Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cancer Metastatic
  • Communication
  • End of Life
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.Masking: Double (Participant, Outcomes Assessor)Masking Description: A trained blinded evaluator will meet with participants to complete baseline and subsequent follow-up measures, including end-of-study chart review data. Physician-nurse dyads for each arm are trained differently and naive to alternate study arm.Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 117 years
Gender
Both males and females

Description

The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnos...

The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.

Tracking Information

NCT #
NCT04330833
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joan E Haase, PhD Indiana University