Colorectal NeoplasmsPRECISENCT07071454
Preventing Early-Onset Colorectal Cancer in the VA
A study testing Patient intervention and PCP intervention in people with Colorectal Neoplasms and Mass Screening, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Mass Screening
- What is being tested?
- Patient intervention and PCP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 45-49 years at screening
Who cannot join
- Up-to-date with colorectal cancer (CRC) screening based on the USPSTF guideline (e.g., colonoscopy within the past 10 years or FIT within the past year)
- Prior colorectal cancer (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 electronic health record (EHR)
- Deactivated national colorectal cancer (CRC) screening and surveillance reminder (due to risk level or comorbidities)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Peter S Liang, MD MPH, (212) 686-7500 ext. 5745, peter.liang@va.gov
Peter S Liang, MD MPH
About this study
Official title: Preventing Early-Onset Colorectal Cancer in the VA Using a Multilevel Screening Intervention
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.
Read the 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
- Being tested
- Patient intervention, PCP intervention
- Keywords
- early onset colorectal cancer, risk stratification, behavioral intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient intervention | Experimental | Only patients receive intervention Receives: Behavioral: Patient intervention |
| Primary care provider (PCP) intervention | Experimental | Only primary care provider (PCP) receives intervention Receives: Behavioral: PCP intervention |
| Combined | Experimental | Both patient and primary care provider (PCP) receive intervention Receives: Behavioral: Patient intervention; Behavioral: PCP intervention |
| Control | No intervention | Neither patient nor primary care provider (PCP) receives intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Screening participation rate in high-risk vs. non-high-risk individuals
Of the 536 individuals the investigators plan to enroll in the trial, 536*(3/4)=402 will be randomized to one of the three intervention arms. The investigators will compare high- vs. non-high-risk individuals in the intervention arms (n=201 in each arm).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter S Liang, MD MPH, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071454
- Sponsor's protocol ID
- IIR 23-005
- Other IDs
- 1I01HX003840-01A2
- Acronym
- PRECISE
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No