Educational intervention for COPD and cardiovascular disease in lung cancer screening
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
This study tests if providing educational support to lung cancer screening patients with COPD and heart issues can help them stick to their medication plans better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 55 Years to 74 Years |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05444062 on ClinicalTrials.gov |
What this trial studies
This trial evaluates whether an educational intervention for patients with untreated COPD and cardiovascular disease can enhance adherence to medication guidelines when integrated into an existing lung cancer screening program. Participants will receive educational materials and treatment recommendations tailored for patients, general practitioners, and pharmacists. The study focuses on individuals screened for lung cancer who also have mild to severe coronary artery calcification and untreated COPD. The primary outcome is to assess medication adherence at 12 months post-intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals screened for lung cancer with untreated COPD and mild to severe coronary artery calcification who are not on guideline-recommended therapies.
Not a fit: Patients with a high suspicion of lung cancer or those already receiving appropriate therapies for COPD or cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved management of COPD and cardiovascular conditions in patients undergoing lung cancer screening.
How similar studies have performed: While this approach is innovative, similar studies integrating educational interventions in screening programs have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec
- McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Nicole Ezer, MD
- Email: nicole.ezer@mcgill.ca
- Phone: (514)-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.