TY - JOUR
T1 - Yorkshire Enhanced Stop Smoking (YESS) study
T2 - a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme
AU - Murray, Rachael L
AU - Brain, Kate
AU - Britton, John
AU - Quinn-Scoggins, Harriet D
AU - Lewis, Sarah
AU - McCutchan, Grace M
AU - Quaife, Samantha L
AU - Wu, Qi
AU - Ashurst, Alex
AU - Baldwin, David
AU - Crosbie, Philip A J
AU - Neal, Richard D
AU - Parrott, Steve
AU - Rogerson, Suzanne
AU - Thorley, Rebecca
AU - Callister, Matthew Ej
N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
PY - 2020/9/10
Y1 - 2020/9/10
N2 - 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.
AB - 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.
KW - Early Detection of Cancer
KW - Electronic Nicotine Delivery Systems
KW - Humans
KW - Lung Neoplasms/diagnostic imaging
KW - Randomized Controlled Trials as Topic
KW - Smoking
KW - Smoking Cessation
KW - Wales
U2 - 10.1136/bmjopen-2020-037086
DO - 10.1136/bmjopen-2020-037086
M3 - Article
C2 - 32912948
SN - 2044-6055
VL - 10
SP - e037086
JO - BMJ Open
JF - BMJ Open
IS - 9
ER -