Smoking Cessation in the Surgical Pathway Before Major Lung Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Trial to Study the Effectiveness of Smoking Cessation in the Surgical Pathway Before Major Lung Surgery: Project MURRAY Feasibility Study

Conditions
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Smoking Cessation, Thoracic Surgery

Intervention / Treatment
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* Behavioral: Integrated Behavioural therapy
* Drug: Integrated Pharmacotherapy
* Device: Integrated Web-based application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Emergency thoracic surgery Inability to perform exhaled carbon monoxide (CO) measurements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integrated smoking cessation<br>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. | Behavioral: Integrated Behavioural therapy<br>* Integrated smoking cessation behavioural therapy<br>Drug: Integrated Pharmacotherapy<br>* Integrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes<br>Device: Integrated Web-based application<br>* Integrated smoking cessation web-based application<br>|
| No Intervention: Usual care smoking cessation<br>Usual care of standard community/hospital based NHS smoking cessation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | To establish the number of patients who agree to participate in the intervention as a proportion of those eligible to enter the study | 0 days from recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration of intervention | Integration of the intervention into the clinical pathway by time from decision to operate from study recruitment | 0 days from recruitment, 1 day or surgery | 
| Barriers to recruitment | Descriptive reasons for non-participation from screening logs | 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 | 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 | 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 | 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 | 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 | 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pulmonary Complications, Smoking Cessation Intervention