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Spiritual Health Scale in Chinese Pediatric Cancer Patients

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05371236
Collaborator
(none)
200
Enrollment
1
Location
10
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Development and Validation of the Spiritual Health Scale in Chinese Pediatric Cancer Patients
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. The adapted spiritual well-being scale of the Functional Assessment of Chronic Illness Therapy-12 (FACIT-Sp-12) for pediatric cancer patients [past senven days]

    For measuring participants' spiritual well-being

  2. The Chinese version of the center for epidemiology studies depression scale for children (CES-DC) [past seven days]

    For measuring participants' depressive symptoms

  3. Pediatric quality of life inventory 3.0 cancer module (PedsQL 3.0 Cancer Module) [past seven days]

    For measuring participants' quality of life

  4. Socio-demographic and clinical characteristics [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hong Kong Polytechnic University Hong Kong Hong Kong 0000

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Ka Yan Ho, PhD, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Eva Ho, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05371236
Other Study ID Numbers:
  • SPH
First Posted:
May 12, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Eva Ho, Assistant Professor, The Hong Kong Polytechnic University
cancer
spiritual health

Study Results

No Results Posted as of May 12, 2022