Clinical trial NCT03786172: Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients
Official title: Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Head and Neck Neoplasms
Keywords: Smoking cessation
Intervention
Head and Neck neoplasms
Cognitive therapy
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
Collaborators: name: Hotel Dieu de France Hospital
First posted: 2018-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 7-day point prevalence abstinence
timeFrame: 12 months
Secondary outcomes:
measure: continuous abstinence
timeFrame: 12 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint-Joseph university
city: Beirut
country: Lebanon
facility: Hôtel-Dieu De France University Hospital
Study officials:
affiliation: Hotel Dieu de France Hospital
name: Amine Haddad, MD ENT
role: STUDY_DIRECTOR
References:
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