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

Oulu University Hospital1,200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,200

Conditions

Smoking Cessation

Interventions

Smartphone applicationOTHER

Suunta smartphone application for smoking cessation

low-dose computed tomographyOTHER

Low-dose computed tomography based screening for lung cancer

Written materials for smoking cessationOTHER

Written materials for smoking cessation

Eligibility

Sex: ALLMin age: 50 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (5)

Helsinki University Hospital

Helsinki, Finland

NOT_YET_RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Rate of smoking cessation

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

Time frame: three months

Secondary Outcomes

Rate of smoking cessation

The percentage of participants who have quitted smoking between all the study arms

Time frame: Three months

Rate of smoking cessation

The percentage of participants who have quitted smoking between all the study arms

Time frame: 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

Time frame: 12 and 24 moths

LDCT findings

The percentage of LDCT negative, indetermined, and positive findings by screening round

Time frame: 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)

Time frame: 24 months, 36 months, and 10 years

Lung cancer incidence

Lung cancer incidence (stage specific) (arms 1\&2 vs. 3)

Time frame: 24 months, 36 months, and 10 years

Frequency of self-reported smoking cessation verified with CO measurement

Central Contacts

Jussi P Koivunen, MD, PhD

CONTACT

+358504182666 jussi.koivunen@pohde.fi

Sanna Iivanainen, MD, PhD

CONTACT

+358504178347 sanna.iivanainen@pohde.fi

Data from ClinicalTrials.gov

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