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NCT Number: NCT07276048

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles General Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Discussion

Other

Attend focus group

Other names: Discuss

Educational Intervention

Other

Complete educational sessions

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

interview

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Number of participants who completed training program

    Time frame: Up to 36 months

    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.

  2. Knowledge gained after training

    Time frame: Up to 36 months

    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.

  3. Confidence of training after training completion

    Time frame: Up to 36 months

    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.

  4. Number of people trained and/or reached in the community

    Time frame: At 6 and 12 month follow up

    Will report number of people trained and/or reached in the community

  5. Completion of focus groups

    Time frame: Up to 2 years

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Community Genetic Navigation Engagement Specialists (CoGENES) Training Program

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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