Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

December 20, 2018 updated by: Saint-Joseph University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon, 1104 2020
        • Not yet recruiting
        • Saint-Joseph University
        • Contact:
        • Principal Investigator:
          • Diane Helou, ENT resident
      • Beirut, Lebanon, 961
        • Recruiting
        • Hôtel-Dieu De France University Hospital
        • Contact:
        • Contact:
          • Nayla Matar, MD; PHD
          • Phone Number: 96103277725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smoking cessation Intervention
Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)
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
Active Comparator: Usual care
A 10-second brief advice to quit smoking
Behavioral: Usual care
A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day point prevalence abstinence
Time Frame: 12 months
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
Time Frame: 12 months
continuous abstinence from smoking at the time of follow-up, since the quit date
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Joseph University

Collaborators

Hotel Dieu de France Hospital

Investigators

  • Study Director: Amine Haddad, MD ENT, Hotel Dieu de France Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEHDF600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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