<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786172</url>
  </required_header>
  <id_info>
    <org_study_id>CEHDF600</org_study_id>
    <nct_id>NCT03786172</nct_id>
  </id_info>
  <brief_title>Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients</brief_title>
  <official_title>Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint-Joseph University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hotel Dieu de France Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Saint-Joseph University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a brief smoking ENT-resident-based&#xD;
      intervention increased smoking cessation in patients with Head and Neck cancer attending a&#xD;
      Lebanese university hospital, as compared with usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to evaluate the effectiveness of a brief smoking&#xD;
      physician-based intervention on smoking-cessation rates in Head and Neck cancer adult&#xD;
      patients. The secondary objective is to assess predictors of long-term smoking cessation in&#xD;
      such patients.&#xD;
&#xD;
      After an initial assessment of demographic, clinical and smoking characteristics, the&#xD;
      patients are randomised (based on a computer randomisation program) in 2 groups:&#xD;
&#xD;
        -  Group 1 will receive the usual care in Lebanon, which consists of a brief advice to quit&#xD;
           (10 seconds)&#xD;
&#xD;
        -  Group 2 will receive a brief (10-15 minutes) standardised smoking cessation counseling&#xD;
           session peri-operatively (immediately before or after surgery), by an ENT residents,&#xD;
           based on the 5 &quot;A&quot;'s motivational interviewing model:&#xD;
&#xD;
        -  Ask (screen for tobacco use)&#xD;
&#xD;
        -  Advise (provide a personalised and strong quit message)&#xD;
&#xD;
        -  Assess (evaluate the smoker's willingness and readiness to quit)&#xD;
&#xD;
        -  Assist (provide cessation counseling, pharmacotherapy, self-help guides)&#xD;
&#xD;
        -  Arrange (for followup to prevent relapse, and evaluate cessation progress) A&#xD;
           motivational gadget will be distributed to group 2 patients. They will also be offered&#xD;
           nicotine replacement therapy (nicotine transdermal patches) for a total of 8 weeks. This&#xD;
           will be followed by a telephone boost session after 6 weeks.&#xD;
&#xD;
      The follow-up at 3, 6 and 12 months will be done, for the 2 groups, by a person not&#xD;
      implicated in either the randomisation or the intervention (single-blind), in person or, if&#xD;
      impossible, by telephone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-day point prevalence abstinence</measure>
    <time_frame>12 months</time_frame>
    <description>The patient is considered abstinent if he reported not smoking for at least 7 days before the interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>continuous abstinence</measure>
    <time_frame>12 months</time_frame>
    <description>continuous abstinence from smoking at the time of follow-up, since the quit date</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Smoking</condition>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>Smoking cessation Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 10-second brief advice to quit smoking</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking cessation Intervention</intervention_name>
    <description>A 10 to 15 minute standardised counseling session performed peri-operatively by an ENT resident, and based on the 5 &quot;A&quot;s motivational interviewing model (Ask, Advise, Assess, Assist, Arrange)&#xD;
A motivational gadget distributed to the patients&#xD;
Nicotine replacement therapy (NRT), consisting of nicotine transdermal patches for 8 weeks, offered to the patients</description>
    <arm_group_label>Smoking cessation Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Head and Neck cancer&#xD;
&#xD;
          -  Patients hospitalised from biopsy or surgery&#xD;
&#xD;
          -  Current smokers = smokers in the past 3 months&#xD;
&#xD;
          -  Reachable by phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nonsmokers in the past 3 months&#xD;
&#xD;
          -  Current drug dependance&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Psychiatric conditions&#xD;
&#xD;
          -  Patients under current smoking cessation intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amine Haddad, MD ENT</last_name>
    <role>Study Director</role>
    <affiliation>Hotel Dieu de France Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diane Helou, ENT resident</last_name>
    <phone>96171112426</phone>
    <email>diane_helou@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nayla Matar, MD ENT</last_name>
    <phone>9613277725</phone>
    <email>naylamatar@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Saint-Joseph university</name>
      <address>
        <city>Beirut</city>
        <zip>1104 2020</zip>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maya Samaha, Librarian</last_name>
      <phone>9611421000</phone>
      <phone_ext>2211</phone_ext>
      <email>msamaha@usj.edu.lb</email>
    </contact>
    <investigator>
      <last_name>Diane Helou, ENT resident</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôtel-Dieu De France University Hospital</name>
      <address>
        <city>Beirut</city>
        <zip>961</zip>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Husein Smayli, MD</last_name>
      <phone>96170817106</phone>
      <email>hussein.smayli@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Nayla Matar, MD; PHD</last_name>
      <phone>96103277725</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <reference>
    <citation>2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.</citation>
    <PMID>18807274</PMID>
  </reference>
  <reference>
    <citation>Nayan S, Gupta MK, Strychowsky JE, Sommer DD. Smoking cessation interventions and cessation rates in the oncology population: an updated systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2013 Aug;149(2):200-11. doi: 10.1177/0194599813490886. Epub 2013 May 28.</citation>
    <PMID>23715685</PMID>
  </reference>
  <reference>
    <citation>Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2203-8. doi: 10.1158/1055-9965.EPI-05-0880.</citation>
    <PMID>17119047</PMID>
  </reference>
  <reference>
    <citation>Schnoll RA, Rothman RL, Wielt DB, Lerman C, Pedri H, Wang H, Babb J, Miller SM, Movsas B, Sherman E, Ridge JA, Unger M, Langer C, Goldberg M, Scott W, Cheng J. A randomized pilot study of cognitive-behavioral therapy versus basic health education for smoking cessation among cancer patients. Ann Behav Med. 2005 Aug;30(1):1-11. doi: 10.1207/s15324796abm3001_1.</citation>
    <PMID>16097900</PMID>
  </reference>
  <reference>
    <citation>Schnoll RA, Zhang B, Rue M, Krook JE, Spears WT, Marcus AC, Engstrom PF. Brief physician-initiated quit-smoking strategies for clinical oncology settings: a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2003 Jan 15;21(2):355-65. doi: 10.1200/JCO.2003.04.122.</citation>
    <PMID>12525530</PMID>
  </reference>
  <reference>
    <citation>Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. doi: 10.1002/14651858.CD001837.pub2.</citation>
    <PMID>17636688</PMID>
  </reference>
  <reference>
    <citation>Wakefield M, Olver I, Whitford H, Rosenfeld E. Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Nurs Res. 2004 Nov-Dec;53(6):396-405. doi: 10.1097/00006199-200411000-00008.</citation>
    <PMID>15586136</PMID>
  </reference>
  <reference>
    <citation>Gosselin MH, Mahoney MC, Cummings KM, Loree TR, Sullivan M, King BA, Warren G, Hyland A. Evaluation of an intervention to enhance the delivery of smoking cessation services to patients with cancer. J Cancer Educ. 2011 Sep;26(3):577-82. doi: 10.1007/s13187-011-0221-3.</citation>
    <PMID>21503842</PMID>
  </reference>
  <reference>
    <citation>Schnoll RA, Rothman RL, Newman H, Lerman C, Miller SM, Movsas B, Sherman E, Ridge JA, Unger M, Langer C, Goldberg M, Scott W, Cheng J. Characteristics of cancer patients entering a smoking cessation program and correlates of quit motivation: implications for the development of tobacco control programs for cancer patients. Psychooncology. 2004 May;13(5):346-58. doi: 10.1002/pon.756.</citation>
    <PMID>15133775</PMID>
  </reference>
  <reference>
    <citation>Gorin SS, Heck JE. Meta-analysis of the efficacy of tobacco counseling by health care providers. Cancer Epidemiol Biomarkers Prev. 2004 Dec;13(12):2012-22.</citation>
    <PMID>15598756</PMID>
  </reference>
  <reference>
    <citation>Sharp L, Johansson H, Fagerstrom K, Rutqvist LE. Smoking cessation among patients with head and neck cancer: cancer as a 'teachable moment'. Eur J Cancer Care (Engl). 2008 Mar;17(2):114-9. doi: 10.1111/j.1365-2354.2007.00815.x.</citation>
    <PMID>18302647</PMID>
  </reference>
  <reference>
    <citation>Gritz ER, Carr CR, Rapkin D, Abemayor E, Chang LJ, Wong WK, Belin TR, Calcaterra T, Robbins KT, Chonkich G, et al. Predictors of long-term smoking cessation in head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 1993 May-Jun;2(3):261-70.</citation>
