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

N/AActive Not RecruitingNCT05630950

Oulu University Hospital200 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Lung Cancer Screening

Interventions

Smoking cessation mobile applicationDEVICE

Mobile application for smoking cessation.

Written material for smoking cessationBEHAVIORAL

Written material for smoking cessation

Eligibility

Sex: ALLMin age: 50 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Oulu University Hospital

Oulu, Finland

Vaasa Central Hospital

Vaasa, Finland

Outcomes

Primary Outcomes

Number of active smokers at 3 months

The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms

Time frame: 3 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 months

The percentage of reduction in number of smoked cigarettes/d at 6 months

Data from ClinicalTrials.gov

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