Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Smoking, Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Smoking cessation Intervention
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and Neck cancer Patients hospitalised from biopsy or surgery Current smokers = smokers in the past 3 months Reachable by phone Exclusion Criteria: Nonsmokers in the past 3 months Current drug dependance Pregnant women Psychiatric conditions Patients under current smoking cessation intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking cessation Intervention<br>Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT) | Behavioral: Smoking cessation Intervention<br>* A 10 to 15 minute standardised counseling session performed peri-operatively by an ENT resident, and based on the 5 As motivational interviewing model (Ask, Advise, Assess, Assist, Arrange) A motivational gadget distributed to the patients Nicotine replacement therapy (NRT), consisting of nicotine transdermal patches for 8 weeks, offered to the patients<br>|
| Active Comparator: Usual care<br>A 10-second brief advice to quit smoking | Behavioral: Usual care<br>* A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence | The patient is considered abstinent if he reported not smoking for at least 7 days before the interview | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous abstinence | continuous abstinence from smoking at the time of follow-up, since the quit date | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking cessation, Intervention, Head and Neck neoplasms, Cognitive therapy