Narrative-based Card Game in Improving Spiritual Well-being Among Chinese Childhood Cancer Patients
November 24, 2022 updated by: Dr Eva Ho, The Hong Kong Polytechnic University
Narrative-based Card Game (NCG) in Improving Spiritual Well-being, Enhancing Hope, Decreasing Psychological Symptoms, and Promoting Quality of Life Among Chinese Childhood Cancer Patients: A Pilot Randomized Controlled Trial
Cancer as a life-threatening disease can trigger children's unique spiritual needs.
Unmet spiritual needs can cause low level of spiritual well-being, which is a central component for the overall quality of life (QoL) of cancer patients and was inversely associated with depressive symptoms, anxiety and a low level of hope.
However, there has been no intervention focused on improving spiritual well-being among childhood cancer patients.
Evidence from adult cancer patients suggests that narrative intervention can effectively address spiritual needs and improve spiritual well-being, while playing card game can combine an emotionally sensitive topic with an enjoyable activity, providing insight into the development of narrative-based card games for childhood cancer patients.
The first objective of this pilot study is to assess the feasibility of narrative-based card game among Chinese childhood cancer patients.
The second objective is to evaluate the preliminary effects of narrative-based card game intervention on spiritual well-being, hope, anxiety, depressive symptoms, and QoL of childhood cancer patients at postintervention and at 1-, and 3-month follow-up postintervention.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
A pilot randomized controlled trial will be carried out.
A convenience sample of 60 children with cancer will be recruited.
Subjects who are randomized into the experimental group which will participate the narrative-based card game or into the control group which will play a PUKE card game only for entertainment purpose, that mimics the time and attention of the intervention.
Feasibility measures (i.e., the eligibility rate, consent rate, randomization rate etc.) will be collected immediately after the completion of the intervention.
Also, all subjects will be asked to complete structured questionnaires to assess their spiritual well-being, hope, anxiety, depressive symptoms, and QoL at postintervention and at 1-, and 3-month follow-up postintervention.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong, 0000
- Hong Kong Polytechnic University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: (1) age 12-17 old (2) diagnosed with any type of cancer and currently undergoing active treatment (3) knowing about their cancer diagnosis, and (4) able to communicate with Chinese.
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Exclusion Criteria: (1) those with identified cognitive and/or behavioural problems which affected their verbal communication; (2) those with advanced cancer, including nonresponsive to treatment, stage IV solid tumor that had recurred or progressed as defined, or physician estimated poor prognosis of <60%.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Narrative-based card game
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This intervention aims to evaluate the preliminary effects of narrative-based card game intervention on spiritual well-being, hope, anxiety, depressive symptoms, and QoL of childhood cancer patients at postintervention and at 1-, and 3-month follow-up postintervention.
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No Intervention: PUKE card game
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The length of recruitment
Time Frame: baseline
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The time used for subject recruitment
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baseline
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Eligibility rate
Time Frame: baseline
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The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment
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baseline
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Consent rate
Time Frame: baseline
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The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients
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baseline
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Randomization rate
Time Frame: baseline
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The number of participants who are randomized divided by the number of consenting children
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baseline
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Attendance rate
Time Frame: post-intervention
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The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group
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post-intervention
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Retention rate
Time Frame: post-intervention, and 1-month, 3- month follow ups
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The number of participants who remain in the study divided by the number of participants randomized.
Retention rate will be calculated at baseline and follow ups.
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post-intervention, and 1-month, 3- month follow ups
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Completion rate
Time Frame: post-intervention, and 1-month, 3-month follow ups
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The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
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post-intervention, and 1-month, 3-month follow ups
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Missing data
Time Frame: post-intervention, 1-month, 3- month follow ups
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The percentage of missing data.
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post-intervention, 1-month, 3- month follow ups
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Adverse events
Time Frame: post-intervention, 1-month, 3-month follow ups
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Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline.
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post-intervention, 1-month, 3-month follow ups
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Chinese version of adapted Functional Assessment of Chronic Illness Therapy Spiritual Well-being Scale at 3 months follow-up
Time Frame: at 3-months follow-up
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Assessing the spiritual well-being of participants, the score for the Chinese version of adapted Functional Assessment of Chronic Illness Therapy Spiritual Well-being Scale is 0-60, with higher scaores indicating higher spiritual well-being
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at 3-months follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
January 1, 2024
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 24, 2022
First Posted (Estimate)
December 6, 2022
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
November 24, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- NCG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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