Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Advanced Cancer
  • Refractory Cancer
  • Relapsed Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 8 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04310345
Collaborators
National Institutes of Health (NIH)
Investigators
Principal Investigator: Maryjo Gilmer, PhD Vanderbilt Medical Center