## Protocol Section
### Identification Module
**NCT ID:** NCT06426927

**Acronym:** PeLear CCC

**Brief Title:** PeLear CCC: Proyecto Latino Contra Cancer Colorectal

**Official 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

#### Organization Study ID Info
**ID:** 22-2980
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**Domain:** NCTraCS Institute
**ID:** CTSC0205
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** North Carolina Translational and Clinical Sciences Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study aims to recruit 60 Spanish speaking individuals who identify as Latinos, are older than 18 years old and attend the Saint Thomas More (STM) Church in Chapel Hill. Study participants will be asked to attend an educational session at STM Church during which their baseline knowledge on colorectal cancer (CRC) and willingness to participate in cancer clinical trials (CCT) will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational videos on CRC in Spanish. After watching the videos, CRC knowledge and willingness to participate in CCTs will be reassessed. Thirty +/- 7 days after participation in the educational session, participants will be invited back at STM Church in order to complete a follow-up questionnaire assessing CRC knowledge, willingness to participate in CCTs and perceived barriers preventing Latinos from participating in CCTs. Twenty of the 60 recruited participants will be asked to participate in a qualitative one-on-one interview aimed at identifying barriers preventing Latinos from participating in CCTs.

It should be noted that cancer is the leading cause of death in the United States (US) Latino community, with CRC accounting for 10% of this overall mortality. Despite this, Latinos suffer from disparities in access to care, cancer screening, treatment, and representation in CCTs. In fact, 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 in a timely fashion. The investigators conducting this study 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. Latino CCT underrepresentation is a multifaceted phenomenon and bidirectional barriers at the physician-, healthcare system-, and patient-level are significant contributors. Therefore, understanding the multiple driving forces and barriers is essential to identifying potential targets for improvement.

**Detailed Description:** This pilot project aims to address the Clinical and Translational Science (CTS) roadblock of underrepresentation of Latinos in cancer clinical trials (CCTs) through a community-based, culturally, and linguistically appropriate educational intervention aimed at increasing health knowledge on a specific cancer. Colorectal cancer (CRC) will be the "use case" and the church will be the venue for Latino recruitment. This project will lead to the identification of novel Latino-perceived barriers to CCT enrollment, which will be applicable in other fields of medicine aiming to increase Latino CCT enrollment. The investigators believe that one barrier to recruitment for CCTs is low health education, specifically regarding cancers affecting the community, such as CRC, a commonly diagnosed cancer in the US Latino population. Therefore, the hypothesis that an increase in health knowledge in Latinos on a specific cancer mediates a change in their willingness to participate in CCTs will be tested. To do this, three educational CRC videos in Spanish will be created. The first video will review CRC symptoms, the second video will review CRC risk factors while the third video will provide information on CRC screening, treatment and CCTs. In addition, a translated, non-validated questionnaire based on 3 sub-scales from 2 CRC knowledge questionnaires previously validated in English will be developed and pilot tested. Therefore, the Specific Aims of this Pilot Project are to:

1. Identify novel Latino-perceived barriers to participation in CCTs.
2. Assess the association between an educational video and CRC knowledge.
3. Explore the potential relationship between an increase in health knowledge of a specific cancer via an educational video in Spanish and willingness to participate in CCTs.
4. Demonstrate that engagement with Latino communities via the church setting is a viable option for the recruitment and retention of Latinos.
5. Translate into Spanish and pilot test 3 health knowledge sub-scales as a preliminary step in the creation and validation of a novel Spanish CRC knowledge questionnaire.

To achieve these aims, recruit 60 Latino, Spanish speaking attendees of the Saint Thomas More (STM) Church in Chapel Hill will be recruited. The study will consist of three Study Days:

1. Study Day 1: Enrolled participants will be asked to attend an educational session at STM Church. During the educational session their baseline knowledge on CRC and their baseline willingness to participate in CCTs will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational CRC videos in Spanish and then their CRC knowledge as well as their willingness to participate in CCTs will be reassessed.
2. Study Day 2: Thirty +/- 7 days after the educational session, participants will be asked to return to STM Church in order to complete a follow-up questionnaire in Spanish. The questionnaire will assess their level of retainment of CRC knowledge, their willingness to participate in CCTs as well as assess in an open-ended fashion their perceived barriers to CCT participation.
3. Study Day 3: Twenty of the 60 enrolled participants will be asked to participate in a qualitative one-on-one interview aimed at identifying Latino perceived barriers to CCT participation.

### Conditions Module

**Conditions:**

- Colorectal Cancer

- Rectal Cancer

- Colon Cancer

- Colon Rectal Cancer

- Rectal Neoplasms

- Colon Adenocarcinoma

- Hereditary Nonpolyposis Colon Cancer

**Keywords:**

- Colorectal Cancer

- Latinx

- Barriers

- Cancer Clinical Trials

- Latino

- Spanish

- Familial Colorectal Cancer

- Lynch Syndrome

- Hispanic

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Enrolled participants will watch three educational videos in Spanish pertaining to: (1) Colorectal Cancer (CRC) symptoms; (2) CRC risk factors and (3) CRC screening, treatment, and Cancer Clinical Trials (CCT).

