<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/NCT04502797</url>
  </required_header>
  <id_info>
    <org_study_id>19-01914</org_study_id>
    <nct_id>NCT04502797</nct_id>
  </id_info>
  <brief_title>A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)</brief_title>
  <acronym>ePVA</acronym>
  <official_title>A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York University</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>
      This randomized, non-blinded, phase 0/I study will assess the feasibility of conducting a&#xD;
      large randomized clinical trial to evaluate the efficacy of the ePVA to improve pain&#xD;
      management and HRQoL in HNC. Thirty participants undergoing radiation therapy (RT) (with or&#xD;
      without chemotherapy) will be randomized to: 1) ePVA intervention or 2) usual care. The&#xD;
      intervention consists of participants completing the ePVA every other week during radiation&#xD;
      therapy (RT), then weeks 4, 12, and 24 after end of RT. Automated reports of ePVA data,&#xD;
      including pain reports and patient-reports of pain medications, will be sent to providers to&#xD;
      inform their clinical decisions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Anticipated">March 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2022</primary_completion_date>
  <phase>Early Phase 1</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>Patient completion of 6 out of 7 assessments</measure>
    <time_frame>24 weeks</time_frame>
    <description>This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in health-related quality of life</measure>
    <time_frame>Baseline, week 4, week 12, week 24</time_frame>
    <description>Measured by EORTC QLQ-C30 global QoL/health scale, which consists of 30 questions, building five functional scales (physical, role, emotional, cognitive, social), a global QoL/health scale, symptom scales (fatigue, pain, nausea and vomiting, dyspnea, sleep disturbance, appetite loss, constipation and diarrhea) and perceived financial difficulties. The scale will be transformed to scores 0 to 100 (100 indicates best quality of life and 0 indicates least).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain severity</measure>
    <time_frame>Baseline, Day 7, Day 21, Day 35</time_frame>
    <description>Measured by European Organization for Research and Treatment of Cancer (EORTC) QLQ-H&amp;N-35 pain scale. The scale will be transformed to scores 0 to 100 (0 indicates least and 100 indicates most symptoms).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Interventional: Electronic Patient Visit Assessment (ePVA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants diagnosed with head and neck cancer randomized to usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Electronic Patient Visit Assessment (ePVA)</intervention_name>
    <description>The ePVA is an mHealth clinical support tool. The ePVA consists of a patient-reported measure that focuses on symptoms common to HNC (i.e. pain, eye, ear, nasal, mouth, voice, fibrosis, edema, skin, gastrointestinal, fatigue, limitation in movement, sleep, breathing, difficulty eating or drinking, swallowing, communication, social activities, anxiety, depression, and daily activities). PROMIS® questionnaires (pain intensity 3a, fatigue 6a, sleep disturbance 6a, anxiety 6a, depression 6a) are embedded within the ePVA.</description>
    <arm_group_label>Interventional: Electronic Patient Visit Assessment (ePVA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible to participate in this study, an individual must meet all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Histologically diagnosed HNC&#xD;
&#xD;
          2. Undergoing RT with or without chemotherapy,&#xD;
&#xD;
          3. English speaking,&#xD;
&#xD;
          4. aged 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Unable to attend scheduled appointment due to geographical, social or mental reseaons,&#xD;
&#xD;
          2. In the opinion of the investigator, is unable or unlikely to comply fully with the&#xD;
             study requirements or procedures for any reason (e.g. cognitve or physical&#xD;
             impairment).&#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 VanCleave, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Janet VanCleave, PhD, RN</last_name>
    <phone>212 - 992 - 7340</phone>
    <email>Janet.vancleave@nyu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>NYU Rory Meyers College of Nursing</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janet VanCleave, PhD, RN</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</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>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to janet.vancleave@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health.</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to janet.vancleave@nyu.edu</ipd_access_criteria>
  </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/NCT04502797
org study id: 19-01914
nct id: NCT04502797
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized, non-blinded, phase 0/I study will assess the feasibility of conducting a
      large randomized clinical trial to evaluate the efficacy of the ePVA to improve pain
      management and HRQoL in HNC. Thirty participants undergoing radiation therapy (RT) (with or
      without chemotherapy) will be randomized to: 1) ePVA intervention or 2) usual care. The
      intervention consists of participants completing the ePVA every other week during radiation
      therapy (RT), then weeks 4, 12, and 24 after end of RT. Automated reports of ePVA data,
      including pain reports and patient-reports of pain medications, will be sent to providers to
      inform their clinical decisions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Patient completion of 6 out of 7 assessments
time frame: 24 weeks
description: This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.
measure: Change in health-related quality of life
time frame: Baseline, week 4, week 12, week 24
description: Measured by EORTC QLQ-C30 global QoL/health scale, which consists of 30 questions, building five functional scales (physical, role, emotional, cognitive, social), a global QoL/health scale, symptom scales (fatigue, pain, nausea and vomiting, dyspnea, sleep disturbance, appetite loss, constipation and diarrhea) and perceived financial difficulties. The scale will be transformed to scores 0 to 100 (100 indicates best quality of life and 0 indicates least).
measure: Change in pain severity
time frame: Baseline, Day 7, Day 21, Day 35
description: Measured by European Organization for Research and Treatment of Cancer (EORTC) QLQ-H&N-35 pain scale. The scale will be transformed to scores 0 to 100 (0 indicates least and 100 indicates most symptoms).
arm group label: Interventional: Electronic Patient Visit Assessment (ePVA)
arm group type: Experimental
description: Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention
arm group label: Usual care
arm group type: No Intervention
description: Participants diagnosed with head and neck cancer randomized to usual care.
intervention type: Behavioral
intervention name: Electronic Patient Visit Assessment (ePVA)
description: The ePVA is an mHealth clinical support tool. The ePVA consists of a patient-reported measure that focuses on symptoms common to HNC (i.e. pain, eye, ear, nasal, mouth, voice, fibrosis, edema, skin, gastrointestinal, fatigue, limitation in movement, sleep, breathing, difficulty eating or drinking, swallowing, communication, social activities, anxiety, depression, and daily activities). PROMIS® questionnaires (pain intensity 3a, fatigue 6a, sleep disturbance 6a, anxiety 6a, depression 6a) are embedded within the ePVA.
arm group label: Interventional: Electronic Patient Visit Assessment (ePVA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janet VanCleave, PhD, RN
role: Principal Investigator
affiliation: NYU Langone Health
last name: Janet VanCleave, PhD, RN
phone: 212 - 992 - 7340
email: Janet.vancleave@nyu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: Yes
ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to janet.vancleave@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health.
ipd access criteria: Requests may be directed to janet.vancleave@nyu.edu