Clinical trial NCT01192256: Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer
Official title: Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: smoking
cessation
mortality
quality of life
Lead sponsor: Hywel Dda Health Board
Sponsor class: OTHER
Collaborators: name: Cardiff and Vale University Health Board
First posted: 2010-09-01
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed lung cancer

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.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of lung cancer

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.
timeFrame: 24 months
Secondary outcomes:
measure: Median survival and 2-year survival rates by smoking status for early (Stage I/II NSCLC) versus those with advanced (Stage III/IV) NSCLC.
timeFrame: 24 months
measure: 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
timeFrame: 2 years
measure: Point prevalence of smoking at 0, 3, 6 12, 24 months
timeFrame: 2 years
measure: Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers
timeFrame: 2 years
measure: Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service
timeFrame: 2 years
measure: Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers
timeFrame: 2 years
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Llandough Hospital, Cardiff and Vale University Health Board
state: Wales
city: Llanelli
country: United Kingdom
facility: Hywel Dda Health Board
state: Wales
Study officials:
affiliation: Hywel Dda
name: Keir E Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gemine RE, Ghosal R, Collier G, Parry D, Campbell I, Davies G, Davies K, Lewis KE; LungCast Investigators. Longitudinal study to assess impact of smoking at diagnosis and quitting on 1-year survival for people with non-small cell lung cancer. Lung Cancer. 2019 Mar;129:1-7. doi: 10.1016/j.lungcan.2018.12.028. Epub 2018 Dec 28.