NCT03735992招募中不适用
Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- General Fatigue
研究概览
简要总结
This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation
- •Physical and mental ability to attent 8 of 11 group units
排除标准
- •Chemotherapy, radiation, or rehabilitation programm during the study period
- •Pregnancy
- •Participation in other studies with behavioral interventions during the study period
研究组 & 干预措施
Mind-body medicine group program
Experimental
Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual.
干预措施: Mind-body medicine group program (Behavioral)
Wait list
No Intervention
Treatment as usual.
结局指标
主要结局
General Fatigue
时间窗: week 12
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
次要结局
- Reduced Motivation(week 24)
- Mental Fatigue(week 24)
- Depression(week 24)
- Anxiety(week 24)
- Sleep(week 24)
- General Fatigue(week 24)
- Physical Fatigue(week 24)
- Reduced Activity(week 24)
- Qaulity of life(week 24)
- Adverse Events(week 24)
- Stress(week 24)
- Physical activity(week 24)
- Fatigability(week 24)
- Physical Fatigue(week 12)
- Reduced Activity(week 12)
- Reduced Motivation(week 12)
- Mental Fatigue(week 12)
- Qaulity of life(week 12)
- Depression(week 12)
- Anxiety(week 12)
- Stress(week 12)
- Sleep(week 12)
- Physical activity(week 12)
- Fatigability(week 12)
- Adverse Events(week 12)
研究者
Holger Cramer
Research Director
Universität Duisburg-Essen
研究点 (2)
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