Smoking Cessation in the Surgical Pathway Before Major Lung Surgery

Not Applicable

• Conditions: Smoking Cessation; Thoracic Surgery
• Interventions: Behavioral: Integrated Behavioural therapy; Drug: Integrated Pharmacotherapy; Device: Integrated Web-based application

• Registration Number: NCT04190966
• Lead Sponsor: University of Birmingham

Brief 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. 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 Timeline

• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06
• Study Start: 2020-01-31
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated smoking cessation	Integrated Behavioural therapy	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.
Integrated smoking cessation	Integrated Pharmacotherapy	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.
Integrated smoking cessation	Integrated Web-based application	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.

Primary Outcome Measures

Name	Time	Method
Recruitment	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

Secondary Outcome Measures

Name	Time	Method
Integration of intervention	0 days from recruitment, 1 day or surgery	Integration of the intervention into the clinical pathway by time from decision to operate from study recruitment
Barriers to recruitment	0 days from recruitment	Descriptive reasons for non-participation from screening logs
Smoking cessation in the usual care group	1 day of surgery, 1 month after surgery	To assess the proportion of patients in an observation only usual care group who have quit smoking
Smoking cessation in the intervention group	1 day of surgery, 1 month after surgery	To assess the proportion of patients who receive the intervention who have quit smoking
Qualitative interview	1 month after surgery	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
Variability of smoking cessation practices	0 days from recruitment, 1 day of surgery, 1 month after surgery	To define the variability of smoking cessation practices in all patients using the nicotine replacement usage questionnaire
Fine tune procedures and data capture forms	0 days from recruitment, 1 day of surgery, 1 month after surgery	To pilot data capture forms aiming for over 90% completion of important perioperative data for each patient