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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Advanced Cancer, Relapsed Cancer, Refractory Cancer

Intervention / Treatment
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* Behavioral: Animal-Assisted Interactions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Animal-Assisted Interaction<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life | The Peds Quality of Life measure will be administered to children and their parents (proxy) at baseline and once a month | Up to 2 months | 
| Anxiety | The state-trait anxiety inventory will be administered to children and their parents at baseline and once a month | Up to 2 months |