<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/NCT02253238</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0535</org_study_id>
    <secondary_id>1R01CA177914-01</secondary_id>
    <secondary_id>NCI-2015-00946</secondary_id>
    <nct_id>NCT02253238</nct_id>
  </id_info>
  <brief_title>Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients</brief_title>
  <official_title>Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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 research study is to learn if home-use of devices to identify dehydration&#xD;
      risk, when added to standard care, will help to lower hospitalizations and emergency room&#xD;
      visits (and related costs) in patients with head and neck cancer.&#xD;
&#xD;
      CYCORE is a software-based system that enables comprehensive collection, storage and analysis&#xD;
      of information related to cancer research and clinical care. In this study, those in the&#xD;
      CYCORE group use devices at home to measure their dehydration risk. This information is&#xD;
      monitored by their clinicians. Those in the standard care group complete health based&#xD;
      surveys, as do those in the CYCORE group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstract:&#xD;
&#xD;
      While head and neck cancer (HNC) is highly curable, primary radiation treatment (RT) is&#xD;
      nonetheless challenging. Despite intensive, high-quality, multidisciplinary symptom&#xD;
      management of HNC patients during RT, up to 80% of these patients experience moderate to&#xD;
      severe levels of oral mucositis making it nearly impossible to drink sufficient fluids and&#xD;
      necessitating opioid care for pain. Our data show that 27 - 32% of HNC patients are admitted&#xD;
      to inpatient or emergency room (ER) units during RT. Those admissions related to dehydration&#xD;
      (and the accompanying costs) are largely preventable, provided at-risk patients can be&#xD;
      identified early for intravenous fluid rehydration. Currently, given standard of care for HNC&#xD;
      patients undergoing RT, clinicians assess patients only once per week during standard clinic&#xD;
      visits. However, the physiological changes underlying the onset of dehydration can develop&#xD;
      rapidly, often between clinic visits. In the proposed project, we focus on this missed&#xD;
      opportunity for prevention by testing the efficacy of a novel method for home-based&#xD;
      dehydration assessment and early intervention to reduce dehydration risk.&#xD;
&#xD;
      This project assesses the efficacy of a coordinated dehydration prevention program using a&#xD;
      system (CYCORE) that links home-based monitoring sensors--that collect biometric and&#xD;
      self-reported symptom data--to a cyber-infrastructure (CI) and sends these data daily to the&#xD;
      patient's healthcare team, who in turn monitor the patients for early signs of dehydration&#xD;
      and provide earlier clinical intervention, when needed. The project is based on our&#xD;
      successful pilot study that evaluated the feasibility of CYCORE use in HNC patients and with&#xD;
      their radiology healthcare team. The patients reported high acceptability of the system,&#xD;
      while clinicians perceived the data as valuable and useful in providing additional&#xD;
      information regarding patient's at-home dehydration status. We will randomize a total of 192&#xD;
      HNC patients receiving RT at MD Anderson Cancer Center (MDACC) to either standard care or&#xD;
      CYCORE + standard care (CYCORE). We hypothesize that patients randomized to CYCORE will&#xD;
      experience fewer hospitalizations and ER admissions (and fewer associated costs) due to&#xD;
      dehydration compared with patients in the standard care arm.&#xD;
&#xD;
      To the best of our knowledge, the application of a system such as CYCORE has not been&#xD;
      explored in the HNC population. Objective, home-based monitoring may be an optimal method of&#xD;
      capturing data critical to early evaluation of dehydration risk; other methods, such as&#xD;
      patient self-report, are limited by the patient's ability to accurately recall symptoms.&#xD;
      MDACC is an ideal environment for conducting the proposed study; more HNC patients are&#xD;
      treated with RT at MDACC compared with any other center in Texas, and it is possible to track&#xD;
      outcomes and cost-related data, given the HNC patients receive all of their RT-related care,&#xD;
      including related hospitalization and ER admissions, at one center. If our efficacy study&#xD;
      proves successful, this dehydration prevention model can potentially be applied to other&#xD;
      health conditions and in other settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 7, 2014</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison Between the Two Groups of the Number of Hospitalizations and ER Visits Due to Dehydration</measure>
    <time_frame>12 - 15 weeks</time_frame>
    <description>Primary outcome is proportion of patients who experience ER visits and/or hospitalizations related to dehydration (ERV) combined with ER visits resulting in hospitalization through the 6-7 weeks of RT. Primary analysis is comparison of proportion of patients in CYCORE group who have an ERV or ERHV and proportion of patients in the standard care group who have an ERV or ERHV. Analysis consists of a binomial test of two proportions using a continuity-corrected chi-square test. Analyses will follow the intention-to-treat principle, that is a patient in either arm who drops out is assumed to have an ERV and/or ERHV. For comparison purposes, data will be analyzed only using patients who have completed the study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">427</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Standard of Care Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Surveys administered in person or by telephone interview and are audio-recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CYCORE Group + Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer).&#xD;
