Advanced Cancer, Refractory Cancer, Relapsed Cancer
Conditions
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.
Interventions
BEHAVIORALAnimal-Assisted Interactions
Child and 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.
Sponsors
Human Animal Bond Research Institute
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed