Effect of Kefir on Symptom Management and Quality of Life in Oncology

NCT06517420 | Completed

• 1 other identifier: BU-SBF-AÖC-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer

Keywords

kefir; symptom management; quality of life; chemotheraphy; oncology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• World Health Organization Mucositis Evaluation Form

  4 months

• Rhodes Index of Nausea, Vomiting and Retching

  4 months

• American Society of Clinical Oncology (ASCO) Diarrhea Rating Scale

  4 months

• Constipation Evaluation Scale (CAS)

  4 months

Study Arms (2)

Control Group (No intervention group)

NO INTERVENTION

Patients were asked "Individual Information Form, Nightingale Symptom Assessment Scale, FACT-G Quality of Life Scale, WHO Mucositis Evaluation Form, Rhodes Nausea Vomiting Gagging Index, ASCO Diarrhea Assessment Scale and Constipation Assessment Scale (CAS)" were filled in. No treatment was performed on the patients in the control group, and the patients continued their chemotherapy treatment. After 4 sessions, Nightingale Symptom Assessment Scale, FACT-G Quality of Life Scale, WHO Mucositis Evaluation Form, Rhodes Nausea Vomiting Gagging Index, ASCO Diarrhea Evaluation Scale and Constipation Assessment Scale (CAS)" were filled in again.

Experimental group (intervention group)

EXPERIMENTAL

Patients were asked "Individual Information Form, Nightingale Symptom Assessment Scale, FACT-G Quality of Life Scale , WHO Mucositis Evaluation Form, Rhodes Nausea Vomiting Gagging Index, ASCO Diarrhea Assessment Scale and Constipation Assessment Scale (CAS)" were filled in. He was informed to consume 250 ml of kefir twice a day, before and after meals, for 1 week after the chemotherapy session, and to gargle in the mouth while consuming kefir, hold it for a while, and then swallow. At the end of each chemotherapy session and the 4th session, the Nightingale Symptom Assessment Scale, FACT-G Quality of Life Scale, WHO Mucositis Evaluation Form, Rhodes Nausea Vomiting Gagging Index, ASCO Diarrhea Assessment Scale and Constipation Assessment Scale (CAS) were applied by the practitioner. .

Other: kefir consumption

Interventions

kefir consumption OTHER

Support and information was received from the Food Technology Department of a university's Experimental Medicine Application and Research Center. It was decided to choose the kefir to be used, which is produced from pasteurized cow's milk, lactase enzyme, probiotic culture (B. Lactis) and kefir culture, will meet the B12 need, contribute to increasing vitality and energy, and has the most suitable content in the market. Kefir, supplied by the researcher, was given to the patients at the end of each session in the amount that the patients should consume for a week, following the cold chain rule. While consuming kefir, it was recommended to gargle it in the mouth, hold it for a while, and then swallow. Patients were contacted for a week after the session to ensure that they applied kefir correctly.

Experimental group (intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Health Sciences University Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital, Additional Service Building

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Olçun Ümit ÜNAL, Assos. Prof.

  HSU-Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: A randomized controlled prospective experimental study

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: June 1, 2023
• Primary Completion: August 21, 2023
• Study Completion: February 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)