Condition category
Mental and Behavioural Disorders
Date applied
17/09/2018
Date assigned
25/09/2018
Last edited
23/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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 31st August 2021.

Who is funding the study?
Yorkshire Cancer Research

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

Trial website

Contact information

Type

Public

Primary contact

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT03750110

Protocol/serial number

18046

Study information

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

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

Trial setting

Community

Trial 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.

Intervention type

Mixed

Phase

Drug names

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

Overall trial start date

01/07/2017

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

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

Mixed

Age group

Mixed

Gender

Both

Target number of participants

2019

Participant exclusion criteria

Participants who do not meet the inclusion criteria

Recruitment start date

05/11/2018

Recruitment end date

31/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Screening Vans in the Yorkshire Lung Screening Trial; Leeds Teaching Hospitals NHS Trust
St James's University Hospital Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Yorkshire Cancer Research

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit

Location

United Kingdom

Results and Publications

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.

IPD sharing statement:
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.

Intention to publish date

30/12/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/05/2019: ClinicalTrials.gov number added.