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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
| Shenzhen Children's Hospital | OTHER_GOV |
| Zhengzhou University | OTHER |
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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.
A methodological, descriptive study was conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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We recruited pediatric oncology patients from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Ka Yan Ho, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ka Yan Ho | Hong Kong | China | Hong Kong | |||
| The Hong Kong Polytechnic University |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2024 | Jun 18, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2024 | Jun 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| Hong Kong |
| Hong Kong |