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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2024
  • participants needed
    60
  • sponsor
    Vanderbilt-Ingram Cancer Center
Updated on 25 May 2022
Accepts healthy volunteers

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.

Details
Condition Advanced Cancer, Relapsed Cancer, Refractory Cancer
Treatment Animal-Assisted Interactions
Clinical Study IdentifierNCT04310345
SponsorVanderbilt-Ingram Cancer Center
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

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

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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