Psychometric Properties of the Chinese Version of PeNAT

NCT04827108 | Unknown

• 1 other identifier: PeNAT validation
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cancer; Child; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Chinese version of the Pediatric Quality of Life Inventory 4.0 Cancer Module (PedsQL 4.0) at baseline

  at baseline

• The Chinese version of Center for Epidemiological Studies Depression Scale for Children (CES-DC) at baseline

  at baseline

Interventions

PeNAT validation OTHER

Children will be required to fill in a set of questionnaires including the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT), the Chinese version of the Pediatric Quality of Life Inventory 4.0 Cancer Module (PedsQL 4.0), and the Chinese version of Center for Epidemiological Studies Depression Scale for Children (CES-DC)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Cognitive or behavioral problems in medical records

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Neoplasms; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine Lam, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Lam, PhD

CONTACT

27666420; kwkatlam@polyu.edu.hk

Eva Ho, PhD

CONTACT

27666417; kyanho@polyu.edu.hk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: September 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: August 31, 2024
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share