Psychometric Properties of the Chinese Version of PeNAT

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04827108
• Other study ID #: PeNAT validation
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2022
• Source: The Hong Kong Polytechnic University
• Contact: Katherine Lam, PhD
• Phone: 27666420
• Email: kwkatlam[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Child
• Nausea
• Vomiting

Intervention

Other:
• PeNAT validation
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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