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/NCT05974150</url>
    </required_header>
    <id_info>
      <org_study_id>OPT-IN Carevive Registry</org_study_id>
      <nct_id>NCT05974150</nct_id>
      <nct_alias>NCT05974137</nct_alias>
    </id_info>
    <brief_title>Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring</brief_title>
    <official_title>Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia (AML) Using Remote Symptom Monitoring</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Carevive Systems, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Carevive Systems, Inc.</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 goal of this study is to create a data set to add to Carevive's registry from real world&#xD;
        clinical and patient reported data collected using an electronic care planning system (CPS)&#xD;
        with remote symptom monitoring that is used in routine care for cancer patients on active&#xD;
        treatment.&#xD;
  &#xD;
        Patients will complete a baseline survey in person using a secured device or remotely using&#xD;
        their own electronic device in a location of their choice. Weekly electronic patient reported&#xD;
        outcome (PRO) surveys are collected from the patients using the Carevive platform for a&#xD;
        minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving&#xD;
        treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 19, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 5, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Create Data Set</measure>
      <time_frame>1 year</time_frame>
      <description>The goal of this registry is to create a data set from real world clinical and patient reported data collected using an electronic care planning system (CPS) that is used in routine care for cancer patients on active treatment</description>
    </primary_outcome>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Lung Cancer</condition>
    <condition>Multiple Myeloma</condition>
    <condition>Ovarian Cancer</condition>
    <condition>Acute Myelogenous Leukemia</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Web based survey</intervention_name>
      <description>online weekly survey</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients receiving cancer treatment for breast, lung, GI or multiple myeloma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All participants must be 18 years of age or older.&#xD;
  &#xD;
            -  Subjects may be any stage and anywhere in the treatment continuum.&#xD;
  &#xD;
            -  Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or&#xD;
               multiple myeloma.&#xD;
  &#xD;
            -  Subjects must be able to complete on-line surveys using a cell phone, tablet, or&#xD;
               computer.&#xD;
  &#xD;
            -  All participants must be able to understand English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any patient who cannot understand written or spoken English.&#xD;
  &#xD;
            -  Any patient without the ability to complete on-line surveys using a cell phone,&#xD;
               tablet, or computer.&#xD;
  &#xD;
            -  Any patient on a treatment clinical trial.&#xD;
  &#xD;
            -  Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B,&#xD;
               C and D).&#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_contact>
      <last_name>JULIE SCOTT, MSN</last_name>
      <phone>8778423210</phone>
      <email>Julie.Scott@Carevive.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Yale Cancer Center</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06511</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kim Blenman</last_name>
        <email>kim.blenman@yale.edu</email>
      </contact>
      <investigator>
        <last_name>Kim Blenman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Northshore University Health System</name>
        <address>
          <city>Evanston</city>
          <state>Illinois</state>
          <zip>31024</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michele Britto</last_name>
        <email>MBritto@northshore.org</email>
      </contact>
      <investigator>
        <last_name>Nicklas Pfanzelter</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Univeristy of North Carolina at Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miriam Perez</last_name>
        <email>miriam_perez@med.unc.edu</email>
      </contact>
      <investigator>
        <last_name>Ashley Bryant, Ph.D</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Duke</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27707</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kris Herring, Ph.D.</last_name>
        <email>kris.herring@duke.edu</email>
      </contact>
      <investigator>
        <last_name>Thomas Leblanc, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cleveland Clinic Mercy Hospital</name>
        <address>
          <city>Canton</city>
          <state>Ohio</state>
          <zip>44708</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Janet Muckley</last_name>
        <email>MUCKLEJ@ccf.org</email>
      </contact>
      <investigator>
        <last_name>Mitchell Haut, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Hospitals Seidman Cancer Center</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jill Severino-Powell, MSN</last_name>
        <email>Jill.Severino-Powell@UHhospitals.org</email>
      </contact>
      <investigator>
        <last_name>Alberto Montero, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tri-County Hematology &amp; Oncology Associates, Inc.</name>
        <address>
          <city>Massillon</city>
          <state>Ohio</state>
          <zip>44646</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Janet Muckley</last_name>
        <email>MUCKLEJ@ccf.org</email>
      </contact>
      <investigator>
        <last_name>Nagaprasad Nagajothi, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 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>Leukemia</mesh_term>
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
      <mesh_term>Leukemia, Myeloid</mesh_term>
      <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05974150
  org study id: OPT-IN Carevive Registry
  nct id: NCT05974150
  nct alias: NCT05974137
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to create a data set to add to Carevive's registry from real world
        clinical and patient reported data collected using an electronic care planning system (CPS)
        with remote symptom monitoring that is used in routine care for cancer patients on active
        treatment.
  
        Patients will complete a baseline survey in person using a secured device or remotely using
        their own electronic device in a location of their choice. Weekly electronic patient reported
        outcome (PRO) surveys are collected from the patients using the Carevive platform for a
        minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving
        treatment.
  observational model: Other
  time perspective: Prospective
  measure: Create Data Set
  time frame: 1 year
  description: The goal of this registry is to create a data set from real world clinical and patient reported data collected using an electronic care planning system (CPS) that is used in routine care for cancer patients on active treatment
  intervention type: Other
  intervention name: Web based survey
  description: online weekly survey
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: JULIE SCOTT, MSN
  phone: 8778423210
  email: Julie.Scott@Carevive.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  mesh term: Leukemia, Myeloid
  mesh term: Leukemia, Myeloid, Acute
  sharing ipd: No