- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04310345
Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Monroe Carell Jr Children's Hospital at Vanderbilt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Animal-Assisted Interaction
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Quality of Life
Time Frame: Up to 2 months
|
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
|
Anxiety
Time Frame: Up to 2 months
|
The state-trait anxiety inventory will be administered to children and their parents at baseline and once a month
|
Up to 2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maryjo Gilmer, PhD, Vanderbilt Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VICC PED 2003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Cancer
-
STORM Therapeutics LTDRecruitingCancer | Advanced Solid Tumor | Advanced CancerUnited States
-
Merck Sharp & Dohme LLCCompletedAdvanced Cancer Relapsed | Advanced Cancer Refractory
-
Teon Therapeutics, Inc.Merck Sharp & Dohme LLCTerminatedCancer | Advanced Solid Tumor | Advanced Cancer | OncologyUnited States
-
BiOneCure Therapeutics Inc.RecruitingCancer | Advanced Solid Tumor | Advanced Cancer | OncologyUnited States
-
Zhejiang UniversityRecruitingAdvanced Colorectal Cancer | Advanced Hepatocellular Carcinoma | Advanced Gastric Cancer | Advanced Pancreatic CancerChina
-
PfizerTerminatedAdvanced Solid Tumors | Advanced CancerUnited States
-
AVEO Pharmaceuticals, Inc.CompletedAdvanced Cancer | Refractory CancerUnited States
-
Avera McKennan Hospital & University Health CenterCompleted
-
AstraZenecaTerminatedCancer | Advanced Solid Tumors | Advanced Solid MalignanciesUnited States
-
University Health Network, TorontoUniversity of UlmRecruiting
Clinical Trials on Animal-Assisted Interactions
-
Vanderbilt-Ingram Cancer CenterHuman Animal Bond Research InstituteCompletedAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt UniversityCompletedChild Development | Learning Problem | Animal-Human BondingUnited States
-
Atlas UniversityNot yet recruitingDepression | Loneliness | Old Age; Debility | Nursing Home | Loss of Interest in Activities
-
Norwegian University of Life SciencesCompleted
-
Daniel Collado-MateoAsociación Dame La PataRecruitingWork Related Stress | Occupational GroupsSpain
-
Daniel Collado-MateoPurina España (Reg. Trademark of Nestle S.A.)Enrolling by invitationEating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/BulimiaSpain
-
Daniel Collado-MateoAsociación de Padres de Personas Con Autismo (APNA); Asociación Nuevo Horizonte and other collaboratorsEnrolling by invitationAutism Spectrum Disorder | AutismSpain
-
Washington State UniversityCompletedStress, Psychological | Stress, Physiological
-
Uskudar UniversityNot yet recruiting
-
Chang Gung Memorial HospitalUnknownSchizophrenia | Animal-assisted TherapyTaiwan