Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer

Lung Cancer Clinical Trial

— LungCast  

Official title:

Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192256
• Other study ID #: 09/WMW01/28
• Secondary ID: WS763986
• Status: Completed
• Start date: March 2010
• Est. completion date: March 15, 2021

Study information

• Verified date: August 2022
• Source: Hywel Dda Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United Kingdom	Llandough Hospital, Cardiff and Vale University Health Board	Cardiff	Wales
United Kingdom	Hywel Dda Health Board	Llanelli	Wales

Sponsors (2)

Lead Sponsor	Collaborator
Dr Keir Lewis	Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.		24 months
Secondary	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
Secondary	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
Secondary	Point prevalence of smoking at 0, 3, 6 12, 24 months		2 years
Secondary	Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers		2 years
Secondary	Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service		2 years
Secondary	Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers		2 years