CoGENES Randomized Controlled Trial (RCT)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of Southern California
- Study ID
- NCT07229443
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Best Practice — OTHERReceive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing
- Health Promotion and Education — OTHERReceive CoGENES training
- Survey Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Jun 20, 2024
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Jun 20, 2027
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: 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.
- Experimental: Group 2 (CoGENES)Participants receive a CoGENES training session over 45-60 minutes.
Primary Outcome Measure
Change in knowledge about colorectal cancer prevention [ Time Frame: Baseline to 12 months ]
Central Contacts
- Bianca Rosales323-865-0811
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Mariana C. Stern (PRINCIPAL_INVESTIGATOR) |
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