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

NCT ID: NCT07331519

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2036-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Smoking cessation with a smartphone application + LDCT lung cancer screening

Group Type EXPERIMENTAL

Smartphone application

Intervention Type OTHER

Suunta smartphone application for smoking cessation

low-dose computed tomography

Intervention Type OTHER

Low-dose computed tomography based screening for lung cancer

Arm 2

Smoking cessation with written materials + LDCT lung cancer screening

Group Type ACTIVE_COMPARATOR

low-dose computed tomography

Intervention Type OTHER

Low-dose computed tomography based screening for lung cancer

Written materials for smoking cessation

Intervention Type OTHER

Written materials for smoking cessation

Arm 3

Smoking cessation with a smartphone application without LDCT lung cancer screening

Group Type ACTIVE_COMPARATOR

Smartphone application

Intervention Type OTHER

Suunta smartphone application for smoking cessation

Interventions

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Smartphone application

Suunta smartphone application for smoking cessation

Intervention Type OTHER

low-dose computed tomography

Low-dose computed tomography based screening for lung cancer

Intervention Type OTHER

Written materials for smoking cessation

Written materials for smoking cessation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Able to provide written informed consent
2. Age between 50-74
3. 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)
4. Access to a smartphone (iPhone or Android)

Exclusion Criteria

1. Current or past melanoma, lung, renal or breast cancer
2. A chest CT examination less than one year before inclusion
3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
4. No access to a smartphone (iPhone or Android)
5. Participant is unwilling or unable to comply with treatment and trial instructions
6. Any condition that study investigators consider an impediment to safe trial participation
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Cancer Society

UNKNOWN

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tytti Särkeälä, PhD

Role: STUDY_DIRECTOR

Finnish Cancer Society

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status NOT_YET_RECRUITING

Oulu University Hospital

Oulu, , Finland

Site Status RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status NOT_YET_RECRUITING

Turku University Hospital

Turku, , Finland

Site Status NOT_YET_RECRUITING

Vaasa Central Hospital

Vaasa, , Finland

Site Status NOT_YET_RECRUITING

Countries

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Finland

Central Contacts

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Jussi P Koivunen, MD, PhD

Role: CONTACT

+358504182666

Sanna Iivanainen, MD, PhD

Role: CONTACT

+358504178347

Facility Contacts

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Ilkka Ilonen, MD, PhD

Role: primary

+358504272280

Jussi P Koivunen, MD, PhD

Role: primary

+358504182666

Hannele Hasala, MD, PhD

Role: primary

+358444735254

Maria Silvoniemi, MD, PhD

Role: primary

+35823138709

Heidi Andersen, MD, PhD

Role: primary

+358401763563

References

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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.

Reference Type RESULT
PMID: 21714641 (View on PubMed)

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.

Reference Type RESULT
PMID: 31995683 (View on PubMed)

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.

Reference Type RESULT
PMID: 39070744 (View on PubMed)

Other Identifiers

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EETMK 15/2025

Identifier Type: OTHER

Identifier Source: secondary_id

EETMK 15/2025

Identifier Type: -

Identifier Source: org_study_id

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