Breast CancerNCT06517420
Effect of Kefir on Symptom Management and Quality of Life in Oncology
A study testing kefir consumption in people with Breast Cancer and Colorectal Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colorectal Cancer
- What is being tested?
- kefir consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital, Additional Service Building
Izmir, 35100
About this study
Official title: The Effect of Kefir on Symptom Management and Quality of Life in Oncology Patients Treated With Chemotherapy
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.
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer
- Being tested
- kefir consumption
- Keywords
- kefir, symptom management, quality of life, chemotheraphy, oncology
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kefir consumptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: Other: kefir consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jun 2023
- Primary completion21 Aug 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled prospective experimental study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslıhan ÖZTÜRK ÇETİN, Izmir Bakircay University
- Investigators
- Olçun Ümit ÜNAL, Assos. Prof., Study chair, HSU-Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517420
- Sponsor's protocol ID
- BU-SBF-AÖC-01
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kefir on Symptom Management and Quality of Life in Oncology Patients Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT06517420
- Acronym / sponsor ID
- BU-SBF-AÖC-01
- Conditions
- Breast Cancer, Colorectal Cancer
- Keywords
- kefir, symptom management, quality of life, chemotheraphy, oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled prospective experimental study
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: kefir consumptionPatients 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. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kefir consumptionSupport 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. | Other | Experimental group (intervention group) |
Primary outcome
Nightingale Symptom Assessment Scale
Time frame: 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
Time frame: 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.
4 secondary outcomes
World Health Organization Mucositis Evaluation Form
Time frame: 4 months
Rhodes Index of Nausea, Vomiting and Retching
Time frame: 4 months
American Society of Clinical Oncology (ASCO) Diarrhea Rating Scale
Time frame: 4 months
Constipation Evaluation Scale (CAS)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olçun Ümit ÜNAL, Assos. Prof. study chair
HSU-Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kefir consumption in people with Breast Cancer and Colorectal Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nightingale Symptom Assessment Scale (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.