Quebec Lung Cancer Screening PLUS Trial

NCT05444062 | Active Not Recruiting

• 1 other identifier: MP-37-2023-8641
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD; Coronary Artery Calcification

Keywords

COPD; Coronary Artery Calcification; Lung cancer screening; Undiagnosed disease; Educational intervention; Medication adherence; Untreated disease; Statins; Inhalers

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  1 year post CT

Secondary Outcomes (8)

• Medication possession ratio (MPR) - Aim 1

  1 year post CT

• Medication possession ratio (MPR) - Aim 2

  1 year post CT

• COPD Symptoms

  Baseline, 6 months post intervention, 12 months post intervention

• Quality of life using SF-36 questionnaire

  Baseline, 12 months post intervention

• Patient satisfaction with communication and decision making

  3 months post intervention

Study Arms (4)

Control Arm: CVD

NO 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

Intervention Arm: CVD

OTHER

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

Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists

Control Arm: COPD

NO INTERVENTION

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

Intervention Arm: COPD

OTHER

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

Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists

Interventions

Educational material and treatment recommendations for patients, general practitioners and pharmacists BEHAVIORAL

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

Intervention Arm: COPD; Intervention Arm: CVD

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicole Ezer, MD, FRCPC, MPH: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3K 2M2, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Undiagnosed Diseases; Medication Adherence

Interventions

General Practitioners; Pharmacists

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of medicine

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 5, 2022
• Study Start: April 23, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)