CoGENES Randomized Controlled Trial (RCT)

NCT ID: NCT07229443

Last Updated: 2026-01-12

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

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2027-06-20

Brief Summary

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This clinical trial evaluates the effectiveness of trained community engagement specialists for improving communication on colorectal cancer (CRC) prevention and genetic testing among Hispanic/Latino/a/x (H/L) communities. CRC is the second and third leading cause of cancer deaths among United States (US) H/L men and women respectively. Knowledge of inherited germline mutations (changes in a gene that occurs in a sperm or egg cell) is critical for understanding cause of disease and can impact patient treatment options and outcomes. Educational programs and participant engagement approaches focused on H/L individuals considering Latino cultural values, literacy, numeracy, barriers faced, cultural beliefs and attitudes, as well as language of participants are much needed to address these observed disparities. The Community Genetic Navigation Specialists (CoGENES) Program focuses on increasing knowledge, and preparing the CoGENES trainees to help respond to questions, fears, and concerns regarding genetic testing, counseling, biospecimen (sample of urine, blood, or tissue cells) donation and participation in clinical trials to H/L community members, patients and their families. CoGENES may improve communication on colorectal cancer prevention and genetic testing which can help reduce cancer disparities among H/L communities.

Detailed Description

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PRIMARY OBJECTIVE:

I. To develop a local workforce of trained community engagement specialists to act as liaison agents to improve communication on genetic research, clinical genetic testing, and counseling to Hispanic/Latino/a/x (H/L) individuals.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP 1: Participants receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing to review at their own pace over 6-10 weeks. Participants may optionally receive a CoGENES training session within 2 weeks post-intervention.

GROUP 2: Participants receive a CoGENES training session over 45-60 minutes.

After completion of study intervention, participants are followed up at 8 weeks, 6 months and 12 months.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group 1 (usual care)

Participants receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing to review at their own pace over 6-10 weeks. Participants may optionally receive a CoGENES training session within 2 weeks post-intervention.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing

Survey Administration

Intervention Type OTHER

Ancillary studies

Group 2 (CoGENES)

Participants receive a CoGENES training session over 45-60 minutes.

Group Type EXPERIMENTAL

Health Promotion and Education

Intervention Type OTHER

Receive CoGENES training

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing

Intervention Type OTHER

Health Promotion and Education

Receive CoGENES training

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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Inclusion Criteria

* Must be 18 years of age or older
* Ability to understand and the willingness to sign a written informed consent
* Self-reported H/L ethnicity, of any race
* Ability to read, write, and speak Spanish or English
* Resides in Los Angeles County

Exclusion Criteria

* Anyone younger than 18 years of age
* Any person with major cognitive deficit or psychiatric impairment
* Any person unable to read and write Spanish or English
* Resides outside of Los Angeles County
* Any person who considers themselves a community health educator or "promotor/a de salud" and/or has taken in the past three years training on colorectal cancer and/or cancer genetics
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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Mariana C Stern, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bianca Rosales

Role: CONTACT

323-865-0811

Facility Contacts

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Mariana C. Stern

Role: primary

323-865-0811

Other Identifiers

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NCI-2025-02815

Identifier Type: REGISTRY

Identifier Source: secondary_id

19PS-24-7

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U2CCA252971-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19PS-24-7

Identifier Type: -

Identifier Source: org_study_id

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