Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer - a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 5
- 主要终点
- Rate of smoking cessation
研究概览
简要总结
The study investigates effectiveness of different smoking cessation methods and low-dose CT based lung cancer screening
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Current or past melanoma, lung, renal or breast cancer
- •A chest CT examination less than one year before inclusion
- •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
研究组 & 干预措施
Arm 1
Smoking cessation with a smartphone application + LDCT lung cancer screening
干预措施: Smartphone application (Other)
Arm 1
Smoking cessation with a smartphone application + LDCT lung cancer screening
干预措施: low-dose computed tomography (Other)
Arm 2
Smoking cessation with written materials + LDCT lung cancer screening
干预措施: low-dose computed tomography (Other)
Arm 2
Smoking cessation with written materials + LDCT lung cancer screening
干预措施: Written materials for smoking cessation (Other)
Arm 3
Smoking cessation with a smartphone application without LDCT lung cancer screening
干预措施: Smartphone application (Other)
结局指标
主要结局
Rate of smoking cessation
时间窗: three months
The percentage of participants who have quitted smoking between the study arms 1 vs. 2
次要结局
- Rate of smoking cessation(12 and 24 months)
- LDCT findings(baseline and 24 months)
- Rate of long-term smoking cessation(12 and 24 moths)
- Sensitivity and specificity of LDCT screening examination(24 months, 36 months, and 10 years)
- Lung cancer incidence(24 months, 36 months, and 10 years)
- Frequency of self-reported smoking cessation verified with CO measurement(24 months)
- Rate of smoking cessation(Three months)