Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer
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Purpose
A large project consisting of:
- 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.
- 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. |
- 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 ]
- 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 2015 |
| Estimated Primary Completion Date: | March 2013 (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:
- 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.
- 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 |
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| 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 |
| 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 | |
| Principal Investigator: | Keir E Lewis, MD | Hywel Dda |
More Information
Additional Information:
No publications provided
| Responsible Party: | Keir Lewis, Hywel Dda Health Board and Swansea University |
| ClinicalTrials.gov Identifier: | NCT01192256 History of Changes |
| Other Study ID Numbers: | 09/WMW01/28, WS763986 |
| Study First Received: | August 27, 2010 |
| Last Updated: | June 24, 2011 |
| 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 Smoking Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Habits |
ClinicalTrials.gov processed this record on June 13, 2013