    <PMID>8318879</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2015</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Intervention</keyword>
  <keyword>Head and Neck neoplasms</keyword>
  <keyword>Cognitive therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786172
org study id: CEHDF600
nct id: NCT03786172
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: 7-day point prevalence abstinence
time frame: 12 months
description: The patient is considered abstinent if he reported not smoking for at least 7 days before the interview
measure: continuous abstinence
time frame: 12 months
description: continuous abstinence from smoking at the time of follow-up, since the quit date
arm group label: Smoking cessation Intervention
arm group type: Experimental
description: Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)
arm group label: Usual care
arm group type: Active Comparator
description: A 10-second brief advice to quit smoking
intervention type: Behavioral
intervention name: Smoking cessation Intervention
description: 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
arm group label: Smoking cessation Intervention
intervention type: Behavioral
intervention name: Usual care
description: A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amine Haddad, MD ENT
role: Study Director
affiliation: Hotel Dieu de France Hospital
last name: Diane Helou, ENT resident
phone: 96171112426
email: diane_helou@hotmail.com
last name: Nayla Matar, MD ENT
phone: 9613277725
email: naylamatar@gmail.com
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Lebanon
citation: 2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
PMID: 18807274
citation: Nayan S, Gupta MK, Strychowsky JE, Sommer DD. Smoking cessation interventions and cessation rates in the oncology population: an updated systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2013 Aug;149(2):200-11. doi: 10.1177/0194599813490886. Epub 2013 May 28.
PMID: 23715685
citation: Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2203-8. doi: 10.1158/1055-9965.EPI-05-0880.
PMID: 17119047
citation: Schnoll RA, Rothman RL, Wielt DB, Lerman C, Pedri H, Wang H, Babb J, Miller SM, Movsas B, Sherman E, Ridge JA, Unger M, Langer C, Goldberg M, Scott W, Cheng J. A randomized pilot study of cognitive-behavioral therapy versus basic health education for smoking cessation among cancer patients. Ann Behav Med. 2005 Aug;30(1):1-11. doi: 10.1207/s15324796abm3001_1.
PMID: 16097900
citation: Schnoll RA, Zhang B, Rue M, Krook JE, Spears WT, Marcus AC, Engstrom PF. Brief physician-initiated quit-smoking strategies for clinical oncology settings: a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2003 Jan 15;21(2):355-65. doi: 10.1200/JCO.2003.04.122.
PMID: 12525530
citation: Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. doi: 10.1002/14651858.CD001837.pub2.
PMID: 17636688
citation: Wakefield M, Olver I, Whitford H, Rosenfeld E. Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Nurs Res. 2004 Nov-Dec;53(6):396-405. doi: 10.1097/00006199-200411000-00008.
PMID: 15586136
citation: Gosselin MH, Mahoney MC, Cummings KM, Loree TR, Sullivan M, King BA, Warren G, Hyland A. Evaluation of an intervention to enhance the delivery of smoking cessation services to patients with cancer. J Cancer Educ. 2011 Sep;26(3):577-82. doi: 10.1007/s13187-011-0221-3.
PMID: 21503842
citation: Schnoll RA, Rothman RL, Newman H, Lerman C, Miller SM, Movsas B, Sherman E, Ridge JA, Unger M, Langer C, Goldberg M, Scott W, Cheng J. Characteristics of cancer patients entering a smoking cessation program and correlates of quit motivation: implications for the development of tobacco control programs for cancer patients. Psychooncology. 2004 May;13(5):346-58. doi: 10.1002/pon.756.
PMID: 15133775
citation: Gorin SS, Heck JE. Meta-analysis of the efficacy of tobacco counseling by health care providers. Cancer Epidemiol Biomarkers Prev. 2004 Dec;13(12):2012-22.
PMID: 15598756
citation: Sharp L, Johansson H, Fagerstrom K, Rutqvist LE. Smoking cessation among patients with head and neck cancer: cancer as a 'teachable moment'. Eur J Cancer Care (Engl). 2008 Mar;17(2):114-9. doi: 10.1111/j.1365-2354.2007.00815.x.
PMID: 18302647
citation: Gritz ER, Carr CR, Rapkin D, Abemayor E, Chang LJ, Wong WK, Belin TR, Calcaterra T, Robbins KT, Chonkich G, et al. Predictors of long-term smoking cessation in head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 1993 May-Jun;2(3):261-70.
PMID: 8318879
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms