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 — OTHER
    Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing
  • Health Promotion and Education — OTHER
    Receive CoGENES training
  • Survey Administration — OTHER
    Ancillary 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

Locations (1)

FacilityCityStateZIPSite coordinators
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Mariana C. Stern
323-865-0811
Mariana C. Stern (PRINCIPAL_INVESTIGATOR)

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