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

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ClinicalTrials.gov Identifier: NCT04190966
Recruitment Status : Not yet recruiting
First Posted : December 9, 2019
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Thoracic Surgery Behavioral: Integrated Behavioural therapy Drug: Integrated Pharmacotherapy Device: Integrated Web-based application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial to Study the Effectiveness of Smoking Cessation in the Surgical Pathway Before Major Lung Surgery: Project MURRAY Feasibility Study
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Recruitment [ Time Frame: 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 :
  1. Integration of intervention [ Time Frame: 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

  2. Barriers to recruitment [ Time Frame: 0 days from recruitment ]
    Descriptive reasons for non-participation from screening logs

  3. Fine tune procedures and data capture forms [ Time Frame: 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

  4. Smoking cessation in the intervention group [ Time Frame: 1 day of surgery, 1 month after surgery ]
    To assess the proportion of patients who receive the intervention who have quit smoking

  5. Smoking cessation in the usual care group [ Time Frame: 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

  6. Variability of smoking cessation practices [ Time Frame: 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

  7. Qualitative interview [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190966


Contacts
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Contact: Amy Kerr 01214241895 amy.kerr@heartofengland.nhs.uk
Contact: Salma Kadiri 01214241396 salma.kadiri@heartofengland.nhs.uk

Sponsors and Collaborators
University of Birmingham
University College, London
Investigators
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Principal Investigator: Babu Naidu, MD University of Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04190966    
Other Study ID Numbers: Worktribe 843842
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: This data will be available in the beginning 3 months and 5 years following article publication.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Birmingham:
Postoperative Pulmonary Complications
Smoking Cessation Intervention