NCT03786172

Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking
• Head and Neck Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	Smoking cessation Intervention	* A 10 to 15 minute standardised counseling session performed peri-operatively by an ENT resident, and based on the 5 "A"s 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
BEHAVIORAL	Usual care	A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-12-24
• Last updated: 2018-12-24

Locations

2 sites across 1 country: Lebanon