Animal-Assisted Interactions in Improving Quality of Life in Children with Advanced, Relapsed, or Refractory Cancer and Their Parents

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • A reported fear of or allergies to canines or cognitive impairment

Locations & Contacts

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Mary Jo Gilmer
Phone: 615-343-0938
Email: maryjo.gilmer@vanderbilt.edu

Trial Objectives and Outline

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 Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Vanderbilt University / Ingram Cancer Center

Principal Investigator
Mary Jo Gilmer

Trial IDs

Primary ID VICC PED 18166
Secondary IDs NCI-2018-03164
Clinicaltrials.gov ID NCT03765099