Surveys administered in person or by telephone interview and are audio-recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality of Life Survey</intervention_name>
    <description>Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT.</description>
    <arm_group_label>CYCORE Group + Standard of Care</arm_group_label>
    <arm_group_label>Standard of Care Group</arm_group_label>
    <other_name>Survey</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Management Surveys</intervention_name>
    <description>Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.</description>
    <arm_group_label>CYCORE Group + Standard of Care</arm_group_label>
    <arm_group_label>Standard of Care Group</arm_group_label>
    <other_name>Questionnaires</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Monitoring Devices</intervention_name>
    <description>Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer)</description>
    <arm_group_label>CYCORE Group + Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Symptoms Surveys</intervention_name>
    <description>Behavioral: Symptoms survey 1; completed at weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.&#xD;
Behaviorial: Symptoms survey 2; completed at baseline, weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.</description>
    <arm_group_label>CYCORE Group + Standard of Care</arm_group_label>
    <arm_group_label>Standard of Care Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Device Usability Survey</intervention_name>
    <description>Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.</description>
    <arm_group_label>CYCORE Group + Standard of Care</arm_group_label>
    <other_name>Questionnaire</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of any of the following cancers: stage 1-4b (includes 4a) oropharyngeal,&#xD;
             hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b (includes&#xD;
             4a) laryngeal; any unknown primary head and neck cancer with cervical metastasis that&#xD;
             will be addressed with treatment to bilateral necks and mucosa; any thyroid cancer&#xD;
             that will be addressed with treatment to the bilateral necks; or other head and neck&#xD;
             cancers medically approved by one of our Radiation Oncology collaborating MDs&#xD;
&#xD;
          2. Currently receiving (or scheduled to receive) radiation treatment for a cancer listed&#xD;
             in the inclusion criteria&#xD;
&#xD;
          3. Age 18 years or older&#xD;
&#xD;
          4. Fluent in English&#xD;
&#xD;
          5. Radiation treatment for this cancer was completed (or will be completed) at MD&#xD;
             Anderson Cancer Center (Post-RT study only)&#xD;
&#xD;
          6. Receiving radiation treatment for this cancer at any site within the MDACC Cancer&#xD;
             Network (Cancer Network study only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Overt cognitive difficulty demonstrated by not being clearly oriented to person or&#xD;
             place or time&#xD;
&#xD;
          2. Zubrod Performance Status &gt;2, or self-reports either not being up and about more than&#xD;
             50% of waking hours or unable to provide self-care&#xD;
&#xD;
          3. History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g.&#xD;
             dysphagia due to underlying neurogenic disorder)&#xD;
&#xD;
          4. Orthopedic, neurologic, or musculoskeletal disability that would interfere with the&#xD;
             functional task of standing on a weight scale&#xD;
&#xD;
          5. Scheduled to receive or receiving unilateral radiation treatment for this cancer&#xD;
&#xD;
          6. Received previous radiation treatment for head and neck cancer&#xD;
&#xD;
          7. Consented to enroll in a trial with a toxicity endpoint&#xD;
&#xD;
          8. Undergoing only palliative (not curative) radiation treatment&#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>Susan K. Peterson, PHD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Head and Neck Cancer</keyword>
  <keyword>Dehydration</keyword>
  <keyword>Sensor-based home monitoring</keyword>
  <keyword>Radiation therapy</keyword>
  <keyword>RT</keyword>
  <keyword>XRT</keyword>
  <keyword>Oropharyngeal cancer</keyword>
  <keyword>Hypopharyngeal cancer</keyword>
  <keyword>Nasopharyngeal cancer</keyword>
  <keyword>Salivary gland cancer</keyword>
  <keyword>Oral cavity cancer</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <keyword>Quality of life</keyword>
  <keyword>QOL</keyword>
  <keyword>Phone calls</keyword>
  <keyword>Self-monitoring devices</keyword>
  <keyword>CYberinfrastructure for COmparative effectiveness REsearch</keyword>
  <keyword>CYCORE</keyword>
  <keyword>Emergency room visits</keyword>
  <keyword>ER</keyword>
  <keyword>Emergency room visits with hospitalization</keyword>
  <keyword>ERHV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Dehydration</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/NCT02253238
org study id: 2013-0535
secondary id: 1R01CA177914-01
secondary id: NCI-2015-00946
nct id: NCT02253238
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to learn if home-use of devices to identify dehydration
      risk, when added to standard care, will help to lower hospitalizations and emergency room
      visits (and related costs) in patients with head and neck cancer.

