<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/NCT03248635</url>
  </required_header>
  <id_info>
    <org_study_id>999917139</org_study_id>
    <secondary_id>17-C-N139</secondary_id>
    <nct_id>NCT03248635</nct_id>
  </id_info>
  <brief_title>Questionnaire Pre-Test Study</brief_title>
  <official_title>Online Questionnaire Pre-Test Study</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>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The Division of Cancer Epidemiology and Genetics does research into the causes of cancer and&#xD;
      ways to prevent it. It uses data from questionnaires. Sometimes, pre-testing a questionnaire&#xD;
      with a group of volunteers can help researchers find errors in it and learn ways to improve&#xD;
      it.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To test a questionnaire for problems that might cause response errors and to develop ideas&#xD;
      for improving it. To test how long it takes people to complete it.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Adults ages 35-75. Volunteers both with and without a history of tobacco use and with or&#xD;
      without a family history of cancer are needed.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with a phone call.&#xD;
&#xD;
      Participants will be told what background data to bring to the 1 study visit.&#xD;
&#xD;
      An interviewer will give the participants the questionnaire. It will be done with pen and&#xD;
      paper. It will take about 1 hour.&#xD;
&#xD;
      There will be multiple-choice and open-ended questions. They will be about lifestyle,&#xD;
      medical, and environmental factors. Some of the questions will be about possibly illegal or&#xD;
      highly sensitive behaviors.&#xD;
&#xD;
      Participants will note any questions that they find hard to answer for any reason. They will&#xD;
      be asked to answer the best they can, but they can skip any question that they prefer not to&#xD;
      answer.&#xD;
&#xD;
      The personal data of participants will be deleted when the study is done.&#xD;
&#xD;
      The interviewer will observe participants while they do the questionnaire. He or she will&#xD;
      look for things like long pauses and confusion.&#xD;
&#xD;
      Participants will discuss the exam with the interviewer after they finish. This will take&#xD;
      about 1 hour.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to conduct&#xD;
      broadbased, high quality, high impact research to uncover the causes of cancer and the means&#xD;
      of its prevention. To this end, DCEG relies on epidemiologic data captured on self-reported&#xD;
      questionnaires. The purpose of this pre-test study is to pilot a questionnaire to: (1) detect&#xD;
      problems that might contribute to response errors; (2) develop ideas for improving the&#xD;
      questionnaire in order to minimize such errors; and (3) assess the length of time to complete&#xD;
      the questionnaire. If there are specific sections of the questionnaire that are skipped by&#xD;
      all 30 initial participants, then six (6) additional, separate individuals may be invited to&#xD;
      pre-test the questionnaire for sections that were missed by the initial set of participants.&#xD;
      After a post-revision of the questionnaire based on the pre-test results, up to 10&#xD;
      additional, separate individuals will be invited to test the revised questionnaire for&#xD;
      duration and comprehensibility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2018</start_date>
  <completion_date type="Actual">April 2, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Understanding of the Questionnaire</measure>
    <time_frame>Time of Interview</time_frame>
    <description>Response errors and comments on interpretation of questions and response categories, and the duration needed to complete the questionnaire modules.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Focus group</arm_group_label>
    <description>Male and female adults age 40-75</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Convenience sample of adult volunteers in geographic proximity to contractor in Durham, NC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  ELIGIBILITY CRITERIA:&#xD;
&#xD;
          -  Age 35 to 75&#xD;
&#xD;
          -  Men or women&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Able to come to the SSS Durham, NC offices for the in-person interview&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark P Purdue, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Social &amp;amp; Scientific Systems, INC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Survey</keyword>
  <keyword>Pre-Test</keyword>
  <!-- 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/NCT03248635
org study id: 999917139
secondary id: 17-C-N139
nct id: NCT03248635
lead sponsor: 
Background:

      The Division of Cancer Epidemiology and Genetics does research into the causes of cancer and
      ways to prevent it. It uses data from questionnaires. Sometimes, pre-testing a questionnaire
      with a group of volunteers can help researchers find errors in it and learn ways to improve
      it.

      Objectives:

      To test a questionnaire for problems that might cause response errors and to develop ideas
      for improving it. To test how long it takes people to complete it.

      Eligibility:

      Adults ages 35-75. Volunteers both with and without a history of tobacco use and with or
      without a family history of cancer are needed.

      Design:

      Participants will be screened with a phone call.

      Participants will be told what background data to bring to the 1 study visit.

      An interviewer will give the participants the questionnaire. It will be done with pen and
      paper. It will take about 1 hour.

      There will be multiple-choice and open-ended questions. They will be about lifestyle,
      medical, and environmental factors. Some of the questions will be about possibly illegal or
      highly sensitive behaviors.

      Participants will note any questions that they find hard to answer for any reason. They will
      be asked to answer the best they can, but they can skip any question that they prefer not to
      answer.

      The personal data of participants will be deleted when the study is done.

      The interviewer will observe participants while they do the questionnaire. He or she will
      look for things like long pauses and confusion.

      Participants will discuss the exam with the interviewer after they finish. This will take
      about 1 hour.
The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to conduct
      broadbased, high quality, high impact research to uncover the causes of cancer and the means
      of its prevention. To this end, DCEG relies on epidemiologic data captured on self-reported
      questionnaires. The purpose of this pre-test study is to pilot a questionnaire to: (1) detect
      problems that might contribute to response errors; (2) develop ideas for improving the
      questionnaire in order to minimize such errors; and (3) assess the length of time to complete
      the questionnaire. If there are specific sections of the questionnaire that are skipped by
      all 30 initial participants, then six (6) additional, separate individuals may be invited to
      pre-test the questionnaire for sections that were missed by the initial set of participants.
      After a post-revision of the questionnaire based on the pre-test results, up to 10
      additional, separate individuals will be invited to test the revised questionnaire for
      duration and comprehensibility.
observational model: Other
time perspective: Cross-Sectional
measure: Understanding of the Questionnaire
time frame: Time of Interview
description: Response errors and comments on interpretation of questions and response categories, and the duration needed to complete the questionnaire modules.
arm group label: Focus group
description: Male and female adults age 40-75
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mark P Purdue, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
responsible party type: Sponsor