Preventing Early-Onset Colorectal Cancer in the VA

NCT07071454 | Not Yet Recruiting

• 1 other identifier: IIR 23-005
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms; Mass Screening

Keywords

early onset colorectal cancer; risk stratification; behavioral intervention

Outcome Measures

Primary Outcomes (2)

• Screening participation rate in groups that received vs. did not receive the patient intervention

  For the patient intervention analysis, the investigators will compare the patient and combined arms vs. the PCP and control arms. Completion of FIT, colonoscopy, and any other USPSTF-recommended screening test will be considered to meet the outcome.

  6 months

• Screening participation rate in groups that received vs. did not receive the PCP intervention

  For the PCP intervention analysis, the investigators will compare the PCP and combined arms vs. the patient and control arms. Completion of FIT, colonoscopy, and any other USPSTF-recommended screening test will be considered to meet the outcome.

  6 months

Secondary Outcomes (1)

• Screening participation rate in high-risk vs. non-high-risk individuals

  6 months

Other Outcomes (3)

• Screening participation rate in individual groups

  6 months

• Screening participation rate in Black vs. non-Black individuals

  6 months

• Shared decision making in different intervention groups

  6 months

Study Arms (4)

Patient intervention

EXPERIMENTAL

Only patients receive intervention

Behavioral: Patient intervention

PCP intervention

EXPERIMENTAL

Only PCP receives intervention

Behavioral: PCP intervention

Combined

EXPERIMENTAL

Both patient and PCP receive intervention

Behavioral: Patient intervention; Behavioral: PCP intervention

Control

NO INTERVENTION

Neither patient nor PCP receives intervention

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.

Combined; Patient intervention

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.

Combined; PCP intervention

Eligibility Criteria

• Age: 45 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 45-49 years at screening

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Peter S Liang, MD MPH

  VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter S Liang, MD MPH

CONTACT

(212) 686-7500; peter.liang@va.gov

Anika Zaman, MPH

CONTACT

(212) 686-7500; anika.zaman@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will use a electronic health record (EHR) based risk score, which has been previously validated, to prospectively identify high-risk and non-high-risk individuals for a multilevel (patient, provider, and clinic) screening intervention. The investigators will employ a 2x2 factorial design for the patient and provider level interventions to quantify independent and potentially synergistic effects.

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)