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临床试验/NCT03786172
NCT03786172Unknown不适用

Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial

Saint-Joseph University4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

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

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

Experimental

Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)

干预措施: Smoking cessation Intervention (Behavioral)

Usual care

Active Comparator

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)

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (4)

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