CancerNCT05991544
The Effect of Training and Follow-up Given to Cancer Patients Receiving Chemotherapy According to the Neuman Systems Model on the Development of Oral Mucositis and Perceptions of Comfort in Patients
A study testing Training and Follow-up According to the Neuman Systems Model in people with Cancer, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to prevent the development of oral mucositis or to reduce the severity of developing oral mucositis with the training to be given to patients receiving chemotherapy according to the Neuman systems model. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Training and Follow-up According to the Neuman Systems Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Jul 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receiving chemotherapy treatment No mental or communication problems, Volunteering to participate in research. having internet, Having at least primary education level, Being able to use smart phone and internet. Being on treatment that causes methotrexate, Cispilatin, Cyclophoshamide, 5-fluorouracil group oral mucositis.
- -
Who cannot join
- lack of internet illiteracy
- -
Trial locations and contacts
1 site in 1 country.
Yasemin Erdem contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atatürk university nursing faculty
Erzurum, Center, 25240
Yasemin Erdem
About this study
Official title: The Effect of Training and Follow-up Given to Cancer Patients Receiving Chemotherapy According to the Neuman Systems Model
It is aimed to prevent the development of oral mucositis or to reduce the severity of developing oral mucositis with the training to be given to patients receiving chemotherapy according to the Neuman systems model.
Read the detailed description
Oral mucositis is a health problem that is commonly seen in patients receiving chemotherapy and radiotherapy, which seriously affects the quality of life and comfort of patients. In the literature, the importance of nursing education in supporting patients has been emphasized, as well as controlling the side effects in patients receiving chemotherapy and systematically evaluating the side effects. The training program to be planned in this context will increase the self-efficacy of patients and their ability to cope with the disease. Studies have shown that planned health education effectively supports knowledge, increases participation in treatment processes, and reduces anxiety. Nurses use various nursing interventions such as coaching, face-to-face education programs, telephone monitoring and home care while providing training in symptom management.
Theories and models in nursing include a set of ideas about people, health-illness, and society that will guide the care of patients.
Nurses can be successful in providing holistic care only through the use of nursing models. By using these models, nursing activities are shifting from service-oriented to patient-oriented service. In addition, the basic concepts and relations between the concepts are determined, problems are defined and solutions can be developed. Neuman Systems Model (NSM), one of these models, adopts the open system approach and the concept of holistic maintenance. The model, whose reliability and scientific aspect has been tried since the day it emerged, has contributed to nursing practices and systematized the nursing care plan. NSM offers a holistic approach to patients by including psychological, physiological, spiritual, sociocultural and five major developmental variables of the individual.
Therefore, it is a suitable model to be used for nursing practices. In this study, NSM will be used in order to evaluate patients holistically and to meet their needs during the treatment process. With the planned training and follow-up to be given to cancer patients receiving chemotherapy, the patients were followed closely for 3 months, and it will provide significant benefits both for the patient and the country's economy by monitoring the development of oral mucositis or providing the management of developing oral mucositis. By preventing the development of oral mucositis, patients will have a more comfortable process and will contribute to the country's economy by preventing hospitalizations. Because oral mucositis causes pain enough to require the use of narcotic drugs and increases the need for total parenteral nutrition. This situation increases the hospital costs and harms the country's economy. The fact that oral mucositis does not develop during the chemotherapy process will allow the treatment process to be comfortable and more effective for the patient.In the light of all this information; It is aimed to prevent the development of oral mucositis or to reduce the severity of developing oral mucositis with the training to be given to patients receiving chemotherapy according to the Neuman systems model. In this direction, it is thought that the study will make a serious contribution to the literature.
- Conditions
- Cancer
- Being tested
- Training and Follow-up According to the Neuman Systems Model
- Keywords
- nurse, oral Mucositis, education
- Medical subject headings
- Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and Follow-up According to the Neuman Systems ModelBehavioural
Neuman Systems Model (NSM) it presents a holistic approach to patients by including physiological, spiritual, sociocultural and five major developmental variables
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Training and Follow-up According to the Neuman Systems Model Receives: Behavioral: Training and Follow-up According to the Neuman Systems Model |
| Control | No intervention | only procedure will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Perception Scale in Oral Mucositis
The scale was developed in 2019 by Erden and İpek Çoban to evaluate the perception of comfort in patients with oral mucositis. The scale consists of 31 items and 2 sub-dimensions.
