NCT07229443

CoGENES Randomized Controlled Trial (RCT)

Evaluation of a Colorectal Cancer Education Training Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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

• Colorectal Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing
OTHER	Health Promotion and Education	Receive CoGENES training
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2024-06-20
• Primary completion: 2026-06-20
• Completion: 2027-06-20
• First posted: 2025-11-17
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States