Education Intervention for Lung Cancer Screening Compliance

(QLC+ Trial)

Overseen By Nicole Ezer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nicole Ezer, MD, FRCPC, MPH

Disqualifiers: Lung cancer suspicion, Atherosclerosis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

330 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it seems to focus on people who are not on certain recommended therapies, so you might not need to stop any current treatments.

What data supports the effectiveness of this treatment for improving lung cancer screening compliance?

Research shows that educational programs for conditions like COPD can improve how well doctors follow treatment guidelines and reduce hospital visits. This suggests that similar educational interventions might help improve compliance with lung cancer screening. ^{1 2 3 4 5}

Is the educational intervention for lung cancer screening compliance safe for humans?

The educational interventions, including those involving pharmacists and outreach for lung cancer screening, have been studied in various contexts like COPD and cardiovascular disease management. These studies focus on improving patient adherence and decision-making without reporting any safety concerns, suggesting that such educational interventions are generally safe for humans. ^{6 7 8 9 10}

How does the education intervention for lung cancer screening compliance differ from other treatments?

This treatment is unique because it focuses on educating patients to improve their compliance with lung cancer screening, rather than using medication or traditional therapies. It involves outreach and decision counseling to encourage patients to follow screening guidelines, which is different from standard medical treatments that typically involve drugs or procedures. ^{1 3 9 11 12}

What is the purpose of this 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

Eligibility Criteria

This trial is for individuals who have been screened for lung cancer and found to have mild to severe coronary artery calcification (CAC) without being on recommended lipid-lowering therapy, or diagnosed with symptomatic COPD not treated with first-line therapies. It's not suitable for those already on appropriate COPD treatment, without CAC, with known heart issues, diabetes, or a high suspicion of lung cancer.

Inclusion Criteria

I have COPD, experience symptoms, and am not on first-line treatment.

You have been screened for lung cancer using a low-dose CT scan of the chest as part of a specific project in Quebec.

I have mild to severe artery plaque and am not on cholesterol-lowering medication.

Exclusion Criteria

I don't have heart calcification, known heart disease, past heart surgery, or diabetes.

I am suspected to have lung cancer with a high-risk rating.

My COPD is either symptom-free or I am on the first line of treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Educational intervention for untreated COPD and cardiovascular disease integrated in an existing lung cancer screening program

12 months

Regular visits as per intervention protocol

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

Follow-up assessments at 6 and 12 months post intervention

Treatment Details

Interventions

• Educational material and treatment recommendations for patients, general practitioners and pharmacists

Trial Overview The study tests if providing educational materials and treatment recommendations can improve adherence to medication guidelines at 12 months in patients with untreated COPD and cardiovascular disease within a lung cancer screening program.

Participant Groups

Group I: Intervention Arm: CVD Experimental Treatment 1 Intervention

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

Group II: Intervention Arm: COPD Experimental Treatment 1 Intervention

Patients with untreated COPD or not on first line guideline recommended therapy.

Group III: Control Arm: CVD Active Control 1 Intervention

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

Group IV: Control Arm: COPD Active Control 1 Intervention

Patients with untreated COPD or not on first line guideline recommended therapy.

Who Is Running the Clinical Trial?

Nicole Ezer, MD, FRCPC, MPH

Lead Sponsor

Trials

2

Recruited

430+

Findings from Research

An educational program for general practitioners (GPs) in Denmark significantly improved adherence to COPD guidelines, with the registration of key patient metrics like FEV1 increasing from 45% to 69% and FEV1 % of predicted from 30% to 56%.

The program also enhanced the management of COPD, including better recording of smoking status and dyspnea severity, and reduced inappropriate use of inhaled corticosteroids in mild COPD patients, demonstrating that targeted education can lead to better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of COPD in general practice in Denmark--participating in an educational program substantially improves adherence to guidelines. Ulrik, CS., Hansen, EF., Jensen, MS., et al.[2021]

An educational program for general practitioners in Sicily improved the management of COPD, as evidenced by an increase in spirometry registrations from 59.7% to 73.0% over two years, compared to a national average of 64.8%.

The program also led to a decrease in COPD-related hospitalizations from 6.9% to 4.0% and all-cause hospitalizations from 23.0% to 18.9%, indicating enhanced patient care despite some quality indicators remaining unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in the management of chronic obstructive pulmonary disease following a clinical educational program: results from a prospective cohort study in the Sicilian general practice setting. Ferrara, R., Ientile, V., Piccinni, C., et al.[2019]

A study involving 293 COPD patients showed that despite improved skills of general practitioners in COPD management, patients' self-management skills did not significantly improve over time, indicating a need for ongoing education.

Patients' information needs about COPD remained high, particularly regarding diet, exercise, and self-management, with 57% reporting unchanged or increased needs after 18 months, suggesting that tailored patient education is crucial for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care patients with mild or stable chronic obstructive pulmonary disease need more support in disease management: a secondary analysis of a cluster randomized controlled trial. Sandelowsky, H., Krakau, I., Modin, S., et al.[2023]

A study of 941 and 927 COPD patient records over two audits in Denmark showed that the quality of care was initially suboptimal but improved significantly after staff participated in an educational program, with referrals to rehabilitation increasing from 56.3% to 62.7%.

