Distress, EmotionalNCT05717972
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors
A study testing Kombucha in people with Distress, Emotional and Sleep, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Distress, Emotional, Sleep
- What is being tested?
- Kombucha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2022to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, 11221
IChing Hou, PhD, 886-2-28267000 ext. 7315, evita@ym.edu.tw
IChing Hou, PhD
About this study
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.
- Conditions
- Distress, Emotional, Sleep
- Being tested
- Kombucha
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KombuchaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | Not described Receives: Other: Kombucha |
| B Group | Other | Waiting list Receives: Other: Kombucha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality Index
The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline State-Trait Anxiety Inventory at Day32
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline Bristol Stool Form Scale at Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start12 Dec 2022
- Primary completion12 Dec 2024 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Ching Hou, National Yang Ming Chiao Tung University
- Investigators
- I-Ching Hou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717972
- Sponsor's protocol ID
- YM111146EF
- Status last verified
- Feb 2023
- First submitted
- 17 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05717972
- Acronym / sponsor ID
- YM111146EF
- Conditions
- Distress, Emotional, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Group | Experimental | Other: Kombucha |
| B Group | Other | Other: KombuchaWaiting list |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KombuchaKombucha 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. | Other | A Group, B Group |
Primary outcome
Sleep Quality Index
Time frame: 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.
Sleep Quality Index
Time frame: 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
Time frame: 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.
Anxiety
Time frame: 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.
25 secondary outcomes
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 2
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 3
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 4
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 5
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 6
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 7
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 8
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 9
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 10
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 11
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 12
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 13
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 14
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 15
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 16
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 17
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 18
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 19
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 20
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 21
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 22
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 23
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 24
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 25
Intestinal Transit Time
Time frame: Change from Baseline Bristol Stool Form Scale at Day 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Ching Hou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kombucha in people with Distress, Emotional and Sleep, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Ching Hou, PhD (886-2-28267000 ext. 67315, evidta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality Index (time frame: Change from Baseline Sleep Quality Index at Day 20). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.