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

NCT07276048 | Active Not Recruiting DMC

• 4 other identifiers: 19PS-24-8NCI-2025-02710P30CA014089U2CCA252971-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Observational (Focus group)

OTHER

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

Other: Discussion

Phase I (Education)

EXPERIMENTAL

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: Educational Intervention; Other: Interview; Other: Survey Administration

Phase II (Training, education)

EXPERIMENTAL

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: Educational Intervention; Other: Interview; Other: Survey Administration

Interventions

Discussion OTHER

Attend focus group

Also known as: Discuss

Observational (Focus group)

Educational Intervention OTHER

Complete educational sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Phase I (Education); Phase II (Training, education)

Interview OTHER

Ancillary studies

Phase I (Education); Phase II (Training, education)

Survey Administration OTHER

Ancillary studies

Phase I (Education); Phase II (Training, education)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Interviews as Topic

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lourdes Baezconde-Garbanati

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 10, 2025
• Study Start: June 23, 2023
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (2)