Quebec Lung Cancer Screening PLUS Trial (QLC+)

Quebec Lung Cancer Screening PLUS Trial - a Randomized Controlled Trial of an Educational Intervention for Untreated Chronic Obstructive Pulmonary Disease (COPD) and/or Cardiovascular Disease (CVD) Identified During Lung Cancer Screening

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 Overview

• Status: Recruiting
• Conditions: COPD; Coronary Artery Calcification
• Intervention / Treatment: Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole EZER, MD; Phone Number: 76192 (514)-934-1934; Email: nicole.ezer@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3K 2M2
      • Recruiting
      • McGill University Health center
      • Contact: Nicole Ezer, MD MPH; Phone Number: 76192 5149341934; Email: nicole.ezer@mcgill.ca
      • Contact: Charlotte Besson, PHD; Phone Number: 4508484141; Email: charlotte.besson@muhc.mcgill.ca
      • Sub-Investigator: Emily McDonald, MD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm: COPD; Patients with untreated COPD or not on first line guideline recommended therapy.
Other: Intervention Arm: COPD; Patients with untreated COPD or not on first line guideline recommended therapy.	Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists; Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.
No Intervention: Control Arm: CVD; 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
Other: Intervention Arm: CVD; 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; Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	Baseline, 12 months post intervention
Patient satisfaction with communication and decision making	COMRADE is a 20-item self-reported measure for use in primary care to assess risk communication and confidence in treatment decision making. It assesses patient satisfaction with information provided about risks/benefits of treatment, perception of participation in treatment decisions, and satisfaction with that decision. COMRADE questionnaire will be sent to patients after their first meeting with their general practitioner up to 3 months after intervention.	3 months post intervention
Health Care Utilisation	Number of unplanned clinic visits, hospitalizations for respiratory or cardiac disease, consultations with specialists (cardiology and respirology), invasive/non-invasive cardiac or respiratory investigations	1 year post intervention
Absenteeism and presenteeism	Work productivity and activity impairment (WPAI) questionnaire	baseline
Health literacy	Health literacy will be assessed at study entry using the Brief Health Literacy Screen.	baseline

Collaborators and Investigators

• Sponsor: Nicole Ezer, MD, FRCPC, MPH

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: COPD; Medication adherence; Statins; Educational intervention; Lung cancer screening; Coronary Artery Calcification; Inhalers; Undiagnosed disease; Untreated disease
• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Calcium Metabolism Disorders; Lung Neoplasms; Calcinosis
• Other Study ID Numbers: MP-37-2023-8641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No