Preventing Early-Onset Colorectal Cancer in the VA (PRECISE)

VA Office of Research and Development

Status: Begins enrollment in 4 months

Conditions: Colorectal Neoplasms; Mass Screening

Treatments: Behavioral: PCP intervention; Behavioral: Patient intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07071454

IIR 23-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 536 estimated patients

Sex: All

Ages: 45 to 49 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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536 participants in 4 patient groups

Patient intervention

Experimental group

Description:

Only patients receive intervention

Treatment:

Behavioral: Patient intervention

PCP intervention

Experimental group

Description:

Only PCP receives intervention

Treatment:

Behavioral: PCP intervention

Combined

Experimental group

Description:

Both patient and PCP receive intervention

Treatment:

Behavioral: Patient intervention

Behavioral: PCP intervention

Control

No Intervention group

Description:

Neither patient nor PCP receives intervention