NCT05630950进行中（未招募）不适用
Low-dose CT Screening for Lung Cancer Combined to Different Smoking Cessation Methods in Finland
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of active smokers at 3 months
研究概览
简要总结
This is a randomized phase II trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose CT (LDCT). The study also evaluates feasibility and outcomes of LDCT screening and potential biomarkers and AI-based evaluation on CT-scans. The study subjects fulfilling I/E-criteria are randomized in 1:1 fashion to yearly LDCT for two rounds with standard smoking cessation (control) or same LDCT approach combined to mobile application based smoking cessation (intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
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
- •A moderate or bad self-reported health; e.g. unable to climb two flights of stairs
- •Body weight ≥ 140 kilogram
- •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
- •Subject is unwilling or unable to comply with treatment and trial instructions
- •Any condition that study investigators consider an impediment to safe trial participation
结局指标
主要结局
Number of active smokers at 3 months
时间窗: 3 months
The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms
次要结局
- The percentage of reduction in number of smoked cigarettes/d at 3 months(3 months)
- Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months(3 months)
- Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months(6 months)
- The reduction in number of smoked cigarettes/d at 3 months(3 months)
- The reduction in number of smoked cigarettes/d at 6 months(6 months)
- The percentage of reduction in number of smoked cigarettes/d at 6 months(6 months)
- Sensitivity of CT screening in the whole cohort(At 2 years)
- Costs related to CT screening including additional investigations(At 2 years)
研究者
Jussi Koivunen
MD PhD
Oulu University Hospital
研究点 (2)
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