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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Gülcan B.TURAN contact

05065576086

glcnbah@hotmail.com

Yasemin Erdem contact

Turkey (Türkiye)1 site, 1 recruiting
  • Atatürk university nursing faculty

    Erzurum, Center, 25240

    Yasemin Erdem

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT05991544
Study groupRoleWhat they receive
ExperimentalExperimentalTraining and Follow-up According to the Neuman Systems Model
Receives: Behavioral: Training and Follow-up According to the Neuman Systems Model
ControlNo interventiononly procedure will be applied

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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.

  1. First posted14 Aug 2023
  2. Study start1 Nov 2023
  3. Primary completion1 Jan 2024
  4. Study completion1 Jul 2024 (estimated)

Resources

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)
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

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.

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