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

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05306509
Collaborator
(none)
120
1
2
29
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NiCE
  • Other: Routine PPC
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nurse-initiated conversations for early integration of palliative care (NiCE)

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

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 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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Scores of children's quality of life [Measured every three months over six months.]

    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.

Secondary Outcome Measures

  1. Incidence of adverse events [Measured every four weeks over six months.]

    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.

  2. Scores of children's mobility [Measured every three months over six months.]

    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.

  3. Scores of children's family caregivers' care burden [Measured every three months over six months.]

    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.

  4. Scores of children's family caregivers' anxiety [Measured every three months over six months.]

    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.

  5. Scores of children's family caregivers' depression [Measured every three months over six months.]

    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.

  6. Acceptability of the NiCE intervention [At the sixth month of the study.]

    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".

  7. Appropriateness of the NiCE intervention [At the sixth month of the study.]

    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".

  8. Feasibility of the NiCE intervention [At the sixth month of the study.]

    Feasibility will be assessed by the number of nurses led conversations that actually occurred during the 6-month period.

  9. Barriers and facilitators [At the sixth month of the study.]

    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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hemotology/Oncology Unit and Surgical Oncology Unit of Children's Hospital of Fudan University Shanghai Minhang China 201102

Sponsors and Collaborators

  • Children's Hospital of Fudan University

Investigators

  • Principal Investigator: Xiaowen Zhai, MD, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT05306509
Other Study ID Numbers:
  • NiCE_21_427
First Posted:
Apr 1, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022