Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

Not Applicable

• Conditions: Smoking; Head and Neck Neoplasms
• Interventions: Behavioral: Usual care; Behavioral: Smoking cessation Intervention

• Registration Number: NCT03786172
• Lead Sponsor: Saint-Joseph University

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-12-10
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Study First Posted: 2018-12-24
• Last Update Posted: 2018-12-24
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	A 10-second brief advice to quit smoking
Smoking cessation Intervention	Smoking cessation Intervention	Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
continuous abstinence	12 months	continuous abstinence from smoking at the time of follow-up, since the quit date

Trial Locations

Locations (2)

Hôtel-Dieu De France University Hospital; 🇱🇧 Beirut, Lebanon

Saint-Joseph university; 🇱🇧 Beirut, Lebanon