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CompletedNCT07053579Updated Jul 8, 2025

Cross-cultural Adaptation and Validation of the P-CIN for Chinese Pediatric Oncology Patients

An observational study in Pediatric Cancer, sponsored by The Hong Kong Polytechnic University. Completed at 2 sites in Hong Kong. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by The Hong Kong Polytechnic University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
313
Ages
6 Years to 18 Years
Sex
All
01

Study summary

The goal of this study was to conduct a cross-cultural adaptation of the P-CIN into the Chinese context, assess its psychometric properties, and determine the cut-off value of CIPN among Chinese pediatric oncology patients.

Participants provided demographic and clinical characteristics, and complete the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life.

Read the detailed description

A methodological, descriptive study was conducted.

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Conditions studied

  • Pediatric Cancer

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Keywords

  • Chemotherapy induced peripheral neuropathy
  • Pediatric Chemotherapy-Induced Neuropathy
  • Pediatric oncology
  • Psychometrics
  • Validation
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In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 313 is above the median of 205 across 1,680 observational studies indexed under Neoplasms.

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Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We recruited pediatric oncology patients from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.

Inclusion criteria

  • (1) 6 to 18 years of age
  • (2) were diagnosed with cancer
  • (3) had received or were currently receiving neurotoxic chemotherapy drugs (e.g., Vincristine, Cisplatin, Carboplatin, Oxaliplatin, Paclitaxel, Docetaxel, Ixabepilone, Bortezomib, Thalidomide)
  • (4) were able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure they understood the P-CIN.

Exclusion criteria

Exclusion Criteria:

  • (1) had a diagnosis of cancer in the central nervous system (CNS) cancer, cancer relapse or secondary cancer
  • (2) in the terminal stage
  • (3) planned to receive multiple cancer treatment (e.g., radiotherapy and immunotherapy)
  • (4) suffered from other neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy)
  • (5) had a developmental deficit (e.g., Down's syndrome and other chromosomal disorders)
  • (6) have suffered from psychiatric diseases or used antipsychotic drugs
  • (7) had peripheral neuropathy symptoms caused by diabetes, genetic diseases, spinal cord injury, or alcoholism, or
  • (8) had other neuromuscular disorders (e.g., traumatic brain injury, cerebral palsy).
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
313 participants (actual)
Target follow-up
1 Week
Patient registry
Yes

Groups and cohorts

  • Questionnaire

    Participants completed the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life.

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What researchers measure

Primary outcomes

  1. Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale

    For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.

    Time frame: Baseline

Other outcomes

  1. Wong-baker Faces Pain Rating scale

    For measuring participants' pain related to chemotherpay induced peripheral neuropathy.This scale contains six faces with increasing degree of pain from left to right, where each face is rated on a scale of 10, in which 0 indicates no hurt, 2 indicates little bit hurts, 4 indicates little more hurts, 6 indicates even more hurts, 8 indicated a whole lot of hurts, and 10 indicated the worst hurts. higher scores indicating more severe pain.

    Time frame: Baseline

  2. Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module

    To assess the participants' quality of life. The participants rated how frequently a particular problem occurred in the past month, using a three-point Likert scale (0 = Not at all, 2 = Sometimes, 4 = A lot) for children 5-7 years old and a five-point Likert scale (0 = Never, 1=Almost never, 2=sometimes, 3=often, 4 = Almost always) for children of 8-18 years old and for the parents of patients of all ages. Each item score will be reversely scored and then linearly transformed into 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). The scale score is the average of the total item scores, with higher scores representing better quality of life.

    Time frame: Baseline

  3. Clinician diagnosis of pediatric CIPN

    To ascertain the clinical diagnosis of CIPN in participants. The clinical diagnosis of CIPN could be made if the results of the nerve conduction study are abnormal, with a score of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ≥ 2 after the clinical consultation with a pediatric neurologist on the chemotherapeutic drugs used, cumulative doses, and clinical characteristics and time course of the CIPN symptoms. NCI-CTCAE items including five items: peripheral sensory neuropathy, peripheral motor neuropathy, constipation, diarrhea, and neuralgia. The sum score for the five NCI-CTCAE items was between 0 and 17.

    Time frame: Baseline

07

Study locations

2 sites
  • Ka Yan Ho
    Hong Kong, China, Hong Kong
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

References and documents

Study documents

  • Study protocol · Dec 18, 2024
  • Informed consent form · Dec 18, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07053579
Lead sponsor
The Hong Kong Polytechnic University
Collaborators
Shanghai Children's Medical Center, Shenzhen Children's Hospital, Zhengzhou University
Responsible party
Dr Eva Ho (Associate professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Jul 8, 2025
Start date
Jan 5, 2025
Primary completion
May 30, 2025
Completion
May 30, 2025
Last update
Jul 8, 2025

Study contacts

Ka Yan Ho, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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