<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/NCT02233842</url>
  </required_header>
  <id_info>
    <org_study_id>140189</org_study_id>
    <secondary_id>14-C-0189</secondary_id>
    <nct_id>NCT02233842</nct_id>
  </id_info>
  <brief_title>Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors</brief_title>
  <official_title>Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - People who have cancer have more medical problems if they smoke. Some studies show that&#xD;
      smoking even makes cancer treatment less effective. Researchers want to teach people about&#xD;
      how tobacco use affects people after a cancer diagnosis. They want to come up with questions&#xD;
      for people who have cancer and who have survived cancer. The questions will be about using&#xD;
      cigarettes and other tobacco products and about second-hand smoke.&#xD;
&#xD;
      The questions will be used to understand how using tobacco affects people with cancer before,&#xD;
      during, and after treatment. This will help doctors plan how to treat people with cancer and&#xD;
      create programs to help people quit smoking in the future.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To evaluate and refine questions that assess tobacco use.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any&#xD;
      site and any stage.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  This study will take about 1 hour.&#xD;
&#xD;
        -  Participants will meet one-on-one with an interviewer. They will fill out a&#xD;
           questionnaire and talk about the questions. Participants will explain how easy or hard&#xD;
           it was to answer the questions and how they decided on their answers.&#xD;
&#xD;
        -  All participants will be asked the same or very similar questions. Specific questions&#xD;
           will be based on the participants own experiences with tobacco products.&#xD;
&#xD;
        -  There will be no follow-up activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Studies comparing cancer patients who smoke cigarettes at the time of diagnosis to former or&#xD;
      never smokers have demonstrated increased difficulty with surgical wound healing and more&#xD;
      treatment morbidity; reduced radiation and chemotherapy efficacy; reduced time to recurrence,&#xD;
      progression, and second primary cancers; and increased mortality. Some studies have found&#xD;
      that smoking interacts with cancer therapy efficacy.&#xD;
&#xD;
      Cigarette smoking is prevalent among patients with lung and head and neck cancers, with rates&#xD;
      as high as 40% to 60% as of the time of diagnosis. The rate of smoking among cancer survivors&#xD;
      has been estimated as 21% for lung cancer survivors and 39% for survivors of other&#xD;
      cancers.(11)&#xD;
&#xD;
      Only 22% of NCI-funded phase III trials conducted by Cooperative Groups record patients&#xD;
      cigarette smoking status among patients at the time of enrollment, and 4% record cigarette&#xD;
      smoking status during follow-up.&#xD;
&#xD;
      We need to examine the impact of tobacco use on a wider range of therapeutic regimens and&#xD;
      settings, with more detailed longitudinal tobacco use assessment. Research in this area is&#xD;
      impeded by inadequate assessment of tobacco use after cancer diagnosis and a lack of valid,&#xD;
      harmonized measures that are tailored to the trajectory of cancer diagnosis, treatment and&#xD;
      survivorship.(15) The NCI-AACR Cancer Patient Tobacco Use Assessment Task Force formed in&#xD;
      2013 to develop recommendations for assessing tobacco use by cancer patients. The long- range&#xD;
      goal of the Task Force is to advance the state of knowledge about the effect of tobacco use&#xD;
      after a cancer diagnosis, to inform cancer treatment decision-making and to guide patients&#xD;
      and providers regarding the timing and clinical significance of tobacco cessation.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To evaluate and refine proposed questionnaire items that assess tobacco use.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Cancer patients with any disease site, stage, and extent of prior therapy and age greater&#xD;
      than or equal to 21 years.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This study will evaluate and refine proposed questionnaire items that assess tobacco use in&#xD;
      the cancer patient and survivor population. This study is purely qualitative. No research&#xD;
      hypotheses will be tested in this study. There will be no therapy, administration of&#xD;
      agent(s), or imaging administered as part of this study. Participants will only be asked to&#xD;
      answer questions and then discuss their answers to the questions.&#xD;
&#xD;
      Patients who consent will participate in a session that will last up to one hour. They will&#xD;
      complete a questionnaire about tobacco use and answer debriefing questions so that the&#xD;
      interviewer can assess question comprehension, ease of answering, and accuracy of response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants to Achieve Saturation in an English-language Paper Questionnaire</measure>
    <time_frame>Last subject interviewed, an average of 5 months</time_frame>
    <description>Saturation is defined as satisfactory measurement of performance without need of further review.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Smokers at the Time of the Interview</measure>
    <time_frame>Day 1 of interview</time_frame>
    <description>Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis</measure>
    <time_frame>Day 1 of interview</time_frame>
    <description>Current and former smokers who were smoking at the time of their cancer diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time From Cancer Diagnosis to the Date of the Interview</measure>
    <time_frame>up to 24 years</time_frame>
    <description>Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Bladder Cancer</condition>
  <condition>Thymic Cancer</condition>
  <arm_group>
    <arm_group_label>Tobacco Use in Cancer Pts &amp; Survivors</arm_group_label>
    <description>Cognitive testing (e.g. participant interview) of tobacco use in patients (pts) who have cancer and who have survived cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Participant interview</intervention_name>
    <description>People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.</description>
    <arm_group_label>Tobacco Use in Cancer Pts &amp; Survivors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults aged 21 or older who have cancer or are cancer survivors. The cancer can be at any&#xD;
        site and any stage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Patients with any prior confirmed cancer diagnosis being treated or followed at the Center&#xD;
        for Cancer Research, Bethesda, Maryland, will be eligible.&#xD;
&#xD;
        3.1.1 Cancer patients with any disease site, stage, and extent of prior therapy will be&#xD;
        eligible.&#xD;
&#xD;
        3.1.2 Patients age 21 years old and over will be eligible. The items are intended for use&#xD;
        with an adult population, so we need to test with representatives of that population.&#xD;
&#xD;
        3.1.3 Additional eligibility criteria:&#xD;
&#xD;
          -  Individuals must be able to understand and willing to answer items about their own&#xD;
             tobacco use.&#xD;
&#xD;
          -  Individuals must be able to read and speak English. For purposes of this study, we&#xD;
             will limit participation to adults who can self-consent and self-report in English&#xD;
             (vs. only being able to respond with the aid of a translator). The materials have been&#xD;
             developed in English; this is intended to be cognitive testing of an English language&#xD;
             questionnaire. (If a Spanish translation of the items will be developed in the future,&#xD;
             a separate cognitive testing effort will be needed to ensure cultural equivalence of&#xD;
             the items.)&#xD;
&#xD;
        3.1.4 Participants must be able to understand and be willing to sign a written informed&#xD;
        consent&#xD;
&#xD;
        document. All participants will be asked to provide explicit consent.&#xD;
&#xD;
        3.1.5 Participants are eligible whether they have never used tobacco products of any type,&#xD;
