Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme

Abstract

IntroductionIntegration of smoking cessation (SC) into lung cancer screening is essential to optimise clinical and cost effectiveness. The most effective way to use this ‘teachable moment’ is unclear. The Yorkshire Enhanced Stop Smoking study will measure the effectiveness of an SC service integrated within the Yorkshire Lung Screening Trial (YLST) and will test the efficacy of a personalised SC intervention, incorporating incidental findings detected on the low-dose CT scan performed as part of YLST.Methods and analysisUnless explicitly declined, all smokers enrolled in YLST will see an SC practitioner at baseline and receive SC support over 4 weeks comprising behavioural support, pharmacotherapy and/or a commercially available e-cigarette. Eligible smokers will be randomised (1:1 in permuted blocks of random size up to size 6) to receive either an enhanced, personalised SC support package, including CT scan images, or continued standard best practice. Anticipated recruitment is 1040 smokers (January 2019–December 2020). The primary objective is to measure 7-day point prevalent carbon monoxide (CO) validated SC after 3 months. Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points. A process evaluation will explore under which circumstances and on which groups the intervention works best, test intervention fidelity and theory test the mechanisms of intervention impact.Ethics and disseminationThis study has been approved by the East Midlands-Derby Research Ethics Committee (18/EM/0199) and the Health Research Authority/Health and Care Research Wales. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via the YLST website.Trial registration numbersISRCTN63825779, NCT03750110.

Personalising lung cancer screening: An overview of risk‐stratification opportunities and challenges

“…A substantial proportion of the screening eligible population is expected to consist of current smokers; over half of the participants of CT lung screening trials consisted of current smokers 1‐8 . Various approaches for integrating smoking cessation interventions in lung cancer screening are being considered, with a recent review suggesting that personalised, multimodal approaches are the most successful in changing smoking behaviours 142‐146 . Yet, if integrated successfully, these interventions may aid in reducing both future lung cancer risk as well as the risk for other tobacco‐related comorbidities 147,148 .…”

“…[1][2][3][4][5][6][7][8] Various approaches for integrating smoking cessation interventions in lung cancer screening are being considered, with a recent review suggesting that personalised, multimodal approaches are the most successful in changing smoking behaviours. [142][143][144][145][146] Yet, if integrated successfully, these interventions may aid in reducing both future lung cancer risk as well as the risk for other tobacco-related comorbidities. 147,148 Decision-aids and the assessment of eligibility for lung cancer screening could be further enhanced by quantifying the effects of smoking cessation on future lung cancer risk and life expectancy for individuals who currently smoke.…”

Opportunistic Non-Governmental Organisation Delivery of a Virtual Stop Smoking Service in England during the COVID-19 Lockdown

“…Participant data, including contact details, demographic information and service process and outcome data was secured on a password protected service database using data management methods outlined in the YESS study protocol [15]. Patients were contacted by the study manager who gave details of the service and use of personal data.…”

An update on CT screening for lung cancer: the first major targeted cancer screening programme

“…54,55 Participants with indeterminate results may have a higher quit rate than others 54 and this has led to further research testing whether detailed information about abnormalities on the CT such as emphysema and coronary artery calcification can help incentivise participants to quit. 56 Smoking cessation rates, as expected strongly influence any cost-effectiveness analysis. 57…”