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Behavioural Intervention

Decision Support Tool for Lung Cancer Screening

N/A
Waitlist Available
Led By Kensaku Kawamoto, MD, PhD, MHS
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Does not already have lung cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
Awards & highlights

Summary

This trial is designed to increase the use of low-dose CT scans to screen for lung cancer by developing and disseminating patient-centered clinical decision support tools. These tools will be integrated with electronic health records and clinical workflows, and will prompt shared decision making when patients meet screening criteria. The goal is to promote standard of care that is endorsed by the Centers for Medicare & Medicaid Services and the US Preventive Services Task Force.

Who is the study for?
This trial is for people aged 55 to 80 who are patients at University of Utah primary care clinics, have a history of heavy smoking (30+ pack-years), and are either current smokers or quit within the last 15 years. It's not for those already diagnosed with lung cancer.Check my eligibility
What is being tested?
The study tests a new tool that helps doctors and patients decide together if lung cancer screening is right. The tool works with electronic health records, prompts shared decision-making when criteria are met, and provides personalized info on screening pros and cons.See study design
What are the potential side effects?
Since this trial involves decision support tools rather than medications or medical procedures, traditional side effects aren't expected. However, there may be psychological impacts from discussing potential benefits and harms of lung cancer screening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have lung cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for the intervention period and 12 months for the baseline period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in LDCT screening rate among eligible patients
Secondary outcome measures
Estimated number of lung cancer deaths prevented
Estimated number of major complications
Other outcome measures
Rate of use of the intervention
Return on investment
Usability of the intervention as measured by System Usability Scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients eligible for LDCT lung cancer screeningExperimental Treatment1 Intervention
This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to USPSTF guidelines, who are seen by a pilot user of the intervention. The inclusion criteria are (i) >= 55 years and <= 80 years old at the time of the visit; (ii) does not already have lung cancer; and (iii) meets USPSTF smoking criteria for LDCT screening (30+ pack-year smoking history and current smoker or quit in the past 15 years) or may meet the criteria if a complete smoking history were taken. USPSTF guidelines may change during the study. In particular, it is anticipated that the guidelines may update during the study whereby the minimum age is reduced to 50 (from 55) and the minimum smoking history is reduced to 20 years (from 30). In the event that the USPSTF guidelines change, the intervention will be updated to match the change to the guidelines. We may also update the study evaluation to match the updated USPSTF guidelines.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,776,556 Total Patients Enrolled
Kensaku Kawamoto, MD, PhD, MHSPrincipal Investigator - University of Utah
University of Utah
2 Previous Clinical Trials
55,570 Total Patients Enrolled

Media Library

EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04498052 — N/A
Lung Cancer Research Study Groups: Patients eligible for LDCT lung cancer screening
Lung Cancer Clinical Trial 2023: EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening Highlights & Side Effects. Trial Name: NCT04498052 — N/A
EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04498052 — N/A
~2483 spots leftby Jul 2025