NCT07229443 · University of Southern California
CoGENES Randomized Controlled Trial (RCT)
What this study is 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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Change in knowledge about colorectal cancer prevention
Time frame: Baseline to 12 months
We will use the WCRF/AICR score, which is a standardized scoring system, typically ranging from 0 to 7 points, that measures an individual's adherence to the World Cancer Research Fund (WCRF) and American Institute for Cancer Research (AICR) recommendations for cancer prevention. A higher score indicates greater compliance with lifestyle factors like maintaining a healthy weight, engaging in physical activity, eating a diet rich in plant-based foods, and limiting alcohol, fast food, and sugary drinks. We will compare pre- and post-intervention to assess knowledge.
Change in knowledge about genetic testing
Time frame: Baseline to 12 months
Will use the Genetic Literacy and Comprehension (GLAC) measure to assess participant knowledge with eight commonly used genetic terms and concepts (genetic, chromosome, susceptibility, mutation, variation, abnormality, heredity, and sporadic) using a 7-point scale of 1 "Strongly Disagree" to 7 "Strongly Agree". We will compare pre- and post- surveys to assess knowledge.
Change in knowledge about tumor testing
Time frame: Baseline to 12 months
Will assess participants knowledge about tumor testing as determined by scores obtained from validated surveys. Will compare pre- and post- surveys to assess knowledge. Higher scores mean better knowledge.
Change in knowledge about genetic counseling
Time frame: Baseline to 12 months
There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire will be administered at pre- and post-genetic education.
Changes in dietary and lifestyle patterns
Time frame: Baseline to 12 months
Measured by scores obtained from surveys developed for this study. Will compare pre- and post- surveys to evaluate changes. Higher scores mean positive changes.
Intention to pursue colorectal cancer screening
Time frame: Up to 12 months
Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely).
Intention to inquire about cancer history among family members
Time frame: Up to 12 months
Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely).
Intention to ask healthcare provider about genetic testing and counseling
Time frame: Up to 12 months
Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations