Preliminary results of a community-based randomized controlled trial to raise colorectal cancer awareness: The Community Genetic Navigation Engagement Specialist (CoGENES) Program

Introduction: Knowledge and awareness of colorectal cancer (CRC) prevention and genetic testing remain limited in many Los Angeles County (LAC) communities. To address this, we trained 42 CRC-specialized community health workers (CoGENES) through a train-the-trainer program. We present preliminary results of a community-based randomized controlled trial (RCT) to evaluate the impact of materials and training delivered by CoGENES as part of an NCI funded PE-CGS network program at USC. Methods: A two-armed, single blinded RCT was launched in August 2024. Participants are ≥ 18 years of age and residents of LAC. The intervention included the delivery of an educational session by CoGENES and an a priori developed educational handbook. The control group received standard CRC and genetic testing materials. Data on demographics, acculturation, cultural values and fatalism, health literacy, numeracy, generalized self-efficacy (GSE), genomic knowledge, cancer prevention behaviors and attitudes, were collected at baseline with validated or team-developed surveys. Follow-up surveys at 6-12 weeks and 6-8 months after intervention receipt evaluate changes in GSE, genomic knowledge, and cancer prevention behaviors. Paired dietary changes were evaluated using McNemar's test. Paired t-tests and independent t-tests were used to compare baseline and follow-up results within and between arms, respectively. Results: A total of 138 participants (mean age = 48.8 years, SD = 13.6) were randomized to the intervention (n = 72) or control (n = 66) arm, with no baseline differences. All were Hispanic/Latine, most were female (83%), Mexican (64%), Catholic (61%), married (50%), completed ≤11 th grade education (51%), and spoke primarily Spanish (69%). Interim analyses showed that by 6-8 weeks, participants in the intervention arm demonstrated improved dietary behaviors, with a higher proportion limiting processed food intake (rarely or never: 48.6% at baseline vs 69.8% at follow-up; p <0.05). We observed significant improvements in cancer genetic knowledge within the intervention arm at 6-12 weeks, with more correct answers (mean difference = 4.32; p <0.01), and fewer “don't know” responses (mean difference = -5.40; p<0.01). These improvements were greater than in the control arm: 2.7 more correct answers (p<0.01) and 3.25 fewer “don't know” responses (p<0.01). Genetic literacy and comprehension scores also improved (mean difference = 11.38; p < 0.01), though not significantly more than in the control group (difference-in-differences = 2.20; p = 0.43). Conclusion: We present preliminary evidence that deploying CRC prevention trained educators in a community setting, may improve CRC genetic knowledge, and highlights opportunities and willingness to improve lifestyle and dietary patterns to reduce CRC incidence.