Smoking CessationMURRAYNCT04190966
Smoking Cessation in the Surgical Pathway Before Major Lung Surgery
A study testing Integrated Behavioural therapy, Integrated Pharmacotherapy and Integrated Web-based application in people with Smoking Cessation and Thoracic Surgery, run by University of Birmingham.
Trial summary
This is a feasibility study of a personalised, integrated smoking cessation in the surgical pathway in patients undergoing major elective thoracic surgery when compared to usual care of standard community/hospital based NHS smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Thoracic Surgery
- What is being tested?
- Integrated Behavioural therapy, Integrated Pharmacotherapy and Integrated Web-based application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current tobacco smoker (smoked within the last 28 days)
- Major Thoracic Surgery (including both open and minimally invasive approach)
- Able to provide written informed consent
- At least 1 weeks' time to surgery
- Age over 18 years
Who cannot join
- Emergency thoracic surgery
- Inability to perform exhaled carbon monoxide (CO) measurements
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Trial to Study the Effectiveness of Smoking Cessation in the Surgical Pathway Before Major Lung Surgery: Project MURRAY Feasibility Study
This is a feasibility study of a personalised, integrated smoking cessation in the surgical pathway in patients undergoing major elective thoracic surgery when compared to usual care of standard community/hospital based NHS smoking cessation. Half the patients will receive the intervention and half the patients will receive usual care.
Read the detailed description
Smoking prior to major thoracic surgery is a major risk factor for development of postoperative complications which effect both short and long-term outcome. Despite this 1 in 5 patients continue to smoke before their operation.
Project MURRAY is a trial comparing the effectiveness of personalised integrated smoking cessation delivered by trained health-care practitioners in the thoracic surgical pathway, and is a three part package of behaviour interventions and pharmacotherapy as per National Institute of Clinical Excellence (NICE)/ National Centre for Smoking Cessation Training (NCSCT) guidance which is supported by an adjunct web-based application. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 5 adult thoracic centres including the trial coordinating site at the University Hospitals Birmingham NHS Foundation Trust. This is a multicentre feasibility study, with aim for equal weighting between the two arms of the integrated smoking cessation and an observation only group of usual care.
- Conditions
- Smoking Cessation, Thoracic Surgery
- Being tested
- Integrated Behavioural therapy, Integrated Pharmacotherapy, Integrated Web-based application
- Keywords
- Postoperative Pulmonary Complications, Smoking Cessation Intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Behavioural therapyBehavioural
Integrated smoking cessation behavioural therapy
Integrated PharmacotherapyDrug
Integrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes
Integrated Web-based applicationDevice
Integrated smoking cessation web-based application
| Study group | Role | What they receive |
|---|---|---|
| Integrated smoking cessation | Active comparator | Integrated smoking cessation delivered by trained health-care practitioners in the thoracic surgical pathway: a three part package of behaviour interventions and pharmacotherapy as per NICE/NCSCT guidance which is supported by an adjunct web-based application. Receives: Behavioral: Integrated Behavioural therapy; Drug: Integrated Pharmacotherapy; Device: Integrated Web-based application |
| Usual care smoking cessation | No intervention | Usual care of standard community/hospital based NHS smoking cessation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
To establish the number of patients who agree to participate in the intervention as a proportion of those eligible to enter the study
Measured: 0 days from recruitment
Secondary outcomes (7)
Integration of intervention
Integration of the intervention into the clinical pathway by time from decision to operate from study recruitment
Measured: 0 days from recruitment, 1 day or surgery
Barriers to recruitment
Descriptive reasons for non-participation from screening logs
Measured: 0 days from recruitment
Fine tune procedures and data capture forms
To pilot data capture forms aiming for over 90% completion of important perioperative data for each patient
Measured: 0 days from recruitment, 1 day of surgery, 1 month after surgery
Smoking cessation in the intervention group
To assess the proportion of patients who receive the intervention who have quit smoking
Measured: 1 day of surgery, 1 month after surgery
Smoking cessation in the usual care group
To assess the proportion of patients in an observation only usual care group who have quit smoking
Measured: 1 day of surgery, 1 month after surgery
Variability of smoking cessation practices
To define the variability of smoking cessation practices in all patients using the nicotine replacement usage questionnaire
Measured: 0 days from recruitment, 1 day of surgery, 1 month after surgery
Qualitative interview
To understand patients' experience of and engagement with the intervention, and any unintended consequences
To establish whether the intervention is acceptable to thoracic surgery patients and staff, and investigate recommendations for optimisation in intervention delivery
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start31 Jan 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Babu Naidu, MD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190966
- Sponsor's protocol ID
- Worktribe 843842
- Acronym
- MURRAY
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion and publication of the study, individual participant data will be shared that underlie the results reported in study after de-identification. Additional related documents will be available including the study protocol, statistical analysis plan and an analytical code.
