Article Text

Download PDFPDF

Protocol
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
  1. Rachael L Murray1,2,
  2. Kate Brain3,
  3. John Britton1,2,
  4. Harriet D Quinn-Scoggins3,
  5. Sarah Lewis1,2,
  6. Grace M McCutchan3,
  7. Samantha L Quaife4,
  8. Qi Wu5,
  9. Alex Ashurst6,
  10. David Baldwin7,
  11. Philip A J Crosbie8,
  12. Richard D Neal9,
  13. Steve Parrott5,
  14. Suzanne Rogerson10,
  15. Rebecca Thorley1,2,
  16. Matthew EJ Callister11
  1. 1Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom
  2. 2UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, United Kingdom
  3. 3Division of Population Medicine, Cardiff University, Cardiff, United Kingdom
  4. 4Research Department of Behavioural Science and Health, University College London, London, United Kingdom
  5. 5Department of Health Sciences, University of York, York, UK
  6. 6Department of Radiology, Leeds Teaching Hospitals, Leeds, United Kingdom
  7. 7Deaprtment of Respiratory Medicine, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom
  8. 8Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Wythenshawe, UK
  9. 9Institute of Health Science, University of Leeds, Leeds, United Kingdom
  10. 10Research and Innivation CSU, Leeds Teaching Hospitals, Leeds, United Kingdom
  11. 11Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom
  1. Correspondence to Professor Rachael L Murray; rachael.murray{at}nottingham.ac.uk

Abstract

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.

Trial registration numbers ISRCTN63825779, NCT03750110.

  • protocols & guidelines
  • public health
  • CT
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Statistics from Altmetric.com

Footnotes

  • Twitter @grace_mccutchan, @DrPhilCrosbie, @richarddneal

  • 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.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.