The quit smoking lung health intervention trial
| ISRCTN | ISRCTN12455871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12455871 |
| IRAS number | 236191 |
| Secondary identifying numbers | IRAS 236191; CPMS 39463 |
- Submission date
- 07/06/2018
- Registration date
- 27/06/2019
- Last edited
- 25/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 55 to 75 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 October 2022 (updated 18/05/2022, previously: May 2022; updated 01/12/2020, previously: 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
Contact information
Scientific
NHLI, Imperial College
Royal Brompton Hospital Campus
Fulham Road
London
SW3 6NP
United Kingdom
 ORCID ID |
0000-0003-3235-0454 |
|---|---|
| Phone | +44 (0)20 7351 8029 |
| n.hopkinson@ic.ac.uk |
Public
Muscle Lab
Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available. The requirement for individual consent was waived by the ethics committee, as obtaining this would itself have been an intervention and influenced outcomes in the control group. |
| Scientific title | QuLIT – the Quit smoking Lung health Intervention Trial |
| Study 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(s) | 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 |
| Condition | Smoking cessation |
| Intervention | Current interventions as of 25/06/2021: 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 a phone call at 3 months. For participants recruited prior to March 2020 the smoking cessation intervention was delivered in face-to-face sessions. Recruitment to the study was then paused as a result of public health guidance during the COVID-19 pandemic. Recruitment then began again in January 2021 with telephone smoking cessation support offered as the method of intervention delivery. Previous interventions: 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 |
| 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 | Current secondary outcome measures as of 18/05/2022: 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) 3. Quit rate at 1 year 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 Previous 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 study start date | 01/08/2018 |
| Overall study end date | 31/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 430 |
| Participant inclusion criteria | Current participant inclusion criteria as of 24/06/2021: 1. Participant in the clinical lung health screening programme (aged 55 to 75 recorded as ever smokers in their medical records) 2. Current smoker 3. Only those who express a wish to quit smoking will be included in the primary endpoint analysis Previous 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 exclusion criteria | Non-smokers |
| Recruitment start date | 01/08/2019 |
| Recruitment end date | 02/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW3 6NP
United Kingdom
Sponsor information
University/education
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 25/06/2021: Separate results publication intended for the two different methods (face-to-face and telephone) of delivery of the smoking cessation intervention. Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Anonymized research data will be shared with third parties via a request to the senior author (NSH). Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal by the end of 2021. IPD sharing statement: Anonymized research data will be shared with third parties via a request to the senior author (NSH). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 28/02/2018 | 01/07/2019 | No | No | |
| Protocol file | version 2 | 11/12/2020 | 30/12/2021 | No | No |
| Results article | Results at 3 months | 01/02/2022 | 07/02/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | Results at 12 months and intervention delivery method | 24/10/2023 | 25/10/2023 | Yes | No |
Additional files
- ISRCTN12455871_PROTOCOL_28Feb18.pdf
- Uploaded 01/07/2019
- ISRCTN12455871_Protocol_V2_11Dec2020.pdf
Editorial Notes
25/10/2023: Publication reference and total final enrolment added.
17/10/2022: The intention to publish date has been changed from 31/12/2022 to 31/03/2023.
18/05/2022: The following changes have been made:
1. The secondary outcome measures have been updated.
2. The overall trial end date has been changed from 02/05/2022 to 31/10/2022 and the plain English summary has been updated to reflect this change.
3. The participant information sheet field has been added.
07/02/2022: Publication reference added.
30/12/2021: The following changes have been made:
1. Protocol file uploaded.
2. The total target enrolment has been changed from 110 to 130.
25/06/2021: The following changes have been made:
1. The interventions have been updated.
2. The publication and dissemination plan has been updated.
24/06/2021: The following changes have been made:
1. The participant inclusion criteria have been updated and the plain English summary has been updated to reflect this change.
2. The IPD sharing statement has been added and the participant level data has been changed from To be made available at a later date to Available on request.
01/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2020 to 02/02/2022.
2. The overall end date was changed from 01/04/2021 to 02/05/2022.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
18/06/2020: Contact details updated.
01/07/2019: Protocol file uploaded (not peer-reviewed).
03/06/2019: Trial's existence confirmed by the NIHR.
