Cancer ChildhoodNCT03544190
Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children
An observational study of Cancer Childhood, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Cancer Childhood
- How many people
- 186 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Feb 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children should be ages between 7 and 14; diagnosed with cancer within the previous 6 months and currently undergoing active treatments, and able to speak Cantonese and read Chinese.
Who may be able to join
- 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.
Who cannot join
- Those children with cognitive and learning problems identified from their medical records will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Cancer Childhood
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience level
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.
Measured: Baseline
Secondary outcomes (2)
Number of depressive symptoms
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.
Measured: Baseline
Levels of self-esteem
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start28 Feb 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer ChildhoodStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oi Kwan Joyce Chung, Dr, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544190
- Sponsor's protocol ID
- UW18-012
- Status last verified
- Nov 2020
- First submitted
- 18 May 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung JOK, Li WHC, Wei X, Cheung AT, Ho LLK, Chan GC. Translation and psychometric evaluation of the Chinese version of the resilience scale for children with cancer. Health Qual Life Outcomes. 2021 Oct 2;19(1):232. doi: 10.1186/s12955-021-01865-y.
PubMed 34600543
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children
- ClinicalTrials.gov ID
- NCT03544190
- Acronym / sponsor ID
- UW18-012
- Conditions
- Cancer Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children should be ages between 7 and 14; diagnosed with cancer within the previous 6 months and currently undergoing active treatments, and able to speak Cantonese and read Chinese.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Those children with cognitive and learning problems identified from their medical records will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resilience level
Time frame: Baseline
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.
2 secondary outcomes
Number of depressive symptoms
Time frame: Baseline
Levels of self-esteem
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 34600543Chung JOK, Li WHC, Wei X, Cheung AT, Ho LLK, Chan GC. Translation and psychometric evaluation of the Chinese version of the resilience scale for children with cancer. Health Qual Life Outcomes. 2021 Oct 2;19(1):232. doi: 10.1186/s12955-021-01865-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oi Kwan Joyce Chung, Dr principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Childhood, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03544190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.