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

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

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 6-17 years old with a life threatening cancer and their parent caregivers.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; Relapsed Cancer; Refractory Cancer
• Intervention / Treatment: Behavioral: Animal-Assisted Interactions

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr Children's Hospital at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Child:

• Children age 6-17 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life	The Pediatric Quality of Life Inventory (PedsQL) was administered to children and their parents (proxy for child quality of life) at baseline, week 4, and week 8 visits. Weeks 4 and 8 were after interacting with a therapy dog. Baseline surveys collected without seeing a therapy dog. The PedsQL Measurement is a validated scale to assess health-related quality of life in children and adolescents with acute and chronic health conditions. Scores are scaled from 1-100, with higher scores indicative of better quality of life.	Up to 2 months
Anxiety	The state-trait anxiety inventory State sub scale was administered to children (STAI-Child) and their parents (STAI) at baseline, week 4, and week 8. The 20-item STAI-CH is a validated scale for anxiety in children aged 5-17; the 20-item STAI is validated to assess anxiety in adult participants. The State subscale is intended to assess level of anxiety at the time of survey administration. Possible range of scores of the STAI-CH State subscale is 20-60, while the possible range from the STAI state subscale for adults is 20-80. Higher scores are indicative of increased anxiety. Baseline data were obtained without seeing a therapy dog, whereas STAI-CH and STAI surveys were conducted after seeing the therapy dog at weeks 4 and 8.	Up to 2 months

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Maryjo Gilmer, PhD, Vanderbilt Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): June 27, 2024

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VICC PED 2003; R21HD097757-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No