        used any type of tobacco previously, or are current tobacco users of any type. (Participant&#xD;
        recruitment will be designed to enroll a variety of patients with respect to tobacco use.)&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        None. (Patients may have already begun protocol treatment.)&#xD;
&#xD;
        INCLUSION OF WOMEN AND MINORITIES:&#xD;
&#xD;
        Both men and women of all races and ethnic groups are eligible for participation in testing&#xD;
        of the items. In fact, to the extent possible, we will try to include diversity of&#xD;
        demographic characteristics (age, race, gender, education level).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie R. Land, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-C-0189.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <results_reference>
    <citation>Land SR, Warren GW, Crafts JL, Hatsukami DK, Ostroff JS, Willis GB, Chollette VY, Mitchell SA, Folz JN, Gulley JL, Szabo E, Brandon TH, Duffy SA, Toll BA. Cognitive testing of tobacco use items for administration to patients with cancer and cancer survivors in clinical research. Cancer. 2016 Jun 1;122(11):1728-34. doi: 10.1002/cncr.29964. Epub 2016 Mar 28.</citation>
    <PMID>27019325</PMID>
  </results_reference>
  <results_reference>
    <citation>Land SR, Toll BA, Moinpour CM, Mitchell SA, Ostroff JS, Hatsukami DK, Duffy SA, Gritz ER, Rigotti NA, Brandon TH, Prindiville SA, Sarna LP, Schnoll RA, Herbst RS, Cinciripini PM, Leischow SJ, Dresler CM, Fiore MC, Warren GW. Research Priorities, Measures, and Recommendations for Assessment of Tobacco Use in Clinical Cancer Research. Clin Cancer Res. 2016 Apr 15;22(8):1907-13. doi: 10.1158/1078-0432.CCR-16-0104. Epub 2016 Feb 17.</citation>
    <PMID>26888828</PMID>
  </results_reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>June 16, 2016</results_first_submitted>
  <results_first_submitted_qc>June 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 27, 2016</results_first_posted>
  <last_update_submitted>August 1, 2016</last_update_submitted>
  <last_update_submitted_qc>August 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institutes of Health Clinical Center (CC)</investigator_affiliation>
    <investigator_full_name>Stephanie Land, Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Qualitative Data</keyword>
  <keyword>Questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thymus Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Thirty-five subjects were recruited for this trial but three were unavailable due to time constraints, one was hesitant to participate and one refused to participate. As a result, only 30 subjects were enrolled in the trial. Five participants were assessed for each of the 6 different questionnaires to total 30 participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tobacco Use in Cancer Patients and Survivors</title>
          <description>Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.&#xD;
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.&#xD;
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Questionnaire 1 Version 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Questionnaire 1 Version 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Questionnaire 2 Version 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Questionnaire 2 Version 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Questionnaire 3 Version 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Questionnaire 3 Version 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.&#xD;
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Age 20-29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 30-39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 40-49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 50-59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 60-69</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 70-79</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/PI (Pacific Islander)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education (highest level completed)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>High School/GED</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postgraduate degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarette smoking status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Former (quit at least 1yr prior to diagnosis)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former at enrollment;current at diagnosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never (current cigar smoker)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Prostate cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bladder cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lung cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pancreatic cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Testicular cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thyroid cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pleural mesothelioma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thymus cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Trials Participants Were Enrolled</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Tumor-directed therapy clinical trial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Observational study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients being screened for trial eligibility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants to Achieve Saturation in an English-language Paper Questionnaire</title>
        <description>Saturation is defined as satisfactory measurement of performance without need of further review.</description>
        <time_frame>Last subject interviewed, an average of 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>People who have cancer and who have survived cancer&#xD;
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants to Achieve Saturation in an English-language Paper Questionnaire</title>
          <description>Saturation is defined as satisfactory measurement of performance without need of further review.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Smokers at the Time of the Interview</title>
        <description>Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.</description>
        <time_frame>Day 1 of interview</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.&#xD;
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.&#xD;
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Smokers at the Time of the Interview</title>
          <description>Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Current Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former Smoker (quit 4-54 years ago)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cigar Smoker (never smoked cigarettes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis</title>
        <description>Current and former smokers who were smoking at the time of their cancer diagnosis.</description>
        <time_frame>Day 1 of interview</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.&#xD;
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.&#xD;
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis</title>
          <description>Current and former smokers who were smoking at the time of their cancer diagnosis.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Current Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time From Cancer Diagnosis to the Date of the Interview</title>
        <description>Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).</description>
        <time_frame>up to 24 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.&#xD;
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.&#xD;
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Cancer Diagnosis to the Date of the Interview</title>
          <description>Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).</description>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Tobacco Use in Cancer Patients and Survivors</title>
          <description>People who have cancer and who have survived cancer&#xD;
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Stephanie Land</name_or_title>
      <organization>National Cancer Institute (NCI)</organization>
      <phone>240-276-6946</phone>
      <email>stephanie.land@nih.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02233842
org study id: 140189
secondary id: 14-C-0189
nct id: NCT02233842
lead sponsor: 
has dmc: No
Background:

