DRKS00027477已完成3 期
Prospective Randomized Group Controlled Study of Clinical Efficacy and Safety of the CE-marked Untire App - Untire II
Facharztpraxis Prof. Dr. med Zenner0 个研究点目标入组 216 人开始时间: 2022年5月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age 18 years or older
- •- Formally diagnosed with a malignancy
- •- 90 days after therapy start or later
- •- Experiences fatigue at the moderate or severe level: an average composite score (items 1-9) of =4 on the Brief Fatigue Inventory (BFI)
- •- German fluency and literacy
- •- Access to smartphone and internet
排除标准
- •-Inability to provide an informed consent
- •-Average composite score (items 1-9) of 3 or less on the Brief Fatigue Inventory (BFI)
- •-No ability to use a smart phone or a tablet
- •-Not German speaking
- •-Use of Untire in the control group
- •-Patients receiving end of life care
- •-Fatigue is caused by demonstrable medical factors such as dehydration, anemia and kidney malfunction.
- •-Patients with other fatigue syndromes than CRF, such as fibromyalgia and chronic fatigue syndrome (CFS)
- •-Receiving treatment for a psychiatric disorder
- •***Absolute contraindications
- •-acute illnesses
- •-acute relapses or decompensation in chronic diseases
- •-fever > 38 degrees
- •-severe pain
- •-inadequately adjusted blood pressure in hypertension
- •***Relative contraindications
- •-anemia < 8 g/dL
- •-Thrombocytopenia and coagulation disorders
- •-bone metastases
- •-Comorbidities such as CHD, pAVK, arterial hypertension, diabetes mellitus,
- •osteoarthritis
- •-administration of cytostatic drugs on the day of sport
- •-mediastinal/cardiac irradiation
- •-flu-like symptoms during immunotherapies
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