<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/NCT02211196</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00021885</org_study_id>
    <secondary_id>NCI-2014-01572</secondary_id>
    <secondary_id>CCCWFU #99413</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <nct_id>NCT02211196</nct_id>
  </id_info>
  <brief_title>Evidence-Based Tobacco Cessation Strategies in Patients With Cancer</brief_title>
  <official_title>Implementing Evidence-Based Tobacco Cessation Strategies in Oncology Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies evidence-based tobacco cessation strategies in patients&#xD;
      with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit&#xD;
      smoking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess oncology providers' self-reported need for training on evidence-based tobacco&#xD;
      cessation strategies and assess their level of interest in future training on evidence-based&#xD;
      tobacco cessation strategies.&#xD;
&#xD;
      II. To test the feasibility of the implementation of evidence-based tobacco cessation&#xD;
      strategies in community oncology clinics.&#xD;
&#xD;
      III. To test the feasibility of surveying community oncology patients after a clinic visit to&#xD;
      assess provider behavior regarding screening and brief intervention for tobacco use.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients complete a survey over approximately 10-15 minutes related to their provider's&#xD;
      cessation advice and assistance with quitting.&#xD;
&#xD;
      After completion of study, patients are followed up at 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Will be estimated and 95% confidence intervals (CI) constructed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage reporting feeling very confident in their ability to counsel smokers</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Will be estimated and 95% CI constructed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage reporting they would be willing to participate in training on evidence-based tobacco cessation strategies</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Will be estimated and 95% CI constructed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of oncology patients willing to complete a survey in an oncology clinic</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Will be estimated and 95% CI constructed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients who report that their provider asked about tobacco use during their visit</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of current smokers who report that their provider advised them to quit during their visit and provided tobacco-cessation strategies</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">377</enrollment>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Health Services Research (smoking cessation intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>smoking cessation intervention</intervention_name>
    <description>Receive evidence-based tobacco cessation strategies</description>
    <arm_group_label>Health Services Research (smoking cessation intervention)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>survey administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Health Services Research (smoking cessation intervention)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Health Services Research (smoking cessation intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with cancer who saw a provider will be eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a nurse or lab visit only&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin Sutfin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>July 2, 2018</last_update_submitted>
  <last_update_submitted_qc>July 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02211196
org study id: IRB00021885
secondary id: NCI-2014-01572
secondary id: CCCWFU #99413
secondary id: P30CA012197
nct id: NCT02211196
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial studies evidence-based tobacco cessation strategies in patients
      with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit
      smoking.
PRIMARY OBJECTIVES:

      I. To assess oncology providers' self-reported need for training on evidence-based tobacco
      cessation strategies and assess their level of interest in future training on evidence-based
      tobacco cessation strategies.

      II. To test the feasibility of the implementation of evidence-based tobacco cessation
      strategies in community oncology clinics.

      III. To test the feasibility of surveying community oncology patients after a clinic visit to
      assess provider behavior regarding screening and brief intervention for tobacco use.

      OUTLINE:

      Patients complete a survey over approximately 10-15 minutes related to their provider's
      cessation advice and assistance with quitting.

      After completion of study, patients are followed up at 1 month.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies
time frame: Up to 1 month
description: Will be estimated and 95% confidence intervals (CI) constructed.
measure: Percentage reporting feeling very confident in their ability to counsel smokers
time frame: Up to 1 month
description: Will be estimated and 95% CI constructed.
measure: Percentage reporting they would be willing to participate in training on evidence-based tobacco cessation strategies
time frame: Up to 1 month
description: Will be estimated and 95% CI constructed.
measure: Proportion of oncology patients willing to complete a survey in an oncology clinic
time frame: Up to 1 month
description: Will be estimated and 95% CI constructed.
measure: Proportion of patients who report that their provider asked about tobacco use during their visit
time frame: Up to 1 month
description: These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.
measure: Proportion of current smokers who report that their provider advised them to quit during their visit and provided tobacco-cessation strategies
time frame: Up to 1 month
description: These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.
arm group label: Health Services Research (smoking cessation intervention)
arm group type: Experimental
description: Participants complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.
intervention type: Behavioral
intervention name: smoking cessation intervention
description: Receive evidence-based tobacco cessation strategies
arm group label: Health Services Research (smoking cessation intervention)
intervention type: Other
intervention name: survey administration
description: Ancillary studies
arm group label: Health Services Research (smoking cessation intervention)
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Health Services Research (smoking cessation intervention)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Erin Sutfin
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms