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

• ClinicalTrials.gov Identifier: NCT01192256
• Recruitment Status: Completed
• First Posted: September 1, 2010
• Last Update Posted: August 4, 2022
• Sponsor: Dr Keir Lewis
• Collaborator: Cardiff and Vale University Health Board
• Information provided by (Responsible Party): Dr Keir Lewis, Hywel Dda Health Board

Tracking Information

• First Submitted Date: August 27, 2010
• First Posted Date: September 1, 2010
• Last Update Posted Date: August 4, 2022
• Actual Study Start Date: March 2010
• Actual Primary Completion Date: March 15, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 31, 2010): Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer. [ Time Frame: 24 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2010)

• Median survival and 2-year survival rates by smoking status for early (Stage I/II NSCLC) versus those with advanced (Stage III/IV) NSCLC. [ Time Frame: 24 months ]
• 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 [ Time Frame: 2 years ]
• Point prevalence of smoking at 0, 3, 6 12, 24 months [ Time Frame: 2 years ]
• Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers [ Time Frame: 2 years ]
• Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service [ Time Frame: 2 years ]
• Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers [ Time Frame: 2 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with newly diagnosed lung cancer
• Condition: Lung Cancer
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 18, 2016): 2400
• Original Estimated Enrollment (submitted: August 31, 2010): 1400
• Actual Study Completion Date: March 15, 2021
• Actual Primary Completion Date: March 15, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01192256
• Other Study ID Numbers: 09/WMW01/28; WS763986 ( Other Grant/Funding Number: GRAND Pfizer )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr Keir Lewis, Hywel Dda Health Board
• Original Responsible Party: Keir Lewis, Hywel Dda Health Board and Swansea University
• Current Study Sponsor: Dr Keir Lewis
• Original Study Sponsor: Hywel Dda Health Board
• Collaborators: Cardiff and Vale University Health Board

Investigators

• Principal Investigator: Keir E Lewis, MD; Hywel Dda

• PRS Account: Hywel Dda Health Board
• Verification Date: August 2022