<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/NCT04463719</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202000837-N</org_study_id>
    <secondary_id>1K08CA248972-01</secondary_id>
    <secondary_id>5K08CA248972-02</secondary_id>
    <secondary_id>OCR34613</secondary_id>
    <nct_id>NCT04463719</nct_id>
  </id_info>
  <brief_title>AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid</brief_title>
  <official_title>Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</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>
      There is an epidemic of thyroid cancer that is harmful to patients and the medical system.&#xD;
      The study hypothesizes that the use of an electronic conversation aid during clinical visits&#xD;
      can help patients and clinicians collaborate. The study aims to update a conversation aid&#xD;
      prototype that was developed to support shared decision making in the diagnosis of thyroid&#xD;
      cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger&#xD;
      efficacy study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 20, 2022</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of eligible patients for feasibility</measure>
    <time_frame>at 6 months of follow up</time_frame>
    <description>Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Thyroid Nodules</condition>
  <condition>Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Counseling using the electronic conversation aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine counseling only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling using the electronic conversation aid</intervention_name>
    <description>Patients receive counseling about thyroid biopsy with the use of the conversation aid.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>counseling by routine care</intervention_name>
    <description>Patients receive counseling by routine care without the use of the conversation aid</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults &gt;18 years old presenting for evaluation of a thyroid nodule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hyperthyroidism&#xD;
&#xD;
          -  Patients with previous biopsy of the nodule of interest&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naykky Singh Ospina</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naykky Singh Ospina, MD</last_name>
      <phone>352-273-8656</phone>
      <email>Naykky.SinghOspina@medicine.ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Naykky Singh Ospina</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Emma Behnken</last_name>
      <email>Behnken.Emma@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Victor Montori</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>thyroid nodules</keyword>
  <keyword>shared decision making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <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/NCT04463719
org study id: IRB202000837-N
secondary id: 1K08CA248972-01
secondary id: 5K08CA248972-02
secondary id: OCR34613
nct id: NCT04463719
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is an epidemic of thyroid cancer that is harmful to patients and the medical system.
      The study hypothesizes that the use of an electronic conversation aid during clinical visits
      can help patients and clinicians collaborate. The study aims to update a conversation aid
      prototype that was developed to support shared decision making in the diagnosis of thyroid
      cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger
      efficacy study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of eligible patients for feasibility
time frame: at 6 months of follow up
description: Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).
arm group label: Intervention group
arm group type: Experimental
description: Counseling using the electronic conversation aid
arm group label: Control Group
arm group type: Active Comparator
description: Routine counseling only
intervention type: Behavioral
intervention name: Counseling using the electronic conversation aid
description: Patients receive counseling about thyroid biopsy with the use of the conversation aid.
arm group label: Intervention group
intervention type: Behavioral
intervention name: counseling by routine care
description: Patients receive counseling by routine care without the use of the conversation aid
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Naykky Singh Ospina
role: Principal Investigator
affiliation: University of Florida
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases
sharing ipd: No