Community Genetic Navigation Engagement Specialists to Increase Knowledge About Colorectal Cancer Genetics in Hispanic/Latino/a Communities

Community Genetic Navigation Engagement Specialists (CoGENES) Training Program

This clinical trial tests how well an educational program for training Hispanic/Latino/a (H/L) community members regarding colorectal cancer genetics works to increase knowledge about genetic and genomic testing. H/L populations are underrepresented in colorectal cancer tumor and genetics studies due to lack of access of patients in clinical genetic testing, very low participation in clinical trials, lack of knowledge about cancer genetics and genomics, and lack of culturally sensitive materials for patient engagement in cancer genetics and genomic research. The community genetic navigation engagement specialist training program may increase knowledge regarding colorectal cancer genetics in H/L communities.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Other: Discussion; Other: Educational Intervention; Other: Educational Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate a genetic education program for H/L community health educators to train them as Community Genetic Navigation Engagement Specialists (CoGENES).

II. To evaluate a culturally tailored CoGENES Educational Tool Kit for H/L communities on genetic research, genetic counseling, and cancer risk assessments to be used by the CoGENES trainees to disseminate to community agencies.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of the CoGENES Educational program to improve the confidence of community health educators to train others in the community, as demonstrated by:

Ia. Self-confidence delivering training survey scores; Ib. Number of educators trained by each CoGENES; Ic. As well as the number of people reached in the community at large.

OUTLINE: Participants are assigned to 1 of 3 groups.

PHASE 1: Participants complete educational sessions regarding colorectal cancer genetics over 3 hours each, one to two times per week, for a total of 18 hours over 3-6 weeks. Participants may attend virtual check-in meetings over 30-60 minutes each month. Participants who complete the training program may then participate in phase II.

PHASE 2: Participants who completed phase I train additional participants via educational sessions regarding colorectal cancer genetics. New phase II participants attend the educational sessions regarding colorectal cancer genetics, led by phase I participants, over a total of 10-18 hours. Participants may attend virtual check-in meetings over 30-60 minutes each month.

FOCUS GROUP: Participants attend a focus group, over 60-90 minutes, on study.

After completion of study intervention, participants in phase I and II are followed up at 6 and 12 months.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Los Angeles General Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• SURVEYS (PHASE 1 AND 2) AND FOCUS GROUP: Must be 18 years of age or older
• SURVEYS (PHASE 1 AND 2) AND FOCUS GROUP: Ability to understand and the willingness to sign a written informed consent
• SURVEYS (PHASE 1 AND 2) AND FOCUS GROUP: Self-reported H/L ethnicity, of any race
• SURVEYS (PHASE 1 AND 2) AND FOCUS GROUP: Ability to read and write English or Spanish

Exclusion Criteria:

• SURVEYS (PHASE 1 AND 2) AND FOCUS GROUP: Any one younger than 18 years of age
• SURVEYS (PHASE 1 AND 2) AND FOCUS GROUP: Any person with major cognitive deficit or psychiatric impairment
• SURVEYS (PHASE 1 AND 2) AND FOCUS GROUP: Any person unable to read English or Spanish, and/or unable to write English or Spanish (for surveys participants only)
• SURVEYS AND FOCUS GROUP: No one younger than 18 years of age
• SURVEYS AND FOCUS GROUP: Any person with major cognitive deficit or psychiatric impairment
• SURVEYS AND FOCUS GROUP: Unable to read English or Spanish, and/or unable to write English or Spanish (for Surveys among CoGENES only)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Observational (Focus group); Participants attend a focus group, over 60-90 minutes, on study.	Other: Discussion; Attend focus group; Other Names: Discuss
Experimental: Phase I (Education); Participants complete educational sessions regarding colorectal cancer genetics over 3 hours each, one to two times per week, for a total of 18 hours over 3-6 weeks. Participants may attend virtual check-in meetings over 30-60 minutes each month. Participants who complete the training program may then participate in phase II.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Educational Intervention; Complete educational sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Train participants; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Experimental: Phase II (Training, education); Participants who completed phase I train additional participants via educational sessions regarding colorectal cancer genetics. New phase II participants attend the educational sessions regarding colorectal cancer genetics, led by phase I participants, over a total of 10-18 hours. Participants may attend virtual check-in meetings over 30-60 minutes each month.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Educational Intervention; Complete educational sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Train participants; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who completed training program	Will report the number of participants started and number of participants who successfully completed the training program. Training is considered successful if they complete the required number of hours. Training lasts 3 hours per session once a week over 6 weeks. We will recruit 10-12 trainees per year for 3 years.	Up to 36 months
Knowledge gained after training	After training, participants will be assessed about their knowledge of genetic testing before training new trainees and educating community members. Will use the Genetic Literacy and Comprehension (GLAC) measure to assess trainees knowledge with eight commonly used genetic terms and concepts (genetic, chromosome, susceptibility, mutation, variation, abnormality, heredity, and sporadic) using a 7-point scale of 1 "Strongly Disagree" to 7 "Strongly Agree". We will compare pre- and post- surveys to assess knowledge.	Up to 36 months
Confidence of training after training completion	Measured by scores obtained from questioners developed by our team to capture confidence level of participants in training peers, focusing on confidence of explaining each module of the program to prospective trainees and answering questions, as well as confidence level using our Educational Toolkit to educate the community at large. Higher scores mean more confidence.	Up to 36 months
Number of people trained and/or reached in the community	Will report number of people trained and/or reached in the community	At 6 and 12 month follow up
Completion of focus groups	Will focus on readability, knowledge, acceptability, barriers. These qualitative analyses focus on the educational materials themselves, and their ability to transfer knowledge in the most effective way, as well as assessing the effectiveness of the materials in transferring information that is understandable, readable and usable for participants to train others.	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lourdes Baezconde-Garbanati, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2027

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Methods; Interviews as Topic; Early Intervention, Educational; Educational Status
• Other Study ID Numbers: 19PS-24-8 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2025-02710 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U2CCA252971-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No