Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents

NCT04310345 | Completed Results DMC

• 2 other identifiers: VICC PED 2003R21HD097757-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effects of human-animal interaction on reducing anxiety, depression, worry, and pain and enhancing quality of life in children ages 6-17 years old with a life threatening cancer and their parent caregivers.

Conditions

Advanced Cancer; Relapsed Cancer; Refractory Cancer

Outcome Measures

Primary Outcomes (2)

• Pediatric Quality of Life

  The Pediatric Quality of Life Inventory (PedsQL) was administered to children and their parents (proxy for child quality of life) at baseline, week 4, and week 8 visits. Weeks 4 and 8 were after interacting with a therapy dog. Baseline surveys collected without seeing a therapy dog. The PedsQL Measurement is a validated scale to assess health-related quality of life in children and adolescents with acute and chronic health conditions. Scores are scaled from 1-100, with higher scores indicative of better quality of life.

  Up to 2 months

• Anxiety

  The state-trait anxiety inventory State sub scale was administered to children (STAI-Child) and their parents (STAI) at baseline, week 4, and week 8. The 20-item STAI-CH is a validated scale for anxiety in children aged 5-17; the 20-item STAI is validated to assess anxiety in adult participants. The State subscale is intended to assess level of anxiety at the time of survey administration. Possible range of scores of the STAI-CH State subscale is 20-60, while the possible range from the STAI state subscale for adults is 20-80. Higher scores are indicative of increased anxiety. Baseline data were obtained without seeing a therapy dog, whereas STAI-CH and STAI surveys were conducted after seeing the therapy dog at weeks 4 and 8.

  Up to 2 months

Study Arms (1)

Animal-Assisted Interaction

EXPERIMENTAL

Children and their caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.

Behavioral: Animal-Assisted Interactions

Interventions

Animal-Assisted Interactions BEHAVIORAL

Child and caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.

Animal-Assisted Interaction

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Child:
• Children age 6-17 years old that have been diagnosed with advanced cancer as defined by any stage of relapsed, recurrent or refractory cancer
• Able to understand English or Spanish to complete consents and surveys
• Parent or Guardian:
• Parent or guardian as determined by person who brings child to \>50% of their clinic visits
• Able to understand English or Spanish to complete consents and surveys

You may not qualify if:

• Self-reported fear of or allergies to canines
• Cognitive impairment as identified by healthcare team or inability to complete consenting process

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Recurrence; Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Mary Jo Gilmer
• Organization: Vanderbilt School of Nursing

maryjo.gilmer@vanderbilt.edu

6153430938

Study Officials

• Maryjo Gilmer, PhD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: March 31, 2021
• Primary Completion: February 9, 2024
• Study Completion: June 27, 2024
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-07

Locations

US (1)