Screening Interventions for Early-Onset Colorectal Cancer

(PRECISE Trial)

PS
AZ
Overseen ByAnika Zaman, MPH
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates ways to improve colorectal cancer screening for younger Veterans, specifically those aged 45-49. It aims to develop a method to identify individuals at higher risk of early-onset colorectal cancer and encourage preventive steps. The trial includes different groups: some patients will receive information about their risk (patient intervention), some providers will be informed (PCP intervention), and some both. It seeks participants who have not had a recent colonoscopy or FIT test and have no history of colorectal cancer. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance early detection and prevention strategies for colorectal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this screening intervention is safe for early-onset colorectal cancer?

Research has shown that having a primary care doctor can improve outcomes in colorectal cancer (CRC) screening. Studies indicate that patients with a primary care doctor are 54% less likely to receive a late-stage CRC diagnosis compared to those without one. This involvement in screening proves beneficial and well-received.

Providing patients with personal support and information about screening is safe and poses no known issues. Involving both patients and their doctors together appears promising, leading to more discussions about CRC screening without any reported negative effects.

Overall, these efforts focus on educating and involving people rather than performing medical procedures, resulting in no major safety concerns. The aim is to encourage more screenings, which can detect cancer early and lead to better treatment outcomes.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve early detection of colorectal cancer, particularly in younger populations. Unlike traditional approaches that rely heavily on patient-initiated screenings or physician recommendations, this trial tests several new intervention strategies: one that involves direct patient engagement, another that targets primary care providers (PCPs), and a combined approach involving both. By exploring these different methods, researchers hope to identify the most effective way to encourage timely screenings and potentially catch cancer earlier, ultimately improving patient outcomes.

What evidence suggests that this trial's interventions could be effective for early-onset colorectal cancer?

Research has shown that having a regular primary care doctor can greatly improve outcomes for early-onset colorectal cancer. Studies have found that patients with a regular doctor are 54% less likely to be diagnosed with advanced colorectal cancer, highlighting the importance of doctors in screening and prevention. In this trial, participants may receive different interventions: some will receive a patient-focused intervention, others a primary care provider (PCP) intervention, and some both. These interventions aim to enhance early detection and improve survival chances. Findings suggest that both regular doctor visits and patient actions can help catch the cancer early and improve survival chances.14678

Who Is on the Research Team?

PS

Peter S Liang, MD MPH

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

This trial is for Veterans aged 45-49 years who are at risk of early-onset colorectal cancer (EOCRC). It aims to engage them in screening programs. Participants must be eligible for VA health care services but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am between 45 and 49 years old.

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)
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)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Conduct a multilevel screening intervention targeting individuals aged 45-49 years, informing high-risk individuals and their providers about their risk status for EOCRC

6 months
Multiple visits as per intervention protocol

Follow-up

Participants are monitored for screening participation rates and effectiveness of the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Patient intervention
  • PCP intervention
Trial Overview The study is testing a multilevel intervention that includes developing a novel EOCRC risk score from VA health records, informing high-risk individuals and their primary care providers about the risk, and evaluating barriers to implementation.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Patient interventionExperimental Treatment1 Intervention
Group II: PCP interventionExperimental Treatment1 Intervention
Group III: CombinedExperimental Treatment2 Interventions
Group IV: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

The Rise of Early-Onset Colorectal Cancer: Clinical ...Clinical, pathologic, molecular, and treatment data were extracted. Survival outcomes were analyzed using Kaplan–Meier methods, and prognostic ...
Gastroenterology Specialist Supply and Early-Onset ...We conducted this study to examine the association of GI and PCP supply with EoCRC outcomes (incidence and mortality) and attempted to determine ...
Long-Term Effectiveness Associated With Fecal ...The results showed a statistically significant 25% reduction in CRC incidence (aRR, 0.75; 95% CI, 0.72-0.77) and a 34% reduction in CRC ...
Engaging primary care physicians is critical in the ...Our results showed that patients who have a PCP experience a 54 % reduction in the odds of having late stage CRC when compared to patients without a PCP. This ...
Preventing Early-Onset Colorectal Cancer in the VAThe 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 ( ...
Engaging primary care physicians is critical in the ...Patients with a PCP had a significantly lower rate of late stage CRC than those without a PCP (42.4 % vs. 68.0 %, p < 0.001). After adjustment, ...
A qualitative study of a new metric for estimating early-onset ...Despite the necessity of PCP recommendations, little data exist regarding PCPs' decision-making to endorse early-onset CRC guidelines in ...
The Effectiveness of a Physician-Only and Physician–Patient ...Our purpose was to assess the effectiveness of physician-only and physician–patient interventions on increasing rates of CRC screening discussions as compared ...
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