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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking cessation application | Experimental |
| |
| Written smoking cessation information | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation mobile application | Device | Mobile application for smoking cessation. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | Finland | ||||
| Vaasa Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39070744 | Derived | Iivanainen S, Kurtti A, Wichmann V, Andersen H, Jekunen A, Kaarteenaho R, Vasankari T, Koivunen JP. Smartphone application versus written material for smoking reduction and cessation in individuals undergoing low-dose computed tomography (LDCT) screening for lung cancer: a phase II open-label randomised controlled trial. Lancet Reg Health Eur. 2024 May 25;42:100946. doi: 10.1016/j.lanepe.2024.100946. eCollection 2024 Jul. |
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National legislation does not make it possible to share clinical data.
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| Written material for smoking cessation | Behavioral | Written material for smoking cessation |
|
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 |
| Vaasa |
| Finland |