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NOT YET RECRUITING
NCT07071454
NA

Preventing Early-Onset Colorectal Cancer in the VA

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

Colorectal cancer is a leading cause of cancer death among Veterans. The starting age for colorectal cancer screening has been lowered from 50 to 45 years in response to the rising incidence of early-onset colorectal cancer (EOCRC), but how to best engage younger Veterans in screening is unclear. The investigators will 1) develop and validate a novel risk score for EOCRC derived from the VA electronic health record data, 2) conduct a multilevel screening intervention that targets individuals aged 45-49 years and informs high-risk individuals and their providers about their risk status for EOCRC, and 3) determine barriers and facilitators to implementing the intervention using a qualitative process evaluation. Aim 2 is the focus of the trial. The overall goal of this study is to create and test a risk stratification approach to prevent EOCRC, which may be especially useful for younger individuals who are less likely to participate in preventive care.

Official title: Preventing Early-Onset Colorectal Cancer in the VA Using a Multilevel Screening Intervention

Key Details

Gender

All

Age Range

45 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

536

Start Date

2026-07-01

Completion Date

2029-06-30

Last Updated

2025-07-23

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Patient intervention

Patient intervention has 2 components. 1) The investigators will send patients a letter that promotes screening and contains targeted messages based on the individual's demographic characteristics. 2) Study staff who is trained in patient navigation will call each patient up to 3 times to confirm receipt of the letter and conduct one-on-one education about screening using a standardized script.

BEHAVIORAL

PCP intervention

PCP intervention has 2 components. 1) PCPs of patients who are randomized to this group will receive an initial email that provides a list of all patients assigned to the PCP who are randomized to the PCP intervention. PCPs will be specifically informed which patients are high-risk. The email will also include a personal report card with the percentage of patients assigned to the provider who are up-to-date with CRC screening in two age groups: 45-49 years and 50-75 years. Subsequently, PCPs will receive weekly emails with a list of patients randomized to the PCP intervention who are scheduled for a clinic visit with them. 2) The investigators will design a local clinical dashboard using Microsoft Power BI that allows PCPs to view a list of their patients who are randomized to the PCP intervention as well as provide a link to this in each email. High-risk patients will be specifically marked.

Locations (1)

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States