<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/NCT03760471</url>
  </required_header>
  <id_info>
    <org_study_id>18-1054</org_study_id>
    <nct_id>NCT03760471</nct_id>
  </id_info>
  <brief_title>Palliative and Oncology Care Intervention: Symptom COACH</brief_title>
  <official_title>A Collaborative Palliative and Oncology Care Intervention to Improve Symptoms and Coping During Treatment for Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fox Chase 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 investigators propose to conduct the first pilot trial of a collaborative palliative and&#xD;
      oncology care intervention for HNC patients receiving CRT to assess the feasibility and&#xD;
      acceptability of the intervention. The intervention will incorporate weekly palliative care&#xD;
      visits into standard oncology care targeting coping, mood, and symptom management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Anticipated">November 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients who comply for acceptability of a collaborative palliative and oncology care intervention for patients with HNC receiving CRT</measure>
    <time_frame>12 months</time_frame>
    <description>The intervention will be considered feasible if &gt;50% of patients agree to enroll on the trial and if &gt; 70% of the participants have at least half of the scheduled palliative care visits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with coping strategies longitudinally in relation to symptom burden, QOL, mood, and health care utilization</measure>
    <time_frame>11 weeks</time_frame>
    <description>This exploratory aim will provide preliminary data on associations of coping with patient outcomes to power a larger trial. We will specifically examine whether approach-oriented coping is associated with lower symptom burden, higher QOL and mood, and reduced health care utilization (e.g fewer hospitalizations, fewer treatment breaks or reductions in chemotherapy dose intensity)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cancer of Head and Neck</condition>
  <arm_group>
    <arm_group_label>Collaborative palliative and oncology care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evidenced-based symptom management and coping intervention</intervention_name>
    <description>The intervention visits will focus on coping and the following symptoms prevalent during CRT: (1) pain and mucositis, (2) nausea, (3) constipation, (4) fatigue, (5) sleep disturbances, (6) xerostomia, (7) thick mucus, and (8) depression</description>
    <arm_group_label>Collaborative palliative and oncology care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. adult patients (≥18 years) with a diagnosis of HNC for which they are undergoing CRT&#xD;
&#xD;
          2. receiving all oncology care at Fox Chase Cancer Center (FCCC)&#xD;
&#xD;
          3. able to speak and read in English or with assistance from an interpreter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with prior history of HNC for which they underwent CRT&#xD;
&#xD;
          2. patients with uncontrolled psychiatric disorders (psychotic disorder, bipolar&#xD;
             disorder, major depression) or other co-morbid disease which the treating clinician&#xD;
             believes prohibits informed consent or participation in the study&#xD;
&#xD;
          3. patients enrolled on other supportive care intervention trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111-2497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</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>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 13, 2022</submitted>
    <returned>September 12, 2022</returned>
  </pending_results>
  <!-- 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/NCT03760471
org study id: 18-1054
nct id: NCT03760471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators propose to conduct the first pilot trial of a collaborative palliative and
      oncology care intervention for HNC patients receiving CRT to assess the feasibility and
      acceptability of the intervention. The intervention will incorporate weekly palliative care
      visits into standard oncology care targeting coping, mood, and symptom management.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percentage of patients who comply for acceptability of a collaborative palliative and oncology care intervention for patients with HNC receiving CRT
time frame: 12 months
description: The intervention will be considered feasible if >50% of patients agree to enroll on the trial and if > 70% of the participants have at least half of the scheduled palliative care visits
measure: Percentage of patients with coping strategies longitudinally in relation to symptom burden, QOL, mood, and health care utilization
time frame: 11 weeks
description: This exploratory aim will provide preliminary data on associations of coping with patient outcomes to power a larger trial. We will specifically examine whether approach-oriented coping is associated with lower symptom burden, higher QOL and mood, and reduced health care utilization (e.g fewer hospitalizations, fewer treatment breaks or reductions in chemotherapy dose intensity)
arm group label: Collaborative palliative and oncology care
arm group type: Experimental
intervention type: Other
intervention name: Evidenced-based symptom management and coping intervention
description: The intervention visits will focus on coping and the following symptoms prevalent during CRT: (1) pain and mucositis, (2) nausea, (3) constipation, (4) fatigue, (5) sleep disturbances, (6) xerostomia, (7) thick mucus, and (8) depression
arm group label: Collaborative palliative and oncology care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: No
submitted: July 13, 2022
returned: September 12, 2022