Smoking Cessation
Conditions
Keywords
smoking cessation, lung cancer, low-dose CT, lung cancer screening
Brief summary
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
OTHERSmartphone application
Suunta smartphone application for smoking cessation
Low-dose computed tomography based screening for lung cancer
OTHERWritten materials for smoking cessation
Written materials for smoking cessation
Sponsors
Oulu University Hospital
Finnish Cancer Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of smoking cessation | three months | The percentage of participants who have quitted smoking between the study arms 1 vs. 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of smoking cessation | Three months | The percentage of participants who have quitted smoking between all the study arms |
| Rate of long-term smoking cessation | 12 and 24 moths | The percentage of participants who have had abstinence of smoking for at least six months |
| LDCT findings | baseline and 24 months | The percentage of LDCT negative, indetermined, and positive findings by screening round |
| Sensitivity and specificity of LDCT screening examination | 24 months, 36 months, and 10 years | Sensitivity and specificity of LDCT screening examination for lung cancer detection (arms 1\&2 vs. 3) |
| Lung cancer incidence | 24 months, 36 months, and 10 years | Lung cancer incidence (stage specific) (arms 1\&2 vs. 3) |
| Frequency of self-reported smoking cessation verified with CO measurement | 24 months | Frequency of self-reported smoking cessation verified with CO measurement |
Countries
Finland
Contacts
CONTACTJussi P Koivunen, MD, PhD
CONTACTSanna Iivanainen, MD, PhD
STUDY_DIRECTORTytti Särkeälä, PhD
Finnish Cancer Society
Outcome results
None listed