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Recruiting NCT05306509

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

No phase Interventional Solid Tumor Hematological Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NiCE, Routine PPC.
Who it may be relevant to
Registry conditions: Solid Tumor, Hematological Malignancies. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Facilitating Early Integration of Palliative Care in Pediatric Oncology: Development and Implementation of a Nurse-initiated Conversation Program for Pediatric Cancer Patients and Their Families

Overview

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.

Detailed 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.

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
  • 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.

Primary outcome measures

  • Scores of children's quality of life [Time frame: Measured every three months over six months.]
Secondary outcome measures (9)
  • Incidence of adverse events [Time frame: Measured every four weeks over six months.]
  • Scores of children's mobility [Time frame: Measured every three months over six months.]
  • Scores of children's family caregivers' care burden [Time frame: Measured every three months over six months.]
  • Scores of children's family caregivers' anxiety [Time frame: Measured every three months over six months.]
  • Scores of children's family caregivers' depression [Time frame: Measured every three months over six months.]
  • Acceptability of the NiCE intervention [Time frame: At the sixth month of the study.]
  • Appropriateness of the NiCE intervention [Time frame: At the sixth month of the study.]
  • Feasibility of the NiCE intervention [Time frame: At the sixth month of the study.]
  • Barriers and facilitators [Time frame: At the sixth month of the study.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • Hemotology/Oncology Unit and Surgical Oncology Unit of Children's Hospital of Fudan Univer — Shanghai

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05306509 · NiCE_21_427

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