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

NCT ID: NCT07276048

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2027-12-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Observational (Focus group)

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

Group Type OTHER

Discussion

Intervention Type OTHER

Attend focus group

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Complete educational sessions

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Complete educational sessions

Educational Intervention

Intervention Type OTHER

Train participants

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Discussion

Attend focus group

Intervention Type OTHER

Educational Intervention

Complete educational sessions

Intervention Type OTHER

Educational Intervention

Train participants

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Discuss Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lourdes Baezconde-Garbanati

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2025-02710

Identifier Type: REGISTRY

Identifier Source: secondary_id

19PS-24-8

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U2CCA252971-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19PS-24-8

Identifier Type: -

Identifier Source: org_study_id

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