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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05630950
Other study ID # EETTKM 21/2022
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 18, 2022
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source Oulu University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 74 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Smoking cessation mobile application
Mobile application for smoking cessation.
Behavioral:
Written material for smoking cessation
Written material for smoking cessation

Locations

Country Name City State
Finland Oulu University Hospital Oulu
Finland Vaasa Central Hospital Vaasa

Sponsors (1)

Lead Sponsor Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Costs related to CT screening including additional investigations The cumulative cost of diagnostic investigations per study subject. At 2 years
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