This trial studies how well animal-assisted interactions work in improving quality of life in children with cancer that has spread extensively to other anatomic sites or is no longer responding to treatment, has come back, or does not respond to treatment, and their parents. Having animal-assisted therapy (AAT) visits on a routine basis with a trained animal-handler and his/her dog may help to make the cancer treatment process less stressful for children and their parents.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03765099.
PRIMARY OBJECTIVES:
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 PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorMary Jo Gilmer
