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/NCT06030011</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-SN-23-0784</org_study_id>
      <nct_id>NCT06030011</nct_id>
    </id_info>
    <brief_title>Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations</brief_title>
    <official_title>Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>New York University Meyers College of Nursing</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>New York University Langone Perlmutter Cancer Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Kansas</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Fox Chase Cancer Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</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>
        The PI and the research team developed the New York University (NYU) Electronic Patient Visit&#xD;
        Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO)&#xD;
        for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported&#xD;
        symptom monitoring system, providing actionable information at point-of-care that enables&#xD;
        clinicians to provide real-time interventions. The study aims to advance the science of&#xD;
        cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported&#xD;
        monitoring system for patients with HNC in real-world settings and identify implementation&#xD;
        strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings.&#xD;
        The study hypothesis is that participants assigned to the ePVA arm will have better&#xD;
        swallowing, taste and smell, and social function than participants assigned to usual care arm&#xD;
        at 4 weeks after completing radiation therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)</measure>
      <time_frame>4 weeks after completing radiation therapy</time_frame>
      <description>The EORTC QLQ-C30 and QLQ-H&amp;N35 will be used to measure head and neck cancer symptoms, such as social function, senses of taste and smell, and swallowing. The scores will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain as assessed by EORTC QLQ-H&amp;N35 Quality of Life Questionnaire (QLQ)</measure>
      <time_frame>4 weeks after completing radiation therapy</time_frame>
      <description>The EORTC QLQ-H&amp;N35 will be used to assess pain. The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)</measure>
      <time_frame>4 weeks after completing radiation therapy</time_frame>
      <description>The EORTC QLQ-H&amp;N35 will be used to assess Health-Related Quality of Life (HRQoL). The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute Care Services Use as assessed by number of acute care visits</measure>
      <time_frame>4 weeks after completing radiation therapy</time_frame>
      <description>Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute Care Services Use as assessed by number of days of using acute care</measure>
      <time_frame>4 weeks after completing radiation therapy</time_frame>
      <description>Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">270</enrollment>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>NYU Electronic Patient Visit Assessment (ePVA)</intervention_name>
      <description>The NYU Electronic Patient Visit Assessment (ePVA) for head and neck cancer is a digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. Patients access the ePVA through a web link and complete the survey questions within 10 minutes on digital devices (e.g., smart phones, laptops, or digital devices provided by the clinic).</description>
      <arm_group_label>NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>Usual care encompasses pre-treatment, on treatment, and post-treatment care. Pre-treatment care includes education of patients on the treatment plan. On-treatment care includes daily monitoring by a nurse in the radiation therapy (RT) department, weekly on-treatment visits with the RT nurse practitioner and radiation oncologist, and weekly visits with medical oncology nurse practitioners and medical oncologists for patients receiving RT plus chemotherapy. Post-treatment care includes follow-up visits with HNC clinicians (i.e., surgeon, medical oncologist, oral maxillofacial surgeons, and radiation oncologist) to assess the patient's cancer status and identify the patient's acute and long-term symptoms. The clinician's decisions on radiologic exams and referrals to appropriate specialist services, including dental care, are based on the patient's cancer status and symptoms.</description>
      <arm_group_label>NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (Patient Participants):&#xD;
  &#xD;
            -  Individuals with histologically diagnosed head and neck cancer (HNC) undergoing&#xD;
               curative radiation therapy with or without chemotherapy&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
          Inclusion Criteria (Clinician Participants):&#xD;
  &#xD;
            -  Clinicians (i.e., physicians, nurses, dentists, physician assistants, social workers,&#xD;
               nutritionists, speech swallow therapists) caring for patients with head and neck&#xD;
               cancer at the participating institutions&#xD;
  &#xD;
          Exclusion Criteria (Patient and Clinician Participants):&#xD;
  &#xD;
            -  Any medical condition that could limit the participant's ability to provide informed&#xD;
               consent and complete the questionnaires.&#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>Janet H. Van Cleave, PhD, RN</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center at Houston (UTHealth Houston)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Janet H. Van Cleave, PhD, RN</last_name>
      <phone>(713) 500-2000</phone>
