Smoking Clinical Trial
Official title:
Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial
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.
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.
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