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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04310345
• Other study ID #: VICC PED 2003
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 8-17 years old with a life threatening cancer and their parent caregivers.

Description:

Objectives:

• To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:

• To identify and document necessary modifications for a safe and feasible intervention

• To obtain recruitment estimates and determine potential recruitment barriers

• To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment)

• To verify safety

• To determine the preliminary efficacy of human-animal interaction sessions:

• On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain

• On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety

Exploratory Objective:

• To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: February 2025
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

Child:

• Children age 8-17 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

Exclusion Criteria for both Children and Parent/Guardian:

• Self-reported fear of or allergies to canines

• Cognitive impairment as identified by healthcare team or inability to complete consenting process

Related Conditions & MeSH terms

• Advanced Cancer
• Refractory Cancer
• Relapsed Cancer

Intervention

Behavioral:
• Animal-Assisted Interactions
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.

Locations

Country	Name	City	State
United States	Monroe Carell Jr Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Quality of Life	The Peds Quality of Life measure will be administered to children and their parents (proxy) at baseline and once a month	Up to 2 months
Primary	Anxiety	The state-trait anxiety inventory will be administered to children and their parents at baseline and once a month	Up to 2 months