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

University of Southern California

Status: Active, not recruiting

Conditions: Colorectal Carcinoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07276048

19PS-24-8 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

U2CCA252971-01A1 (U.S. NIH Grant/Contract)

NCI-2025-02710 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Observational (Focus group)

Other group

Description:

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

Treatment:

Other: Discussion

Phase I (Education)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Educational Intervention

Other: Survey Administration

Other: Educational Intervention

Phase II (Training, education)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Educational Intervention

Other: Survey Administration

Other: Educational Intervention