Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
NCT ID: NCT04310345
Last Updated: 2024-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2021-03-31
2024-06-27
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Cognitive impairment as identified by healthcare team or inability to complete consenting process
6 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Maryjo Gilmer
Principal Investigator
Principal Investigators
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Maryjo Gilmer, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center
Locations
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Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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VICC PED 2003
Identifier Type: -
Identifier Source: org_study_id
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