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

NCT05306509 | Recruiting

• 1 other identifier: NiCE_21_427
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Solid Tumor; Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• Scores of children's quality of life

  Scores of children's quality of life will be measured by Peds Quality of Life TM4.0 scale. It encompasses four subscales: physical, emotional, social and school functioning. It asks how much of a problem each item has been during the past month. It comprised of parallel child self-report and parent proxy-report formats. Child self-report includes ages 5-7 years (young child), ages 8-12 years (child), and ages 13-18 years (adolescent). All items use a five-point Likert response set range from 'never' to 'almost always'. Items are reverse-scored and linear-early transformed to a scale of 0 to 100 (0 = 100, 1= 75, 2= 50, 3= 25, 4=0), so that higher scores indicate a better quality of life. It is a repeated measurement, will be measured at baseline, three months and six months, for three times.

  Measured every three months over six months.

Secondary Outcomes (9)

• Incidence of adverse events

  Measured every four weeks over six months.

• Scores of children's mobility

  Measured every three months over six months.

• Scores of children's family caregivers' care burden

  Measured every three months over six months.

• Scores of children's family caregivers' anxiety

  Measured every three months over six months.

• Scores of children's family caregivers' depression

  Measured every three months over six months.

Study Arms (2)

Nurse-initiated conversations for early integration of palliative care (NiCE)

EXPERIMENTAL

Participants will receive nurse-initiated conversations facilitating early integration of palliative care in pediatric oncology.

Behavioral: NiCE

Routine PPC

OTHER

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

Other: Routine PPC

Interventions

NiCE BEHAVIORAL

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.

Nurse-initiated conversations for early integration of palliative care (NiCE)

Routine PPC OTHER

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

Routine PPC

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Hemotology/Oncology Unit and Surgical Oncology Unit of Children's Hospital of Fudan University

Shanghai, Minhang, 201102, China

RECRUITING

Related Publications (8)

• Schmidt P, Otto M, Hechler T, Metzing S, Wolfe J, Zernikow B. Did increased availability of pediatric palliative care lead to improved palliative care outcomes in children with cancer? J Palliat Med. 2013 Sep;16(9):1034-9. doi: 10.1089/jpm.2013.0014. Epub 2013 Jul 31.

  PMID: 23901834 BACKGROUND

• Snaman J, McCarthy S, Wiener L, Wolfe J. Pediatric Palliative Care in Oncology. J Clin Oncol. 2020 Mar 20;38(9):954-962. doi: 10.1200/JCO.18.02331. Epub 2020 Feb 5.

  PMID: 32023163 BACKGROUND

• Haun MW, Estel S, Rucker G, Friederich HC, Villalobos M, Thomas M, Hartmann M. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD011129. doi: 10.1002/14651858.CD011129.pub2.

  PMID: 28603881 BACKGROUND

• Mahmood LA, Casey D, Dolan JG, Dozier AM, Korones DN. Feasibility of Early Palliative Care Consultation for Children With High-Risk Malignancies. Pediatr Blood Cancer. 2016 Aug;63(8):1419-22. doi: 10.1002/pbc.26024. Epub 2016 May 3.

  PMID: 27148856 BACKGROUND

• Neuburg L. Early Initiation of Pediatric Palliative Care. J Pediatr Health Care. 2021 Jan-Feb;35(1):114-119. doi: 10.1016/j.pedhc.2020.05.006. Epub 2020 Jul 10.

  PMID: 32660809 BACKGROUND

• Lafond DA, Kelly KP, Hinds PS, Sill A, Michael M. Establishing Feasibility of Early Palliative Care Consultation in Pediatric Hematopoietic Stem Cell Transplantation. J Pediatr Oncol Nurs. 2015 Sep-Oct;32(5):265-77. doi: 10.1177/1043454214563411. Epub 2015 Jan 23.

  PMID: 25616372 BACKGROUND

• Levine DR, Johnson LM, Snyder A, Wiser RK, Gibson D, Kane JR, Baker JN. Integrating Palliative Care in Pediatric Oncology: Evidence for an Evolving Paradigm for Comprehensive Cancer Care. J Natl Compr Canc Netw. 2016 Jun;14(6):741-8. doi: 10.6004/jnccn.2016.0076.

  PMID: 27283167 BACKGROUND

• Baker JN, Hinds PS, Spunt SL, Barfield RC, Allen C, Powell BC, Anderson LH, Kane JR. Integration of palliative care practices into the ongoing care of children with cancer: individualized care planning and coordination. Pediatr Clin North Am. 2008 Feb;55(1):223-50, xii. doi: 10.1016/j.pcl.2007.10.011.

  PMID: 18242323 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xiaowen Zhai, MD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Cheng, PhD

CONTACT

+8602164161784; chenglei@fudan.edu.cn

Xiaowen Zhai, MD

CONTACT

+8602164931123; zhaixiaowendy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 1, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)