<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/NCT03227068</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00077090</org_study_id>
    <nct_id>NCT03227068</nct_id>
  </id_info>
  <brief_title>Parent Educational Discharge Support Strategies</brief_title>
  <official_title>Nurse-Led Parent Educational Discharge Support Strategies (PEDSS) for Children Newly Diagnosed With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Health System of Texas Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cohen Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Levine Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maine Children's Cancer Program at Maine Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern Medicine Central DuPage Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Louis Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Peter's University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin Health American Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West Virginia Univeristy Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King Faisal Specialist Hospital &amp; Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nicklaus Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      After the initial hospitalization, parents of children newly diagnosed with cancer assume&#xD;
      responsibility for assessing and managing their care; however, parents are often overwhelmed&#xD;
      with information received throughout the hospitalization and are apprehensive about caring&#xD;
      for their child at home. Parents want concise, focused information on how to care for their&#xD;
      child after the hospital discharge. Two parent education discharge support strategies (PEDSS)&#xD;
      were created to use at hospital discharge. PEDSS consists of a symptom management&#xD;
      intervention and a support for the caregiver intervention. A cluster randomized control trial&#xD;
      will assess the effectiveness and feasibility of the two different interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Providing education to parents of children newly diagnosed with cancer is a primary component&#xD;
      of nursing practice, but best practices regarding delivery of information are not known.&#xD;
      Parents often report confusion and worry with the complexity and large volume of information&#xD;
      received during the initial hospitalization that leads to concerns in caring for their child&#xD;
      after discharge. In addition, the amount and content of education is not standardized across&#xD;
      institutions. This results in considerable variability in educational practices, including&#xD;
      symptom education. During a recent qualitative study, parents described helpful discharge&#xD;
      education strategies as having written materials, keeping information concise, and receiving&#xD;
      anticipatory guidance so they knew what to expect. These preferences were succinctly&#xD;
      summarized by a mother of a child newly diagnosed with leukemia who stated &quot;…it would be nice&#xD;
      to have one sheet of paper that just said 'these are the signs that you're looking for at&#xD;
      home'.&quot; The purpose of this research study is to implement and evaluate parent educational&#xD;
      discharge support strategies (PEDSS) for parents of children newly diagnosed with cancer.&#xD;
      Findings from this study will provide a framework for nurses to deliver concise and&#xD;
      consistent information to parents of children newly diagnosed with cancer, and will assist&#xD;
      parents with their child after hospital discharge.&#xD;
&#xD;
      The goal of this study is to determine the effectiveness and feasibility of two parent&#xD;
      education discharge support strategies (PEDSS - symptom management vs. PEDSS - support for&#xD;
      the caregiver) for parents of children newly diagnosed with cancer. Specific aims of the&#xD;
      study include:&#xD;
&#xD;
      Specific Aim 1: Explore the effects of parent education discharge support strategies on&#xD;
      childhood cancer symptoms (fever, pain, fatigue, nausea, appetite changes, and sleep&#xD;
      problems) and parents' perception of their ability to care for their child with a new cancer&#xD;
      diagnosis during the first two months following the initial hospital discharge.&#xD;
&#xD;
      Specific Aim 2: Determine whether implementation of parent education discharge support&#xD;
      strategies decreases unplanned utilization of healthcare services (unscheduled clinic visits,&#xD;
      emergency room visits, unplanned hospitalizations), and preventable toxicity (malnutrition,&#xD;
      sepsis) among children with cancer during the first two months following the initial&#xD;
      hospitalization.&#xD;
&#xD;
      Specific Aim 3: Examine the feasibility and fidelity of implementing the PEDSS at the initial&#xD;
      hospital discharge among parents of newly diagnosed children with cancer for use through the&#xD;
      first two months following hospital discharge at participating Magnet institutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2017</start_date>
  <completion_date type="Actual">June 29, 2020</completion_date>
  <primary_completion_date type="Actual">June 29, 2020</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>
    <intervention_model_description>All subjects in both groups will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge including a list of home medications, and information regarding whom to call for emergencies. The PEDSS - symptom management and PEDSS - support for the caregiver are additional tools designed to reinforce care after the initial hospital discharge.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline pain severity to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>Wong-Baker Faces Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline fatigue severity to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>Categorized as none to mild or moderate to severe from the Adolescent Fatigue Scale for adolescents 13-17 years of age, the Childhood Fatigue Scale for children 7-12 years of age, or the Parent Fatigue Scale to obtain proxy responses from parents of children &lt; 7 years of age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline nausea severity to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>Visual Analogue Scale in the form of a thermometer that rates the severity of nausea from 0-100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline appetite changes to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>Simplified Nutritional Appetite Questionnaire, 4-item asking about child's appetite and rated on a 5-point Likert Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline sleep disturbances to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>The Sleep Wake Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline pain behavior to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>PROMIS® Pediatric - Pain Behavior Short Form</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>Seven items asking the parent to rate perceptions of the care of their child's symptoms on a 5-point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned utilization of healthcare services</measure>
    <time_frame>At one and two months from start of study</time_frame>
