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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Randomization rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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%.
结局指标
主要结局
Randomization rate
时间窗: baseline
The number of participants who are randomized divided by the number of consenting children
Consent rate
时间窗: baseline
The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients
Attendance rate
时间窗: post-intervention
The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group
Retention rate
时间窗: post-intervention, and 1-month, 3- month follow ups
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.
The length of recruitment
时间窗: baseline
The time used for subject recruitment
Missing data
时间窗: post-intervention, 1-month, 3- month follow ups
The percentage of missing data.
Adverse events
时间窗: post-intervention, 1-month, 3-month follow ups
Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline.
Eligibility rate
时间窗: baseline
The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment
Completion rate
时间窗: post-intervention, and 1-month, 3-month follow ups
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
次要结局
- The Chinese version of adapted Functional Assessment of Chronic Illness Therapy Spiritual Well-being Scale at 3 months follow-up(at 3-months follow-up)
研究者
Dr Eva Ho
Assistant Professor
The Hong Kong Polytechnic University