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

John A A Nichols, Paul Grob, Wendy Kite, Peter Williams, Simon de Lusignan, John A A Nichols, Paul Grob, Wendy Kite, Peter Williams, Simon de Lusignan

Abstract

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).

Keywords: Genetic testing; Lung neoplasms; Primary health care; Smoking cessation.

Figures

Fig. 1
Fig. 1
Individualised lung cancer risk score graph based on genome-wide association studies of smokers with cancer and a control group of smokers that had not developed lung cancer. Given a risk score, the level of risk and the increased risk compared with a non-smoker can be read off
Fig. 2
Fig. 2
Recruitment flow chart
Fig. 3
Fig. 3
Mean values for motivators and influences that have helped to reduce or stop smoking: “Please score each of the items below according to how strong an influence they have been in helping you to quit smoking”. Scores for motivators for individual participants were calculated as percentages of the sum of total scores of the individual and mean values calculated from these percentage scores (Taken from: [31]). ** Data for “Results of Respiragene test” as a motivator is based on feedback from the test group only

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