Animal-Assisted Interactions in Improving Quality of Life in Children with Advanced, Relapsed, or Refractory Cancer and Their Parents
- CHILDREN: Ages of 3-17 years
- CHILDREN: Diagnosed with advanced cancer as defined by any stage of relapsed or refractory cancer in medical record
- CHILDREN: Able to understand English or Spanish to complete consents and surveys
- CAREGIVERS: Primary caregiver as determined by parent who brings child to > 50% of their clinic visits
- CAREGIVERS: Able to understand English or Spanish to complete consents and surveys
- A reported fear of or allergies to canines or cognitive impairment
I. Examine feasibility of animal-assisted interactions (AAI) sessions for children with a life-threatening condition (LTC) and primary caregiver, specifically to identify and document necessary 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), and verify safety.
II. Determine the preliminary efficacy of AAI sessions for children with a LTC for the outcomes of health-related quality of life (HRQoL), stress, and anxiety, primary caregivers of children with a LTC for the outcomes of stress and anxiety.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive AAI over 15 minutes during each potentially anxiety-producing visit to the hospital or clinic.
GROUP II: Participants receive usual care.
Trial Phase Phase NA
Trial Type Supportive care
Vanderbilt University / Ingram Cancer Center
Mary Jo Gilmer
- Primary ID VICC PED 18166
- Secondary IDs NCI-2018-03164
- Clinicaltrials.gov ID NCT03765099