      <email>Janet.H.VanCleave@uth.tmc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Kansas Cancer Center</name>
        <address>
          <city>Kansas City</city>
          <state>Kansas</state>
          <zip>66160</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Chris Lominska, MD</last_name>
        <email>clominska@kumc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>NYU Meyers College of Nursing</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10010</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Abraham A. Brody, PhD, RN</last_name>
        <email>ab.brody@nyu.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>NYU Langone Perlmutter Cancer Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kenneth Hu, MD</last_name>
        <email>Kenneth.Hu@nyulangone.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fox Chase Cancer Center</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19111</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jessica Bauman, MD</last_name>
        <email>Jessica.Bauman@fccc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UTHealth Houston Cizik School of Nursing</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Janet H. Van Cleave, PhD, RN</last_name>
        <email>Janet.H.VanCleave@uth.tmc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Janet Van Cleave</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Head and Neck Neoplasms</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/NCT06030011
  org study id: HSC-SN-23-0784
  nct id: NCT06030011
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The PI and the research team developed the New York University (NYU) Electronic Patient Visit
        Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO)
        for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported
        symptom monitoring system, providing actionable information at point-of-care that enables
        clinicians to provide real-time interventions. The study aims to advance the science of
        cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported
        monitoring system for patients with HNC in real-world settings and identify implementation
        strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings.
        The study hypothesis is that participants assigned to the ePVA arm will have better
        swallowing, taste and smell, and social function than participants assigned to usual care arm
        at 4 weeks after completing radiation therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
  time frame: 4 weeks after completing radiation therapy
  description: The EORTC QLQ-C30 and QLQ-H&N35 will be used to measure head and neck cancer symptoms, such as social function, senses of taste and smell, and swallowing. The scores will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.
  measure: Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)
  time frame: 4 weeks after completing radiation therapy
  description: The EORTC QLQ-H&N35 will be used to assess pain. The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.
  measure: Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)
  time frame: 4 weeks after completing radiation therapy
  description: The EORTC QLQ-H&N35 will be used to assess Health-Related Quality of Life (HRQoL). The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.
  measure: Acute Care Services Use as assessed by number of acute care visits
  time frame: 4 weeks after completing radiation therapy
  description: Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.
  measure: Acute Care Services Use as assessed by number of days of using acute care
  time frame: 4 weeks after completing radiation therapy
  description: Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.
  arm group label: NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
  arm group type: Experimental
  arm group label: Usual Care
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: NYU Electronic Patient Visit Assessment (ePVA)
  description: The NYU Electronic Patient Visit Assessment (ePVA) for head and neck cancer is a digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. Patients access the ePVA through a web link and complete the survey questions within 10 minutes on digital devices (e.g., smart phones, laptops, or digital devices provided by the clinic).
  arm group label: NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
  intervention type: Behavioral
  intervention name: Usual Care
  description: Usual care encompasses pre-treatment, on treatment, and post-treatment care. Pre-treatment care includes education of patients on the treatment plan. On-treatment care includes daily monitoring by a nurse in the radiation therapy (RT) department, weekly on-treatment visits with the RT nurse practitioner and radiation oncologist, and weekly visits with medical oncology nurse practitioners and medical oncologists for patients receiving RT plus chemotherapy. Post-treatment care includes follow-up visits with HNC clinicians (i.e., surgeon, medical oncologist, oral maxillofacial surgeons, and radiation oncologist) to assess the patient's cancer status and identify the patient's acute and long-term symptoms. The clinician's decisions on radiologic exams and referrals to appropriate specialist services, including dental care, are based on the patient's cancer status and symptoms.
  arm group label: NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Janet H. Van Cleave, PhD, RN
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center at Houston (UTHealth Houston)
  last name: Janet H. Van Cleave, PhD, RN
  phone: (713) 500-2000
  email: Janet.H.VanCleave@uth.tmc.edu
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Janet Van Cleave
  investigator title: Associate Professor
  mesh term: Head and Neck Neoplasms
  sharing ipd: No