    <description>Combined frequency of the number of unscheduled clinic visits, emergency room visits, and unplanned hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline nutritional status to two months</measure>
    <time_frame>At baseline and monthly for two additional months</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sepsis</measure>
    <time_frame>At one and two months from start of study</time_frame>
    <description>Frequency of septic events over the past month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEDSS intervention feasibility</measure>
    <time_frame>At baseline</time_frame>
    <description>Nurse documentation of completion of PEDSS discussion and distribution of PEDSS worksheet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEDSS intervention satisfaction</measure>
    <time_frame>At two months after intervention delivery</time_frame>
    <description>Descriptive items asking about timing of intervention and frequency of intervention use then 6 items scored on a 5-point Likert scale asking about ease of use and satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">289</enrollment>
  <condition>Educational Activities</condition>
  <arm_group>
    <arm_group_label>PEDSS - symptom management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Content for the PEDSS - symptom management includes the most commonly experienced treatment-related physical symptoms, descriptions of each symptom, strategies to reduce symptom distress, and when and how to contact the cancer care team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEDSS - support for the caregiver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Content for the PEDSS - support for the caregiver includes five topics and suggestions on how caregivers can care for themselves during this time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEDSS - symptom management</intervention_name>
    <description>All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - symptom management will be delivered prior to the initial hospital discharge. The nurse will review the symptom management worksheet verbally with the parent, then distribute the written worksheet to the parent.</description>
    <arm_group_label>PEDSS - symptom management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEDSS - support for the caregiver</intervention_name>
    <description>All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - support for the caregiver will be delivered prior to the initial hospital discharge. The nurse will review the worksheet verbally with the parent, then distribute the written worksheet to the parent.</description>
    <arm_group_label>PEDSS - support for the caregiver</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A parent (referred to as &quot;parent&quot; but includes a parent or legal guardian) of a&#xD;
             patient 3 to 17 years of age who is newly diagnosed with any type of malignant disease&#xD;
             on an inpatient oncology unit&#xD;
&#xD;
          -  Must speak English, Spanish, or Arabic&#xD;
&#xD;
          -  Child will be or is receiving chemotherapy and/or radiation therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A parent of a child diagnosed with histiocytosis or any hematological disease&#xD;
             considered non-malignant&#xD;
&#xD;
          -  A parent whose child received the initial cancer diagnosis and initial cancer&#xD;
             treatment while hospitalized on a non-oncology unit (i.e., surgical ward)&#xD;
&#xD;
          -  A parent of a child who is experienced a relapse of a malignant disease&#xD;
&#xD;
          -  A parent who is the primary caregiver of the child with cancer and is illiterate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marilyn Hockenberry, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Megan Arthur, BS</last_name>
    <role>Study Director</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann and Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Central DuPage Hospital</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Children's Cancer Program at Maine Medical Center</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Peter's University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cohen Children's Medical Center Northwell Health</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Children's Hospital</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina Children's Hospital</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Health System of Texas Children's Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Medicine</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Health American Children's Hospital</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital and Research Centre-Riyadh</name>
      <address>
        <city>Riyadh</city>
        <zip>12713 2796</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric oncology</keyword>
  <keyword>parent</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Each site PI participating in the study will receive a copy of their anonymous data upon completion of the study.</ipd_description>
  </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/NCT03227068
org study id: Pro00077090
nct id: NCT03227068
lead sponsor: 
collaborator: 
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collaborator: 
collaborator: 
collaborator: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
After the initial hospitalization, parents of children newly diagnosed with cancer assume
      responsibility for assessing and managing their care; however, parents are often overwhelmed
      with information received throughout the hospitalization and are apprehensive about caring
      for their child at home. Parents want concise, focused information on how to care for their
      child after the hospital discharge. Two parent education discharge support strategies (PEDSS)
      were created to use at hospital discharge. PEDSS consists of a symptom management
      intervention and a support for the caregiver intervention. A cluster randomized control trial
      will assess the effectiveness and feasibility of the two different interventions.
Providing education to parents of children newly diagnosed with cancer is a primary component
      of nursing practice, but best practices regarding delivery of information are not known.
      Parents often report confusion and worry with the complexity and large volume of information
      received during the initial hospitalization that leads to concerns in caring for their child
      after discharge. In addition, the amount and content of education is not standardized across
      institutions. This results in considerable variability in educational practices, including
      symptom education. During a recent qualitative study, parents described helpful discharge
      education strategies as having written materials, keeping information concise, and receiving
      anticipatory guidance so they knew what to expect. These preferences were succinctly
      summarized by a mother of a child newly diagnosed with leukemia who stated "…it would be nice
      to have one sheet of paper that just said 'these are the signs that you're looking for at
      home'." The purpose of this research study is to implement and evaluate parent educational
      discharge support strategies (PEDSS) for parents of children newly diagnosed with cancer.
