Preventing Early-Onset Colorectal Cancer in the VA

NCT ID: NCT07071454

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-01
• Study Completion Date: 2029-06-30

Brief 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.

Detailed Description

Background: Incidence and mortality of early-onset colorectal cancer (EOCRC), defined as colorectal cancer (CRC) diagnosed before age 50 years, has been increasing in the US since the 1990s. In response to these concerning trends, in 2021 the US Preventive Services Task Force recommended lowering the age to initiate CRC screening from 50 to 45 years. Within the VA health care system, 60% of eligible individuals aged 50-75 years and only 42% of those aged 45-49 years were up-to-date with screening in May 2024. Younger individuals are less likely to perceive the need for screening, but informing individuals who are at higher risk about their status may increase their interest and participation in screening.

Significance: CRC is a leading cause of cancer death among Veterans. To maximize CRC screening benefit in individuals younger than 50 years, it is critical to 1) identify high-risk individuals in this age group who may be targeted for screening and 2) assess the effectiveness and implementation of interventions to promote screening in all younger individuals. Innovation & Impact: Currently there are no risk scores for EOCRC in clinical use, and risk scores developed for research often use genetic and survey data but omit more readily accessible information from the electronic health record (EHR) to identify individuals at increased risk. In addition to identifying high-risk individuals, it is also crucial to study interventions that will increase screening in the younger population. Otherwise, data show that younger adults are less likely to engage in screening and passive adoption of new clinical guidelines occurs slowly among physicians.

Specific Aims:

Aim 1: To develop and validate a risk score for EOCRC using EHR data Aim 2: To determine the effectiveness of a multilevel intervention to increase screening in individuals aged 45-49 years, using personal risk as a motivator for high-risk individuals. This aim is the focus of the trial.

Aim 3: To evaluate the implementation of the multilevel intervention.

Methodology: The investigators plan to 1) build and validate an EOCRC risk score using EHR data from the VA Corporate Data Warehouse (CDW), 2) identify a prospective cohort of Veterans aged 45-49 years and conduct a 2x2 factorial multilevel intervention that includes informing high-risk patients and their primary care providers about their risk status, and 3) assess for barriers and facilitators to implementing the multilevel intervention through a qualitative process evaluation with key informants.

Next Steps/Implementation: If this novel risk stratification strategy to prevent EOCRC is effective at a single site, then the investigators will work with partners to implement it throughout the VA and test it outside of the VA system.

Conditions

Colorectal Neoplasms; Mass Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patient intervention

Only patients receive intervention

Group Type: EXPERIMENTAL

Patient intervention

Intervention Type: 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

Only PCP receives intervention

Group Type: EXPERIMENTAL

PCP intervention

Intervention Type: 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.

Combined

Both patient and PCP receive intervention

Group Type: EXPERIMENTAL

Patient intervention

Intervention Type: 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

Intervention Type: 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.

Control

Neither patient nor PCP receives intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 45-49 years at screening

Exclusion Criteria

• Up-to-date with CRC screening based on the USPSTF guideline (e.g., colonoscopy within the past 10 years or FIT within the past year)
• Prior CRC diagnosis
• Prior total colectomy
• Limited life expectancy (defined as terminal illness, hospice enrollment, or documented life expectancy <6 months on the medical problem list or a health factor in the EHR
• Deactivated national CRC screening and surveillance reminder (due to risk level or comorbidities)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter S Liang, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA NY Harbor Healthcare System, New York, NY

Locations

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Countries

United States

Central Contacts

Peter S Liang, MD MPH

Role: CONTACT

peter.liang@va.gov

(212) 686-7500 ext. 5745

Anika Zaman, MPH

Role: CONTACT

anika.zaman@va.gov

(212) 686-7500

Facility Contacts

Peter S Liang, MD MPH

Role: primary

peter.liang@va.gov

212-686-7500 ext. 5745

Other Identifiers

IIR 23-005

Identifier Type: -

Identifier Source: org_study_id