Preventing Early-Onset Colorectal Cancer in the VA
NCT07071454 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 536
Last updated 2026-07-29
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 modify the national colorectal cancer screening reminder locally so that participants who are randomized to this intervention and are calculated to be at high risk will be identified as such.
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
- 2026-10-01
- Primary Completion
- 2028-07-01
- Completion
- 2029-06-30
Countries
- United States
Study Locations
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