Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Change in disease-specific quality of life (FACT-MM)
研究概览
简要总结
In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with advanced tumour diseases. (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with advanced tumour diseases on current therapy, who suffer from persistent disease- or therapy-associated symptoms and limitations (screening by distress thermometer, score ≥ 5)
- •Informed consent.
排除标准
- •medical reasons or
- •a mental condition which, in the opinion of the investigator, does not allow the patient to participate in the study,
- •a planned radiation therapy in the area of the skull (to avoid potential scattered radiation),
- •a missing legally binding signature on the informed consent form,
- •participation in another acupuncture/acupressure study.
研究组 & 干预措施
Auricular Acupuncture
Intervention group: Ear acupressure is performed on both ears with permanent pellets according to the NADA (National Acupuncture Detoxification Association) protocol over a period of 8 weeks (presentation at the study center 1x/week, application of the acupressure patches there; these remain on both ears for 5 days and should be massaged 3x/day by the patients themselves according to the instructions provided).
In addition, patients receive a 30-minute psychoeducational talk at the first treatment appointment to promote their own health competence.
干预措施: Auricular Acupuncture (Other)
Waitlist
Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline.
结局指标
主要结局
Change in disease-specific quality of life (FACT-MM)
时间窗: after 8 weeks (end of intervention)
The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself. The diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study.
次要结局
- Change of individual symptom burden(after 8 weeks (end of intervention))
- Change of Fatigue(12 weeks post-intervention)
- Change of pain(12 weeks post-intervention)
- Change of sleep disorders and sleep quality(12 weeks post-intervention)
- Change in anxiety and depressiveness(12 weeks post-intervention)
- Number of pateints with adverse events(through study completion, an average of 3 Years)
- Change in anxiety and depressiveness(2 weeks post-intervention)
- Change of individual symptom burden(fourth week of intervention)
- Change in anxiety and depressiveness(fourth week of intervention)
- Change in anxiety and depressiveness(after 8 weeks (end of intervention))
- Change of pain(fourth week of intervention)
- Change of pain(after 8 weeks (end of intervention))
- Change of pain(2 weeks post-intervention)
- Change of Fatigue(fourth week of intervention)
- Change of Fatigue(after 8 weeks (end of intervention))
- Change of Fatigue(2 weeks post-intervention)
- Change of sleep disorders and sleep quality(fourth week of intervention)
- Change of sleep disorders and sleep quality(after 8 weeks (end of intervention))
- Change of sleep disorders and sleep quality(2 weeks post-intervention)