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

NCT05306509 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

NiCE

Participants will receive an initial conversation led by a trained senior nurse within eight weeks after initial oncologic diagnosis or relapse/recurrent disease diagnosis, with an introduction to the intervention and learning about the goals, values, hopes, and fears of each patient and family. The PPC team will then follow each patient by ongoing regular conversations (related to the child and family's conditions) led by the same nurse, every 4 weeks for six months, when symptom assessment and management, goal-directed supportive care, team collaboration, and care coordination will be delivered according to the family's needs. Increased PPC involvement, end-of-life care and bereavement care will be involved when necessary. If a participant feels any discomfort or distress during the intervention, a break will be taken until they feel better. If not, the central contact person will come and discussion about the participant's feeling and wiliness to continue the intervention.

OTHER

Routine PPC

Participants will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Xiaowen Zhai, MD · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2026-05-31
Completion
2026-07-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306509 on ClinicalTrials.gov