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Trial Title:
Narrative-based Card Game in Improving Spiritual Well-being Among Chinese Childhood Cancer Patients
NCT ID:
NCT05639062
Condition:
Pediatric Cancer
Conditions: Keywords:
spiritual well-being
intervention
childhood cancer patients
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Narrative-based card game
Description:
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.
Arm group label:
Narrative-based card game
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.
Criteria for 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.
- 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%.
-
Gender:
All
Minimum age:
12 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hong Kong Polytechnic University
Address:
City:
Hong Kong
Zip:
0000
Country:
Hong Kong
Start date:
January 1, 2023
Completion date:
January 1, 2024
Lead sponsor:
Agency:
The Hong Kong Polytechnic University
Agency class:
Other
Source:
The Hong Kong Polytechnic University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05639062
