Smoking Cessation in the Surgical Pathway Before Major Lung Surgery (MURRAY)

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.

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation; Thoracic Surgery
• Intervention / Treatment: Behavioral: Integrated Behavioural therapy; Drug: Integrated Pharmacotherapy; Device: Integrated Web-based application

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Kerr; Phone Number: 01214241895; Email: amy.kerr@heartofengland.nhs.uk
• Study Contact Backup: Name: Salma Kadiri; Phone Number: 01214241396; Email: salma.kadiri@heartofengland.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: University College, London
• Investigators: Principal Investigator: Babu Naidu, MD, University of Birmingham

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2020
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative Pulmonary Complications; Smoking Cessation Intervention
• Other Study ID Numbers: Worktribe 843842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: This data will be available in the beginning 3 months and 5 years following article publication.
• IPD Sharing Access Criteria: To those who provide a methodologically sound proposal for analysis to achieve the aims in the approved proposal. All proposals should be directed to b.naidu@bham.ac.uk. To gain access requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No