Publications
Lugg ST, Kerr A, Kadiri S, Budacan AM, Farley A, Perski O, West R, Brown J, Thickett DR, Naidu B; Project MURRAY Investigators. Protocol for a feasibility study of smoking cessation in the surgical pathway before major lung surgery: Project MURRAY. BMJ Open. 2020 Nov 6;10(11):e036568. doi: 10.1136/bmjopen-2019-036568.
PubMed 33158819
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Study the Effectiveness of Smoking Cessation in the Surgical Pathway Before Major Lung Surgery: Project MURRAY Feasibility Study
- ClinicalTrials.gov ID
- NCT04190966
- Acronym / sponsor ID
- MURRAY / Worktribe 843842
- Conditions
- Smoking Cessation, Thoracic Surgery
- Keywords
- Postoperative Pulmonary Complications, Smoking Cessation Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 31 Jan 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study of a personalised, integrated smoking cessation in the surgical pathway in patients undergoing major elective thoracic surgery when compared to usual care of standard community/hospital based NHS smoking cessation. Half the patients will receive the intervention and half the patients will receive usual care.
Detailed description
Smoking prior to major thoracic surgery is a major risk factor for development of postoperative complications which effect both short and long-term outcome. Despite this 1 in 5 patients continue to smoke before their operation.
Project MURRAY is a trial comparing the effectiveness of personalised integrated smoking cessation delivered by trained health-care practitioners in the thoracic surgical pathway, and is a three part package of behaviour interventions and pharmacotherapy as per National Institute of Clinical Excellence (NICE)/ National Centre for Smoking Cessation Training (NCSCT) guidance which is supported by an adjunct web-based application. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 5 adult thoracic centres including the trial coordinating site at the University Hospitals Birmingham NHS Foundation Trust. This is a multicentre feasibility study, with aim for equal weighting between the two arms of the integrated smoking cessation and an observation only group of usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated smoking cessation | Active comparator | Behavioral: Integrated Behavioural therapy, Drug: Integrated Pharmacotherapy, Device: Integrated Web-based applicationIntegrated smoking cessation delivered by trained health-care practitioners in the thoracic surgical pathway: a three part package of behaviour interventions and pharmacotherapy as per NICE/NCSCT guidance which is supported by an adjunct web-based application. |
| Usual care smoking cessation | No intervention | –Usual care of standard community/hospital based NHS smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current tobacco smoker (smoked within the last 28 days)
- Major Thoracic Surgery (including both open and minimally invasive approach)
- Able to provide written informed consent
- At least 1 weeks' time to surgery
- Age over 18 years
Key exclusion criteria (2 listed)
- Emergency thoracic surgery
- Inability to perform exhaled carbon monoxide (CO) measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Behavioural therapyIntegrated smoking cessation behavioural therapy | Behavioural | Integrated smoking cessation |
| Integrated PharmacotherapyIntegrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes | Drug | Integrated smoking cessation |
| Integrated Web-based applicationIntegrated smoking cessation web-based application | Device | Integrated smoking cessation |
Primary outcome
Recruitment
Time frame: 0 days from recruitment
To establish the number of patients who agree to participate in the intervention as a proportion of those eligible to enter the study
7 secondary outcomes
Integration of intervention
Time frame: 0 days from recruitment, 1 day or surgery
Barriers to recruitment
Time frame: 0 days from recruitment
Fine tune procedures and data capture forms
Time frame: 0 days from recruitment, 1 day of surgery, 1 month after surgery
Smoking cessation in the intervention group
Time frame: 1 day of surgery, 1 month after surgery
Smoking cessation in the usual care group
Time frame: 1 day of surgery, 1 month after surgery
Variability of smoking cessation practices
Time frame: 0 days from recruitment, 1 day of surgery, 1 month after surgery
Qualitative interview
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Derived from this study: PubMed 33158819Lugg ST, Kerr A, Kadiri S, Budacan AM, Farley A, Perski O, West R, Brown J, Thickett DR, Naidu B; Project MURRAY Investigators. Protocol for a feasibility study of smoking cessation in the surgical pathway before major lung surgery: Project MURRAY. BMJ Open. 2020 Nov 6;10(11):e036568. doi: 10.1136/bmjopen-2019-036568.
- Individual participant dataSharing planned: Yes. Upon completion and publication of the study, individual participant data will be shared that underlie the results reported in study after de-identification. Additional related documents will be available including the study protocol, statistical analysis plan and an analytical code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babu Naidu, MD principal investigator
University of Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Behavioural therapy, Integrated Pharmacotherapy and Integrated Web-based application in people with Smoking Cessation and Thoracic Surgery, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Kerr (01214241895, amy.kerr@heartofengland.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 0 days from recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04190966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.