Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- 7-day point prevalence abstinence
研究概览
简要总结
The purpose of this study is to determine whether a brief smoking ENT-resident-based intervention increased smoking cessation in patients with Head and Neck cancer attending a Lebanese university hospital, as compared with usual care.
详细描述
The primary objective of the study is to evaluate the effectiveness of a brief smoking physician-based intervention on smoking-cessation rates in Head and Neck cancer adult patients. The secondary objective is to assess predictors of long-term smoking cessation in such patients.
After an initial assessment of demographic, clinical and smoking characteristics, the patients are randomised (based on a computer randomisation program) in 2 groups:
- Group 1 will receive the usual care in Lebanon, which consists of a brief advice to quit (10 seconds)
- Group 2 will receive a brief (10-15 minutes) standardised smoking cessation counseling session peri-operatively (immediately before or after surgery), by an ENT residents, based on the 5 "A"'s motivational interviewing model:
- Ask (screen for tobacco use)
- Advise (provide a personalised and strong quit message)
- Assess (evaluate the smoker's willingness and readiness to quit)
- Assist (provide cessation counseling, pharmacotherapy, self-help guides)
- Arrange (for followup to prevent relapse, and evaluate cessation progress) A motivational gadget will be distributed to group 2 patients. They will also be offered nicotine replacement therapy (nicotine transdermal patches) for a total of 8 weeks. This will be followed by a telephone boost session after 6 weeks.
The follow-up at 3, 6 and 12 months will be done, for the 2 groups, by a person not implicated in either the randomisation or the intervention (single-blind), in person or, if impossible, by telephone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Head and Neck cancer
- •Patients hospitalised from biopsy or surgery
- •Current smokers = smokers in the past 3 months
- •Reachable by phone
排除标准
- •Nonsmokers in the past 3 months
- •Current drug dependance
- •Pregnant women
- •Psychiatric conditions
- •Patients under current smoking cessation intervention
研究组 & 干预措施
Smoking cessation Intervention
Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)
干预措施: Smoking cessation Intervention (Behavioral)
Usual care
A 10-second brief advice to quit smoking
干预措施: Usual care (Behavioral)
结局指标
主要结局
7-day point prevalence abstinence
时间窗: 12 months
The patient is considered abstinent if he reported not smoking for at least 7 days before the interview
次要结局
- continuous abstinence(12 months)
