Psychometric Properties of the Chinese Version of PeNAT

Psychometric Properties of the Chinese Version of the Pediatric Nausea Assessment Tool (PeNAT) to Measure Nausea and Vomiting in Hong Kong Chinese Children Undergoing Chemotherapy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Nausea; Vomiting; Child
• Intervention / Treatment: Other: PeNAT validation

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Katherine Lam, PhD; Phone Number: 27666420; Email: kwkatlam@polyu.edu.hk
• Study Contact Backup: Name: Eva Ho, PhD; Phone Number: 27666417; Email: kyanho@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study targets to recruit 150 subjects from the Hong Kong Children's Hospital.

Children who meet the inclusion criteria will be eligible to participate.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) 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.	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Chinese version of the Pediatric Quality of Life Inventory 4.0 Cancer Module (PedsQL 4.0) 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.	at baseline
The Chinese version of Center for Epidemiological Studies Depression Scale for Children (CES-DC) 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.	at baseline

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Katherine Lam, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: PeNAT validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No