Quebec Lung Cancer Screening PLUS Trial

Not Applicable

Recruiting

• Conditions: Coronary Artery Calcification; COPD
• Interventions: Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists

• Registration Number: NCT05444062
• Lead Sponsor: Nicole Ezer, MD, FRCPC, MPH

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-05
• Study Start: 2023-04-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm: COPD	Educational material and treatment recommendations for patients, general practitioners and pharmacists	Patients with untreated COPD or not on first line guideline recommended therapy.
Intervention Arm: CVD	Educational material and treatment recommendations for patients, general practitioners and pharmacists	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

Primary Outcome Measures

Name	Time	Method
Guideline concordant statin therapy 1 year following the first low dose CT scan.	1 year post CT	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	1 year post CT	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

Name	Time	Method
Medication possession ratio (MPR) - Aim 1	1 year post CT	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	1 year post CT	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	Baseline, 6 months post intervention, 12 months post intervention	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	Baseline, 12 months post intervention	SF-36 questionnaire will be filled at baseline and 12 months post intervention
Absenteeism and presenteeism	baseline	Work productivity and activity impairment (WPAI) questionnaire
Patient satisfaction with communication and decision making	3 months post intervention	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	1 year post intervention	Number of unplanned clinic visits, hospitalizations for respiratory or cardiac disease, consultations with specialists (cardiology and respirology), invasive/non-invasive cardiac or respiratory investigations
Health literacy	baseline	Health literacy will be assessed at study entry using the Brief Health Literacy Screen.

Trial Locations

Locations (1)

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada