Clinical trial NCT03765099: Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents
Official title: Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Relapsed Cancer
Refractory Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: Human Animal Bond Research Institute
First posted: 2018-12-05
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pediatric Quality of Life
timeFrame: up to 3 months
measure: Anxiety
timeFrame: up to 3 months
measure: Stress
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Maryjo Gilmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cowfer BA, Akard TF, Gilmer MJ. Animal-Assisted Interventions for Children with Advanced Cancer: Child and Parent Perceptions. Palliat Med Rep. 2021 Nov 17;2(1):328-334. doi: 10.1089/pmr.2021.0039. eCollection 2021.