Clinical trial NCT05306509: Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Hematological Malignancies
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 120
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Scores of children's quality of life
timeFrame: Measured every three months over six months.
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Measured every four weeks over six months.
measure: Scores of children's mobility
timeFrame: Measured every three months over six months.
measure: Scores of children's family caregivers' care burden
timeFrame: Measured every three months over six months.
measure: Scores of children's family caregivers' anxiety
timeFrame: Measured every three months over six months.
measure: Scores of children's family caregivers' depression
timeFrame: Measured every three months over six months.
measure: Acceptability of the NiCE intervention
timeFrame: At the sixth month of the study.
measure: Appropriateness of the NiCE intervention
timeFrame: At the sixth month of the study.
measure: Feasibility of the NiCE intervention
timeFrame: At the sixth month of the study.
measure: Barriers and facilitators
timeFrame: At the sixth month of the study.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hemotology/Oncology Unit and Surgical Oncology Unit of Children's Hospital of Fudan University
state: Minhang
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaowen Zhai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.