Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
smoking, cessation, mortality, quality of life
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Physician Advice Type: Behavioral
Name: Intensive quit smoking support Type: Behavioral
Overall Status
Recruiting
Summary
A large project consisting of:

1. 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.

2. 400 smokers with lung cancer who express a desire to quit, will be offered entry in a randomised trial. Here they will receive either standardized physician advice or intensive specialist support to quit smoking. eCO, survival, quality of life, cancer progression and treatment complications will be compared in both groups. The cost-effectiveness of the 2 quit-smoking strategies will also be estimated.
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
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.
Locations
Llandough Hospital, Cardiff and Vale University Health Board
Cardiff, Wales, United Kingdom
Status: Recruiting
Contact: Diane Parry, FRCP - +44 2920 747747 - diane.parry@wales.nhs.uk
Hywel Dda Health Board
Llanelli, Wales, United Kingdom
Status: Recruiting
Contact: Keir E Lewis, MD - +44 1554783133 - k.e.lewis@swansea.ac.uk
Start Date
March 2010
Completion Date
March 2016
Sponsors
Dr Keir Lewis
Source
Hywel Dda Health Board
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page