CoGENES Randomized Controlled Trial (RCT)

NCT07229443 | Recruiting DMC

• 4 other identifiers: 19PS-24-7NCI-2025-02815P30CA014089U2CCA252971-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (8)

• Change in knowledge about colorectal cancer prevention

  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.

  Baseline to 12 months

• Change in knowledge about genetic testing

  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.

  Baseline to 12 months

• Change in knowledge about tumor testing

  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.

  Baseline to 12 months

• Change in knowledge about genetic counseling

  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.

  Baseline to 12 months

• Changes in dietary and lifestyle patterns

  Measured by scores obtained from surveys developed for this study. Will compare pre- and post- surveys to evaluate changes. Higher scores mean positive changes.

  Baseline to 12 months

• Intention to pursue colorectal cancer screening

  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).

  Up to 12 months

• Intention to inquire about cancer history among family members

  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).

  Up to 12 months

• Intention to ask healthcare provider about genetic testing and counseling

  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).

  Up to 12 months

Study Arms (2)

Group 1 (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Survey Administration

Group 2 (CoGENES)

EXPERIMENTAL

Participants receive a CoGENES training session over 45-60 minutes.

Other: Health Promotion and Education; Other: Survey Administration

Interventions

Health Promotion and Education OTHER

Receive CoGENES training

Group 2 (CoGENES)

Best Practice OTHER

Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing

Also known as: standard of care, standard therapy

Group 1 (usual care)

Survey Administration OTHER

Ancillary studies

Group 1 (usual care); Group 2 (CoGENES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Southern California: lead

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Health Promotion; Educational Status

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Mariana C Stern, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Rosales

CONTACT

323-865-0811; Biancar@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 17, 2025
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)