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Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study Alongside a Randomised Trial of Different Smoking Cessation Interventions.


N/A
18 Years
90 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study Alongside a Randomised Trial of Different Smoking Cessation Interventions.


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 consists of two simultaneous studies:

1. 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.

2. A pilot controlled trial (RCT) where proven (eCO>10 ppm or self reported) smokers
receiving a diagnosis of lung cancer will be randomised to receive either standardized
physician-initiated advice to stop smoking or a referral to our specialist
hospital-based smoking cessation service.

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 trial 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Keir E Lewis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hywel Dda

Authority:

United Kingdom: National Health Service

Study ID:

09/WMW01/28

NCT ID:

NCT01192256

Start Date:

March 2010

Completion Date:

March 2015

Related Keywords:

  • Lung Cancer
  • smoking
  • cessation
  • mortality
  • quality of life
  • Lung Neoplasms
  • Smoking

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