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NCT Number: NCT01192256

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

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.

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Key information

Conditions

Lung Cancer Behavior Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Llandough Hospital, Cardiff and Vale University Health Board, Cardiff, Wales, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr Keir Lewis

Other

Collaborators

  • Cardiff and Vale University Health Board

Registry information

Official study title

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

Acronym: LungCast

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2010
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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