Smoking Cessation in the Surgical Pathway Before Major Lung Surgery

Smoking Cessation Clinical Trial

— MURRAY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04190966
• Other study ID #: Worktribe 843842
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2020
• Source: University of Birmingham
• Contact: Amy Kerr
• Phone: 01214241895
• Email: amy.kerr[@]heartofengland.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Half the patients will receive the intervention and half the patients will receive usual care.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Thoracic Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Barriers to recruitment	Descriptive reasons for non-participation from screening logs	0 days from recruitment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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