Effects of a Ritual Training Program in the Head and Neck Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Disfigurement
研究概览
简要总结
To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients.
详细描述
The purpose of this study will to evaluate the effects of a ritual training program on disfigurement, self-esteem, social interaction, and body image in head and neck cancer (HNC) patients.
A prospective, repeated measures, randomized controlled therapeutic intervention design was employed. The experimental group will receive a ritual training program, and the control group will receive routine care. Patients will be assessed at three time points: baseline assessment (T0), and then at 1, 2, and 3-months (T1, T2, and T3) after participating in the ritual training program or routine care.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •> 20 years old,
- •newly diagnosed first occurrence of HNC,
- •completion of treatment and more than 3 months post-treatment
排除标准
- •recurrence
研究组 & 干预措施
Ritual training program
ritual training program for 8 weeks, biweekly
干预措施: Ritual training program (Behavioral)
Routine care
Routine care following hospital
干预措施: Routine care (Behavioral)
结局指标
主要结局
Disfigurement
时间窗: Change from Baseline Disfigurement at 6 months
Observer-rated disfigurement scale (1-9, higher score indicating greater levels of self-esteem higher disfigurement)
Body Image
时间窗: Change from Baseline Body Image at 6 months
Body Image Scale (0-30, higher scores indicate greater symptoms or distress in terms of body image concerns)
Social Interaction
时间窗: Change from Baseline Social Interaction at 6 months
Liebowitz Social Anxiety Scale(0-72, higher scores indicate greater fear or avoidance social interaction
Depression
时间窗: Change from Baseline Depression at 6 months
Hospital Anxiety and Depression Scale-Depression Subscale (0-21, higher score indicates a higher level of depression).
Self-Esteem
时间窗: Change from Baseline Self-Esteem at 6 months
Rosenberg Self-Esteem Scale(10-40, higher scores indicating greater levels of self-esteem)
次要结局
未报告次要终点
研究者
Shu-Ching Chen
Professor
Ministry of Science and Technology, Taiwan