CoGENES Randomized Controlled Trial (RCT)

University of Southern California

Status: Enrolling

Conditions: Colorectal Carcinoma

Treatments: Other: Best Practice; Other: Health Promotion and Education; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07229443

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

19PS-24-7 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2025-02815 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Group 1 (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Best Practice

Group 2 (CoGENES)

Experimental group

Description:

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

Treatment:

Other: Survey Administration

Other: Health Promotion and Education