**Intervention Names:**

- Other: Colorectal Cancer Educational Videos in Spanish

**Label:** Educational Videos

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Educational Videos

**Description:** Enrolled participants will watch three educational videos on Colorectal Cancer (CRC) in Spanish. Knowledge on CRC symptoms, risk factors, screening and treatment will be assessed before and immediately after the educational video and at 30 +/- 7 days. In addition, the association between increase in CRC knowledge and willingness to participate in Cancer Clinical Trials (CCT) will be explored.

**Name:** Colorectal Cancer Educational Videos in Spanish

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The 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 cancer clinical trials, and perceptions 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.

**Measure:** Barriers Preventing Latinos from Participating in Cancer Clinical Trials

**Time Frame:** 30 days after participation in Study Day 2

#### Secondary Outcomes

**Description:** Use of appropriate statistical measures to compare total number of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (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 greater knowledge of symptoms.

**Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms

**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2

**Description:** Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (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.

**Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors

**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2

**Description:** Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge of Colorectal Cancer (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 symptoms.

**Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts

**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2

**Description:** Appropriate statistical measures on the paired responses of participants will be used to test the association between watching the video and willingness to participate in CCTs. The mediating effect of health knowledge levels (M) on the relationship between educational video (X) and willingness to participate in CCTs (Y) will be explored. In a structural equation model with a series of mixed-effects generalized linear models, Y will be predicted by both X and M, combining the estimated relationship of M and Y. The mediated indirect effect (from X to Y, through M) will then be estimated and tested using the bootstrapping method with 1,000 replications, and the proportion of the effect being mediated will be reported as the effect size.

**Measure:** Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials

**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Spanish speaking
* Identifying as Latino
* Older than 18 years old

Exclusion Criteria:

* Non-Spanish speakers
* Not identifying as Latino
* Younger than 18 years old

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jose_guillem@med.unc.edu

**Name:** José G. Guillem, MD, MPH, MBA

**Phone:** 919-966-8436

**Role:** CONTACT

**Contact 2:**

**Email:** dimitrios_varvoglis@med.unc.edu

**Name:** Dimitrios Varvoglis, MD

**Phone:** 919-966-8436

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chapel Hill

**Contacts:**

***Contact 1:***

- **Email:** jose_guillem@med.unc.edu

- **Name:** Jose G Guillem, MD, MPH, MBA

- **Phone:** 919-966-8436

- **Role:** CONTACT

***Contact 2:***

- **Email:** dimitrios_varvoglis@med.unc.edu

- **Name:** Dimitrios Varvoglis, MD

- **Phone:** 919-966-8436

- **Role:** CONTACT

**Country:** United States

**Facility:** Saint Thomas More Church

**State:** North Carolina

**Zip:** 27514

#### Overall Officials

**Official 1:**

**Affiliation:** University of North Carolina, Chapel Hill

**Name:** José G. Guillem, MD, MPH, MBA

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Sepucha KR, Feibelmann S, Cosenza C, Levin CA, Pignone M. Development and evaluation of a new survey instrument to measure the quality of colorectal cancer screening decisions. BMC Med Inform Decis Mak. 2014 Aug 20;14:72. doi: 10.1186/1472-6947-14-72.

**PMID:** 25138444

**Citation:** American Cancer Society. Cancer Facts & Figures for Hispanic/Latino People 2021-2023. Atlanta: American Cancer Society, Inc. 2021.

**Citation:** Power E, Simon A, Juszczyk D, Hiom S, Wardle J. Assessing awareness of colorectal cancer symptoms: measure development and results from a population survey in the UK. BMC Cancer. 2011 Aug 23;11:366. doi: 10.1186/1471-2407-11-366.

**PMID:** 21859500

#### See Also Links

**Label:** Bowel Cancer Awareness Measure

**URL:** https://www.cancerresearchuk.org/sites/default/files/health_professional_bowel_cam_toolkit_version_2.1_09.02.11.pdf

**Label:** Racial and Ethnic Composition of the United States

**URL:** https://www.census.gov/library/stories/2021/08/improved-race-ethnicity-measures-reveal-united-states-population-much-more-multiracial.html

**Label:** National Cancer Institute Triennial Inclusion of Women and Minorities in Clinical Research Report

**URL:** https://report.nih.gov/sites/report/files/docs/NCITriennialInclusionReportFY2019_FY2021Final.pdf

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000009386

- Term: Neoplastic Syndromes, Hereditary

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000049914

- Term: DNA Repair-Deficiency Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: HIGH

- As Found: Rectal Cancer

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M6338

- Name: Colonic Neoplasms

- Relevance: HIGH

- As Found: Colon Cancer

- ID: M6351

- Name: Colorectal Neoplasms, Hereditary Nonpolyposis

- Relevance: HIGH

- As Found: Hereditary Nonpolyposis Colon Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12331

- Name: Neoplastic Syndromes, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M26131

- Name: DNA Repair-Deficiency Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2203

- Name: Familial Colorectal Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000012004

- Term: Rectal Neoplasms

- ID: D000003110

- Term: Colonic Neoplasms

- ID: D000003123

- Term: Colorectal Neoplasms, Hereditary Nonpolyposis

### Misc Info Module

- Version Holder: 2024-05-31
