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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Solid Tumor, Hematological Malignancies

Intervention / Treatment
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* Behavioral: NiCE
* Other: Routine PPC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence of adverse events (AEs) will be measured by the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PED-PRO-CTCAE). This study will measure the incidence of 15 core AEs (abdominal pain, anorexia, nausea, vomiting, constipation, diarrhea, cough, pain, headache, neuropathy, mucositis, anxiety, depression, fatigue, insomnia), as perceived and reported by children 7 to 18 years of age or parent proxy (0-18 years), using a 7-day reference period with 4 response options per item. Presence of each of the 15 AEs will be measured as a dichotomous variable of the AE symptom (1-if any of the AEs happens; 0-none AEs). It is a repeated measurement, will be measured at baseline and every four weeks, for seven times. | Measured every four weeks over six months. | 
| Scores of children's mobility | Scores of children's mobility will be measured by Pediatric patient-reported outcomes measurement information system (Pediatric PROMIS) Short Form v2.0 - Mobility 8a. It can be reported by children 7 to 18 years of age or parent proxy (0-18 years) in relation to the past 7 days and in terms of a five-point response option range from 'never' to 'almost always' in most measures. Higher scores mean more of the measured symptom being experienced. The short form measure has 8 items and receives a T-score with a mean of 50 and a standard deviation of 10 based on the original reference sample. It is a repeated measurement, will be measured at baseline and every four weeks, for seven times. | Measured every three months over six months. | 
| Scores of children's family caregivers' care burden | Scores of children's family caregivers' care burden will be measured by Zarit Burden Inventory, by the family caregivers' self-reports. It is a 22-item, 5-point scale ranging from never (0) to always (4). A higher score indicates higher care burden. 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. | 
| Scores of children's family caregivers' anxiety | Scores of children's family caregivers' anxiety will be measured by Zung's Self-Rating Anxiety Scale (SAS), by the family caregivers' self-reports. It is a 20-item, 4-point scale ranging from never (1) to often (4). The total score of 1.25 is the final standard score. A higher score indicates a severer anxiety symptom. 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. | 
| Scores of children's family caregivers' depression | Scores of children's family caregivers' depression will be measured by Zung's Self-Rating Depression Scale (SDS) , by the family caregivers' self-reports. It is a 20-item, 4-point scale ranging from never (1) to often (4). The total score of 1.25 is the final standard score. A higher score indicates severer depressive symptoms. 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. | 
| Acceptability of the NiCE intervention | Acceptability will be captured by interviews of family caregivers and healthcare workers about whether the content of this intervention is acceptable. Each participant will be asked about the same question: Please tell me whether you think this intervention is acceptable? Please tell me more about your answer to this question. Acceptability will be defined when the participant clearly answered yes. | At the sixth month of the study. | 
| Appropriateness of the NiCE intervention | Appropriateness will be assessed by interviews of family caregivers and healthcare workers of the intervention arm whether the content of this intervention is appropriate. Each participant will be asked about the same question: Please tell me whether you think this intervention is appropriate? Please tell me more about your answer to this question. Appropriateness will be defined when the participant clearly answered yes. | At the sixth month of the study. | 
| Feasibility of the NiCE intervention | Feasibility will be assessed by the number of nurses led conversations that actually occurred during the 6-month period. | At the sixth month of the study. | 
| Barriers and facilitators | Barriers and facilitators will be assessed by interviews of family caregivers and healthcare workers of the intervention arm. Each participant will be asked about the same two questions: (1) Please tell me whether you think there is any barrier during the intervention? Please tell me more about your answer to this question. (2) Please tell me whether you think there is any facilitators during the intervention? Please tell me more about your answer to this question. | At the sixth month of the study. |