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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 belowSelect...
I am between 50 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with lung cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)
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)
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 moreOther 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 moreAwards & 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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,987 Previous Clinical Trials
2,290,664 Total Patients Enrolled
4 Trials studying Smoking
3,784 Patients Enrolled for Smoking
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,113 Total Patients Enrolled
66 Trials studying Smoking
57,606 Patients Enrolled for Smoking
Li-Shiun Chen, M.D., MPH, ScDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Smoking
90 Patients Enrolled for Smoking
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently smoking or stopped smoking within the last 15 years.You have not been screened for lung cancer before.You have smoked the equivalent of one pack a day for 20 years or more.I have been diagnosed with lung cancer.I am between 50 and 80 years old.The analysis of your DNA sample was not successful.
Research Study Groups:
This trial has the following groups:- Group 1: RiskProfile-Clin
- Group 2: RiskProfile-Gen
- Group 3: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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