Clinical trial NCT05639062: Narrative-based Card Game in Improving Spiritual Well-being Among Chinese Childhood Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Cancer
Keywords: spiritual well-being
intervention
childhood cancer patients
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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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Primary outcomes:
measure: The length of recruitment
timeFrame: baseline
measure: Eligibility rate
timeFrame: baseline
measure: Consent rate
timeFrame: baseline
measure: Randomization rate
timeFrame: baseline
measure: Attendance rate
timeFrame: post-intervention
measure: Retention rate
timeFrame: post-intervention, and 1-month, 3- month follow ups
measure: Completion rate
timeFrame: post-intervention, and 1-month, 3-month follow ups
measure: Missing data
timeFrame: post-intervention, 1-month, 3- month follow ups
measure: Adverse events
timeFrame: post-intervention, 1-month, 3-month follow ups
Secondary outcomes:
measure: The Chinese version of adapted Functional Assessment of Chronic Illness Therapy Spiritual Well-being Scale at 3 months follow-up
timeFrame: at 3-months follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Polytechnic University
Study officials:
References: