Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorChildren's Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
NiCE
BehavioralParticipants 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.
Routine PPC
Other interventionParticipants will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Nurse-initiated conversations for early integration of palliative care (NiCE)Experimental treatment 1 intervention
Group B: Routine PPCOther 1 intervention
Trial outcomes
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.
Time frame
Measured every three months over six months.Secondary outcomes
1
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.
Time frame
Measured every four weeks over six months.2
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.
Time frame
Measured every three months over six months.3
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.
Time frame
Measured every three months over six months.4
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.
Time frame
Measured every three months over six months.Sponsors and contacts
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Source ClinicalTrials.gov