Psychometric Properties of the Chinese Version of PeNAT

Not yet recruiting

• Conditions: Nausea; Vomiting; Cancer; Child

• Registration Number: NCT04827108
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

Cancer is a leading cause of death for children. Chemotherapy is the most common treatment for cancer. Notwithstanding the improved survival, children with cancer still have to face a significant amount of symptoms associated with chemotherapy. Two major symptoms induced by chemotherapy are nausea and vomiting. These two symptoms were demonstrated to cause serious disruption in patients' daily function and quality of life. Given these devastating impacts, intervening children with appropriate methods to alleviate nausea and vomiting during chemotherapy is therefore crucial. It is imperative for nurses to develop non-pharmacological interventions to reduce nausea and vomiting, with the goal of improving the QoL of children with cancer when undergoing chemotherapy First, however, careful assessment of nausea and vomiting in children with cancer is a necessary step towards designing appropriate interventions. This study aims to translate and validate an instrument (PeNAT) which can assess nausea and vomiting among Hong Kong Chinese children and adolescents undergoing chemotherapy

Detailed Description

Currently, the most effective anti-emetics appear to be 5-HT3 inhibitors, followed by NK1 inhibitors and neuroleptic drugs. Nevertheless, anti-emetics alone are not sufficient to manage these two symptoms. This poor symptom control could be due to healthcare professionals' perception that nausea and vomiting are solely biological problems, and their heavy reliance on pharmacological treatment for management. After literature search, we can identify only one validated instrument, the Pediatric Nausea Assessment tool (PeNAT), assessing chemotherapy-induced nausea and vomiting in children. Yet, this instruments is not available in Chinese. This study aims to translate and validate an instrument (PeNAT) which can assess nausea and vomiting among Hong Kong Chinese children and adolescents undergoing chemotherapy

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23
• Study Start: 2022-09-01
• Primary Completion: 2024-02-28
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Aged 4 - 17
• A confirmed diagnosis of cancer
• Currently undergoing chemotherapy
• Able to speak Cantonese and read Chinese

Exclusion Criteria

• Cognitive or behavioral problems in medical records

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at baseline	at baseline	Children will be required to fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at baseline. The score ranges from 1 to 4. Higher scores represent a more severe nausea.

Secondary Outcome Measures

Name	Time	Method
The Chinese version of the Pediatric Quality of Life Inventory 4.0 Cancer Module (PedsQL 4.0) at baseline	at baseline	Children will be required to fill in the Chinese version of Pediatric Quality of Life Inventory 4.0 Cancer Module (PedsQL 4.0) at baseline. The score ranges from 0 to 100. Higher scores represent a better quality of life.
The Chinese version of Center for Epidemiological Studies Depression Scale for Children (CES-DC) at baseline	at baseline	Children will be required to fill in the Chinese version of Center for Epidemiological Studies Depression Scale for Children (CES-DC) at baseline. The score ranges from 0 to 60. Higher scores represent a higher number of depressive symptoms.