Lung Cancer Screening
Conditions
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).
Interventions
DEVICESmoking cessation mobile application
Mobile application for smoking cessation.
BEHAVIORALWritten material for smoking cessation
Written material for smoking cessation
Sponsors
Oulu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of active smokers at 3 months | 3 months | The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The reduction in number of smoked cigarettes/d at 3 months | 3 months | Magnitude of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms. |
| Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months | 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 |
| Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months | 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 |
| Sensitivity of CT screening in the whole cohort | At 2 years | The amount of true positive CT scans for lung cancer compared to false negative CT scans for lung cancer. |
| The percentage of reduction in number of smoked cigarettes/d at 3 months | 3 months | Percentage of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms. |
| The percentage of reduction in number of smoked cigarettes/d at 6 months | 6 months | Percentage of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms. |
| Costs related to CT screening including additional investigations | At 2 years | The cumulative cost of diagnostic investigations per study subject. |
| The reduction in number of smoked cigarettes/d at 6 months | 6 months | Magnitude of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms. |
Countries
Finland
Outcome results
None listed