Measured: 12 week
Oral Mucositis Grading Index:
Developed by the World Health Organization and
It is a staging scale. Grade 0: No symptoms. Grade 1: Pain or erythema. Grade 2: Painful, erythema, edema or ulcer present, but the patient can take solid foods. Grade 3:
There is pain, erythema, edema or ulcer, the patient can only take liquid foods. Grade 4: No feeding.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Nov 2023
- Primary completion1 Jan 2024
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
- Investigators
- Gülcan B.TURAN, Principal investigator, Firat UniversityYasemin Erdem, Principal investigator, Erzurum Technical UniversitySeda Karaman, Principal investigator, Atatatürk Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991544
- Sponsor's protocol ID
- B.30.2.ATA
- Status last verified
- Jan 2024
- First submitted
- 6 Aug 2023
- Last updated
- 31 Jan 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training and Follow-up Given to Cancer Patients Receiving Chemotherapy According to the Neuman Systems Model
- ClinicalTrials.gov ID
- NCT05991544
- Acronym / sponsor ID
- B.30.2.ATA
- Conditions
- Cancer
- Keywords
- nurse, oral Mucositis, education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
It is aimed to prevent the development of oral mucositis or to reduce the severity of developing oral mucositis with the training to be given to patients receiving chemotherapy according to the Neuman systems model.
Detailed description
Oral mucositis is a health problem that is commonly seen in patients receiving chemotherapy and radiotherapy, which seriously affects the quality of life and comfort of patients. In the literature, the importance of nursing education in supporting patients has been emphasized, as well as controlling the side effects in patients receiving chemotherapy and systematically evaluating the side effects. The training program to be planned in this context will increase the self-efficacy of patients and their ability to cope with the disease. Studies have shown that planned health education effectively supports knowledge, increases participation in treatment processes, and reduces anxiety. Nurses use various nursing interventions such as coaching, face-to-face education programs, telephone monitoring and home care while providing training in symptom management.
Theories and models in nursing include a set of ideas about people, health-illness, and society that will guide the care of patients.
Nurses can be successful in providing holistic care only through the use of nursing models. By using these models, nursing activities are shifting from service-oriented to patient-oriented service. In addition, the basic concepts and relations between the concepts are determined, problems are defined and solutions can be developed. Neuman Systems Model (NSM), one of these models, adopts the open system approach and the concept of holistic maintenance. The model, whose reliability and scientific aspect has been tried since the day it emerged, has contributed to nursing practices and systematized the nursing care plan. NSM offers a holistic approach to patients by including psychological, physiological, spiritual, sociocultural and five major developmental variables of the individual.
Therefore, it is a suitable model to be used for nursing practices. In this study, NSM will be used in order to evaluate patients holistically and to meet their needs during the treatment process. With the planned training and follow-up to be given to cancer patients receiving chemotherapy, the patients were followed closely for 3 months, and it will provide significant benefits both for the patient and the country's economy by monitoring the development of oral mucositis or providing the management of developing oral mucositis. By preventing the development of oral mucositis, patients will have a more comfortable process and will contribute to the country's economy by preventing hospitalizations. Because oral mucositis causes pain enough to require the use of narcotic drugs and increases the need for total parenteral nutrition. This situation increases the hospital costs and harms the country's economy. The fact that oral mucositis does not develop during the chemotherapy process will allow the treatment process to be comfortable and more effective for the patient.In the light of all this information; It is aimed to prevent the development of oral mucositis or to reduce the severity of developing oral mucositis with the training to be given to patients receiving chemotherapy according to the Neuman systems model. In this direction, it is thought that the study will make a serious contribution to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Training and Follow-up According to the Neuman Systems ModelTraining and Follow-up According to the Neuman Systems Model |
| Control | No intervention | –only procedure will be applied |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving chemotherapy treatment No mental or communication problems, Volunteering to participate in research. having internet, Having at least primary education level, Being able to use smart phone and internet. Being on treatment that causes methotrexate, Cispilatin, Cyclophoshamide, 5-fluorouracil group oral mucositis.
- -
Key exclusion criteria (2 listed)
- lack of internet illiteracy
- -
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 |
|---|---|---|
| Training and Follow-up According to the Neuman Systems ModelNeuman Systems Model (NSM) it presents a holistic approach to patients by including physiological, spiritual, sociocultural and five major developmental variables | Behavioural | Experimental |
Primary outcome
Comfort Perception Scale in Oral Mucositis
Time frame: 12 week
The scale was developed in 2019 by Erden and İpek Çoban to evaluate the perception of comfort in patients with oral mucositis. The scale consists of 31 items and 2 sub-dimensions.
Oral Mucositis Grading Index:
Time frame: 12 week
Developed by the World Health Organization and It is a staging scale. Grade 0: No symptoms. Grade 1: Pain or erythema. Grade 2: Painful, erythema, edema or ulcer present, but the patient can take solid foods. Grade 3: There is pain, erythema, edema or ulcer, the patient can only take liquid foods. Grade 4: No feeding.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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.
Yasemin Erdem contact
Gülcan B.TURAN principal investigator
Firat University
Yasemin Erdem principal investigator
Erzurum Technical University
Seda Karaman principal investigator
Atatatürk Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and Follow-up According to the Neuman Systems Model in people with Cancer, run by Ataturk 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülcan B.TURAN (05065576086, glcnbah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort Perception Scale in Oral Mucositis (time frame: 12 week). 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 31 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.