Psychometric Properties of the Chinese Version of PeNAT

March 22, 2022 updated by: Dr Katherine Lam, The Hong Kong Polytechnic University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at baseline
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Lam, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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