Quebec Lung Cancer Screening PLUS Trial

COPD Clinical Trial

— QLC+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444062
• Other study ID #: MP-37-2023-8641
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2023
• Est. completion date: September 2027

Study information

• Verified date: July 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Nicole Ezer, MD
• Phone: (514)-934-1934
• Email: nicole.ezer[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calcinosis
• COPD
• Coronary Artery Calcification
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Nicole Ezer, MD, FRCPC, MPH

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Absenteeism and presenteeism	Work productivity and activity impairment (WPAI) questionnaire	baseline
Secondary	Health literacy	Health literacy will be assessed at study entry using the Brief Health Literacy Screen.	baseline