Preventing Early-Onset Colorectal Cancer in the VA

NCT07071454 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms
  • Mass Screening

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Peter S Liang, MD MPH · VA NY Harbor Healthcare System, New York, NY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-01
Completion
2029-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071454 on ClinicalTrials.gov