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Personalized Risk Feedback for Lung Cancer Screening and Smoking Cessation (PRECISE Trial)

N/A
Waitlist Available
Led By Li-Shiun Chen, M.D., MPH, ScD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 50 to 80 years of age, inclusive
Be older than 18 years old
Must not have
Lung cancer diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how two versions of a personalized risk feedback tool affect lung cancer screening and tobacco treatment. It looks at how clinicians and patients respond.

Who is the study for?
This trial is for current smokers or those who quit within the last 15 years, aged 50-80, with a history of heavy smoking (≥20 pack-years), and have never been screened for lung cancer. Participants must be patients of clinicians in the study's clinics and speak English. Those already scheduled for lung cancer screening, diagnosed with lung cancer, or unable to provide a DNA sample are excluded.
What is being tested?
The trial examines two personalized risk feedback tools—clinically-informed (RiskProfile-Clin) and genetically-informed (RiskProfile-Gen)—against standard care. It aims to see if these tools affect how often doctors order lung cancer screenings/smoking cessation treatments and if their patients follow through.
What are the potential side effects?
Since this trial involves risk assessment tools rather than medications or medical procedures, there are no direct side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with lung cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Clinician ordering of lung cancer screening
Clinician prescribing of tobacco treatment
Patient completion of lung cancer screening
+6 more
Other study objectives
Patient-centeredness of care discussions regarding screening and treatment (Clinicians)
Patient-centeredness of care discussions regarding screening and treatment (Patients)
Perceived benefits of screening and treatment (Clinicians)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: RiskProfile-GenExperimental Treatment1 Intervention
RiskProfile-Gen is a genetically-informed risk feedback tool to activate cancer risk-reducing behaviors.
Group II: RiskProfile-ClinExperimental Treatment1 Intervention
RiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors.
Group III: Usual CareActive Control1 Intervention
Annual 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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,997 Previous Clinical Trials
2,297,846 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,264 Total Patients Enrolled
Li-Shiun Chen, M.D., MPH, ScDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
90 Total Patients Enrolled
Alex Ramsey, Ph.D.Principal InvestigatorWashington University School of Medicine

Media Library

RiskProfile-Clin Clinical Trial Eligibility Overview. Trial Name: NCT05627674 — N/A
Smoking Cessation Research Study Groups: RiskProfile-Clin, RiskProfile-Gen, Usual Care
Smoking Cessation Clinical Trial 2023: RiskProfile-Clin Highlights & Side Effects. Trial Name: NCT05627674 — N/A
RiskProfile-Clin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627674 — N/A
~330 spots leftby Jan 2026