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NCT Number: NCT07053579

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ka Yan Ho, Hong Kong, China

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About this study

A methodological, descriptive study was conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • (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).

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

    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.

Other outcomes

  1. Wong-baker Faces Pain Rating scale

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

  3. Clinician diagnosis of pediatric CIPN

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Shanghai Children's Medical Center
  • Shenzhen Children's Hospital
  • Zhengzhou University

Registry information

Official study title

Cross-cultural Adaptation and Validation of the Pediatric Chemotherapy-induced Neuropathy (P-CIN) for Chinese Pediatric Oncology Patients: A Multi-center Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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