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

NCT07053579 | Completed

• 1 other identifier: Validation study_P-CIN
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Cancer

Keywords

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

Outcome Measures

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.

  Baseline

Other Outcomes (3)

• Wong-baker Faces Pain Rating scale

  Baseline

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

  Baseline

• Clinician diagnosis of pediatric CIPN

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Shanghai Children's Medical Center: collaborator
• Shenzhen Children's Hospital: collaborator
• The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital: collaborator

Study Sites (2)

Ka Yan Ho

Hong Kong, China, Hong Kong

Location

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ka Yan Ho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 8, 2025
• Study Start: January 5, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)