Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors

Study Overview
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Brief Summary
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Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.

Official Title
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Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors

Conditions
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Distress, Emotional, Sleep

Intervention / Treatment
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* Other: Kombucha


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Group<br> | Other: Kombucha<br>* Kombucha is a fermented tea drink that originated in ancient Chinese civilization. It is made by combining tea, juice, and SCOBY (Symbiotic Culture of Bacteria and Yeast). During the fermentation process, the yeast in the SCOBY breaks down the sugar in the tea releasing friendly probiotic bacteria, giving kombucha its fizzy body and its sweet and tangy taste.<br>|
| Other: B Group<br>Waiting list | Other: Kombucha<br>* Kombucha is a fermented tea drink that originated in ancient Chinese civilization. It is made by combining tea, juice, and SCOBY (Symbiotic Culture of Bacteria and Yeast). During the fermentation process, the yeast in the SCOBY breaks down the sugar in the tea releasing friendly probiotic bacteria, giving kombucha its fizzy body and its sweet and tangy taste.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality Index | The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality. | Change from Baseline Sleep Quality Index at Day 20 | 
| Sleep Quality Index | The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality. | Change from Baseline Sleep Quality Index at Day32 | 
| Anxiety | 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. | Change from Baseline State-Trait Anxiety Inventory at Day20 | 
| Anxiety | 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. | Change from Baseline State-Trait Anxiety Inventory at Day32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 2 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 3 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 4 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 5 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 6 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 7 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 8 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 9 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 10 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 11 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 12 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 13 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 14 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 15 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 16 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 17 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 18 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 19 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 20 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 21 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 22 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 23 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 24 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 25 | 
| Intestinal Transit Time | Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Change from Baseline Bristol Stool Form Scale at Day 26 |