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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Hywel Dda Health Board
Sponsor:
Collaborator:
Cardiff and Vale University Health Board
Information provided by (Responsible Party):
Dr Keir Lewis, Hywel Dda Health Board
ClinicalTrials.gov Identifier:
NCT01192256
First received: August 27, 2010
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.

Condition Intervention
Lung Cancer
Behavioral: Physician Advice
Behavioral: Intensive quit smoking support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study Alongside a Randomised Trial of Different Smoking Cessation Interventions.

Resource links provided by NLM:


Further study details as provided by Hywel Dda Health Board:

Primary Outcome Measures:
  • Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Point prevalence of smoking at 0, 3, 6 12, 24 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: March 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physician Advice to quit Behavioral: Physician Advice
5 minutes advice, reading from a script based on the 5 'A's approach to smoking cessation and offered pharmacotherapy
Experimental: Intensive quit smoking support Behavioral: Intensive quit smoking support
Support by a hospital smoking cessation specialist and pharmacotherapy as per local stop-smoking and British Thoracic Society protocols

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192256

Contacts
Contact: Rachel E Roberts, BSc 44 1554756567 ext 3569 r.e.roberts@swansea.ac.uk
Contact: Keir Lewis, MD FRCP +44 1554783133 k.e.lewis@swansea.ac.uk

Locations
United Kingdom
Llandough Hospital, Cardiff and Vale University Health Board Recruiting
Cardiff, Wales, United Kingdom
Contact: Diane Parry, FRCP    +44 2920 747747    diane.parry@wales.nhs.uk   
Contact: Tamsin Rees       tamsin.rees@wales.nhs.uk   
Sub-Investigator: Ian Campbell, FRCP         
Sub-Investigator: Tamsin Rees, BSc         
Sub-Investigator: Helen Davies, MRCP         
Hywel Dda Health Board Recruiting
Llanelli, Wales, United Kingdom, SA14 8QF
Contact: Keir E Lewis, MD    +44 1554783133    k.e.lewis@swansea.ac.uk   
Contact: Chris Tattersall, BSc       chris.tattersal@wales.nhs.uk   
Sub-Investigator: Gareth Collier, MRCP         
Principal Investigator: Rachel Roberts, BSc         
Sponsors and Collaborators
Dr Keir Lewis
Cardiff and Vale University Health Board
Investigators
Principal Investigator: Keir E Lewis, MD Hywel Dda
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Keir Lewis, Reader in Medicine and Consultant Chest Physician, Hywel Dda Health Board
ClinicalTrials.gov Identifier: NCT01192256     History of Changes
Other Study ID Numbers: 09/WMW01/28, WS763986
Study First Received: August 27, 2010
Last Updated: August 27, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Hywel Dda Health Board:
smoking
cessation
mortality
quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014