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Recruiting NCT07331519

Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer

No phase Interventional Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone application, low-dose computed tomography, Written materials for smoking cessation.
Who it may be relevant to
Registry conditions: Smoking Cessation. Basic parameters: 50 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer - a Randomized Study

Overview

The study investigates effectiveness of different smoking cessation methods and low-dose CT based lung cancer screening

Detailed description

The study population consists of individuals aged 50-74 years with a significant smoking history who continue to smoke. The study design is a prospective and participants are randomized into three study arms: low-dose CT (LDCT) + smoking cessation with a smartphone application (arm 1), LDCT + smoking cessation with written materials (arm 2), smoking cessation with a smartphone application without LDCT (arm 3). The study compares effectiveness of smoking cessation methods, LDCT in lung cancer screening, lung cancer stage distribution, and lung cancer specific survival.

Interventions

  • Other Smartphone application
    Suunta smartphone application for smoking cessation
  • Other low-dose computed tomography
    Low-dose computed tomography based screening for lung cancer
  • Other Written materials for smoking cessation
    Written materials for smoking cessation

Primary outcome measures

  • Rate of smoking cessation [Time frame: three months]
Secondary outcome measures (7)
  • Rate of smoking cessation [Time frame: Three months]
  • Rate of smoking cessation [Time frame: 12 and 24 months]
  • Rate of long-term smoking cessation [Time frame: 12 and 24 moths]
  • LDCT findings [Time frame: baseline and 24 months]
  • Sensitivity and specificity of LDCT screening examination [Time frame: 24 months, 36 months, and 10 years]
  • Lung cancer incidence [Time frame: 24 months, 36 months, and 10 years]
  • Frequency of self-reported smoking cessation verified with CO measurement [Time frame: 24 months]

Eligibility criteria

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

  • 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
  • No access to a smartphone (iPhone or Android)
  • Participant is unwilling or unable to comply with treatment and trial instructions
  • Any condition that study investigators consider an impediment to safe trial participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 5 centers
  • Helsinki University Hospital — Helsinki
  • Oulu University Hospital — Oulu
  • Tampere University Hospital — Tampere
  • Turku University Hospital — Turku
  • Vaasa Central Hospital — Vaasa

Publications

  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
  • de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized T PMID 31995683
  • Iivanainen S, Kurtti A, Wichmann V, Andersen H, Jekunen A, Kaarteenaho R, Vasankari T, Koivunen JP. Smartphone application versus written material for smoking reduction and cessation in individuals undergoing low-dose computed tomography (LDCT) screening for lung cancer: a phase II open-label randomised controlled trial. Lancet Reg Health Eur. 2024 May 25;42:100946. doi: 10.1016/j.lanepe.2024.1009 PMID 39070744

Identifiers

NCT: NCT07331519 · EETMK 15/2025 · EETMK 15/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