Condition category
Mental and Behavioural Disorders
Date applied
07/06/2018
Date assigned
27/06/2019
Last edited
01/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Smoking is a major cause of ill health including lung disease, health disease and cancer. It is important that the NHS makes use of the best approaches to help people to stop smoking. People with a history of smoking are now being offered screening by CT scan in order to detect early lung cancer so these can be treated and cured. This screening program is also an opportunity to help people to quit smoking. The usual approach would be to direct individuals to NHS or local authority smoking cessation services. The aim of this study is to see if a more intense approach, where smokers can see a smoking cessation counsellor immediately, is more effective.

Who can participate?
Smokers aged 50 to 65 who wish to quit who are going through the screening programme

What does the study involve?
Participants are randomly allocated to receive either immediate smoking cessation input including pharmacotherapy (drug treatment) or usual care, which is advice and signposting to local services. Smoking rates are compared 3 months later.

What are the possible benefits and risks of participating?
The intervention may increase the likelihood of quitting smoking.

Where is the study run from?
Royal Brompton and Harefield NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
February 2018 to April 2019

Who is funding the study?
Royal Marsden Partners (UK)

Who is the main contact?
1. Dr Nicholas Hopkinson
n.hopkinson@ic.ac.uk
2. Dr Ahmad Sadaka
a.sadaka@rbht.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Hopkinson

ORCID ID

http://orcid.org/0000-0003-3235-0454

Contact details

NHLI
Imperial College
Royal Brompton Hospital Campus
Fulham Road
London
SW3 6NP
United Kingdom

Type

Public

Additional contact

Dr Ahmad Sadaka

ORCID ID

Contact details

Muscle Lab
Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS 236191; CPMS 39463

Study information

Scientific title

QuLIT – the Quit smoking Lung health Intervention Trial

Acronym

QuLIT

Study hypothesis

In people who smoke attending a lung cancer CT screening programme, does the provision of immediate smoking cessation support including pharmacotherapy compared to signposting to a smoking cessation service improve quit rates at 3 months?

Ethics approval

Approved 30/04/2018, South Central - Oxford C Research Ethics Committee (Level 3, Block B, Whitefriars Building, Lewins Mead, Bristol, BS1 2NT; Tel: +44 (0)20 7104 8049; Email: nrescommittee.southcentral-oxfordc@nhs.net), REC ref:18/SC/0236

Study design

Randomised; Interventional; Design type: Treatment, Screening, Drug, Education or Self-Management, Imaging, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Smoking cessation

Intervention

A study comparing the effectiveness of two different smoking cessation strategies applied in a pseudo-randomised fashion. Smokers attending a lung health screening service, focussed on CT screening to detect early lung cancer, will receive either:
1. Immediate smoking cessation input including pharmacotherapy
2. Usual care, which will be advice and signposting to local services

Limited resources mean that a specialist smoking cessation practitioner will only be available on 5 days every fortnight so treatment allocation will depend on this (i.e., which day patients attend on).

Follow up will be by phone call at 3 months.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Quit rate in those wishing to quit, based on self-report by telephone call at 3 months following the initial screening visit

Secondary outcome measures

1. Quit rate in all screening program participants, based on self-report by telephone call at 3 months following the initial screening visit
2. Mortality at 1 year (available as part of the routine evaluation of the screening protocol)

Exploratory outcomes:
1. The impact of the smoking cessation interventions (based on self-report by telephone call at three months) in different baseline groups including:
1.1. Those with new abnormal findings found as part of screening (e.g. spirometry)
1.2. Those with or without an abnormal CT finding that requires further follow up
2. The number of individuals who are smoking and who wish to quit will also be documented to provide guidance for service development and resource requirements

Overall trial start date

01/08/2018

Overall trial end date

01/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participant in the clinical lung health screening programme (aged 50 to 65 and any history of smoking)
2. Current smoker
3. Only those who express a wish to quit smoking will be included in the primary endpoint analysis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

Non-smokers

Recruitment start date

01/08/2019

Recruitment end date

01/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton and Harefield NHS Foundation Trust
Fulham Road
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

South Kensington Campus
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Marsden Partners

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal by the end of 2021.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/07/2019: Protocol file uploaded (not peer-reviewed). 03/06/2019: Trial's existence confirmed by the NIHR.