      Findings from this study will provide a framework for nurses to deliver concise and
      consistent information to parents of children newly diagnosed with cancer, and will assist
      parents with their child after hospital discharge.

      The goal of this study is to determine the effectiveness and feasibility of two parent
      education discharge support strategies (PEDSS - symptom management vs. PEDSS - support for
      the caregiver) for parents of children newly diagnosed with cancer. Specific aims of the
      study include:

      Specific Aim 1: Explore the effects of parent education discharge support strategies on
      childhood cancer symptoms (fever, pain, fatigue, nausea, appetite changes, and sleep
      problems) and parents' perception of their ability to care for their child with a new cancer
      diagnosis during the first two months following the initial hospital discharge.

      Specific Aim 2: Determine whether implementation of parent education discharge support
      strategies decreases unplanned utilization of healthcare services (unscheduled clinic visits,
      emergency room visits, unplanned hospitalizations), and preventable toxicity (malnutrition,
      sepsis) among children with cancer during the first two months following the initial
      hospitalization.

      Specific Aim 3: Examine the feasibility and fidelity of implementing the PEDSS at the initial
      hospital discharge among parents of newly diagnosed children with cancer for use through the
      first two months following hospital discharge at participating Magnet institutions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All subjects in both groups will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge including a list of home medications, and information regarding whom to call for emergencies. The PEDSS - symptom management and PEDSS - support for the caregiver are additional tools designed to reinforce care after the initial hospital discharge.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline pain severity to two months
time frame: At baseline and monthly for two additional months
description: Wong-Baker Faces Scale
measure: Change from baseline fatigue severity to two months
time frame: At baseline and monthly for two additional months
description: Categorized as none to mild or moderate to severe from the Adolescent Fatigue Scale for adolescents 13-17 years of age, the Childhood Fatigue Scale for children 7-12 years of age, or the Parent Fatigue Scale to obtain proxy responses from parents of children < 7 years of age
measure: Change from baseline nausea severity to two months
time frame: At baseline and monthly for two additional months
description: Visual Analogue Scale in the form of a thermometer that rates the severity of nausea from 0-100
measure: Change from baseline appetite changes to two months
time frame: At baseline and monthly for two additional months
description: Simplified Nutritional Appetite Questionnaire, 4-item asking about child's appetite and rated on a 5-point Likert Scale
measure: Change from baseline sleep disturbances to two months
time frame: At baseline and monthly for two additional months
description: The Sleep Wake Scale
measure: Change from baseline pain behavior to two months
time frame: At baseline and monthly for two additional months
description: PROMIS® Pediatric - Pain Behavior Short Form
measure: Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two months
time frame: At baseline and monthly for two additional months
description: Seven items asking the parent to rate perceptions of the care of their child's symptoms on a 5-point Likert scale
measure: Unplanned utilization of healthcare services
time frame: At one and two months from start of study
description: Combined frequency of the number of unscheduled clinic visits, emergency room visits, and unplanned hospitalizations
measure: Change in baseline nutritional status to two months
time frame: At baseline and monthly for two additional months
description: Body mass index
measure: Sepsis
time frame: At one and two months from start of study
description: Frequency of septic events over the past month
measure: PEDSS intervention feasibility
time frame: At baseline
description: Nurse documentation of completion of PEDSS discussion and distribution of PEDSS worksheet
measure: PEDSS intervention satisfaction
time frame: At two months after intervention delivery
description: Descriptive items asking about timing of intervention and frequency of intervention use then 6 items scored on a 5-point Likert scale asking about ease of use and satisfaction.
arm group label: PEDSS - symptom management
arm group type: Experimental
description: Content for the PEDSS - symptom management includes the most commonly experienced treatment-related physical symptoms, descriptions of each symptom, strategies to reduce symptom distress, and when and how to contact the cancer care team.
arm group label: PEDSS - support for the caregiver
arm group type: Experimental
description: Content for the PEDSS - support for the caregiver includes five topics and suggestions on how caregivers can care for themselves during this time.
intervention type: Other
intervention name: PEDSS - symptom management
description: All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - symptom management will be delivered prior to the initial hospital discharge. The nurse will review the symptom management worksheet verbally with the parent, then distribute the written worksheet to the parent.
arm group label: PEDSS - symptom management
intervention type: Other
intervention name: PEDSS - support for the caregiver
description: All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - support for the caregiver will be delivered prior to the initial hospital discharge. The nurse will review the worksheet verbally with the parent, then distribute the written worksheet to the parent.
arm group label: PEDSS - support for the caregiver
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
last name: Marilyn Hockenberry, PhD
role: Principal Investigator
affiliation: Duke University
last name: Megan Arthur, BS
role: Study Director
affiliation: Duke University
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country: Saudi Arabia
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: Each site PI participating in the study will receive a copy of their anonymous data upon completion of the study.