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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01192256
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : August 4, 2022
Sponsor:
Collaborator:
Cardiff and Vale University Health Board
Information provided by (Responsible Party):
Dr Keir Lewis, Hywel Dda Health Board

Study Description
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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.


Condition or disease
Lung Cancer

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 Design
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Study Type : Observational
Actual Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.
Actual Study Start Date : March 2010
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Smoking

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Point prevalence of smoking at 0, 3, 6 12, 24 months [ Time Frame: 2 years ]
  4. Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers [ Time Frame: 2 years ]
  5. Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service [ Time Frame: 2 years ]
  6. Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed lung cancer
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192256


Locations
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United Kingdom
Llandough Hospital, Cardiff and Vale University Health Board
Cardiff, Wales, United Kingdom
Hywel Dda Health Board
Llanelli, Wales, United Kingdom, SA14 8QF
Sponsors and Collaborators
Dr Keir Lewis
Cardiff and Vale University Health Board
Investigators
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Principal Investigator: Keir E Lewis, MD Hywel Dda
More Information
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Publications of Results:

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Responsible Party: Dr Keir Lewis, Professor in Medicine and Consultant Chest Physician, Hywel Dda Health Board
ClinicalTrials.gov Identifier: NCT01192256    
Other Study ID Numbers: 09/WMW01/28
WS763986 ( Other Grant/Funding Number: GRAND Pfizer )
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Keywords provided by Dr Keir Lewis, Hywel Dda Health Board:
smoking
cessation
mortality
quality of life
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases