Clinical trial NCT06517420: Effect of Kefir on Symptom Management and Quality of Life in Oncology
Official title: The Effect of Kefir on Symptom Management and Quality of Life in Oncology Patients Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Keywords: kefir
symptom management
quality of life
chemotheraphy
oncology
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled prospective experimental study
Primary purpose: OTHER

Brief summary: This study was planned as a randomized controlled prospective experimental study to determine the effect of kefir on symptom management and quality of life in oncology patients receiving chemotherapy. The population of the study consisted of 600 cancer patients who received chemotherapy in the outpatient chemotherapy unit of a university hospital between June 1, 2023 and February 1, 2024.

G\*Power 3.1 package program was used to determine the number of samples. The sample size to ensure the power of the test (1-β = 0.80) was determined as a minimum of 26 people for each group. Considering the possibility of losses, 106 patients were included in the study. Data from 22 patients who were followed up during the preparation phase of the study were not included in the study. Simple random sampling method was used to avoid bias in providing patients to be included in the study before the data collection phase. With the computer-based randomization method, patients were numbered in the order of arrival and divided into experimental and control. The sample of the study was determined as 84, 42 in the experimental group and 42 in the control group.

In collecting data, "Individual Information Form, Nightingale Symptom Assessment Scale (NSD-S), FACT-G Quality of Life Scale, WHO Mucositis Evaluation Form, Rhodes Nausea Vomiting Gagging Index, ASCO Diarrhea Assessment Scale and Constipation Assessment Scale" were used. CAS)" was used.

Detailed description: This study was planned as a randomized controlled prospective experimental study to determine the effect of kefir on symptom management and quality of life in oncology patients receiving chemotherapy. The population of the study consisted of 600 cancer patients who received chemotherapy in the outpatient chemotherapy unit of a university hospital between June 1, 2023 and February 1, 2024.

G\*Power 3.1 package program was used to determine the number of samples. The sample size to ensure the power of the test (1-β = 0.80) was determined as a minimum of 26 people for each group. Considering the possibility of losses, 106 patients were included in the study. Data from 22 patients who were followed up during the preparation phase of the study were not included in the study. Simple random sampling method was used to avoid bias in providing patients to be included in the study before the data collection phase. With the computer-based randomization method, patients were numbered in the order of arrival and divided into experimental and control. The sample of the study was determined as 84, 42 in the experimental group and 42 in the control group.

In collecting data, "Individual Information Form, Nightingale Symptom Assessment Scale (NSD-S), FACT-G Quality of Life Scale, WHO Mucositis Evaluation Form, Rhodes Nausea Vomiting Gagging Index, ASCO Diarrhea Assessment Scale and Constipation Assessment Scale" were used. CAS)" was used.

Kefir, which is among the complementary treatments today, is a practice in the literature due to its positive effects in the management of many symptoms.

The use of kefir stands out because it can be applied regardless of place and time, is safe and cost-effective.

It is thought that kefir consumption, which has positive effects on many symptoms and strengthening the immune system, can be applied in the management of oral mucositis, nausea-vomiting, diarrhea and constipation, but the literature remains limited on this subject.

Since cancer patients, whose prevalence is increasing day by day, frequently experience symptoms during their treatment process, especially due to the chemotherapy they have received or are currently receiving, this study will add innovation to nursing science and literature and guide new research by determining whether kefir use is effective in symptom management and quality of life in oncology patients undergoing chemotherapy. It will happen.

Eligibility criteria: Inclusion Criteria:

* Being literate
* A diagnosis of breast and colorectal cancer
* Aged 18 or over
* The ability to communicate effectively and without language difficulties
* No diagnosis of mental or psychiatric illness
* No hearing or visual impairment
* No use of kefir, milk or dairy products prior to and/or during the treatment period
* The capacity to use a telephone for counselling

Exclusion Criteria:

* Having lactose intolerance,
* Allergy to milk and dairy products,
* Hearing and visual impairment,
* Not volunteering to participate in the study,
* Having mental disability or perception problem

Primary outcomes:
measure: Nightingale Symptom Assessment Scale
timeFrame: 4 months
measure: FACT-G Quality of Life Scale
timeFrame: 4 months
Secondary outcomes:
measure: World Health Organization Mucositis Evaluation Form
timeFrame: 4 months
measure: Rhodes Index of Nausea, Vomiting and Retching
timeFrame: 4 months
measure: American Society of Clinical Oncology (ASCO) Diarrhea Rating Scale
timeFrame: 4 months
measure: Constipation Evaluation Scale (CAS)
timeFrame: 4 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Health Sciences University Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital, Additional Service Building
Study officials:
affiliation: HSU-Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital
name: Olçun Ümit ÜNAL, Assos. Prof.
role: STUDY_CHAIR
References: