The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: a Three-arm Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Change of the symptom improvments
研究概览
简要总结
The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).
详细描述
After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects randomly assigned to either ASC group or SSC group will be blinded to their group assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage IIIB or IV;
- •Aged 18 years or above;
- •Expected survival time longer than 16 weeks;
排除标准
- •Disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count < 35000/µL; INR > 1.5; hemoglobin ≤ 90 g/dL; white blood cell count ≤ 4x109/L;
- •Uncontrolled active skin infection;
- •Needle phobia;
- •Inability to read and understand Chinese;
- •Not signed written informed consent.
- •Receiving surgery during the whole study period;
- •Receiving acupuncture treatment in the last 3 months
结局指标
主要结局
Change of the symptom improvments
时间窗: Change from baseline score at 3 weeks
The Edmonton Symptom Assessment System (ESAS) is used to rate the intensity of nine common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)
次要结局
- EORTC QLQ-C15-PAL(weeks 0, 3, 7 and 11)
- Numeric Rating Scale(weeks 0, 3, 7 and 11)
- Symptom improvments(weeks 0, 1, 2, 7 and 11)
- The Insomnia Severity Index(weeks 0, 3, 7 and 11)
- Fatigue(weeks 0, 3, 7 and 11)
- The Hospital Anxiety and Depression Scale(weeks 0, 3, 7 and 11)