Preventing Early-Onset Colorectal Cancer in the VA

Part of paid clinical trials in New York, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT07071454
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Patient intervention — BEHAVIORAL
    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.
  • PCP intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jul 2025
Primary completion
Jul 1, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
536 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING

Arms

  • Experimental: Patient intervention
    Only patients receive intervention
  • Experimental: PCP intervention
    Only PCP receives intervention
  • Experimental: Combined
    Both patient and PCP receive intervention
  • No Intervention: Control
    Neither patient nor PCP receives intervention

Primary Outcome Measure

Screening participation rate in groups that received vs. did not receive the patient intervention [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA NY Harbor Healthcare System, New York, NYNew YorkNew York10010-5011
Peter S Liang, MD MPH
[email protected]
212-686-7500
Peter S Liang, MD MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
VA NY Harbor Healthcare System, New York, NY· New York, NY

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