<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/NCT03765099</url>
  </required_header>
  <id_info>
    <org_study_id>VICC PED 18166</org_study_id>
    <nct_id>NCT03765099</nct_id>
  </id_info>
  <brief_title>Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents</brief_title>
  <official_title>Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt-Ingram Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Human Animal Bond Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt-Ingram Cancer Center</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 study will evaluate the effects of animal-assisted interactions (AAI) on stress,&#xD;
      anxiety, and quality of life in children with a life-threatening condition and their parents.&#xD;
      It is anticipated to be a milestone in understanding the human-animal bond.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
        1. Examine the feasibility of animal-assisted interactions sessions for children with a&#xD;
           life-threatening condition and primary caregiver to:&#xD;
&#xD;
             -  Identify and document modifications for a safe and feasible intervention,&#xD;
&#xD;
             -  Obtain recruitment estimates and determine potential recruitment barriers&#xD;
&#xD;
             -  Evaluate elements of implementation fidelity (design, training, delivery/receipt of&#xD;
                Treatment, enactment)&#xD;
&#xD;
             -  Verify safety.&#xD;
&#xD;
           H1-1: Children and parents (&gt;60%) will complete the interventions and provide positive&#xD;
           acceptability data. H1-2: Implementation fidelity can be achieved with the proposed&#xD;
           methodology&#xD;
&#xD;
        2. Determine the preliminary efficacy of animal-assisted interactions sessions for:&#xD;
&#xD;
             -  Children with a life-threatening condition (LTC) for the outcome of health-related&#xD;
                quality of life&#xD;
&#xD;
             -  Children with a LTC and their primary caregivers for the outcomes of stress and&#xD;
                anxiety&#xD;
&#xD;
      H2-1 Children with a life-threatening condition who receive animal-assisted interactions will&#xD;
      experience improved health-related quality of life (HRQOL) more than patients who do not&#xD;
      receive animal-assisted interactions.&#xD;
&#xD;
      H2-2a Children with life-threatening condition who receive animal-assisted interactions will&#xD;
      experience decreased stress and anxiety more than parents of children who do not receive&#xD;
      animal-assisted interactions.&#xD;
&#xD;
      H2-2b Primary caregivers of children with a life-threatening condition who receive&#xD;
      animal-assisted interactions will experience decreased stress and anxiety more than parents&#xD;
      of children who do not receive animal-assisted interactions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pediatric Quality of Life</measure>
    <time_frame>up to 3 months</time_frame>
    <description>The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>up to 3 months</time_frame>
    <description>The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Advanced Cancer</condition>
  <condition>Relapsed Cancer</condition>
  <condition>Refractory Cancer</condition>
  <arm_group>
    <arm_group_label>Animal-Assisted Interactions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children and their caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Animal-Assisted Interactions</intervention_name>
    <description>Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.</description>
    <arm_group_label>Animal-Assisted Interactions</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
    <other_name>AAI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 3-17 years old&#xD;
&#xD;
          -  Confirmed diagnosis of relapsed or refractory cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reported fear or anxiety of dogs (child or parent)&#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>Maryjo Gilmer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Monroe Carell Jr Children's Hospital at Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
    <investigator_full_name>Maryjo Gilmer</investigator_full_name>
    <investigator_title>Sponsor Investigator</investigator_title>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03765099/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03765099
org study id: VICC PED 18166
nct id: NCT03765099
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effects of animal-assisted interactions (AAI) on stress,
      anxiety, and quality of life in children with a life-threatening condition and their parents.
      It is anticipated to be a milestone in understanding the human-animal bond.
Objectives:

        1. Examine the feasibility of animal-assisted interactions sessions for children with a
           life-threatening condition and primary caregiver to:

             -  Identify and document modifications for a safe and feasible intervention,

             -  Obtain recruitment estimates and determine potential recruitment barriers

             -  Evaluate elements of implementation fidelity (design, training, delivery/receipt of
                Treatment, enactment)

             -  Verify safety.

           H1-1: Children and parents (>60%) will complete the interventions and provide positive
           acceptability data. H1-2: Implementation fidelity can be achieved with the proposed
           methodology

        2. Determine the preliminary efficacy of animal-assisted interactions sessions for:

             -  Children with a life-threatening condition (LTC) for the outcome of health-related
                quality of life

             -  Children with a LTC and their primary caregivers for the outcomes of stress and
                anxiety

      H2-1 Children with a life-threatening condition who receive animal-assisted interactions will
      experience improved health-related quality of life (HRQOL) more than patients who do not
      receive animal-assisted interactions.

      H2-2a Children with life-threatening condition who receive animal-assisted interactions will
      experience decreased stress and anxiety more than parents of children who do not receive
      animal-assisted interactions.

      H2-2b Primary caregivers of children with a life-threatening condition who receive
      animal-assisted interactions will experience decreased stress and anxiety more than parents
      of children who do not receive animal-assisted interactions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pediatric Quality of Life
time frame: up to 3 months
description: The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month
measure: Anxiety
time frame: up to 3 months
description: The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit
measure: Stress
time frame: up to 3 months
description: Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group
arm group label: Animal-Assisted Interactions
arm group type: Experimental
description: Children and their caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
arm group label: Usual Care
arm group type: Active Comparator
description: Children and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the hospital.
intervention type: Behavioral
intervention name: Animal-Assisted Interactions
description: Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
arm group label: Animal-Assisted Interactions
arm group label: Usual Care
other name: AAI
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
last name: Maryjo Gilmer, PhD
role: Principal Investigator
affiliation: Vanderbilt Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt-Ingram Cancer Center
investigator full name: Maryjo Gilmer
investigator title: Sponsor Investigator
provided document: 