The Effect of Kefir on Symptom Management and Quality of Life in Oncology Patients Treated With Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Nightingale Symptom Assessment Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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 study data will be analyzed by an independent statistician.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Nightingale Symptom Assessment Scale
时间窗: 4 months
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.
FACT-G Quality of Life Scale
时间窗: 4 months
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.
次要结局
- Rhodes Index of Nausea, Vomiting and Retching(4 months)
- Constipation Evaluation Scale (CAS)(4 months)
- World Health Organization Mucositis Evaluation Form(4 months)
- American Society of Clinical Oncology (ASCO) Diarrhea Rating Scale(4 months)
研究者
Aslıhan ÖZTÜRK ÇETİN
Research Assistant
Izmir Bakircay University