Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,400
- 试验地点
- 2
- 主要终点
- Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.
研究概览
简要总结
A large project consisting of:
a) an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.
详细描述
Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications but prospective well-designed studies are lacking.
This project is an observational cohort study recording outcomes in smokers, never-smokers, and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for further lung cancer clinics.
This project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test, and those enrolled in the smoking cessation treatments or not will also complete a generic quality of life questionnaire at regular intervals. These appointments will coincide with other hospital appointments wherever possible, and survival status will reported up to 24 months after enrolment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of lung cancer
排除标准
- •refusal Consent
- •inability to provide exhaled CO
- •active psychiatric illness or substance misuse
- •concurrent malignancies of another type other than non-melanoma skin cancer
- •unable to travel for sessions with smoking cessation counsellor and / or outpatient visits from outset
- •WHO performance status 4
- •Life expectancy less than 6 weeks.
结局指标
主要结局
Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.
时间窗: 24 months
次要结局
- Point prevalence of smoking at 0, 3, 6 12, 24 months(2 years)
- Median survival and 2-year survival rates by smoking status for early (Stage I/II NSCLC) versus those with advanced (Stage III/IV) NSCLC.(24 months)
- Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service(2 years)
- Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers(2 years)
- Number of treatment complications in smokers versus non-smokers (frequency surgical wound complications, radiotherapy induced pneumonitis and median total radiation (Gy) dose; frequency and duration of neutropenic sepses(2 years)
- Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers(2 years)
研究者
Dr Keir Lewis
Professor in Medicine and Consultant Chest Physician
Hywel Dda Health Board