NCT01458457已完成4 期
Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
研究概览
简要总结
Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease specific quality of life of an individualized additional complementary medicine treatment in addition to usual care with usual care only in 280 women with breast cancer
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed breast cancer
- •current usual care treatment
- •willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group
- •informed consent
排除标准
- •complementary treatment at the Hospital Meran in the last 6 months
- •no German or Italian language ability
- •participation in other study
结局指标
主要结局
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
时间窗: 6 months
次要结局
- Functional Assessment of Chronic Illness Therapy-Fatigue(3, 6 months)
- Satisfaction and patient-reported effectiveness(3, 6 months)
- Survival(6 months)
- Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)(3 months)
- Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(3, 6 months)
- Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being)(3, 6 months)
- Used complementary Therapies and their frequency(6 months)
- Pain, quality of sleep, and nausea (single items of the FACT-B)(3, 6 months)
- Survival without relapse(6 months)
- Quality of Life (SF-12 Health Survey)(3, 6 months)
- Undesirable Effects and Interactions(6 months)
- Goal Attainment Scale(3 months)
- Expectations at Baseline(Baseline)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (2)
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