LDCT-SC-FI Low-dose CT Screening for Lung Cancer

Study Overview
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Brief Summary
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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).

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

Conditions
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Lung Cancer Screening

Intervention / Treatment
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* Device: Smoking cessation mobile application
* Behavioral: Written material for smoking cessation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking cessation application<br> | Device: Smoking cessation mobile application<br>* Mobile application for smoking cessation.<br>|
| Active Comparator: Written smoking cessation information<br> | Behavioral: Written material for smoking cessation<br>* Written material for smoking cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of active smokers at 3 months | The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months | The percentage of subjects who have reduced the amount of smoked cigrattes/d at 3 months after inclusion compared to between the study arms | 3 months | 
| Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months | The percentage of subjects who have reduced the amount of smoked cigrattes/d at 6 months after inclusion compared to baseline between the study arms | 6 months | 
| The reduction in number of smoked cigarettes/d at 3 months | Magnitude of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms. | 3 months | 
| The reduction in number of smoked cigarettes/d at 6 months | Magnitude of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms. | 6 months | 
| The percentage of reduction in number of smoked cigarettes/d at 3 months | Percentage of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms. | 3 months | 
| The percentage of reduction in number of smoked cigarettes/d at 6 months | Percentage of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms. | 6 months | 
| Sensitivity of CT screening in the whole cohort | The amount of true positive CT scans for lung cancer compared to false negative CT scans for lung cancer. | At 2 years | 
| Costs related to CT screening including additional investigations | The cumulative cost of diagnostic investigations per study subject. | At 2 years |