Low-dose CT Screening for Lung Cancer Combined to Different Smoking Cessation Methods in Finland

Oulu University Hospital2 sites in 1 country200 target enrollmentNovember 18, 2022

ConditionsLung Cancer Screening

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lung Cancer Screening
Sponsor: Oulu University Hospital
Enrollment: 200
Locations: 2
Primary Endpoint: Number of active smokers at 3 months
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized phase II trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose CT (LDCT). The study also evaluates feasibility and outcomes of LDCT screening and potential biomarkers and AI-based evaluation on CT-scans. The study subjects fulfilling I/E-criteria are randomized in 1:1 fashion to yearly LDCT for two rounds with standard smoking cessation (control) or same LDCT approach combined to mobile application based smoking cessation (intervention).

Registry

clinicaltrials.gov

Start Date

November 18, 2022

End Date

December 31, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oulu University Hospital

Responsible Party

Principal Investigator

Jussi Koivunen

MD PhD

Oulu University Hospital

Eligibility Criteria

Inclusion Criteria

•Able to provide written informed consent
•Age between 50-74
•Smoked ≥ 15 cigarettes/day for ≥ 25 years or smoked ≥ 10 cigarettes/day for ≥ 30 years and are active smokers (smoking during the last two weeks)
•Access to a smartphone (iPhone or Android)

Exclusion Criteria

•A moderate or bad self-reported health; e.g. unable to climb two flights of stairs
•Body weight ≥ 140 kilogram
•Current or past melanoma, lung, renal or breast cancer
•A chest CT examination less than one year before inclusion
•Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
•Subject is unwilling or unable to comply with treatment and trial instructions
•Any condition that study investigators consider an impediment to safe trial participation

Outcomes

Primary Outcomes

Number of active smokers at 3 months

Time Frame: 3 months

The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms

Secondary Outcomes

The percentage of reduction in number of smoked cigarettes/d at 3 months(3 months)
Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months(3 months)
Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months(6 months)
The reduction in number of smoked cigarettes/d at 3 months(3 months)
The reduction in number of smoked cigarettes/d at 6 months(6 months)
The percentage of reduction in number of smoked cigarettes/d at 6 months(6 months)
Sensitivity of CT screening in the whole cohort(At 2 years)
Costs related to CT screening including additional investigations(At 2 years)