Narrative-based Card Game in Improving Spiritual Well-being Among Chinese Childhood Cancer Patients

Pediatric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05639062
• Other study ID #: NCG
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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%. -

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The length of recruitment	The time used for subject recruitment	baseline
Primary	Eligibility rate	The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment	baseline
Primary	Consent rate	The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients	baseline
Primary	Randomization rate	The number of participants who are randomized divided by the number of consenting children	baseline
Primary	Attendance rate	The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group	post-intervention
Primary	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.	post-intervention, and 1-month, 3- month follow ups
Primary	Completion rate	The number of participants who complete the questionnaire divided by the number of questionnaires distributed.	post-intervention, and 1-month, 3-month follow ups
Primary	Missing data	The percentage of missing data.	post-intervention, 1-month, 3- month follow ups
Primary	Adverse events	Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline.	post-intervention, 1-month, 3-month follow ups
Secondary	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	at 3-months follow-up