Yorkshire Enhanced Stop Smoking (YESS)

Plain English Summary

Background and study aims
There is currently no standard of ‘usual care’ for offering smoking cessation (help to stop smoking) within lung cancer screening programmes. More than 4 out of 5 cases of lung cancer are caused by tobacco smoking. Stopping smoking, at any age, greatly reduces lung cancer risk. Lung cancer screening programme should provide smoking cessation support. Doing this makes lung cancer screening programmes more successful overall.
Studies have shown that when healthcare services provide personalised information on the risk of illness, more people try to quit smoking and more successfully quit smoking. The purpose of the study is to try to find out the best way of providing support to smokers who would like to quit smoking after they have had a lung health check.

Who can participate?
Anyone who had a Lung Health Check in the first 2 years of the Yorkshire Lung Screening Trial (ISRCTN42704678), who has smoked within the last month or has an exhaled carbon monoxide (CO) level of 6 ppm or above. Participants must be able to give informed consent.

What does the study involve?
All participants will get the standard best treatment. This includes a combination of behavioural support, nicotine replacement therapies (NRT) and/or an e-cigarette. Participants will be randomly allocated to standard treatment alone or standard treatment along with a personalised interaction that includes information and images from their recent lung scan. As part of the study we will contact participants at 3 and 12 months after their lung health check to complete a short questionnaire. If participants have quit smoking, they will be asked to provide us with a breath test to measure CO levels.

What are the possible benefits and risks of participating?
The information that we get from this study may help the study participants and others to stop smoking. If our study shows that we can improve the chances of staying off cigarettes after lung screening then participants will have contributed to the evaluation of a new service which could guide how smoking cessation is integrated into future lung screening programmes. The only potential disadvantages of the study are the inconvenience of us contacting study participants, of them answering our questions and providing measures of carbon monoxide.

Where is the study run from?
University of Nottingham, UK

When is the study starting and how long is it expected to run for?
The study will start in in November 2018 and will recruit participants until 31st August 2020, with data collection ending 14th March 2022.

Who is funding the study?
Yorkshire Cancer Research (UK)

Who is the main contact?
Dr Rachael Murray (public contact)
Rachael.murray@nottingham.ac.uk

Study website

Type

Public

Contact name

Dr Rachael Murray

ORCID ID

http://orcid.org/0000-0001-5477-2557

Contact details

Room C114
Clinical Sciences Building
Nottingham
NG5 1PB
United Kingdom
0115 8231389
rachael.murray@nottingham.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

NCT03750110

Protocol/serial number

18046

Scientific title

Yorkshire Enhanced Stop Smoking (YESS): The effect of adding a personalised smoking cessation intervention to a lung cancer screening programme

Acronym

YESS

Study hypothesis

This study aims to address a deficiency in the evidence base by comparing a theory-based enhanced smoking cessation intervention with standard care for smokers who participate in the Yorkshire Lung Screening Trial ((YLST) ISRCTN42704678)

Ethics approval(s)

East Midlands - Derby Research Ethics Committee, 31/08/2018, 18/EM/0199

Study design

Pragmatic parallel-group open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Community

Study type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Tobacco/nicotine dependence

Intervention

All participants:
All individuals attending for a Lung Health Check who have smoked within the last month (eligible individuals) will be offered an immediate consultation with an Smoking Cessation Practitioner (SCP), trained to National Centre for Smoking Cessation and Training standards. The SCP will explain, advise and deliver smoking cessation support in accordance with NHS Stop Smoking Service best practice (and NICE PH48 guidance) over a 4-week period. Individuals will be able to decline the offer of support should they so wish.
After the screening visit, but before the 4-week follow up, all eligible individuals will be randomised to either standard best care or intervention.
At the 4-week follow up visit (which will take place either at home, on the mobile unit or the community location according to patient preference) the SCP will collect written consent for participation in the trial and if participants agree to take part they will be treated according to their pre-assigned treatment group.

Usual care:
In accordance with current standard practice, smoking status will be assessed and validated in those reporting cessation by measuring exhaled CO. Participants who have successfully quit smoking at this point will be provided with continued pharmacotherapy/e-cigarettes and behavioural support in accordance with standard practice, and those who have relapsed to smoking encouraged to make another attempt to quit, with further behavioural support and pharmacotherapy as appropriate. All consenting participants will be contacted at 3 and 12 months after screening to ascertain current smoking status, with in-person visits for collection of exhaled CO samples arranged if abstinence is reported. Pharmacotherapy/e-cigarettes and behavioural support will continue to be offered and arranged, as outlined above.

