Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Cancer
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Pediatric Quality of Life
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Maryjo Gilmer
Sponsor Investigator
Vanderbilt-Ingram Cancer Center
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)
Outcomes
Primary Outcomes
Pediatric Quality of Life
Time Frame: up to 3 months
The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month
Anxiety
Time Frame: 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
Time Frame: 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