Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep Quality Index
研究概览
简要总结
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 0-III Breast Cancer
- •No any cancer treatment in the following year
- •Perceived emotional distress and poor sleep quality
- •Agree to follow the protocol of this study
排除标准
- •Stage IV Breast Cancer
- •Pregnant women
- •Abnormal liver, kidney, gastric, internal , immune, sleep disorder, metabolic, psychic functions and need to take the prescription medications or medical treatments regularly
- •could not follow the protocol of this study
研究组 & 干预措施
A Group
干预措施: Kombucha (Other)
B Group
Waiting list
干预措施: Kombucha (Other)
结局指标
主要结局
Sleep Quality Index
时间窗: Change from Baseline Sleep Quality Index at Day32
The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.
Anxiety
时间窗: Change from Baseline State-Trait Anxiety Inventory at Day32
The State-Trait Anxiety Inventory, STAI. It includes two types of anxiety. The state anxiety is considered to be individual's temporary perception toward fear, nervousness, discomfort etc. and the trait anxiety be the individual's experience on a daily basis The range of each measurement score was 20-80. Higher scores indicate greater anxiety.
Sleep Quality Index
时间窗: Change from Baseline Sleep Quality Index at Day 20
The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.
Anxiety
时间窗: Change from Baseline State-Trait Anxiety Inventory at Day20
The State-Trait Anxiety Inventory, STAI. It includes two types of anxiety. The state anxiety is considered to be individual's temporary perception toward fear, nervousness, discomfort etc. and the trait anxiety be the individual's experience on a daily basis The range of each measurement score was 20-80. Higher scores indicate greater anxiety.
次要结局
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 26)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 2)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 3)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 4)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 5)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 6)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 7)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 8)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 9)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 10)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 11)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 12)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 13)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 14)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 15)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 16)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 17)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 18)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 19)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 20)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 21)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 22)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 23)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 24)
- Intestinal Transit Time(Change from Baseline Bristol Stool Form Scale at Day 25)
研究者
I-Ching Hou
Associate Professor
National Yang Ming Chiao Tung University