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Prediction Augmented Screening Initiative

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Massachusetts
VA Bedford HealthCare System, Bedford, MA
NOT_YET_RECRUITING
Bedford
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
NOT_YET_RECRUITING
Boston
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
NOT_YET_RECRUITING
Ann Arbor
South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
RECRUITING
Charleston
Contact Information
Primary
Nichole T Tanner, MD MS BS
Nichole.Tanner@va.gov
(843) 789-7341
Backup
Abby G Wenzel, PhD MS BS
abby.wenzel@va.gov
(843) 789-6965
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 23520
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov