Head and Neck Neoplasms, Smoking
Conditions
Keywords
Smoking cessation, Intervention, Head and Neck neoplasms, Cognitive therapy
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.
Interventions
BEHAVIORALSmoking cessation Intervention
* 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
BEHAVIORALUsual care
A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident
Sponsors
Hotel Dieu de France Hospital
Saint-Joseph University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence abstinence | 12 months | The patient is considered abstinent if he reported not smoking for at least 7 days before the interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| continuous abstinence | 12 months | continuous abstinence from smoking at the time of follow-up, since the quit date |
Countries
Lebanon
Contacts
Primary ContactDiane Helou, ENT resident
Backup ContactNayla Matar, MD ENT
Outcome results
None listed