Spiritual Health Scale in Chinese Pediatric Cancer Patients

Child Clinical Trial

Official title:

Development and Validation of the Spiritual Health Scale in Chinese Pediatric Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05371236
• Other study ID #: SPH
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Child

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