Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT01192256
- Lead Sponsor
- Dr Keir Lewis
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2400
- clinical diagnosis of lung cancer
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer. 24 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Llandough Hospital, Cardiff and Vale University Health Board
🇬🇧Cardiff, Wales, United Kingdom
Hywel Dda Health Board
🇬🇧Llanelli, Wales, United Kingdom