      - People who have cancer have more medical problems if they smoke. Some studies show that
      smoking even makes cancer treatment less effective. Researchers want to teach people about
      how tobacco use affects people after a cancer diagnosis. They want to come up with questions
      for people who have cancer and who have survived cancer. The questions will be about using
      cigarettes and other tobacco products and about second-hand smoke.

      The questions will be used to understand how using tobacco affects people with cancer before,
      during, and after treatment. This will help doctors plan how to treat people with cancer and
      create programs to help people quit smoking in the future.

      Objective:

      - To evaluate and refine questions that assess tobacco use.

      Eligibility:

      - Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any
      site and any stage.

      Design:

        -  This study will take about 1 hour.

        -  Participants will meet one-on-one with an interviewer. They will fill out a
           questionnaire and talk about the questions. Participants will explain how easy or hard
           it was to answer the questions and how they decided on their answers.

        -  All participants will be asked the same or very similar questions. Specific questions
           will be based on the participants own experiences with tobacco products.

        -  There will be no follow-up activities.
Background:

      Studies comparing cancer patients who smoke cigarettes at the time of diagnosis to former or
      never smokers have demonstrated increased difficulty with surgical wound healing and more
      treatment morbidity; reduced radiation and chemotherapy efficacy; reduced time to recurrence,
      progression, and second primary cancers; and increased mortality. Some studies have found
      that smoking interacts with cancer therapy efficacy.