Key assessments such as BMI and dyspnoea evaluation also saw dramatic improvements, with BMI assessment rising from 7.8% to 56.1% and dyspnoea assessment from 7.2% to 47.2%, indicating that systematic staff education can enhance adherence to COPD care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of COPD care in hospital outpatient clinics in Denmark: The KOLIBRI study. Lange, P., Andersen, KK., Munch, E., et al.[2009]

In a study of 1,078 COPD patients, only 40.4% had self-management plans, highlighting a significant gap in the implementation of recommended self-management support as per UK guidelines.

Patients with self-management plans were more likely to adhere to their medication, attend support groups, and have better knowledge about COPD, indicating that these plans are crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management behaviour and support among primary care COPD patients: cross-sectional analysis of data from the Birmingham Chronic Obstructive Pulmonary Disease Cohort. Khan, A., Dickens, AP., Adab, P., et al.[2022]

A multicenter study involving 390 COPD patients showed that a simple educational intervention significantly improved adherence to management recommendations for COPD and general health, with 53% of cases showing progress after 6 months.

While the intervention was effective in enhancing overall management, it had limited impact on specific cardiovascular comorbidities, particularly ischemic heart disease and coronary artery disease, indicating a need for more targeted strategies in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a simple intervention on management of acute exacerbations of chronic obstructive pulmonary disease and its cardiovascular comorbidities: COREPOC study. Díez-Manglano, J., Recio Iglesias, J., Varela Aguilar, JM., et al.[2018]

A pharmacist-led intervention for patients with chronic obstructive pulmonary disease (COPD) aims to improve medication adherence and inhaler technique, potentially enhancing health-related quality of life and reducing healthcare resource use.

This study, involving community pharmacies in Newfoundland and Labrador, will measure the effectiveness of the intervention over 6 months, focusing on changes in medication adherence and quality of life, indicating a promising approach to managing COPD in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial. Davis, E., Marra, C., Gamble, JM., et al.[2023]

A 1-month study involving 181 COPD patients showed that pharmacist-led educational interventions significantly improved medication adherence rates from 66.3% to 90.1% (p < 0.001).

In addition to enhancing adherence, the intervention also led to improvements in patients' knowledge about their disease and medication, as well as better dyspnea scores and inhalation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of clinical pharmacist intervention on medication adherence in patients with chronic obstructive pulmonary disease - A randomized controlled study. Nguyen, T., Truong, MTX., Lam, DN., et al.[2023]

A randomized controlled trial involving 3,376 patients showed that outreach contact combined with decision counseling significantly increased lung cancer screening rates to 5.5% compared to 1.8% in usual care, indicating effective strategies to boost screening participation.

While the combination of outreach and decision counseling led to higher screening rates than outreach alone (7% vs. 4%), the difference was not statistically significant, suggesting that further research is needed to fully understand the impact of shared decision-making on screening uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outreach to primary care patients in lung cancer screening: A randomized controlled trial. DiCarlo, M., Myers, P., Daskalakis, C., et al.[2022]

The Global Initiative for Chronic Obstructive Lung Disease Report emphasizes the importance of proper management and prevention strategies for COPD, particularly in older adults who are most affected by this condition.

Pharmacists play a crucial role in improving COPD management by providing counseling on medication selection, educating patients about the disease, ensuring adherence to treatment, and teaching proper inhaler techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Obstructive Pulmonary Disease, Part 2: A Review of Pharmacotherapy Options. Naberhaus, T.[2023]

A study involving 18 general practices in Poland will evaluate a tailored implementation strategy aimed at improving general practitioners' adherence to COPD management guidelines, focusing on four key recommendations.

The trial will compare the effectiveness of these tailored interventions against usual care over a nine-month period, with the primary outcome being adherence to recommendations such as smoking cessation advice and proper inhaler use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial. Godycki-Cwirko, M., Zakowska, I., Kosiek, K., et al.[2021]

In a study of 156 patients, only 30% were compliant with their prescribed pulmonary medication, indicating a significant issue with adherence in general practice settings.

Patients who understood their prescription as requiring regular medication were more likely to comply, suggesting that improving patient education about medication regimens could enhance compliance rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with pulmonary medication in general practice. Dekker, FW., Dieleman, FE., Kaptein, AA., et al.[2013]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Management of COPD in general practice in Denmark--participating in an educational program substantially improves adherence to guidelines. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Improvement in the management of chronic obstructive pulmonary disease following a clinical educational program: results from a prospective cohort study in the Sicilian general practice setting. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Primary care patients with mild or stable chronic obstructive pulmonary disease need more support in disease management: a secondary analysis of a cluster randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Quality of COPD care in hospital outpatient clinics in Denmark: The KOLIBRI study. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Self-management behaviour and support among primary care COPD patients: cross-sectional analysis of data from the Birmingham Chronic Obstructive Pulmonary Disease Cohort. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Effectiveness of a simple intervention on management of acute exacerbations of chronic obstructive pulmonary disease and its cardiovascular comorbidities: COREPOC study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of clinical pharmacist intervention on medication adherence in patients with chronic obstructive pulmonary disease - A randomized controlled study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Outreach to primary care patients in lung cancer screening: A randomized controlled trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Chronic Obstructive Pulmonary Disease, Part 2: A Review of Pharmacotherapy Options. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Compliance with pulmonary medication in general practice. [2013]