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Active, Not Recruiting

NCT Number: NCT05444062

Quebec Lung Cancer Screening PLUS Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

COPD Behavior Chronic Disease Coronary Artery Calcification Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Treatment Adherence and Compliance Undiagnosed Diseases

Age range

55 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Center

Montreal, Quebec, H3K 2M2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Guideline concordant statin therapy 1 year following the first low dose CT scan.

    Time frame: 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)

  2. Guideline concordant inhaler therapy 1 year following the first low dose CT scan

    Time frame: 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 outcomes

  1. Medication possession ratio (MPR) - Aim 1

    Time frame: 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.

  2. Medication possession ratio (MPR) - Aim 2

    Time frame: 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.

  3. COPD Symptoms

    Time frame: 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

  4. Quality of life using SF-36 questionnaire

    Time frame: Baseline, 12 months post intervention

    SF-36 questionnaire will be filled at baseline and 12 months post intervention

  5. Patient satisfaction with communication and decision making

    Time frame: 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.

  6. Health Care Utilisation

    Time frame: 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

  7. Absenteeism and presenteeism

    Time frame: baseline

    Work productivity and activity impairment (WPAI) questionnaire

  8. Health literacy

    Time frame: baseline

    Health literacy will be assessed at study entry using the Brief Health Literacy Screen.

Sponsors and collaborators

Lead sponsor

Nicole Ezer, MD, FRCPC, MPH

Other

Registry information

Official study 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

Acronym: QLC+

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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