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

Study Overview
=================
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.

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

Conditions
-----------------
Pediatric Cancer

Intervention / Treatment
-----------------
* Behavioral: Narrative-based card game


Participation Criteria
=================
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%. -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narrative-based card game<br> | Behavioral: Narrative-based card game<br>* 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.<br>|
| No Intervention: PUKE card game<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of recruitment | The time used for subject recruitment | baseline | 
| Eligibility rate | The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment | baseline | 
| Consent rate | The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients | baseline | 
| Randomization rate | The number of participants who are randomized divided by the number of consenting children | 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 | 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. | 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. | post-intervention, and 1-month, 3-month follow ups | 
| Missing data | The percentage of missing data. | 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. | post-intervention, 1-month, 3-month follow ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spiritual well-being, intervention, childhood cancer patients