be contacted by our study Research Assistant who will walk 
them through the telephonic version of the RIS. If they indicate that their preferred mode of 
communication is email, our study Research Assistant will email them a link leading to the online 
version of the RIS. It should be noted that all three versions of the RIS (in-person, online, telephonic) 
explain the study procedures in detail as well as the potential risks and benefits. Those that opt for 
either the in-person or the telephonic consent will be guided through the RIS by members of the study 
team. Those that indicate they would prefer to complete the RIS on their own will be advised to 
contact the study team via phone with any questions regarding the online consenting process. 
 
11.     PLANS FOR PUBLICATION  
Our study is designed to capture novel data in multiple fields of research including the identification of 
barriers preventing Latinos from participating in CCTs as well as the mediating effect that an increase in 
CRC knowledge may have on the willingness to participate in CCTs. We envision publishing multiple 
impactful papers.  
 
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APPENDIX