Back to resultsQuebec Lung Cancer Screening PLUS Trial (QLC+)
Primary Purpose
COPD, Coronary Artery Calcification
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational material and treatment recommendations for patients, general practitioners and pharmacists
Sponsored by
About this trial
This is an interventional other trial for COPD focused on measuring COPD, Coronary Artery Calcification, Lung cancer screening, Undiagnosed disease, Educational intervention, Medication adherence, Untreated disease, Statins, Inhalers
Eligibility Criteria
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: moderate to severe CAC identified on low dose CT, not on guideline recommended statin therapy.
- COPD aim: diagnosed with COPD, symptomatic (mMRC 2 or greater) and untreated, or not on first line guideline recommended therapy for COPD. (ie. inhaled corticosteroids (ICS) alone or short acting beta agonists alone).
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 or mild CAC, known clinical atherosclerosis, Diabetes Mellitus.
- COPD aim: asymptomatic, or already on appropriate first line COPD therapy (LAMA, long acting beta agonist (LABA), combined LAMA-LABA, combined LAMA-LABA-ICS).
Sites / Locations
- McGill University Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Other
No Intervention
Other
Arm Label
Control Arm: CVD
Intervention Arm: CVD
Control Arm: COPD
Intervention Arm: COPD
Arm Description
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
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
Patients with untreated COPD or not on first line guideline recommended therapy.
Patients with untreated COPD or not on first line guideline recommended therapy.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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.
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.
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
Quality of life using SF-36 questionnaire
SF-36 questionnaire will be filled at baseline and 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.
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
Absenteeism and presenteeism
Work productivity and activity impairment (WPAI) questionnaire
Health literacy
Health literacy will be assessed at study entry using the Brief Health Literacy Screen.
Full Information
NCT ID
NCT05444062
First Posted
June 27, 2022
Last Updated
July 20, 2023
Sponsor
Nicole Ezer, MD, FRCPC, MPH
1. Study Identification
Unique Protocol Identification Number
NCT05444062
Brief Title
Quebec Lung Cancer Screening PLUS Trial
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicole Ezer, MD, FRCPC, MPH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Coronary Artery Calcification
Keywords
COPD, Coronary Artery Calcification, Lung cancer screening, Undiagnosed disease, Educational intervention, Medication adherence, Untreated disease, Statins, Inhalers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm: CVD
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention Arm: CVD
Arm Type
Other
Arm Description
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
Arm Title
Control Arm: COPD
Arm Type
No Intervention
Arm Description
Patients with untreated COPD or not on first line guideline recommended therapy.
Arm Title
Intervention Arm: COPD
Arm Type
Other
Arm Description
Patients with untreated COPD or not on first line guideline recommended therapy.
Intervention Type
Behavioral
Intervention Name(s)
Educational material and treatment recommendations for patients, general practitioners and pharmacists
Intervention Description
Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.
Primary Outcome Measure Information:
Title
Guideline concordant statin therapy 1 year following the first low dose CT scan.
Description
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
Title
Guideline concordant inhaler therapy 1 year following the first low dose CT scan
Description
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 Outcome Measure Information:
Title
Medication possession ratio (MPR) - Aim 1
Description
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
Title
Medication possession ratio (MPR) - Aim 2
Description
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
Title
COPD Symptoms
Description
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
Title
Quality of life using SF-36 questionnaire
Description
SF-36 questionnaire will be filled at baseline and 12 months post intervention
Time Frame
Baseline, 12 months post intervention
Title
Patient satisfaction with communication and decision making
Description
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.
Time Frame
3 months post intervention
Title
Health Care Utilisation
Description
Number of unplanned clinic visits, hospitalizations for respiratory or cardiac disease, consultations with specialists (cardiology and respirology), invasive/non-invasive cardiac or respiratory investigations
Time Frame
1 year post intervention
Title
Absenteeism and presenteeism
Description
Work productivity and activity impairment (WPAI) questionnaire
Time Frame
baseline
Title
Health literacy
Description
Health literacy will be assessed at study entry using the Brief Health Literacy Screen.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Ezer, MD
Phone
(514)-934-1934
Ext
76192
Email
nicole.ezer@mcgill.ca
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3K 2M2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Ezer, MD MPH
Phone
5149341934
Ext
76192
Email
nicole.ezer@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Charlotte Besson, PHD
Phone
4508484141
Email
charlotte.besson@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Emily McDonald, MD MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Quebec Lung Cancer Screening PLUS Trial
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