Effect of Kefir on Symptom Management and Quality of Life in Oncology
NCT Number: NCT06517420
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Colorectal Cancer
Interventions: OTHER: kefir consumption
Sponsor: Izmir Bakircay University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2023-06-01
Completion Date: 2024-02-01
Locations: Health Sciences University Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital, Additional Service Building, İzmir, 35100, Turkey

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.

Primary Outcome Measures: Nightingale Symptom Assessment Scale, Nightingale Symptom Assessment Scale (N-SDS) is a symptom assessment scale developed by Can and Aydıner for cancer patients in 2009 (Can and Aydıner, 2011). The scale (N-SDS), consisting of a total of 38 items, has three subscales (Physical Well-Being, Social Well-Being and Psychological Well-Being). When used alone, each item in the scale can reflect the extent to which cancer patients who are planning to receive or are receiving chemotherapy are affected by the problems caused by the disease/treatment, as well as how their quality of life is. While evaluating the scores on this Likert-type scale, the patient's response to the items is scored as "0" if the answer is no, "1" if the answer is very little, "2" if it is very little, "3" if it is little. "4" if many, "4" if many. A high score indicates that patients are highly affected by problems arising from the disease/treatment., 4 months|FACT-G Quality of Life Scale, The FACIT Measurement System is health-related Quality of Life (HRQOL) surveys targeting the management of chronic diseases. In FACT-G, Çetiner et al. It has been translated into Turkish by and its reliability and validity have been proven (Çetiner et al. 2004). The 4th version of the FACT-G survey is a compilation of 27 items and the general questions are divided into four main groups (Physical well-being, Social life and family well-being, Functional well-being, Emotional well-being). For each item of the rating scale; 0 points are given for the item "Not at all", 1 point for the item "Very little", 2 points for the item "Somewhat", 3 points for the item "A lot", and 3 points for the item "A lot". "4 points are given. An increase in the score obtained from the scale indicates that the quality of life is high., 4 months
Secondary Outcome Measures: World Health Organization Mucositis Evaluation Form, It is used in clinics to evaluate the oral mucosa and grade oral mucositis. Generally, the scale is recommended for use in identifying toxicities caused by cytotoxic agents. Anatomical changes related to the oral mucosa and the severity of mucositis are scored between 0 and 4 points. In this scoring, the oral mucosa of the patients is evaluated objectively (erythema, ulceration, etc.), subjectively (oral pain, etc.) and functionally (patient's ability to eat, etc.). If these scores are 0, it is considered as no oral mucositis, while a score of '1' indicates that it is mild, a score of '2' indicates that it is moderate, a score of '3' indicates that it is serious, and a score of '4' indicates that it is at a life-threatening level (Çakmak and Nural, 2020)., 4 months|Rhodes Index of Nausea, Vomiting and Retching, "Nausea-Vomiting and Gagging Index" was developed by Rhodes and McDaniel in 1999, and its validity and reliability were tested by Rhodes and McDaniel. The alpha internal consistency coefficient of the index is 0.98, and the alpha internal consistency coefficients of the subgroups vary between 0.83 and 0.99 (Rhodes and McDaniel, 1999). The adaptation of BKÖI to Turkish society was made by Genç (2010). In the adaptation made by Genç (2010), the internal consistency coefficient was found to be 0.95, and the alpha internal consistency number for subgroups was found to be between 0.81-0.95. In scoring the "Nausea-Vomiting and Gagging Index", items 1, 3, 6 and 7 are reversed. In scoring, for each answer, 4 means the highest level of distress and 0 means the least distress. The patient's experience of nausea and vomiting on each of the 8 items is collected. 32 is the highest possible value and indicates the most severe symptom formation (Genç, 2010)., 4 months|American Society of Clinical Oncology (ASCO) Diarrhea Rating Scale, This fact sheet was developed by the American Society of Clinical Oncology (ASCO, 2022). All rights reserved worldwide. No sponsor was involved in the development of the content. It is the responsibility of the treating physician or other healthcare provider to determine medication dosages and the best dose, based on the patient's independent experience and knowledge. ASCO assumes no liability for any injury or damage to persons or property arising from or relating to any use of the information document or any errors or omissions. The information in ASCO's patient education materials is not intended to be medical advice or a substitute for medical advice. Patients with health care questions should call or see their physician or other health care provider immediately and should not disregard professional medical advice or delay seeking it because of information encountered here (ASCO, 2020)., 4 months|Constipation Evaluation Scale (CAS), The Constipation Assessment Scale was developed by McMillan and Williams (1989) to evaluate the constipation problem experienced by cancer patients in the last week (McMillan and Williams 1989). The original language of the scale is English. . The scale consists of 8 items and a single sub-dimension. The scale is prepared according to the three-point Likert type (0=No problems, 1=There are some problems, 2=There are serious problems) and the minimum score is 0 and the maximum score is 16. The scale score shows that the constipation problem is increasing. The patient rates each constipation item on a three-point scale (no problem to severe problem). Total scores range from 0 (no constipation) to 16 (worst possible constipation). The cutoff score for constipation has not been reported (McMillan and Williams, 1989; Wickham, 2016)., 4 months