NCT05371236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

January 28, 2022

Last Update Submit

May 7, 2022

Conditions

Keywords

cancerspiritual health

Outcome Measures

Primary Outcomes (4)

  • 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

  • The Chinese version of the center for epidemiology studies depression scale for children (CES-DC)

    For measuring participants' depressive symptoms

    past seven days

  • Pediatric quality of life inventory 3.0 cancer module (PedsQL 3.0 Cancer Module)

    For measuring participants' quality of life

    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.

    on that day filling out questionnaire

Interventions

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.

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children with cancer

You may qualify if:

  • 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.

You may not qualify if:

  • younger than age 8-17 years old
  • cancer survivors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ka Yan Ho, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Yan Ho, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2022

First Posted

May 12, 2022

Study Start

May 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations