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

March 17, 2026 updated by: Children's Hospital of Fudan University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Minhang
      • Shanghai, Minhang, China, 201102
        • Recruiting
        • Hemotology/Oncology Unit and Surgical Oncology Unit of Children's Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scores of children's quality of life
Time Frame: 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.
Measured every three months over six months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 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.
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 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
Time Frame: 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.
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' 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
Time Frame: 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.
Measured every three months over six months.
Acceptability of the NiCE intervention
Time Frame: 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".
At the sixth month of the study.
Appropriateness of the NiCE intervention
Time Frame: 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".
At the sixth month of the study.
Feasibility of the NiCE intervention
Time Frame: 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.
At the sixth month of the study.
Barriers and facilitators
Time Frame: 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".
At the sixth month of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaowen Zhai, MD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NiCE_21_427

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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