Clinical trial NCT04190966: Smoking Cessation in the Surgical Pathway Before Major Lung Surgery
Official title: A Trial to Study the Effectiveness of Smoking Cessation in the Surgical Pathway Before Major Lung Surgery: Project MURRAY Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Thoracic Surgery
Keywords: Postoperative Pulmonary Complications
Smoking Cessation Intervention
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2019-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: 0 days from recruitment
Secondary outcomes:
measure: Integration of intervention
timeFrame: 0 days from recruitment, 1 day or surgery
measure: Barriers to recruitment
timeFrame: 0 days from recruitment
measure: Fine tune procedures and data capture forms
timeFrame: 0 days from recruitment, 1 day of surgery, 1 month after surgery
measure: Smoking cessation in the intervention group
timeFrame: 1 day of surgery, 1 month after surgery
measure: Smoking cessation in the usual care group
timeFrame: 1 day of surgery, 1 month after surgery
measure: Variability of smoking cessation practices
timeFrame: 0 days from recruitment, 1 day of surgery, 1 month after surgery
measure: Qualitative interview
timeFrame: 1 month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Birmingham
name: Babu Naidu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.