Introduction Integration 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 analysis Unless 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 dissemination This 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.
- protocols & guidelines
- public health
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Contributors All authors contributed to the development and set up of the study. RLM, MC and JB led the design of the study. RLM and MC are responsible for the overall conduct of the study. RLM and RT are responsible for the day to day running of the study. SR provides operational management to the SP team. SL developed the study statistical/analysis plan, SP and QW developed the health economic study design. KB, GMM, SQ, RLM, MC and all authors contributed to developing the intervention content and patient facing literature. HDQ-S developed interview schedules, protocols and analysis plan for the process evaluation. MC, JB, DB, PAJC and RDN provide guidance around clinical aspects of the study. AA developed radiological processes for extraction and annotation of patient scan images. RLM drafted the manuscript, all authors contributed to, reviewed and approved the final version of the manuscript.
Funding This work is funded by Yorkshire Cancer Research grant number NOT414.
Competing interests PAJC has received consultation fees and share options from Everest Detection.
Patient and public involvement The study has involved patients/public throughout its development. This included advising on study design, intervention content and participant facing literature. We will seek advice from patients/public about the dissemination of results, particularly to lay audiences.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
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