- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544190
Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children
Study Overview
Status
Conditions
Detailed Description
It has been well documented that cancer and its treatment may have adverse effects on the physical and psychological well-being of children with cancer. Such adverse effects may start from diagnosis and continue for months or even years after the completion of therapy. Cancer and its treatments may also have long-term effects on the psychological well-being of children with cancer, such as decreased self-esteem, increased anxiety and depression that can adversely affect their quality of life.
Numerous studies indicated that resilience effectively prevents the development of mental health problems and is associated with positive mental health outcomes in children and adolescents, such as reduced levels of anxiety, depression and obsessive compulsive symptoms. Assessing resilience in children with cancer is therefore crucial for a thorough understanding of their responses to stress and adversity, which is an essential prerequisite for the design of an appropriate psychological intervention to enhance their resilience and foster the development of their coping mechanisms and positive mental well-being.
This study aims to translate the original English version of Resilience Scale for Children (RS10) into traditional Chinese. It will then test the psychometric properties of the newly translated RS10. In addition, the factorial structure of RS10 will be examined using confirmatory factor analysis (CFA).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- The University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ages between 7 and 14;
- diagnosed with cancer within the previous 6 months and currently undergoing active treatments;
- able to speak Cantonese and read Chinese.
Exclusion Criteria:
- Those children with cognitive and learning problems identified from their medical records will be excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resilience level
Time Frame: Baseline
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The Resilience Scale for Children (RS10) was developed to measure a child's capacity to respond to the life changes.
The RS10 measures the child's resilience capacity along five core elements: (1) Sense of purpose and meaning, (2) Authenticity, (3) Equanimity, (4) Self-Reliance, and (5) Perseverance.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of depressive symptoms
Time Frame: Baseline
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The subjects' depressive symptoms will be assessed using the Chinese version of the CES-DC.
The CES-DC comprises 20 fully standardized items to evaluate depressive symptoms.
All items are evaluated on a four-point self-report scale in relation to their incidence during the last week, which were scored from 0 to 3, with total possible scores ranging from 0 to 60, with higher scores indicating greater symptomatology.
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Baseline
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Levels of self-esteem
Time Frame: Baseline
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The subjects' self-esteem will be assessed using the Chinese version of the RSES.
The RSES is designed to measure the global self-esteem of children and adolescents.
The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 to 4, with total possible scores ranging from 10 to 40.
Higher scores indicate higher levels of self-esteem.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oi Kwan Joyce Chung, Dr, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UW18-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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