PeLear CCC: Proyecto Latino Contra Cancer Colorrectal

NCT06426927 | Completed Results

• 2 other identifiers: 22-2980CTSC0205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to recruit 60 Spanish speaking individuals who identify as Latinos, are 18 years or older 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.

Conditions

Colorectal Cancer; Rectal Cancer; Colon Cancer; Colon Rectal Cancer; Rectal Neoplasms; Colon Adenocarcinoma; Hereditary Nonpolyposis Colon Cancer

Keywords

Colorectal Cancer; Latino; Barriers; Cancer Clinical Trials; Spanish; Familial Colorectal Cancer; Lynch Syndrome; Hispanic

Outcome Measures

Primary Outcomes (4)

• Attitudes Regarding Participation in Clinical Trials-Conceptual Themes (General Clinical Trials)

  Twenty participants were invited for qualitative interviews. 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 for attitudes regarding general clinical trials will be reported in terms of percentage of participants.

  30 days after participation in Study Day 2

• Attitudes Regarding Participation in Cancer Clinical Trials-Conceptual Themes (Cancer Clinical Trials)

  Twenty participants were invited for qualitative interviews. 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 for attitudes regarding cancer clinical trials will be reported in terms of percentage of participants.

  30 days after participation in Study Day 2

• Perceptions of Latino Community for Increasing Enrollment in Randomized Clinical Trials-Conceptual Themes (General Clinical Trials)

  Twenty participants were invited for qualitative interviews. 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 for perceptions of the Hispanic/Latino community will be reported in terms of percentage of participants.

  30 days after participation in Study Day 2

• Holistic Themes

  Twenty participants were invited for qualitative interviews. 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 3 holistic themes will be reported in terms of percentage of participants.

  30 days after participation in Study Day 2

Secondary Outcomes (4)

• Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms

  On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 days

• Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors

  On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 days

• Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts

  On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 days

• Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials

  On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes) after the video projection

Study Arms (1)

Educational Videos

EXPERIMENTAL

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

Other: Colorectal Cancer Educational Videos in Spanish

Interventions

Colorectal Cancer Educational Videos in Spanish OTHER

Enrolled participants will watch three educational videos on Colorectal Cancer (CRC) in Spanish. Knowledge on CRC symptoms, risk factors, facts, 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.

Educational Videos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spanish speaking
• Identifying as Latino
• years or older

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

Saint Thomas More Church

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (3)

• 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 BACKGROUND

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

  BACKGROUND

• 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 BACKGROUND

Related Links

• Bowel Cancer Awareness Measure
• Racial and Ethnic Composition of the United States
• National Cancer Institute Triennial Inclusion of Women and Minorities in Clinical Research Report

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: José Guillem, MD, MPH
• Organization: University of North Carolina at Chapel Hill

jgguillem41@gmail.com

717-531-5164

Study Officials

• José G. Guillem, MD, MPH, MBA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 23, 2024
• Study Start: October 27, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: January 21, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)