      CYCORE is a software-based system that enables comprehensive collection, storage and analysis
      of information related to cancer research and clinical care. In this study, those in the
      CYCORE group use devices at home to measure their dehydration risk. This information is
      monitored by their clinicians. Those in the standard care group complete health based
      surveys, as do those in the CYCORE group.
Abstract:

      While head and neck cancer (HNC) is highly curable, primary radiation treatment (RT) is
      nonetheless challenging. Despite intensive, high-quality, multidisciplinary symptom
      management of HNC patients during RT, up to 80% of these patients experience moderate to
      severe levels of oral mucositis making it nearly impossible to drink sufficient fluids and
      necessitating opioid care for pain. Our data show that 27 - 32% of HNC patients are admitted
      to inpatient or emergency room (ER) units during RT. Those admissions related to dehydration
      (and the accompanying costs) are largely preventable, provided at-risk patients can be
      identified early for intravenous fluid rehydration. Currently, given standard of care for HNC
      patients undergoing RT, clinicians assess patients only once per week during standard clinic
      visits. However, the physiological changes underlying the onset of dehydration can develop
      rapidly, often between clinic visits. In the proposed project, we focus on this missed
      opportunity for prevention by testing the efficacy of a novel method for home-based
      dehydration assessment and early intervention to reduce dehydration risk.

      This project assesses the efficacy of a coordinated dehydration prevention program using a
      system (CYCORE) that links home-based monitoring sensors--that collect biometric and
      self-reported symptom data--to a cyber-infrastructure (CI) and sends these data daily to the
      patient's healthcare team, who in turn monitor the patients for early signs of dehydration
      and provide earlier clinical intervention, when needed. The project is based on our
      successful pilot study that evaluated the feasibility of CYCORE use in HNC patients and with
      their radiology healthcare team. The patients reported high acceptability of the system,
      while clinicians perceived the data as valuable and useful in providing additional
      information regarding patient's at-home dehydration status. We will randomize a total of 192
      HNC patients receiving RT at MD Anderson Cancer Center (MDACC) to either standard care or
      CYCORE + standard care (CYCORE). We hypothesize that patients randomized to CYCORE will
      experience fewer hospitalizations and ER admissions (and fewer associated costs) due to
      dehydration compared with patients in the standard care arm.

      To the best of our knowledge, the application of a system such as CYCORE has not been
      explored in the HNC population. Objective, home-based monitoring may be an optimal method of
      capturing data critical to early evaluation of dehydration risk; other methods, such as
      patient self-report, are limited by the patient's ability to accurately recall symptoms.
      MDACC is an ideal environment for conducting the proposed study; more HNC patients are
      treated with RT at MDACC compared with any other center in Texas, and it is possible to track
      outcomes and cost-related data, given the HNC patients receive all of their RT-related care,
      including related hospitalization and ER admissions, at one center. If our efficacy study
      proves successful, this dehydration prevention model can potentially be applied to other
      health conditions and in other settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Comparison Between the Two Groups of the Number of Hospitalizations and ER Visits Due to Dehydration
time frame: 12 - 15 weeks
description: Primary outcome is proportion of patients who experience ER visits and/or hospitalizations related to dehydration (ERV) combined with ER visits resulting in hospitalization through the 6-7 weeks of RT. Primary analysis is comparison of proportion of patients in CYCORE group who have an ERV or ERHV and proportion of patients in the standard care group who have an ERV or ERHV. Analysis consists of a binomial test of two proportions using a continuity-corrected chi-square test. Analyses will follow the intention-to-treat principle, that is a patient in either arm who drops out is assumed to have an ERV and/or ERHV. For comparison purposes, data will be analyzed only using patients who have completed the study.
arm group label: Standard of Care Group
arm group type: Other
description: Surveys administered in person or by telephone interview and are audio-recorded.
arm group label: CYCORE Group + Standard of Care
arm group type: Experimental
description: Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer).
Surveys administered in person or by telephone interview and are audio-recorded.
intervention type: Behavioral
intervention name: Quality of Life Survey
description: Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT.
arm group label: CYCORE Group + Standard of Care
arm group label: Standard of Care Group
other name: Survey
intervention type: Behavioral
intervention name: Health Management Surveys
description: Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.
arm group label: CYCORE Group + Standard of Care
arm group label: Standard of Care Group
other name: Questionnaires
intervention type: Other
intervention name: Monitoring Devices
description: Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer)
arm group label: CYCORE Group + Standard of Care
intervention type: Behavioral
intervention name: Symptoms Surveys
description: Behavioral: Symptoms survey 1; completed at weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.
Behaviorial: Symptoms survey 2; completed at baseline, weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.
arm group label: CYCORE Group + Standard of Care
arm group label: Standard of Care Group
intervention type: Behavioral
intervention name: Device Usability Survey
description: Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.
arm group label: CYCORE Group + Standard of Care
other name: Questionnaire
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan K. Peterson, PHD, MPH
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Dehydration