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

Vanderbilt University Medical Center

Status: Completed

Conditions: Advanced Cancer; Relapsed Cancer; Refractory Cancer

Treatments: Behavioral: Animal-Assisted Interactions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04310345

R21HD097757-01 (U.S. NIH Grant/Contract)

VICC PED 2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Animal-Assisted Interaction

Experimental group

Description:

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.

Treatment:

Behavioral: Animal-Assisted Interactions