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Lung CancerPASINCT06538636

Prediction Augmented Screening Initiative

A study testing PCP-Facing Tools and LCS team population management tools in people with Lung Cancer and Lung Cancer Screening, run by VA Office of Research and Development at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Lung Cancer, Lung Cancer Screening
What is being tested?
PCP-Facing Tools and LCS team population management tools
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23,520 participants
Where
4 sitesUnited States
Study dates
1 Jun 2026to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nichole T Tanner, MD MS BS contact

(843) 789-7341

Nichole.Tanner@va.gov

Abby G Wenzel, PhD MS BS contact

(843) 789-6965

abby.wenzel@va.gov

United States4 sites, 4 recruiting
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303

    Tanner Caverly, MD, tanner.caverly@va.gov

    Sarah Dorin, sarah.dorin@va.gov

    Not yet recruiting
  • VA Bedford HealthCare System, Bedford, MA

    Bedford, Massachusetts, 01730-1114

    Gemmae Fix, PhD, gemmae.fix@va.gov

    Renda Wiener, renda.wiener@va.gov

    Not yet recruiting
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817

    Renda Wiener, MD, Renda.Wiener@va.gov

    Gemmae Fix, gemmae.fix@va.gov

    Not yet recruiting
  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5703

    Qwaneshia Wilson, MS, (843) 789-6710 ext. 206710, Qwaneshia.Wilson@va.gov

    Sarah A Jackson, BA MA, (843) 789-6700, sarah.jackson@va.gov

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Background: Despite large-randomized trials demonstrating the mortality benefit from lung cancer screening (LCS) and a recommendation from the US Preventive Services Task Force (USPSTF) and VHA since 2013, only 20% of eligible Veterans have received LCS. Uptake is even lower among Black Veterans despite higher lung cancer risk. Current USPSTF eligibility criteria of age and smoking history are simple, but do not incorporate the heterogeneity in lung cancer risk and life expectancy across people and leads to exclusion of some persons, especially Blacks, with potential for high benefit from LCS. While the USPSTF acknowledged that using prediction models to augment simple eligibility criteria is more efficient and equitable, they stopped short of recommending prediction-augmented LCS, noting that a pragmatic trial was needed to demonstrate that prediction-augmented LCS can be feasibly implemented in real-world settings and assess its impact on LCS uptake. Significance: By demonstrating the real-world feasibility of prediction-augmented LCS, and its ability to improve LCS uptake especially in those of high-benefit, the VA as a learning healthcare system will influence national LCS guidelines and improve LCS outcomes both inside and outside the VA. Innovation \& Impact: Prediction-augmented LCS is based on strong evidence, yet implementing this approach would represent paradigm shift from typical preventive cancer screening. The proposed work is a unique opportunity for the VA to advance implementation of more equitable, personalized LCS by improving on the status quo of making broad 'one-size-fits-all' recommendations. The innovation is the advancement of primary care-facing and population management informatics tools that present individualized information on how strongly to encourage LCS, with the potential to be expanded to other cancer screenings. Specific Aims: 1. Conduct a pragmatic stepped wedge (site-level) factorial trial comparing usual care (USPSTF criteria) versus prediction-augmented LCS (supported by primary care-facing informatics tools, LCS team population management tools, external facilitation) on effectiveness at increasing LCS uptake. 2. Determine what drives implementation success of prediction-augmented LCS in various contexts, using mixed methods. Methodology: The investigators will utilize a factorial stepped wedge design in the Lung Precision Oncology Program network to establish the effectiveness and evaluate the implementation of precision-augmented LCS. Veterans assigned a PCP at a participating site and who meet inclusion criteria based on Clinical Data Warehouse data will be passively enrolled in the study: 1) patients meeting USPSTF criteria for LCS; OR 2) patients whose predicted LCS benefit exceeds a stringent high-benefit threshold of life gained with annual LCS (to capture high-benefit Veterans currently excluded by USPSTF criteria). The primary outcome is the probability of completion of an initial LDCT scan among eligible subjects defined as high-benefit during each quarter of the study (quarter assigned by date of the LDCT order as this event is most proximal to the LCS decision). The factorial design allows us to discern the effect on LCS uptake of primary care-facing vs LCS team population management tools. Secondary outcomes include 1) LDCT orders and completion among all eligible Veterans; 2) LCS orders and completion among high-benefit Black Veterans and among all eligible Black Veterans; 3) LDCT orders and completion among eligible but non-high-benefit Veterans and among those with high comorbidity; 4) Effects on lung cancer detection rates; 5) LCS outcomes (invasive procedures and complications) and projected cancer outcomes (e.g., lung cancer deaths avoided) among additional people screened due to the interventions, and care gaps in which LCS was ordered but not completed. Implementation evaluation will be guided by the i-PARIHS framework using mixed methods. This approach combines data drawn from across all trial sites (tool usage data, clinician surveys, facilitation data, patient interviews) to gain a broad view of implementation, with in-depth ethnographic assessments from 6 selected sites that will provide deeper insights into how and why implementation succeeded (or faced challenges) in different contexts. Our findings will inform creation of an implementation playbook to support enterprise-wide spread of prediction-augmented LCS. Next Steps / Implementation: The investigators will work with our operational partners to spread implementation of prediction-augmented LCS across the VA enterprise.

Being tested
PCP-Facing Tools, LCS team population management tools
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCP-Facing ToolsOther

    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 toolsOther

    site-specific dashboard and proactive outreach toolkit

Study groups in NCT06538636
Study groupRoleWhat they receive
Usual CareNo interventionUsual care
PCP facing toolsExperimentalSuite of PCP facing tools activated
Receives: Other: PCP-Facing Tools; Other: LCS team population management tools
LCS team population management toolsExperimentalsite-specific dashboard and proactive outreach toolkit
Receives: Other: PCP-Facing Tools; Other: LCS team population management tools
PCP facing tools plus LCS population management dashboardExperimentalboth interventions activated
Receives: Other: PCP-Facing Tools; Other: LCS team population management tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDCT receipt in high-benefit Veterans

    The probability of completion of an initial LDCT scan among eligible subjects defined as high-benefit during each quarter of the study (quarter assigned by date of the LDCT order as this event is most proximal to the LCS decision; passage of time between order and scan completion could lead to erroneous attribution of primary outcome to the wrong study phase if scan date is used)

    Measured: From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks

Secondary outcomes (1)
  1. LDCT receipt among all eligible Veterans

    The probability of completion of an initial LDCT scan among eligible subjects during each quarter of the study (quarter assigned by date of the LDCT order as this event is most proximal to the LCS decision; passage of time between order and scan completion could lead to erroneous attribution of primary outcome to the wrong study phase if scan date is used)

    Measured: From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start1 Jun 2026
  3. Primary completion5 Mar 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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 factorial stepped wedge design (SWD) over over 9 calendar quarters, with 8 sequence arms and 3 trial sites randomized per sequence to support estimation of separate and combined effects for two intervention types (1-PCP-facing tools and 2-LCS team population management tools). Each half of the arms will sequentially implement one of the interventions, followed by implementation of the second intervention
Masking
None (open label)
Enrolment
23,520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538636
Sponsor's protocol ID
SPLP-001-24S
Other IDs
CX002850
Acronym
PASI
Status last verified
Jun 2026
First submitted
30 Jul 2024
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PCP-Facing Tools and LCS team population management tools in people with Lung Cancer and Lung Cancer Screening, run by VA Office of Research and Development at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nichole T Tanner, MD MS BS ((843) 789-7341, Nichole.Tanner@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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