<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/NCT03231852</url>
  </required_header>
  <id_info>
    <org_study_id>19844</org_study_id>
    <nct_id>NCT03231852</nct_id>
  </id_info>
  <brief_title>Patient Perceptions and Willingness to Enroll in Clinical Trials</brief_title>
  <official_title>Patient Perceptions and Willingness to Enroll in Clinical Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</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>
      The objective of our study is to determine which factors affect willingness to participate in&#xD;
      gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will&#xD;
      be approached to complete a survey assessing willingness to participate in clinical trials.&#xD;
      The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess&#xD;
      willingness to participate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Willingness to Participate in Clinical Trials</measure>
    <time_frame>6 months</time_frame>
    <description>Bivariate outcome derived from ARTQ survey</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">166</enrollment>
  <condition>Cancer, Clinical Trials</condition>
  <arm_group>
    <arm_group_label>Study Population</arm_group_label>
    <description>Women with a gynecologic malignancy will complete several surveys to assess their willingness to participate in clinical trials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>Attitudes and Randomized Trial Questionnaire (ARTQ), Hospital Anxiety and Depression Scale, Perception Survey</description>
    <arm_group_label>Study Population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All women presenting to the gynecologic oncology clinic meeting the inclusion/exclusion&#xD;
        criteria will be approached to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of gynecologic malignancy&#xD;
&#xD;
          -  English or Spanish literate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior enrollment in a clinical trial&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Currently incarcerated&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Duska, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Linda R Duska</investigator_full_name>
    <investigator_title>Professor, Department of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03231852
org study id: 19844
nct id: NCT03231852
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of our study is to determine which factors affect willingness to participate in
      gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will
      be approached to complete a survey assessing willingness to participate in clinical trials.
      The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess
      willingness to participate.
observational model: Cohort
time perspective: Prospective
measure: Willingness to Participate in Clinical Trials
time frame: 6 months
description: Bivariate outcome derived from ARTQ survey
arm group label: Study Population
description: Women with a gynecologic malignancy will complete several surveys to assess their willingness to participate in clinical trials.
intervention type: Other
intervention name: Survey
description: Attitudes and Randomized Trial Questionnaire (ARTQ), Hospital Anxiety and Depression Scale, Perception Survey
arm group label: Study Population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Linda Duska, MD, MPH
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Linda R Duska
investigator title: Professor, Department of Obstetrics and Gynecology
sharing ipd: No