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Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04310345
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : May 11, 2022
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Maryjo Gilmer, Vanderbilt-Ingram Cancer Center

Study Description
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Brief Summary:
This study will evaluate the effects of human-animal interaction on reducing anxiety, depression, worry, and pain and enhancing quality of life in children ages 8-17 years old with a life threatening cancer and their parent caregivers.

Condition or disease Intervention/treatment Phase
Advanced Cancer Relapsed Cancer Refractory Cancer Behavioral: Animal-Assisted Interactions Not Applicable

Detailed Description:

Objectives:

  • To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:

    • To identify and document necessary modifications for a safe and feasible intervention
    • To obtain recruitment estimates and determine potential recruitment barriers
    • To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment)
    • To verify safety

  • To determine the preliminary efficacy of human-animal interaction sessions:

    • On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain
    • On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety

Exploratory Objective:

- To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Animal-Assisted Interaction
Children and their caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
 Behavioral: Animal-Assisted Interactions
Child and caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.


Outcome Measures
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Primary Outcome Measures :
  1. Pediatric Quality of Life [ Time Frame: Up to 2 months ]
    The Peds Quality of Life measure will be administered to children and their parents (proxy) at baseline and once a month

  2. Anxiety [ Time Frame: Up to 2 months ]
    The state-trait anxiety inventory will be administered to children and their parents at baseline and once a month


Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Child:

  • Children age 8-17 years old that have been diagnosed with advanced cancer as defined by any stage of relapsed, recurrent or refractory cancer
  • Able to understand English or Spanish to complete consents and surveys

Parent or Guardian:

  • Parent or guardian as determined by person who brings child to >50% of their clinic visits
  • Able to understand English or Spanish to complete consents and surveys

Exclusion Criteria for both Children and Parent/Guardian:

  • Self-reported fear of or allergies to canines
  • Cognitive impairment as identified by healthcare team or inability to complete consenting process
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310345


Contacts
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Contact: Maryjo Gilmer, PhD 800-811-8480 maryjo.gilmer@Vanderbilt.Edu

Locations
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United States, Tennessee
Monroe Carell Jr Children's Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Maryjo Gilmer, PhD Vanderbilt Medical Center
More Information
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Responsible Party: Maryjo Gilmer, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04310345    
Other Study ID Numbers: VICC PED 2003
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No