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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07053579
Enrollment
313
Registered
2025-07-08
Start date
2025-01-05
Completion date
2025-05-30
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

Keywords

Chemotherapy induced peripheral neuropathy, Pediatric Chemotherapy-Induced Neuropathy, Pediatric oncology, Psychometrics, Validation

Brief 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.

Detailed description

A methodological, descriptive study was conducted.

Interventions

None listed

Sponsors

Shanghai Children's Medical Center
CollaboratorOTHER
Shenzhen Children's Hospital
CollaboratorOTHER_GOV
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
CollaboratorUNKNOWN
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scaleBaselineFor 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

MeasureTime frameDescription
Wong-baker Faces Pain Rating scaleBaselineFor 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.
Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer ModuleBaselineTo 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.
Clinician diagnosis of pediatric CIPNBaselineTo 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026