<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/NCT03300284</url>
  </required_header>
  <id_info>
    <org_study_id>17-382</org_study_id>
    <nct_id>NCT03300284</nct_id>
  </id_info>
  <brief_title>Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer</brief_title>
  <official_title>Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to understand the decision-making process regarding management&#xD;
      choice in low-risk papillary thyroid cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">July 13, 2023</completion_date>
  <primary_completion_date type="Actual">July 13, 2023</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>influencing decision making pre-visit</measure>
    <time_frame>3 years</time_frame>
    <description>Patients will complete a pre-visit questionnaire and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>influencing decision making post-visit</measure>
    <time_frame>3 years</time_frame>
    <description>Patients will complete a post-visit questionnaire, and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">186</enrollment>
  <condition>Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Thyroid cancer</arm_group_label>
    <description>This study does not involve any intervention, but rather data collection on patient and physician preferences and beliefs, communication, and patient psychological outcomes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Quality of Life Questionnaires</description>
    <arm_group_label>Thyroid cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted primarily in the MSK endocrinology and surgery clinics, which&#xD;
        have a large volume of patients with LR-PTC choosing both surgery and AS. We also expect to&#xD;
        expand this study to several clinics within the MSK Alliance Network and outside&#xD;
        participating sites.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to read, write, and communicate in English Patients who have been diagnosed with&#xD;
             LR-PTC as described above&#xD;
&#xD;
          -  For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice&#xD;
             between surgery and AS&#xD;
&#xD;
          -  For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3&#xD;
             months prior, but no more than 4 years prior to their routine follow-up visit at which&#xD;
             they are being recruited for this study.&#xD;
&#xD;
          -  Active patients of MSK and participating institutions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have been diagnosed with a tumor greater than 2 cm&#xD;
&#xD;
          -  Patients with clinically suspicious lymphadenopathy in the neck&#xD;
&#xD;
          -  Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Roman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hartford Healthcare (Data Collection)</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (Consent and Follow up)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAIMONIDES MEDICAL CENTER (Data collection only)</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Decision Making</keyword>
  <keyword>17-382</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT03300284
org study id: 17-382
nct id: NCT03300284
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is being done to understand the decision-making process regarding management
      choice in low-risk papillary thyroid cancer.
observational model: Cohort
time perspective: Prospective
measure: influencing decision making pre-visit
time frame: 3 years
description: Patients will complete a pre-visit questionnaire and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
measure: influencing decision making post-visit
time frame: 3 years
description: Patients will complete a post-visit questionnaire, and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
arm group label: Thyroid cancer
description: This study does not involve any intervention, but rather data collection on patient and physician preferences and beliefs, communication, and patient psychological outcomes.
intervention type: Behavioral
intervention name: Questionnaires
description: Quality of Life Questionnaires
arm group label: Thyroid cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Roman, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Cancer, Papillary
mesh term: Thyroid Diseases