Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents

Not Applicable

Completed

• Conditions: Advanced Cancer; Relapsed Cancer; Refractory Cancer
• Interventions: Behavioral: Animal-Assisted Interactions

• Registration Number: NCT03765099
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2019-02-21
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Children 3-17 years old
• Confirmed diagnosis of relapsed or refractory cancer

Exclusion Criteria

• Reported fear or anxiety of dogs (child or parent)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Animal-Assisted Interactions	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.
Animal-Assisted Interactions	Animal-Assisted Interactions	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.

Primary Outcome Measures

Name	Time	Method
Pediatric Quality of Life	up to 3 months	The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month
Anxiety	up to 3 months	The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit
Stress	up to 3 months	Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group

Trial Locations

Locations (1)

Monroe Carell Jr Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States