      Cigarette smoking is prevalent among patients with lung and head and neck cancers, with rates
      as high as 40% to 60% as of the time of diagnosis. The rate of smoking among cancer survivors
      has been estimated as 21% for lung cancer survivors and 39% for survivors of other
      cancers.(11)

      Only 22% of NCI-funded phase III trials conducted by Cooperative Groups record patients
      cigarette smoking status among patients at the time of enrollment, and 4% record cigarette
      smoking status during follow-up.

      We need to examine the impact of tobacco use on a wider range of therapeutic regimens and
      settings, with more detailed longitudinal tobacco use assessment. Research in this area is
      impeded by inadequate assessment of tobacco use after cancer diagnosis and a lack of valid,
      harmonized measures that are tailored to the trajectory of cancer diagnosis, treatment and
      survivorship.(15) The NCI-AACR Cancer Patient Tobacco Use Assessment Task Force formed in
      2013 to develop recommendations for assessing tobacco use by cancer patients. The long- range
      goal of the Task Force is to advance the state of knowledge about the effect of tobacco use
      after a cancer diagnosis, to inform cancer treatment decision-making and to guide patients
      and providers regarding the timing and clinical significance of tobacco cessation.

      Objectives:

      To evaluate and refine proposed questionnaire items that assess tobacco use.

      Eligibility:

      Cancer patients with any disease site, stage, and extent of prior therapy and age greater
      than or equal to 21 years.

      Design:

      This study will evaluate and refine proposed questionnaire items that assess tobacco use in
      the cancer patient and survivor population. This study is purely qualitative. No research
      hypotheses will be tested in this study. There will be no therapy, administration of
      agent(s), or imaging administered as part of this study. Participants will only be asked to
      answer questions and then discuss their answers to the questions.

      Patients who consent will participate in a session that will last up to one hour. They will
      complete a questionnaire about tobacco use and answer debriefing questions so that the
      interviewer can assess question comprehension, ease of answering, and accuracy of response.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of Participants to Achieve Saturation in an English-language Paper Questionnaire
time frame: Last subject interviewed, an average of 5 months
description: Saturation is defined as satisfactory measurement of performance without need of further review.
measure: Number of Smokers at the Time of the Interview
time frame: Day 1 of interview
description: Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.
measure: Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis
time frame: Day 1 of interview
description: Current and former smokers who were smoking at the time of their cancer diagnosis.
measure: Time From Cancer Diagnosis to the Date of the Interview
time frame: up to 24 years
description: Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).
arm group label: Tobacco Use in Cancer Pts & Survivors
description: Cognitive testing (e.g. participant interview) of tobacco use in patients (pts) who have cancer and who have survived cancer.
intervention type: Behavioral
intervention name: Participant interview
description: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.
arm group label: Tobacco Use in Cancer Pts & Survivors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 110 Years
healthy volunteers: No
last name: Stephanie R. Land, Ph.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-C-0189.html
description: NIH Clinical Center Detailed Web Page
citation: Land SR, Warren GW, Crafts JL, Hatsukami DK, Ostroff JS, Willis GB, Chollette VY, Mitchell SA, Folz JN, Gulley JL, Szabo E, Brandon TH, Duffy SA, Toll BA. Cognitive testing of tobacco use items for administration to patients with cancer and cancer survivors in clinical research. Cancer. 2016 Jun 1;122(11):1728-34. doi: 10.1002/cncr.29964. Epub 2016 Mar 28.
PMID: 27019325
citation: Land SR, Toll BA, Moinpour CM, Mitchell SA, Ostroff JS, Hatsukami DK, Duffy SA, Gritz ER, Rigotti NA, Brandon TH, Prindiville SA, Sarna LP, Schnoll RA, Herbst RS, Cinciripini PM, Leischow SJ, Dresler CM, Fiore MC, Warren GW. Research Priorities, Measures, and Recommendations for Assessment of Tobacco Use in Clinical Cancer Research. Clin Cancer Res. 2016 Apr 15;22(8):1907-13. doi: 10.1158/1078-0432.CCR-16-0104. Epub 2016 Feb 17.
PMID: 26888828
responsible party type: Principal Investigator
investigator affiliation: National Institutes of Health Clinical Center (CC)
investigator full name: Stephanie Land, Ph.D.
investigator title: Principal Investigator
mesh term: Thymus Neoplasms
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 