Pediatric CancerNCT05639062
Narrative-based Card Game in Improving Spiritual Well-being Among Chinese Childhood Cancer Patients
A study testing Narrative-based card game in people with Pediatric Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Narrative-based card game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
-
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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Narrative-based card game
- Keywords
- spiritual well-being, intervention, childhood cancer patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative-based card gameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Narrative-based card game | Active comparator | Not described Receives: Behavioral: Narrative-based card game |
| PUKE card game | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of recruitment
The time used for subject recruitment
Measured: baseline
Eligibility rate
The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment
Measured: baseline
Consent rate
The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients
Measured: baseline
Randomization rate
The number of participants who are randomized divided by the number of consenting children
Measured: baseline
Attendance rate
The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group
Measured: post-intervention
Retention rate
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.
Measured: post-intervention, and 1-month, 3- month follow ups
Completion rate
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Measured: post-intervention, and 1-month, 3-month follow ups
Missing data
The percentage of missing data.
Measured: post-intervention, 1-month, 3- month follow ups
Adverse events
Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline.
Measured: post-intervention, 1-month, 3-month follow ups
Secondary outcomes (1)
The Chinese version of adapted Functional Assessment of Chronic Illness Therapy Spiritual Well-being Scale at 3 months follow-up
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
Measured: at 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639062
- Sponsor's protocol ID
- NCG
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Q, Ho KY, Lam KKW, Wong FKY, Lam W, Cheng F, Wei H, Chan K, Ting M, Yang FN, Xiao P, Luo T, Wang HX, Yorke J. Preliminary effectiveness and feasibility of an integrated hope techniques and narrative-based card game intervention for pediatric cancer patients in China: a randomized controlled trial. BMC Med. 2025 Jul 31;23(1):449. doi: 10.1186/s12916-025-04287-5.
PubMed 40745312
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05639062
- Acronym / sponsor ID
- NCG
- Conditions
- Pediatric Cancer
- Keywords
- spiritual well-being, intervention, childhood cancer patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative-based card game | Active comparator | Behavioral: Narrative-based card game |
| PUKE card game | No intervention | – |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative-based card gameThis 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. | Behavioural | Narrative-based card game |
Primary outcome
The length of recruitment
Time frame: baseline
The time used for subject recruitment
Eligibility rate
Time frame: baseline
The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment
Consent rate
Time frame: baseline
The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients
Randomization rate
Time frame: baseline
The number of participants who are randomized divided by the number of consenting children
Attendance rate
Time frame: post-intervention
The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group
Retention rate
Time frame: post-intervention, and 1-month, 3- month follow ups
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.
Completion rate
Time frame: post-intervention, and 1-month, 3-month follow ups
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Missing data
Time frame: post-intervention, 1-month, 3- month follow ups
The percentage of missing data.
Adverse events
Time frame: post-intervention, 1-month, 3-month follow ups
Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 40745312Liu Q, Ho KY, Lam KKW, Wong FKY, Lam W, Cheng F, Wei H, Chan K, Ting M, Yang FN, Xiao P, Luo T, Wang HX, Yorke J. Preliminary effectiveness and feasibility of an integrated hope techniques and narrative-based card game intervention for pediatric cancer patients in China: a randomized controlled trial. BMC Med. 2025 Jul 31;23(1):449. doi: 10.1186/s12916-025-04287-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative-based card game in people with Pediatric Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of recruitment (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.