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

NCT ID: NCT07053579

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

313 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-05

Study Completion Date

2025-05-30

Brief Summary

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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

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A methodological, descriptive study was conducted.

Conditions

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Pediatric Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Children's Medical Center

OTHER

Sponsor Role collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role collaborator

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

UNKNOWN

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Eva Ho

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka Yan Ho, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Ka Yan Ho

Hong Kong, China, Hong Kong

Site Status

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Validation study_P-CIN

Identifier Type: -

Identifier Source: org_study_id

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