LDCT-SC-FI Low-dose CT Screening for Lung Cancer
- Conditions
- Lung Cancer Screening
- Interventions
- Behavioral: Written material for smoking cessationDevice: Smoking cessation mobile application
- Registration Number
- NCT05630950
- Lead Sponsor
- Oulu University Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Written smoking cessation information Written material for smoking cessation - Smoking cessation application Smoking cessation mobile application -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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.
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.
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.
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.
Costs related to CT screening including additional investigations At 2 years The cumulative cost of diagnostic investigations per study subject.
Trial Locations
- Locations (2)
Oulu University Hospital
🇫🇮Oulu, Finland
Vaasa Central Hospital
🇫🇮Vaasa, Finland