A Trial to Study the Effectiveness of Smoking Cessation in the Surgical Pathway Before Major Lung Surgery: Project MURRAY Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Emergency thoracic surgery
- •Inability to perform exhaled carbon monoxide (CO) measurements
研究组 & 干预措施
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.
干预措施: Integrated Behavioural therapy (Behavioral)
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.
干预措施: Integrated Pharmacotherapy (Drug)
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.
干预措施: Integrated Web-based application (Device)
结局指标
主要结局
Recruitment
时间窗: 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
次要结局
- Integration of intervention(0 days from recruitment, 1 day or surgery)
- Barriers to recruitment(0 days from recruitment)
- Smoking cessation in the usual care group(1 day of surgery, 1 month after surgery)
- Smoking cessation in the intervention group(1 day of surgery, 1 month after surgery)
- Qualitative interview(1 month after surgery)
- Variability of smoking cessation practices(0 days from recruitment, 1 day of surgery, 1 month after surgery)
- Fine tune procedures and data capture forms(0 days from recruitment, 1 day of surgery, 1 month after surgery)