Clinical trial NCT05717972: Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors
Official title: Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distress, Emotional
Sleep
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep Quality Index
timeFrame: Change from Baseline Sleep Quality Index at Day 20
measure: Sleep Quality Index
timeFrame: Change from Baseline Sleep Quality Index at Day32
measure: Anxiety
timeFrame: Change from Baseline State-Trait Anxiety Inventory at Day20
measure: Anxiety
timeFrame: Change from Baseline State-Trait Anxiety Inventory at Day32
Secondary outcomes:
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 2
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 3
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 4
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 5
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 6
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 7
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 8
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 9
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 10
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 11
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 12
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 13
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 14
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 15
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 16
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 17
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 18
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 19
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 20
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 21
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 22
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 23
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 24
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 25
measure: Intestinal Transit Time
timeFrame: Change from Baseline Bristol Stool Form Scale at Day 26
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: I-Ching Hou, PhD
role: PRINCIPAL_INVESTIGATOR
References: