Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer (ISC-LDCT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Smartphone application; Other: low-dose computed tomography; Other: Written materials for smoking cessation

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jussi P Koivunen, MD, PhD; Phone Number: +358504182666; Email: jussi.koivunen@pohde.fi
• Study Contact Backup: Name: Sanna Iivanainen, MD, PhD; Phone Number: +358504178347; Email: sanna.iivanainen@pohde.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Not yet recruiting
    • Helsinki University Hospital
    • Contact: Ilkka Ilonen, MD, PhD; Phone Number: +358504272280; Email: ilkka.ilonen@hus.fi
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Jussi P Koivunen, MD, PhD; Phone Number: +358504182666
  • Tampere, Finland
    • Not yet recruiting
    • Tampere University Hospital
    • Contact: Hannele Hasala, MD, PhD; Phone Number: +358444735254; Email: hannele.hasala@pirha.fi
  • Turku, Finland
    • Not yet recruiting
    • Turku University Hospital
    • Contact: Maria Silvoniemi, MD, PhD; Phone Number: +35823138709
  • Vaasa, Finland
    • Not yet recruiting
    • Vaasa Central Hospital
    • Contact: Heidi Andersen, MD, PhD; Phone Number: +358401763563; Email: heidi.andersen@ovph.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Smoking cessation with a smartphone application + LDCT lung cancer screening	Other: Smartphone application; Suunta smartphone application for smoking cessation; Other: low-dose computed tomography; Low-dose computed tomography based screening for lung cancer
Active Comparator: Arm 2; Smoking cessation with written materials + LDCT lung cancer screening	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
Active Comparator: Arm 3; Smoking cessation with a smartphone application without LDCT lung cancer screening	Other: Smartphone application; Suunta smartphone application for smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of smoking cessation	The percentage of participants who have quitted smoking between the study arms 1 vs. 2	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of smoking cessation	The percentage of participants who have quitted smoking between all the study arms	Three months
Rate of smoking cessation	The percentage of participants who have quitted smoking between all the study arms	12 and 24 months
Rate of long-term smoking cessation	The percentage of participants who have had abstinence of smoking for at least six months	12 and 24 moths
LDCT findings	The percentage of LDCT negative, indetermined, and positive findings by screening round	baseline and 24 months
Sensitivity and specificity of LDCT screening examination	Sensitivity and specificity of LDCT screening examination for lung cancer detection (arms 1&2 vs. 3)	24 months, 36 months, and 10 years
Lung cancer incidence	Lung cancer incidence (stage specific) (arms 1&2 vs. 3)	24 months, 36 months, and 10 years
Frequency of self-reported smoking cessation verified with CO measurement	Frequency of self-reported smoking cessation verified with CO measurement	24 months

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Finnish Cancer Society
• Investigators: Study Director: Tytti Särkeälä, PhD, Finnish Cancer Society

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2036

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; smoking cessation; lung cancer screening; low-dose CT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Behavior; Health Behavior; Lung Neoplasms; Smoking Cessation
• Other Study ID Numbers: EETMK 15/2025 (Other Identifier: Ethics Committee of the Wellbeing Services County of North Ostrobothnia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in this article will be shared.
• IPD Sharing Time Frame: The data will be available beginning 6 months after publication and ending 3 years thereafter.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No