DRKS00031951招募中Unknown
A Prospective Multi-Center RCT Assessing Clinical Efficacy and Safety of the CE-marked Untire App®, Targeting Breast Cancer Patients (ICD-10 C50) with Cancer-Related Fatigue in the Post-Primary Treatment Phase of their Cancer, Powered to Detect Significant Fatigue Improvement (Untire-III-B) - Untire-III-B
Tired of Cancer B.V.0 个研究点目标入组 184 人开始时间: 2024年3月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 184
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Informed consent signed
- •Formally diagnosed with breast cancer stages I-III (diagnosis confirmed by the investigator)
- •Completed primary oncological treatment (i.e., curative surgery and/or curative radiotherapy and/or curative chemotherapy and/or curative immunotherapy) at least three weeks prior to the study except for hormonal/antihormonal or neoadjuvant/adjuvant/targeted therapy treatment (requirement of completed wound healing).
- •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
- •Breast cancer: UICC IV (all T, all N, M1),
- •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
- •usage of the Untire app before the study for both groups and Untire app use for the control group during the study
- •Patients receiving palliative (including end of life care)
- •In-faust prognosis
- •Fatigue is caused by demonstrable non-oncological factors such as dehydration, anemia and kidney malfunction
- •Patients with other fatigue syndromes then CRF, such as fibromyalgia and chronic fatigue syndrome (CFS). This is checked by the case history (using a checklist that patients were asked by the study doctor, patients were asked to bring the hospital/doctor report which is checked by the study doctor, further, lab test reports were checked by the study doctor)
- •Relevant severe psychiatric differential diagnosis and severe comorbidities, checked by study doctor based on the hospital and or doctors’ report/doctors case report, are excluded (e.g., severe depression).
- •Severe sleep-wake disorders (i.e., severe hypersomnia)
- •Receiving treatment (i.e., medication) for a severe psychiatric disorder at inclusion
- •Acute illnesses and/or acute relapses or decompensation in chronic diseases that prevents patients from participation in the study in the opinion of the study physician
- •Fever > 38 degrees
- •Severe pain (usually indicates analgesics drug use)
- •Inadequately adjusted blood pressure in hypertension
- •Relative contraindications:
- •anemia < 8 g/dL
- •Thrombocytopenia and coagulation disorders
- •Comorbidities such as CHD, pAVK, arterial hypertension, diabetes mellitus, osteoarthritis
- •mediastinal/cardiac irradiation
研究者
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