ChildNCT05371236
Spiritual Health Scale in Chinese Pediatric Cancer Patients
An observational study of Child, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Pediatric cancer patients experience spiritual concerns such as meaningless, hopeless of life, fear of death and losses at all stages of illness. The availability of a valid and reliable instrument that accurately assesses the level of spiritual health among pediatric cancer patients is crucial before any appropriate… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Child
- What is being tested?
- Questionnaire
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2022to 1 Mar 2023
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: children with cancer
Who may be able to join
- age 8-17 years old,
- diagnosed with any type of cancer who were treated at these sites at any point after their diagnosis,
- knowing about condition and prognosis of their disease,
- their parents agree to sign the informed consent form,
- able to communicate with Chinese and read Chinese.
Who cannot join
- younger than age 8-17 years old
- cancer survivors
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Hong Kong Polytechnic University
Hong Kong, 0000
Ka Yan Ho, PhD, 2766647, kyeva.ho@polyu.edu
About this study
Official title: Development and Validation of the Spiritual Health Scale in Chinese Pediatric Cancer Patients
Pediatric cancer patients experience spiritual concerns such as meaningless, hopeless of life, fear of death and losses at all stages of illness. The availability of a valid and reliable instrument that accurately assesses the level of spiritual health among pediatric cancer patients is crucial before any appropriate interventions to solve their spiritual concerns can be appropriately planned and evaluated.
Read the detailed description
The study aimed to adapt the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) scale and validate it in Chinese pediatric cancer patients.
A two-phase sequential method design will be used. Phase I will use a descriptive qualitative approach to understand pediatric cancer patients' opinions related with spiritual issues and experience. At least 12 participants are expected to be interviewed. The results of the qualitative study will be used to compare with the items of the original scale, and emerging themes will be used to generate new items. Phase Ⅱ will translates and adapt the scale based on the result of Phase I. Further, the adapted version of the scale will be validated among 200 pediatric cancer patients.
- Conditions
- Child
- Being tested
- Questionnaire
- Keywords
- cancer, spiritual health
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Phase I will use a descriptive qualitative approach to understand pediatric cancer patients' opinions related with spiritual issues and experience. The results of the qualitative study will be used to compare with the items of the original scale, and emerging themes will be used to generate new items. Phase Ⅱ will translates the original scale and validates the psychological properties of scale adapted for pediatric cancer patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
The adapted spiritual well-being scale of the Functional Assessment of Chronic Illness Therapy-12 (FACIT-Sp-12) for pediatric cancer patients
For measuring participants' spiritual well-being
Measured: past senven days
The Chinese version of the center for epidemiology studies depression scale for children (CES-DC)
For measuring participants' depressive symptoms
Measured: past seven days
Pediatric quality of life inventory 3.0 cancer module (PedsQL 3.0 Cancer Module)
For measuring participants' quality of life
Measured: past seven days
Socio-demographic and clinical characteristics
For collecting the background information of the participants, including their age, gender, educational attainment, household income, number of siblings, parents' marital status and religious belief. In addition, participants' medical records will be retrieved to acquire their diagnosis.
Measured: on that day filling out questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Ka Yan Ho, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371236
- Sponsor's protocol ID
- SPH
- Status last verified
- May 2022
- First submitted
- 28 Jan 2022
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Spiritual Health Scale in Chinese Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT05371236
- Acronym / sponsor ID
- SPH
- Conditions
- Child
- Keywords
- cancer, spiritual health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 12 May 2022 (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.
Pediatric cancer patients experience spiritual concerns such as meaningless, hopeless of life, fear of death and losses at all stages of illness. The availability of a valid and reliable instrument that accurately assesses the level of spiritual health among pediatric cancer patients is crucial before any appropriate interventions to solve their spiritual concerns can be appropriately planned and evaluated.
Detailed description
The study aimed to adapt the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) scale and validate it in Chinese pediatric cancer patients.
A two-phase sequential method design will be used. Phase I will use a descriptive qualitative approach to understand pediatric cancer patients' opinions related with spiritual issues and experience. At least 12 participants are expected to be interviewed. The results of the qualitative study will be used to compare with the items of the original scale, and emerging themes will be used to generate new items. Phase Ⅱ will translates and adapt the scale based on the result of Phase I. Further, the adapted version of the scale will be validated among 200 pediatric cancer patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with cancer
Key inclusion criteria (5 listed)
- age 8-17 years old,
- diagnosed with any type of cancer who were treated at these sites at any point after their diagnosis,
- knowing about condition and prognosis of their disease,
- their parents agree to sign the informed consent form,
- able to communicate with Chinese and read Chinese.
Key exclusion criteria (2 listed)
- younger than age 8-17 years old
- cancer survivors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePhase I will use a descriptive qualitative approach to understand pediatric cancer patients' opinions related with spiritual issues and experience. The results of the qualitative study will be used to compare with the items of the original scale, and emerging themes will be used to generate new items. Phase Ⅱ will translates the original scale and validates the psychological properties of scale adapted for pediatric cancer patients. | Other | – |
Primary outcome
The adapted spiritual well-being scale of the Functional Assessment of Chronic Illness Therapy-12 (FACIT-Sp-12) for pediatric cancer patients
Time frame: past senven days
For measuring participants' spiritual well-being
The Chinese version of the center for epidemiology studies depression scale for children (CES-DC)
Time frame: past seven days
For measuring participants' depressive symptoms
Pediatric quality of life inventory 3.0 cancer module (PedsQL 3.0 Cancer Module)
Time frame: past seven days
For measuring participants' quality of life
Socio-demographic and clinical characteristics
Time frame: on that day filling out questionnaire
For collecting the background information of the participants, including their age, gender, educational attainment, household income, number of siblings, parents' marital status and religious belief. In addition, participants' medical records will be retrieved to acquire their diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- 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.
Ka Yan Ho, PhD principal investigator
The Hong Kong Polytechnic University
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 Child, run by The Hong Kong Polytechnic University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Yan Ho, PhD (27666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adapted spiritual well-being scale of the Functional Assessment of Chronic Illness Therapy-12 (FACIT-Sp-12) for pediatric cancer patients (time frame: past senven days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2022.