<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/NCT02188563</url>
  </required_header>
  <id_info>
    <org_study_id>J1407</org_study_id>
    <secondary_id>NA_00089912</secondary_id>
    <secondary_id>P50DE019032</secondary_id>
    <nct_id>NCT02188563</nct_id>
  </id_info>
  <brief_title>A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers</brief_title>
  <official_title>Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <brief_summary>
    <textblock>
      Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and&#xD;
      neck) and negatively impacts survival and other outcomes, but many patients have difficulty&#xD;
      quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far&#xD;
      have had limited success. This is a pilot randomized controlled trial designed to determine&#xD;
      if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates&#xD;
      for cancer patients who smoke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking cessation</measure>
    <time_frame>8 weeks</time_frame>
    <description>Smoking cessation will be defined as BOTH (1) self-reported 7-day abstinence from smoking and (2) exhaled carbon monoxide level of 8 or lower as biochemical confirmation of abstinence.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <condition>Head and Neck Neoplasms</condition>
  <condition>Thoracic Neoplasms</condition>
  <condition>Radiation</condition>
  <arm_group>
    <arm_group_label>Comprehensive intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New evidence-based comprehensive smoking cessation intervention including several elements that have proven successful in non-cancer patients but not used for cancer patients before.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comprehensive smoking cessation intervention</intervention_name>
    <arm_group_label>Comprehensive intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced usual care</intervention_name>
    <arm_group_label>Enhanced usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New diagnosis of head and neck or thoracic (including lung) cancer&#xD;
&#xD;
          -  Undergoing radiation at Johns Hopkins Radiation Oncology for 5 or more weeks&#xD;
&#xD;
          -  English-speaking and able to provide informed consent&#xD;
&#xD;
          -  Smoked any cigarettes in previous 14 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Palliative radiation&#xD;
&#xD;
          -  Undergoing stereotactic radiosurgery&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gypsyamber D'Souza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Head and neck neoplasms</keyword>
  <keyword>Lung neoplasms</keyword>
  <keyword>Thoracic neoplasms</keyword>
  <keyword>Radiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Thoracic Neoplasms</mesh_term>
    <mesh_term>Tobacco Use Disorder</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/NCT02188563
org study id: J1407
secondary id: NA_00089912
secondary id: P50DE019032
nct id: NCT02188563
lead sponsor: 
collaborator: 
Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and
      neck) and negatively impacts survival and other outcomes, but many patients have difficulty
      quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far
      have had limited success. This is a pilot randomized controlled trial designed to determine
      if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates
      for cancer patients who smoke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Smoking cessation
time frame: 8 weeks
description: Smoking cessation will be defined as BOTH (1) self-reported 7-day abstinence from smoking and (2) exhaled carbon monoxide level of 8 or lower as biochemical confirmation of abstinence.
arm group label: Comprehensive intervention
arm group type: Experimental
description: New evidence-based comprehensive smoking cessation intervention including several elements that have proven successful in non-cancer patients but not used for cancer patients before.
arm group label: Enhanced usual care
arm group type: Active Comparator
description: Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.
intervention type: Other
intervention name: Comprehensive smoking cessation intervention
arm group label: Comprehensive intervention
intervention type: Behavioral
intervention name: Enhanced usual care
arm group label: Enhanced usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 105 Years
healthy volunteers: No
last name: Gypsyamber D'Souza, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Head and Neck Neoplasms
mesh term: Thoracic Neoplasms
mesh term: Tobacco Use Disorder