Smoking Cessation in the Surgical Pathway Before Major Lung Surgery

NCT ID: NCT04190966

Last Updated: 2020-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation Thoracic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Integrated Behavioural therapy

Intervention Type BEHAVIORAL

Integrated smoking cessation behavioural therapy

Integrated Pharmacotherapy

Intervention Type DRUG

Integrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes

Integrated Web-based application

Intervention Type DEVICE

Integrated smoking cessation web-based application

Usual care smoking cessation

Usual care of standard community/hospital based NHS smoking cessation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Integrated Behavioural therapy

Integrated smoking cessation behavioural therapy

Intervention Type BEHAVIORAL

Integrated Pharmacotherapy

Integrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes

Intervention Type DRUG

Integrated Web-based application

Integrated smoking cessation web-based application

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College, London

OTHER

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Babu Naidu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amy Kerr

Role: CONTACT

01214241895

Salma Kadiri

Role: CONTACT

01214241396

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33158819 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Worktribe 843842

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pre to Postoperative Smoking Cessation
NCT02683161 TERMINATED PHASE2
Mobile Contingency Management for Smoking Cessation
NCT04881630 ACTIVE_NOT_RECRUITING NA
Smoking Cessation Intervention for Cancer Patients
NCT00575718 ACTIVE_NOT_RECRUITING NA