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/NCT05997329</url>
    </required_header>
    <id_info>
      <org_study_id>569956</org_study_id>
      <nct_id>NCT05997329</nct_id>
    </id_info>
    <brief_title>Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home</brief_title>
    <acronym>NUTREAT</acronym>
    <official_title>Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oslo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Oslo University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of South-Eastern Norway</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Oslo</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>
        Patients with cancer have increased risk of malnutrition due to the disease itself and the&#xD;
        treatment regimen they undergo. This is particularly relevant for patients with head and neck&#xD;
        cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers,&#xD;
        including oral cavity, larynx, pharynx and salivary glands. The present project will study&#xD;
        the effectiveness and implementation of remote patient monitoring of nutrition and tailored&#xD;
        nutrition support throughout the treatment course in patients with head and neck cancer. The&#xD;
        implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the&#xD;
        project is to reduce the prevalence of malnutrition and increase the quality of life among&#xD;
        patients with HNC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Malnutrition</measure>
      <time_frame>17 weeks</time_frame>
      <description>Patient-Generated Subjective Global Assessment (PG-SGA). The tool categories participants into: category A (Well-nourished), B (Moderately malnutrition or possible malnutrition), or C (serious malnutrition)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Weight change</measure>
      <time_frame>During the 17 weeks</time_frame>
      <description>weight measurements</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutrition intake</measure>
      <time_frame>Monthly up to three months</time_frame>
      <description>24-hour recall interviews</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition</measure>
      <time_frame>Monthly up to three months</time_frame>
      <description>Bioelectrical Impedance Analysis (BIA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>Monthly up to three months</time_frame>
      <description>EuroQol Research Foundation, Netherlands (EQ5D-5L). Assess health in 5 dimensions each of which has three response levels (1: No problems, 2: some problems and 3: extreme problems/unable to do).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants compliant to the intervention</measure>
      <time_frame>At 17 weeks</time_frame>
      <description>Review of reported use of the MyFood app in the electronic patient record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with non-elective readmissions</measure>
      <time_frame>At 17 weeks</time_frame>
      <description>Review of readmissions in the electronic patient record</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">125</enrollment>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>MyFood (App for diet record)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of an App for diet record</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>App for diet record (MyFood)</intervention_name>
      <description>Patients in the intervention group will record their food intake, tube feeding, nutrition-related symptoms and body weight in the MyFood app in at least three consecutive days in advance of follow-up.The patients will thus be able to keep track of their nutrition status. They will also have access to nutrition tips for how to reach requirements if they struggle to eat sufficiently or relief symptoms that can affect food intake.Healthcare staff at the hospital and outpatient clinics will use MyFood to monitor the patient's nutrition and document this information in the electronic patient record. They will also receive decision support tailored to each individual patient, e.g. recommendations for how to use oral nutrition supplements if the patient's intake of energy or protein is too low. Patients who struggle to fulfill their requirements will receive an additional referral to a registered dietitian for nutrition treatment between week 5 and 11.</description>
      <arm_group_label>MyFood (App for diet record)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Head and neck cancer&#xD;
  &#xD;
            -  Older than 18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients admitted with the classification of malignant tumors (TNM) stage 4&#xD;
  &#xD;
            -  Terminal condition (life expectancy &lt; 6 months)&#xD;
  &#xD;
            -  Patients who do not understand the Norwegian language.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Christine Henriksen, PhD</last_name>
      <phone>+4799003128</phone>
      <email>christine.henriksen@medisin.uio.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mari Mohn Paulsen, PhD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Oslo</name>
        <address>
          <city>Oslo</city>
          <zip>0316</zip>
          <country>Norway</country>
        </address>
      </facility>
      <contact>
        <last_name>Christine Henriksen, PhD</last_name>
        <phone>+4799003128</phone>
        <email>christine.henriksen@medisin.uio.no</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Oslo University Hospital</name>
        <address>
          <city>Oslo</city>
          <country>Norway</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicole Warmbrodt, MSc</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Oslo</investigator_affiliation>
      <investigator_full_name>Christine Henriksen</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Head and Neck Neoplasms</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/NCT05997329
  org study id: 569956
  nct id: NCT05997329
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients with cancer have increased risk of malnutrition due to the disease itself and the
        treatment regimen they undergo. This is particularly relevant for patients with head and neck
        cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers,
        including oral cavity, larynx, pharynx and salivary glands. The present project will study
        the effectiveness and implementation of remote patient monitoring of nutrition and tailored
        nutrition support throughout the treatment course in patients with head and neck cancer. The
        implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the
        project is to reduce the prevalence of malnutrition and increase the quality of life among
        patients with HNC.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Malnutrition
  time frame: 17 weeks
  description: Patient-Generated Subjective Global Assessment (PG-SGA). The tool categories participants into: category A (Well-nourished), B (Moderately malnutrition or possible malnutrition), or C (serious malnutrition)
  measure: Weight change
  time frame: During the 17 weeks
  description: weight measurements
  measure: Nutrition intake
  time frame: Monthly up to three months
  description: 24-hour recall interviews
  measure: Body composition
  time frame: Monthly up to three months
  description: Bioelectrical Impedance Analysis (BIA)
  measure: Health-related quality of life
  time frame: Monthly up to three months
  description: EuroQol Research Foundation, Netherlands (EQ5D-5L). Assess health in 5 dimensions each of which has three response levels (1: No problems, 2: some problems and 3: extreme problems/unable to do).
  measure: Number of Participants compliant to the intervention
  time frame: At 17 weeks
  description: Review of reported use of the MyFood app in the electronic patient record
  measure: Number of patients with non-elective readmissions
  time frame: At 17 weeks
  description: Review of readmissions in the electronic patient record
  arm group label: MyFood (App for diet record)
  arm group type: Experimental
  description: Use of an App for diet record
  arm group label: Usual care
  arm group type: No Intervention
  description: Usual care
  intervention type: Other
  intervention name: App for diet record (MyFood)
  description: Patients in the intervention group will record their food intake, tube feeding, nutrition-related symptoms and body weight in the MyFood app in at least three consecutive days in advance of follow-up.The patients will thus be able to keep track of their nutrition status. They will also have access to nutrition tips for how to reach requirements if they struggle to eat sufficiently or relief symptoms that can affect food intake.Healthcare staff at the hospital and outpatient clinics will use MyFood to monitor the patient's nutrition and document this information in the electronic patient record. They will also receive decision support tailored to each individual patient, e.g. recommendations for how to use oral nutrition supplements if the patient's intake of energy or protein is too low. Patients who struggle to fulfill their requirements will receive an additional referral to a registered dietitian for nutrition treatment between week 5 and 11.
  arm group label: MyFood (App for diet record)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Christine Henriksen, PhD
  phone: +4799003128
  email: christine.henriksen@medisin.uio.no
  last name: Mari Mohn Paulsen, PhD
  facility: 
  contact: 
  facility: 
  contact: 
  country: Norway
  responsible party type: Principal Investigator
  investigator affiliation: University of Oslo
  investigator full name: Christine Henriksen
  investigator title: Associate professor
  mesh term: Head and Neck Neoplasms
  sharing ipd: No