xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991544</url>
    </required_header>
    <id_info>
      <org_study_id>B.30.2.ATA</org_study_id>
      <nct_id>NCT05991544</nct_id>
    </id_info>
    <brief_title>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</brief_title>
    <official_title>The Effect of Training and Follow-up Given to Cancer Patients Receiving Chemotherapy According to the Neuman Systems Model</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        It is aimed to prevent the development of oral mucositis or to reduce the severity of&#xD;
        developing oral mucositis with the training to be given to patients receiving chemotherapy&#xD;
        according to the Neuman systems model.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Oral mucositis is a health problem that is commonly seen in patients receiving chemotherapy&#xD;
        and radiotherapy, which seriously affects the quality of life and comfort of patients. In the&#xD;
        literature, the importance of nursing education in supporting patients has been emphasized,&#xD;
        as well as controlling the side effects in patients receiving chemotherapy and systematically&#xD;
        evaluating the side effects. The training program to be planned in this context will increase&#xD;
        the self-efficacy of patients and their ability to cope with the disease. Studies have shown&#xD;
        that planned health education effectively supports knowledge, increases participation in&#xD;
        treatment processes, and reduces anxiety. Nurses use various nursing interventions such as&#xD;
        coaching, face-to-face education programs, telephone monitoring and home care while providing&#xD;
        training in symptom management.&#xD;
  &#xD;
        Theories and models in nursing include a set of ideas about people, health-illness, and&#xD;
        society that will guide the care of patients.&#xD;
  &#xD;
        Nurses can be successful in providing holistic care only through the use of nursing models.&#xD;
        By using these models, nursing activities are shifting from service-oriented to&#xD;
        patient-oriented service. In addition, the basic concepts and relations between the concepts&#xD;
        are determined, problems are defined and solutions can be developed. Neuman Systems Model&#xD;
        (NSM), one of these models, adopts the open system approach and the concept of holistic&#xD;
        maintenance. The model, whose reliability and scientific aspect has been tried since the day&#xD;
        it emerged, has contributed to nursing practices and systematized the nursing care plan. NSM&#xD;
        offers a holistic approach to patients by including psychological, physiological, spiritual,&#xD;
        sociocultural and five major developmental variables of the individual.&#xD;
  &#xD;
        Therefore, it is a suitable model to be used for nursing practices. In this study, NSM will&#xD;
        be used in order to evaluate patients holistically and to meet their needs during the&#xD;
        treatment process. With the planned training and follow-up to be given to cancer patients&#xD;
        receiving chemotherapy, the patients were followed closely for 3 months, and it will provide&#xD;
        significant benefits both for the patient and the country's economy by monitoring the&#xD;
        development of oral mucositis or providing the management of developing oral mucositis. By&#xD;
        preventing the development of oral mucositis, patients will have a more comfortable process&#xD;
        and will contribute to the country's economy by preventing hospitalizations. Because oral&#xD;
        mucositis causes pain enough to require the use of narcotic drugs and increases the need for&#xD;
        total parenteral nutrition. This situation increases the hospital costs and harms the&#xD;
        country's economy. The fact that oral mucositis does not develop during the chemotherapy&#xD;
        process will allow the treatment process to be comfortable and more effective for the&#xD;
        patient.In the light of all this information; It is aimed to prevent the development of oral&#xD;
        mucositis or to reduce the severity of developing oral mucositis with the training to be&#xD;
        given to patients receiving chemotherapy according to the Neuman systems model. In this&#xD;
        direction, it is thought that the study will make a serious contribution to the literature.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comfort Perception Scale in Oral Mucositis</measure>
      <time_frame>12 week</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral Mucositis Grading Index:</measure>
      <time_frame>12 week</time_frame>
      <description>Developed by the World Health Organization and&#xD;
  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:&#xD;
  There is pain, erythema, edema or ulcer, the patient can only take liquid foods. Grade 4: No feeding.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">94</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Training and Follow-up According to the Neuman Systems Model</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>only procedure will be applied</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Training and Follow-up According to the Neuman Systems Model</intervention_name>
      <description>Neuman Systems Model (NSM) it presents a holistic approach to patients by including physiological, spiritual, sociocultural and five major developmental variables</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Receiving chemotherapy treatment No mental or communication problems, Volunteering to&#xD;
          participate in research. having internet, Having at least primary education level, Being&#xD;
          able to use smart phone and internet. Being on treatment that causes methotrexate,&#xD;
          Cispilatin, Cyclophoshamide, 5-fluorouracil group oral mucositis.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          lack of internet illiteracy&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gülcan B.TURAN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Firat University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yasemin Erdem</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erzurum Technical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Seda Karaman</last_name>
      <role>Principal Investigator</role>
      <affiliation>Atatatürk Üniversitesi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gülcan B.TURAN</last_name>
      <phone>05065576086</phone>
      <email>glcnbah@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yasemin Erdem</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Atatürk university nursing faculty</name>
        <address>
          <city>Erzurum</city>
          <state>Center</state>
          <zip>25240</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yasemin Erdem</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>gülcan bahcecioğlu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>nurse</keyword>
    <keyword>oral Mucositis</keyword>
    <keyword>education</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mucositis</mesh_term>
      <mesh_term>Stomatitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991544
  org study id: B.30.2.ATA
  nct id: NCT05991544
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Comfort Perception Scale in Oral Mucositis
  time frame: 12 week
  description: 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.
  measure: Oral Mucositis Grading Index:
  time frame: 12 week
  description: 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.
  arm group label: Experimental
  arm group type: Experimental
  description: Training and Follow-up According to the Neuman Systems Model
  arm group label: Control
  arm group type: No Intervention
  description: only procedure will be applied
  intervention type: Behavioral
  intervention name: Training and Follow-up According to the Neuman Systems Model
  description: Neuman Systems Model (NSM) it presents a holistic approach to patients by including physiological, spiritual, sociocultural and five major developmental variables
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gülcan B.TURAN
  role: Principal Investigator
  affiliation: Firat University
  last name: Yasemin Erdem
  role: Principal Investigator
  affiliation: Erzurum Technical University
  last name: Seda Karaman
  role: Principal Investigator
  affiliation: Atatatürk Üniversitesi
  last name: Gülcan B.TURAN
  phone: 05065576086
  email: glcnbah@hotmail.com
  last name: Yasemin Erdem
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ataturk University
  investigator full name: gülcan bahcecioğlu
  investigator title: Principal Investigator
  mesh term: Mucositis
  mesh term: Stomatitis
  sharing ipd: No