Intervention group:
Those allocated to the intervention group will receive, in addition to usual care, the personalised feedback outlined below:
At the 4-week follow up visit, personalised feedback from the participant's screening appointment will be provided.
The exact content of the intervention, and method of presentation is currently being refined but is likely to include:
• For participants with emphysema, an image of their own emphysematous lung compared to a library image of normal lung, or a section of their own non-emphysematous lung. Where emphysema is not present, library pictures showing normal and emphysematous lung will be used.
• For participants with coronary artery calcification, a cross-sectional segment from their chest scan (either horizontal or vertical) showing the calcium compared to a library image of coronary arteries without calcification and/or a healthy section of the participant’s own heart scan. Where coronary artery calcification is not present, library pictures showing normal and calcified coronary arteries will be provided.

Sub-study:
Those who decline to see the SCP, and those who decline to take part in the YESS study will be asked to complete a short screening questionnaire to explore their reasons for this decision. Some will also be invited to take part in a sub-section of the main trial comprising of an interview (n = 30), and also asked to provide smoking status over the telephone (and CO validation in quitters) 3 and 12 months after screening.

Added 03/09/2020:
The researchers have recently made the following minor amendments to the protocol:
1. Amended consenting procedures to include taking verbal consent over the telephone If social distancing is recommended or the patient is self –isolating due to COVID-19.
2. Provide an option for the intervention leaflet to be delivered over the telephone to those patients where social distancing is recommended or patient is self –isolating due to COVID-19. In short, the Smoking Cessation Practitioner (SCP) will describe the leaflet to the patient, post the leaflet to the patient and then telephone the patient to check understanding and answer any queries.
3. CO validation of quits not collected if social distancing is recommended or the patient is self –isolating due to COVID-19.

Intervention type

Mixed

Primary outcome measure

7-day point prevalence of smoking cessation validated by exhaled CO at 3 months after the Lung Health Check

Secondary outcome measures

1. Self-reported continuous smoking cessation at 3 months after the Lung Health Check
2. Self-reported continuous cessation at 12 months after the Lung Health Check
3. CO-validated cessation at 12 months after the Lung Health Check
4. Self-reported continuous cessation at 4 weeks after the Lung Health Check
5. CO-validated cessation at 4 weeks after the Lung Health Check
6. 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

Added 03/09/2020:
7. 7-day point prevalent self-reported smoking cessation at 3 months after the Lung Health Check, to account for the inability to measure 12-week CO validated smoking cessation (primary outcome) in a proportion of study participants due to COVID-19 restrictions

Overall study start date

01/07/2017

Overall study end date

11/03/2022

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Aged 55 to 80 years
2. Residing in the newly merged Leeds South & East, Leeds West or Leeds North CCG
3. Registered as a current or ex-smoker in a General Practice participating in YLST
4. Have attended ‘Lung Health Check’ as part of YLST, and agree to see the on-site Smoking Cessation Practitioner (SCP)
5. Smoked within the last month or have exhaled CO reading of 6 ppm or above.
6. Have capacity to provide informed consent.

Participant type(s)

Mixed

Age group

Mixed

Sex

Both

Target number of participants

1040

Total final enrolment

1001

Participant exclusion criteria

Participants who do not meet the inclusion criteria

Recruitment start date

05/11/2018

Recruitment end date

24/03/2021

Countries of recruitment

England, United Kingdom

Study participating centre

Screening Vans in the Yorkshire Lung Screening Trial; Leeds Teaching Hospitals NHS Trust
Room 07/0B/06A
Leeds Chest Clinic
Martin Wing
Leeds General Infirmary
Great George Street
LS1 3EX
Leeds
LS9 7TF
United Kingdom

Organisation

University of Nottingham

Sponsor details

Research and Innovation
University of Nottingham
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
England
United Kingdom

Sponsor type

University/education

Website

ROR

https://ror.org/01ee9ar58

Funder type

Not defined

Funder name

Yorkshire Cancer Research

Alternative name(s)

YCR

Funding Body Type

government organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United Kingdom

Publication and dissemination plan

The results will be disseminated at clinical meetings and by publication in peer-reviewed journal. A summary of study findings will be made available to participants on request. Exact plans are unknown but publication is intended for December 2022.

Intention to publish date

31/08/2023

Individual participant data (IPD) sharing plan

The datasets generated during the current study will be available upon request from Rachael.murray@nottingham.ac.uk after 31st December 2021 and until 2028.

IPD sharing plan summary

Available on request

Study outputs