Using a genetic/clinical risk score to stop smoking (GeTSS): randomised controlled trial.

BACKGROUND: As genetic tests become cheaper, the possibility of their widespread availability must be considered. This study involves a risk score for lung cancer in smokers that is roughly 50% genetic (50% clinical criteria). The risk score has been shown to be effective as a smoking cessation motivator in hospital recruited subjects (not actively seeking cessation services). METHODS: This was an RCT set in a United Kingdom National Health Service (NHS) smoking cessation clinic. Smokers were identified from medical records. Subjects that wanted to participate were randomised to a test group that was administered a gene-based risk test and given a lung cancer risk score, or a control group where no risk score was performed. Each group had 8 weeks of weekly smoking cessation sessions involving group therapy and advice on smoking cessation pharmacotherapy and follow-up at 6 months. The primary endpoint was smoking cessation at 6 months. Secondary outcomes included ranking of the risk score and other motivators. RESULTS: 67 subjects attended the smoking cessation clinic. The 6 months quit rates were 29.4%, (10/34; 95% CI 14.1-44.7%) for the test group and 42.9% (12/28; 95% CI 24.6-61.2%) for the controls. The difference is not significant. However, the quit rate for test group subjects with a "very high" risk score was 89% (8/9; 95% CI 68.4-100%) which was significant when compared with the control group (p = 0.023) and test group subjects with moderate risk scores had a 9.5% quit rate (2/21; 95% CI 2.7-28.9%) which was significantly lower than for above moderate risk score 61.5% (8/13; 95% CI 35.5-82.3; p = 0.03). CONCLUSIONS: Only the sub-group with the highest risk score showed an increased quit rate. Controls and test group subjects with a moderate risk score were relatively unlikely to have achieved and maintained non-smoker status at 6 months. ClinicalTrials.gov ID NCT01176383 (date of registration: 3 August 2010).

Genetic test to stop smoking (GeTSS) trial protocol: randomised controlled trial of a genetic test (Respiragene) and Auckland formula to assess lung cancer risk.

BACKGROUND: A gene-based estimate of lung cancer risk in smokers has been shown to act as a smoking cessation motivator in hospital recruited subjects. The objective of this trial is to determine if this motivator is as effective in subjects recruited from an NHS primary care unit. METHOD/DESIGN: Subjects will be recruited by mailings using smoking entries on the GP electronic data-base (total practice population = 32,048) to identify smokers who may want to quit. Smoking cessation clinics based on medical centre premises will run for eight weeks. Clinics will be randomised to have the gene-based test for estimation of lung cancer risk or to act as controls groups. The primary endpoint will be smoking cessation at eight weeks and six months. Secondary outcomes will include ranking of the gene-based test with other smoking cessation motivators. DISCUSSION: The results will inform as to whether the gene-based test is both effective as motivator and acceptable to subjects recruited from primary care. TRIAL REGISTRATION: Registered with Clinical Trials.gov, REGISTRATION NUMBER: NCT01176383.