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

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

Abstract

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.

Figures

Figure 1
Figure 1
Research that established the respiragene test. Distribution of the Respiragene score in a cross-sectional study of 484 control smokers (blue) and 446 with lung cancer (red) (Total = 930) and from the prospective study of 52 lung cancer cases (green). Reference [8].
Figure 2
Figure 2
Efficacy of the variety of smoking cessation strategies. Percent increase of success for six months over unaided attempts for each type of quitting (chart from West & Shiffman based on Cochrane review data). Totally unaided smoking cessation has a 3-6% success rate. Therefore telephone support (Table 1) increases success rate by 6% = 9-12% quit rate.
Figure 3
Figure 3
Consort 2010 flow diagram for GeTTS recruitment.
Figure 4
Figure 4
Timeline of project.
Figure 5
Figure 5
Flow chart for the duration of the trial. a. Flow chart of project from start to week 12. b. Flow chart of project to week 36.

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Source: PubMed

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