Clinical trial NCT04827108: Psychometric Properties of the Chinese Version of PeNAT
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Child
Nausea
Vomiting
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at baseline
timeFrame: at baseline
Secondary outcomes:
measure: The Chinese version of the Pediatric Quality of Life Inventory 4.0 Cancer Module (PedsQL 4.0) at baseline
timeFrame: at baseline
measure: The Chinese version of Center for Epidemiological Studies Depression Scale for Children (CES-DC) at baseline
timeFrame: at baseline
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Katherine Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: