xml: <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/NCT06036810</url>
    </required_header>
    <id_info>
      <org_study_id>2022-0539</org_study_id>
      <secondary_id>NCI-2023-07034</secondary_id>
      <nct_id>NCT06036810</nct_id>
    </id_info>
    <brief_title>Engaging Patients in Decision Making: The Development and Pilot Testing of a Low Literacy Spanish Language Shared Medical Decision Tool for Ovarian Cancer Maintenance Therapy</brief_title>
    <official_title>Engaging Patients in Decision Making: The Development and Pilot Testing of a Low Literacy Spanish Language Shared Medical Decision Tool for Ovarian Cancer Maintenance Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Merk</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>M.D. Anderson Cancer Center</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>
        To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make&#xD;
        decisions about their maintenance therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives:&#xD;
  &#xD;
          -  Create a low literacy version of a shared decision-making (SDM) tool for ovarian cancer&#xD;
             maintenance therapy for Spanish speaking individuals.&#xD;
  &#xD;
          -  To explore the feasibility and acceptability of incorporating the SDM tool into routine&#xD;
             clinical care for Spanish speaking individuals.&#xD;
  &#xD;
          -  To estimate the effectiveness of the SDM tool on quality of the decision making in&#xD;
             patients with ovarian cancer who are making decisions about maintenance therapy through&#xD;
             a pilot study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Decision Regret Scale questionnaire</measure>
      <time_frame>through study completion; an average of 1 year.</time_frame>
      <description>This scale measures decisional regret related to health care decisions at a specific point in time. This tool consists of 5 questions answered on a Likert scale (1=&quot;Strongly agree&quot; to 5=&quot;Strongly disagree&quot;).</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>Phase1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients for the initial testing of the SDM tool</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase2A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with Usual Care- Control</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase2B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with Shared medical decision tool- Intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Shared Medical Decision Tool</intervention_name>
      <description>standard of care</description>
      <arm_group_label>Phase1</arm_group_label>
      <arm_group_label>Phase2A</arm_group_label>
      <arm_group_label>Phase2B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Engaging Patients in Decision Making</intervention_name>
      <description>standard of care</description>
      <arm_group_label>Phase1</arm_group_label>
      <arm_group_label>Phase2A</arm_group_label>
      <arm_group_label>Phase2B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Literacy Spanish Language</intervention_name>
      <description>standard of care</description>
      <arm_group_label>Phase1</arm_group_label>
      <arm_group_label>Phase2A</arm_group_label>
      <arm_group_label>Phase2B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Study population: This study will enroll patients and clinical providers.&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Eligible patients must be: 1) individuals ≥ 18 years with advanced stage high grade&#xD;
               epithelial ovarian, fallopian tube or primary peritoneal cancer who are receiving or&#xD;
               have completed platinum-based chemotherapy for ovarian cancer and are potentially&#xD;
               eligible to receive maintenance therapy; 2) able to understand, speak or read in&#xD;
               Spanish.&#xD;
  &#xD;
            -  Eligible clinicians will include: 1) MD Anderson gynecologic oncologists and advanced&#xD;
               practice providers who practice at the Houston Area Locations (HALs), MD Anderson&#xD;
               Cancer Center, or our county safety net hospital, The Harris Health System (LBJ&#xD;
               Hospital).&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          1) Inability or unwillingness to sign informed consent&#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>Larissa Meyer, Meyer</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D. Anderson Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Larissa Meyer, M D</last_name>
      <phone>(713) 745-0973</phone>
      <email>Lmeyer@mdanderson.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>M D Anderson Cancer Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Larissa Meyer, M D</last_name>
        <phone>713-745-0973</phone>
        <email>lmeyer@mdanderson.org</email>
      </contact>
      <investigator>
        <last_name>Larissa Meyer, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mdanderson.org</url>
      <description>M D Anderson Cancer Center</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036810
  org study id: 2022-0539
  secondary id: NCI-2023-07034
  nct id: NCT06036810
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make
        decisions about their maintenance therapy
  Objectives:
  
          -  Create a low literacy version of a shared decision-making (SDM) tool for ovarian cancer
             maintenance therapy for Spanish speaking individuals.
  
          -  To explore the feasibility and acceptability of incorporating the SDM tool into routine
             clinical care for Spanish speaking individuals.
  
          -  To estimate the effectiveness of the SDM tool on quality of the decision making in
             patients with ovarian cancer who are making decisions about maintenance therapy through
             a pilot study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Decision Regret Scale questionnaire
  time frame: through study completion; an average of 1 year.
  description: This scale measures decisional regret related to health care decisions at a specific point in time. This tool consists of 5 questions answered on a Likert scale (1="Strongly agree" to 5="Strongly disagree").
  arm group label: Phase1
  arm group type: Experimental
  description: Patients for the initial testing of the SDM tool
  arm group label: Phase2A
  arm group type: Experimental
  description: Patients with Usual Care- Control
  arm group label: Phase2B
  arm group type: Experimental
  description: Patients with Shared medical decision tool- Intervention
  intervention type: Other
  intervention name: Shared Medical Decision Tool
  description: standard of care
  arm group label: Phase1
  arm group label: Phase2A
  arm group label: Phase2B
  intervention type: Behavioral
  intervention name: Engaging Patients in Decision Making
  description: standard of care
  arm group label: Phase1
  arm group label: Phase2A
  arm group label: Phase2B
  intervention type: Behavioral
  intervention name: Literacy Spanish Language
  description: standard of care
  arm group label: Phase1
  arm group label: Phase2A
  arm group label: Phase2B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Larissa Meyer, Meyer
  role: Principal Investigator
  affiliation: M.D. Anderson Cancer Center
  last name: Larissa Meyer, M D
  phone: (713) 745-0973
  email: Lmeyer@mdanderson.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://www.mdanderson.org
  description: M D Anderson Cancer Center
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial