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Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03786172
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Hotel Dieu de France Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Head and Neck Neoplasms Behavioral: Smoking cessation Intervention Behavioral: Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. continuous abstinence [ Time Frame: 12 months ]
    continuous abstinence from smoking at the time of follow-up, since the quit date

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03786172

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Contact: Diane Helou, ENT resident 96171112426
Contact: Nayla Matar, MD ENT 9613277725

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Saint-Joseph university Not yet recruiting
Beirut, Lebanon, 1104 2020
Contact: Maya Samaha, Librarian    9611421000 ext 2211   
Principal Investigator: Diane Helou, ENT resident         
Hôtel-Dieu De France University Hospital Recruiting
Beirut, Lebanon, 961
Contact: Husein Smayli, MD    96170817106   
Contact: Nayla Matar, MD; PHD    96103277725      
Sponsors and Collaborators
Saint-Joseph University
Hotel Dieu de France Hospital
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Study Director: Amine Haddad, MD ENT Hotel Dieu de France Hospital

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Responsible Party: Saint-Joseph University Identifier: NCT03786172    
Other Study ID Numbers: CEHDF600
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Keywords provided by Saint-Joseph University:
Smoking cessation
Head and Neck neoplasms
Cognitive therapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site