Prediction Models for Lung Cancer Screening

(PASI Trial)

Not yet recruiting at 3 trial locations
AG
NT
Overseen ByNichole T Tanner, MD MS BS
Age: 18+
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 tests a new method for screening lung cancer using prediction models to catch the disease early when it's more treatable. The focus is on Veterans, particularly those who smoke or recently quit, as they have a higher risk of lung cancer. The trial compares different methods, including the Prediction Augmented Screening Initiative, which provides new tools for healthcare providers and patient management systems, against usual care to determine which is more effective in increasing screening rates. Veterans who have never been screened for lung cancer and meet specific smoking history criteria may be suitable for this trial. As an unphased trial, it offers Veterans the chance to contribute to innovative research that could enhance early detection of lung 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.

What prior data suggests that this prediction model is safe for lung cancer screening?

Research has shown that the Prediction Augmented Screening Initiative enhances lung cancer screening. This initiative includes tools for primary care doctors, tested in other studies, which have increased screening rates. Importantly, no reports of harm or safety issues have emerged, indicating likely safety.

Tools for managing lung cancer screening, such as dashboards and outreach kits, have also been studied and found safe. These tools assist doctors and health teams in managing screenings more effectively.

When both primary care tools and management dashboards are used together, studies suggest they improve screening rates. Again, no safety concerns have been reported.

Overall, these tools aim to help doctors and health teams enhance lung cancer screening without posing any safety risk to patients.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve lung cancer screening using innovative tools. Unlike traditional screening methods, which often rely solely on standard imaging and physician assessments, this trial introduces prediction models and specialized tools to enhance early detection. The "PCP facing tools" provide primary care providers with advanced resources, while the "LCS team population management tools" offer a dashboard and outreach toolkit for proactive patient management. These features could lead to more personalized and timely screenings, potentially catching lung cancer earlier and improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for improving lung cancer screening uptake?

Research has shown that prediction models can help detect lung cancer earlier. Studies have found that screening with low-dose CT scans can reduce the risk of dying from lung cancer by up to 25%. In this trial, participants may receive different interventions to enhance screening rates. One arm will use PCP-facing tools, another will use LCS team population management tools, a third will combine both interventions, and a fourth will follow usual care. Digital tools can help patients understand their options and make informed choices. Technology-based management tools can also increase screening rates among high-risk groups. Using these methods together might further improve screening rates and save more lives.16789

Who Is on the Research Team?

NT

Nichole Tanner, MD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for individuals eligible for lung cancer screening, particularly focusing on Veterans who are at high risk but have low screening rates. It aims to improve early detection in this group, with an emphasis on reducing disparities and increasing uptake among Black Veterans.

Inclusion Criteria

I am 50-80 years old, have a 20 pack-year smoking history, and either currently smoke or quit less than 15 years ago.
Predicted benefit calculated using LYFS-CTVA model exceeds a stringent high-benefit threshold of life-year gains with annual LCS, as recommended in the 2021 CHEST LCS guidelines
Veterans assigned a PCP at a participating site and who meet inclusion criteria at any point during the study timeframe will be enrolled into the trial. There will be two paths to patient inclusion:

Exclusion Criteria

Veterans who have previously undergone lung cancer screening
Veterans who do not meet the eligibility criteria outlined above
I am a veteran diagnosed with lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of prediction-augmented lung cancer screening using primary care-facing informatics tools and LCS team population management tools

169 weeks
Quarterly visits (in-person or virtual)

Follow-up

Participants are monitored for lung cancer detection rates, uptake among high-benefit Veterans, and complications from invasive procedures

3 years
Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Prediction Augmented Screening Initiative
Trial Overview The study tests whether using prediction models alongside population management tools can increase the efficiency of lung cancer screenings (LCS) and encourage higher participation rates among Veterans.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: PCP facing tools plus LCS population management dashboardExperimental Treatment2 Interventions
Group II: PCP facing toolsExperimental Treatment2 Interventions
Group III: LCS team population management toolsExperimental Treatment2 Interventions
Group IV: Usual CareActive 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

Effectiveness of Technology-Based Interventions in Promoting ...This study reviews how technology-based interventions have been designed and implemented to promote lung cancer screening (LCS), ...
NCT06538636 | Prediction Augmented Screening InitiativeThe factorial design allows us to discern the effect on LCS uptake of primary care-facing vs LCS team population management tools. Secondary outcomes include ...
Interventions targeted to improve lung cancer screening ...Combined intervention and patient navigation are most effective in increasing lung cancer screening uptake among high-risk individuals.
Outcomes From More Than 1 Million People Screened for ...Lung cancer screening (LCS) with low-dose CT (LDCT) imaging was recommended in 2013, making approximately 8 million Americans eligible for LCS.
Development of an Electronic Health Record–Based ...Through early detection resulting in improved lung cancer outcomes, lung cancer screening (LCS) now provides an additional avenue, along ...
Implementation of a Web-Based Tool for Shared Decision ...We created DecisionPrecision, a clinician-facing web-based decision support tool, to help tailor the LCS discussion to a patient's individualized lung cancer ...
Components Necessary for High-Quality Lung Cancer ...LCS programs should develop an approach to screen-detected lung nodule management that includes guideline-based follow-up of low-risk ...
Lung Cancer Screening Before and After a Multifaceted ...This study found that a multifaceted electronic health record–integrated intervention was associated with increased care gap closure for lung cancer screening.
Participant adherence in a lung cancer screening (LCS) ...Background: LCS guidelines in smoking populations includes an annual low-dose CT Chest (LDCT) scan. Historically, real-world adherence to ...
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