Quebec Lung Cancer Screening PLUS Trial

N/AActive Not RecruitingNCT05444062

Nicole Ezer, MD, FRCPC, MPH330 enrolled

Overview

Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

330

Conditions

COPD Coronary Artery Calcification

Interventions

Educational material and treatment recommendations for patients, general practitioners and pharmacistsBEHAVIORAL

Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient screened for lung cancer as part of the Quebec Lung Cancer Demonstration project by low dose CT scan of the chest. * Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy. * COPD aim: diagnosed with COPD, symptomatic (mMRC \>=1 or CAT\>= 10) and untreated, or not on first line guideline recommended therapy for COPD. Exclusion Criteria: * 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. * Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus. * COPD aim: asymptomatic, or already on appropriate first line COPD therapy.

Locations (1)

McGill University Health Center

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Among patients with moderate to severe coronary artery calcifications (CAC) not on a statin at baseline, any statin prescribed for primary prevention at least once in the 1 year following the first low dose CT scan. (aim 1)

Time frame: 1 year post CT

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

Among patients who have untreated or inappropriately treated COPD at baseline, any long acting muscarinic antagonist inhaler prescribed at least once in the 1 year following the first low dose CT scan (aim 2)

Time frame: 1 year post CT

Secondary Outcomes

Medication possession ratio (MPR) - Aim 1

Reflects patient adherence. Days of drug supply over 1 year with cholesterol lowering medication in the previous 1 year from pharmacy dispensation records.

Time frame: 1 year post CT

Medication possession ratio (MPR) - Aim 2

Reflects patient adherence. Days of drug supply over 1 year with guideline concordant inhaler therapy for COPD in the previous 1 year from pharmacy dispensation records.

Time frame: 1 year post CT

COPD Symptoms

COPD Assessment Test is a validated patient-reported outcome. It measures 8 symptoms of COPD on a 0-5 point scale at baseline, 6 and 12 months post intervention

Time frame: Baseline, 6 months post intervention, 12 months post intervention

Quality of life using SF-36 questionnaire

SF-36 questionnaire will be filled at baseline and 12 months post intervention

Time frame: Baseline, 12 months post intervention

Data from ClinicalTrials.gov

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