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

NCT07331519 | Recruiting

• 1 other identifier: EETMK 15/2025
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Smoking Cessation

Keywords

smoking cessation; lung cancer; low-dose CT; lung cancer screening

Outcome Measures

Primary Outcomes (1)

• Rate of smoking cessation

  The percentage of participants who have quitted smoking between the study arms 1 vs. 2

  three months

Secondary Outcomes (7)

• Rate of smoking cessation

  Three months

• Rate of smoking cessation

  12 and 24 months

• Rate of long-term smoking cessation

  12 and 24 moths

• LDCT findings

  baseline and 24 months

• Sensitivity and specificity of LDCT screening examination

  24 months, 36 months, and 10 years

Study Arms (3)

Arm 1

EXPERIMENTAL

Smoking cessation with a smartphone application + LDCT lung cancer screening

Other: Smartphone application; Other: low-dose computed tomography

Arm 2

ACTIVE COMPARATOR

Smoking cessation with written materials + LDCT lung cancer screening

Other: low-dose computed tomography; Other: Written materials for smoking cessation

Arm 3

ACTIVE COMPARATOR

Smoking cessation with a smartphone application without LDCT lung cancer screening

Other: Smartphone application

Interventions

Smartphone application OTHER

Suunta smartphone application for smoking cessation

Arm 1; Arm 3

low-dose computed tomography OTHER

Low-dose computed tomography based screening for lung cancer

Arm 1; Arm 2

Written materials for smoking cessation OTHER

Written materials for smoking cessation

Arm 2

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Current or past melanoma, lung, renal or breast cancer
• 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

Sponsors & Collaborators

• Oulu University Hospital: lead
• Finnish Cancer Society: collaborator

Study Sites (5)

Helsinki University Hospital

Helsinki, Finland

NOT YET RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

Vaasa Central Hospital

Vaasa, Finland

NOT YET RECRUITING

Related Publications (3)

• 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 RESULT

• 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 Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.

  PMID: 31995683 RESULT

• 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.2024.100946. eCollection 2024 Jul.

  PMID: 39070744 RESULT

MeSH Terms

Conditions

Smoking Cessation; Lung Neoplasms

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tytti Särkeälä, PhD

  Finnish Cancer Society

  STUDY DIRECTOR

Central Study Contacts

Jussi P Koivunen, MD, PhD

CONTACT

+358504182666; jussi.koivunen@pohde.fi

Sanna Iivanainen, MD, PhD

CONTACT

+358504178347; sanna.iivanainen@pohde.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 12, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2036
• Last Updated: February 6, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available beginning 6 months after publication and ending 3 years thereafter.
• Access Criteria: Data will be shared with qualified researchers who submit a methodologically sound proposal for analyses that align with the original study aims. Proposals should be submitted to the corresponding author. Access will require a data use agreement.

Locations

FI (5)