Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment
PRECISE
Precision Approaches to Lung Cancer Screening and Smoking Cessation Treatment in Primary Care
2 other identifiers
interventional
915
1 country
1
Brief Summary
This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. The trial assesses the multilevel effects of these precision risk feedback tools on the likelihood of clinicians to order lung cancer screening and tobacco treatment and of their patients to utilize these cancer prevention interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2022
CompletedFirst Posted
Study publicly available on registry
November 28, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
December 24, 2025
December 1, 2025
4.7 years
November 2, 2022
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinician ordering of lung cancer screening
This will be quantified by the proportion of screen-eligible patients who receive a clinician order for lung cancer screening.
From enrollment through 6 months post-intervention
Patient completion of lung cancer screening
This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening.
From enrollment through 6 months post-intervention
Secondary Outcomes (9)
Clinician ordering of lung cancer screening
From enrollment through 18 months post-intervention
Patient completion of lung cancer screening
From enrollment through 18 months post-intervention
Patient completion of lung cancer screening, of those with order for screening
From enrollment through 18 months post-intervention
Patient ongoing adherence to annual repeat lung cancer screening
From enrollment through 18 months post-intervention
Clinician prescribing of tobacco treatment
From enrollment through 18 months post-intervention
- +4 more secondary outcomes
Other Outcomes (6)
Personal relevance (Patients)
From enrollment through 18 months post-intervention
Perceived disease risk (Patients)
From baseline through 18 months post-intervention
Perceived benefits of screening and treatment (Patients)
From baseline through 18 months post-intervention
- +3 more other outcomes
Study Arms (3)
Usual Care
ACTIVE COMPARATORAnnual lung cancer screening with low-dose computed tomography (LDCT) is currently recommended in the U.S. for at-risk patients. Tobacco treatment and cessation is recommended for patients who smoke.
RiskProfile-Clin
EXPERIMENTALRiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors.
RiskProfile-Gen
EXPERIMENTALRiskProfile-Gen is a genetically-informed risk feedback tool to activate cancer risk-reducing behaviors.
Interventions
RiskProfile-Gen incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors and genetic factors.
RiskProfile-Clin incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors.
Eligibility Criteria
You may qualify if:
- CLINICIANS:
- \- Primary care clinician with active caseload in participating clinics
- PATIENTS:
- Patient of participating primary care clinician
- Lung cancer screening naïve
- Between 50 to 80 years of age, inclusive
- Current or former smokers
- Pack years ≥ 20
- English-speaking
You may not qualify if:
- PATIENTS:
- Lung cancer diagnosis
- Current order placed for lung cancer screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Ramsey, Ph.D.
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Li-Shiun Chen, M.D., MPH, ScD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2022
First Posted
November 28, 2022
Study Start
January 1, 2023
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The genotype data will be made available 12 months after trial completion in a NIH-designated data repository after data cleaning and quality control completion, which we anticipate to be in year 5, without restrictions on publication or other dissemination.
The University will share anonymized human genomic data and relevant associated data from approximately 825 research participants by depositing these data in a NIH-designated data repository or other repositories that meet the appropriate data security measures, confidentiality, privacy, and data use measures. In addition, information necessary to interpret the submitted data will be included, such as study protocols, data instruments and survey tools.