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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05371236
Other study ID # SPH
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date March 1, 2023

Study information

Verified date May 2022
Source The Hong Kong Polytechnic University
Contact Ka Yan Ho, PhD
Phone 27666417
Email kyeva.ho@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 interventions to solve their spiritual concerns can be appropriately planned and evaluated.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - younger than age 8-17 years old - cancer survivors

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
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 ? will translates the original scale and validates the psychological properties of scale adapted for pediatric cancer patients.

Locations

Country Name City State
Hong Kong Hong Kong Polytechnic University Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 past senven days
Primary The Chinese version of the center for epidemiology studies depression scale for children (CES-DC) For measuring participants' depressive symptoms past seven days
Primary Pediatric quality of life inventory 3.0 cancer module (PedsQL 3.0 Cancer Module) For measuring participants' quality of life past seven days
Primary 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. on that day filling out questionnaire
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