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Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology (NiCE)

Fudan University logo

Fudan University

Status

Enrolling

Conditions

Solid Tumor
Hematological Malignancies

Treatments

Other: Routine PPC
Behavioral: NiCE

Study type

Interventional

Funder types

Other

Identifiers

NCT05306509
NiCE_21_427

Details and patient eligibility

About

This study aims to develop and implement a pediatric palliative care (PPC) program. It is an open-label, randomized trial (2:1 randomization) in pediatric oncology department of Children's Hospital of Fudan University. The intervention group will receive Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology (NiCE). The control group will receive routine PPC (will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment). The intervention will take 6 months.

Full description

Early integration of PPC, endorsed by a number of international societies, is well supported by evidence on providing multi-layer relief in children and their families over the course of any life-threatening illness. This study will leverage oncology nurses' role, culturally adapt the well-recognized St. Jude Children's Individualized Care Planning and Coordination (ICPC) Model to develop and evaluate a nurse-initiated conversation program to facilitate early integration of palliative care in pediatric oncology care.

Enrollment

120 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children within eight weeks of initial oncologic diagnosis or within eight weeks of relapse/recurrent disease diagnosis
  • Children speaking Chinese
  • Children's family caregivers accompanying the child in the hospital (only one family member is eligible to take this role under current hospital policy)
  • Children's family caregivers speaking Chinese
  • Health care providers who are taking care of the eligible children, including but not limited to physicians, nurses, and social workers

Exclusion criteria

  • Children who, in the opinion of their physician, are not capable mentally or verbally of participating in the survey or interview

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Nurse-initiated conversations for early integration of palliative care (NiCE)
Experimental group
Description:
Participants will receive nurse-initiated conversations facilitating early integration of palliative care in pediatric oncology.
Treatment:
Behavioral: NiCE
Routine PPC
Other group
Description:
Participants will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment.
Treatment:
Other: Routine PPC

Trial contacts and locations

1

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Central trial contact

Xiaowen Zhai, MD; Lei Cheng, PhD

Data sourced from clinicaltrials.gov

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