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Education Intervention for Lung Cancer Screening Compliance (QLC+ Trial)

N/A

Recruiting

Research Sponsored by Nicole Ezer, MD, FRCPC, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

COPD aim: diagnosed with COPD, symptomatic (mMRC >=1 or CAT>= 10) and untreated, or not on first line guideline recommended therapy for COPD

Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy

Must not have

Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus

Any participant with a high suspicion of lung cancer, defined as Lung-RADS (Lung Imaging Reporting and Data System) 3 or 4, as this is an inopportune time to initiate new medical therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post ct

Awards & highlights

No Placebo-Only Group

Summary

This trial tested if an educational intervention improves medication adherence in COPD and cardiovascular patients, leading to better health outcomes.

Who is the study for?

This trial is for individuals who have been screened for lung cancer and found to have mild to severe coronary artery calcification (CAC) without being on recommended lipid-lowering therapy, or diagnosed with symptomatic COPD not treated with first-line therapies. It's not suitable for those already on appropriate COPD treatment, without CAC, with known heart issues, diabetes, or a high suspicion of lung cancer.

What is being tested?

The study tests if providing educational materials and treatment recommendations can improve adherence to medication guidelines at 12 months in patients with untreated COPD and cardiovascular disease within a lung cancer screening program.

What are the potential side effects?

Since the intervention involves educational material rather than medications or invasive procedures, there are no direct side effects associated with it. However, changes in medication adherence as a result of education may lead to typical drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have COPD, experience symptoms, and am not on first-line treatment.

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I have mild to severe artery plaque and am not on cholesterol-lowering medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have heart calcification, known heart disease, past heart surgery, or diabetes.

Select...

I am suspected to have lung cancer with a high-risk rating.

Select...

My COPD is either symptom-free or I am on the first line of treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post ct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post ct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post ct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Guideline concordant inhaler therapy 1 year following the first low dose CT scan

X-Ray Computed Tomography

Secondary study objectives

Absenteeism and presenteeism

Chronic Obstructive Airway Disease

Health Care Utilisation

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm: CVDExperimental Treatment1 Intervention

Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy. CAC score obtained from lung cancer screening CT Scan images

Group II: Intervention Arm: COPDExperimental Treatment1 Intervention

Patients with untreated COPD or not on first line guideline recommended therapy.

Group III: Control Arm: CVDActive Control1 Intervention

Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy. Coronary artery Calcification (CAC) score obtained from lung cancer screening CT Scan images

Group IV: Control Arm: COPDActive Control1 Intervention

Patients with untreated COPD or not on first line guideline recommended therapy.

0 / 5Eligibility criteria met