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.
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.
United States4 sites, 4 recruiting
- Not yet 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
- 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
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.
- Conditions
- Lung Cancer, Lung Cancer Screening
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care |
| PCP facing tools | Experimental | Suite of PCP facing tools activated Receives: Other: PCP-Facing Tools; Other: LCS team population management tools |
| LCS team population management tools | Experimental | site-specific dashboard and proactive outreach toolkit Receives: Other: PCP-Facing Tools; Other: LCS team population management tools |
| PCP facing tools plus LCS population management dashboard | Experimental | both 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.
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)
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.
- First posted6 Aug 2024
- Study start1 Jun 2026
- Primary completion5 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nichole T Tanner, MD MS BS, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Augmented Screening Initiative
- ClinicalTrials.gov ID
- NCT06538636
- Acronym / sponsor ID
- PASI / SPLP-001-24S
- Conditions
- Lung Cancer, Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23,520 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 5 Mar 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care |
| PCP facing tools | Experimental | Other: PCP-Facing Tools, Other: LCS team population management toolsSuite of PCP facing tools activated |
| LCS team population management tools | Experimental | Other: PCP-Facing Tools, Other: LCS team population management toolssite-specific dashboard and proactive outreach toolkit |
| PCP facing tools plus LCS population management dashboard | Experimental | Other: PCP-Facing Tools, Other: LCS team population management toolsboth interventions activated |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Veterans who have previously undergone lung cancer screening, are diagnosed with lung cancer, or who do not meet eligibility criteria outlined above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCP-Facing ToolsPCP-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 | Other | LCS team population management tools, PCP facing tools, PCP facing tools plus LCS population management dashboard |
| LCS team population management toolssite-specific dashboard and proactive outreach toolkit | Other | LCS team population management tools, PCP facing tools, PCP facing tools plus LCS population management dashboard |
Primary outcome
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
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)
1 secondary outcome
LDCT receipt among all eligible Veterans
Time frame: From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nichole T Tanner, MD MS BS principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
4 sites in 1 country: see every site and its status.
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.