CoGENES Randomized Controlled Trial (RCT)
Purpose
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.
Condition
- Colorectal Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Los Angeles, California 90033
More Details
- Status
- Recruiting
- Sponsor
- University of Southern California
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.