Recruiting

Prediction-Augmented LCS

Sponsor:

VA Office of Research and Development

Code:

NCT06538636

Conditions

Lung Cancer

Lung Cancer Screening

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

PCP-Facing Tools

LCS team population management tools

Study Details

Brief summary:

Lung cancer is responsible for more deaths in the United States than breast, prostate and colon cancer combined and is the number one cancer killer of Veterans. This is because lung cancer is usually diagnosed when the disease has spread, and cure is less likely. Lung cancer screening (LCS) finds cancer at an earlier stage when it is curable, yet only 20% of eligible Veterans have been screened. Uptake is even lower among Black Veterans despite higher lung cancer risk. Using prediction models to identify high-benefit people for whom LCS should be encouraged improves efficiency and reduces disparities. Moreover, it is more patient-centered as shared decision-making conversations can be tailored with personalized information. The US Preventive Services Task Force has called for research to demonstrate that prediction-augmented LCS can be feasibly implemented at the point-of-care. The investigators propose for VA to lead this effort with a large-scale pragmatic clinical trial to show that prediction-augmented LCS is both feasible and improves LCS uptake.

Conditions

Lung Cancer

Lung Cancer Screening

Study ID

NCT06538636

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Mar 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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:

  • meeting USPSTF eligibility criteria for LCS, as currently encoded in the background logic of LCS clinical reminders maintained by the VA National Center for Lung Cancer Screening (i.e., age 50-80 years; smoked 20 pack-years; current smoking or quit <15 years ago) OR
  • 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

Exclusion Criteria:

  • Veterans who have previously undergone lung cancer screening, are diagnosed with lung cancer, or who do not meet eligibility criteria outlined above

Study Design

Enrollment

23520 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Usual care

experimental: PCP facing tools

Suite of PCP facing tools activated

experimental: LCS team population management tools

site-specific dashboard and proactive outreach toolkit

experimental: PCP facing tools plus LCS population management dashboard

both interventions activated

Interventions

PCP-Facing Tools

PCP-facing tools will be turned on as a package: a) enhanced LCS clinical reminder including DP+ generated smart message; b) Integrated one-click DP+ full decision tool for automating personalized information about the net benefit of LCS based on patient characteristics; c) the TurboHM tool: automated Health maintenance app for tracking all preventive care, including a dedicated LCS section with personalized information

LCS team population management tools

site-specific dashboard and proactive outreach toolkit

Primary outcome measure

  • LDCT receipt in high-benefit Veterans [ Time Frame: From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks ]

Central Contacts and Locations

Central contacts

Nichole T Tanner, MD MS BS

(843) 789-7341Nichole.Tanner@va.gov

Abby G Wenzel, PhD MS BS

(843) 789-6965abby.wenzel@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Principal Investigator:

Nichole T Tanner, MD MS BS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-26.