An interventional study of Narrative-based card game in Pediatric Cancer, sponsored by The Hong Kong Polytechnic University. Status unknown at 1 site in Hong Kong. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-12-06.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
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.
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.
The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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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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Behavioral: Narrative-based card game
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.
The length of recruitment
The time used for subject recruitment
Time frame: baseline
Eligibility rate
The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment
Time frame: baseline
Consent rate
The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients
Time frame: baseline
Randomization rate
The number of participants who are randomized divided by the number of consenting children
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: post-intervention, and 1-month, 3-month follow ups
Missing data
The percentage of missing data.
Time frame: 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.
Time frame: post-intervention, 1-month, 3-month follow ups
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
Time frame: at 3-months follow-up
Plan to share: No
No publications or documents are linked to this record.
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The Hong Kong Polytechnic University