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

O

Oulu University Hospital

Status

Active, not recruiting

Conditions

Lung Cancer Screening

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05630950
EETTKM 21/2022

Details and patient eligibility

About

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).

Enrollment

200 estimated patients

Sex

All

Ages

50 to 74 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Smoking cessation application
Experimental group
Treatment:
Device: Smoking cessation mobile application
Written smoking cessation information
Active Comparator group
Treatment:
Behavioral: Written material for smoking cessation

Trial contacts and locations

2

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Central trial contact

Jussi Pekka Koivunen, Md PhD; Sanna Iivanainen, MD PhD

Data sourced from clinicaltrials.gov

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