<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/NCT03031106</url>
  </required_header>
  <id_info>
    <org_study_id>TVO</org_study_id>
    <nct_id>NCT03031106</nct_id>
  </id_info>
  <brief_title>Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease</brief_title>
  <official_title>Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease; Focus on the Patient's Preferences and Life Situation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to adjust and test an existing internet-based tool for collecting&#xD;
      patient-reported outcome measures and to use the internet-based tool in an multidisciplinary&#xD;
      follow-up of patients treated for malignant hematological diseases. The patient-reported&#xD;
      outcome measurements will be used in describing the patients' health-related quality of life&#xD;
      (HRQoL) and to investigate whether the HRQol will increase due to participation in&#xD;
      multidisciplinary follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Health-Related Quality of Life (HRQoL) - General</measure>
    <time_frame>HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.</time_frame>
    <description>Patients will be asked to electronically fill out questionnaires before each consultation.&#xD;
The questionnaire that will be used to measure HRQoL is SF-36. SF-36 is a generic questionnaire which can be used to assess HRQoL in the general public.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health-Related Quality of Life (HRQoL) - Disease specific</measure>
    <time_frame>HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.</time_frame>
    <description>Patients will be asked to electronically fill out questionnaires before each consultation.&#xD;
The questionnaire that will be used to measure HRQoL is EORTC C30 QLQ. EORTC C30 QLQ is a disease specific questionnaire which can be used to assess HRQoL in patients diagnosed with cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms of depression and anxiety</measure>
    <time_frame>Symptoms of depression and anxiety will be assessed every 2, 3, 4 or 6 month, up to 18 months</time_frame>
    <description>Data on symptoms of depression and anxiety will be collected before and after each consultation using an international validated questionnaire.&#xD;
The questionnaire which will be used is:&#xD;
Hospital Depression and Anxiety Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of hematological disease</measure>
    <time_frame>Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months</time_frame>
    <description>Data on symptoms of disease will be collected before each consultation using an international validated questionnaire.&#xD;
The questionnaire which will be used is:&#xD;
Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Malignant Hematologic Neoplasm</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with chemotherapy for primary hematological disease and patients followed&#xD;
        in a Wait &amp; Watch regimen&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with malignant hematological disease; Morbus Hodgkin and B- and&#xD;
             T-cell disease&#xD;
&#xD;
          -  patients followed before or after 1. line treatment&#xD;
&#xD;
          -  patients in stable phase &gt; 6 months after 1. line treatment&#xD;
&#xD;
          -  the patients participation in the study must be assessed and decided by the doctor&#xD;
             responsible for the patient's course of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health conditions which demands close medical monitoring&#xD;
&#xD;
          -  conditions which compromise the ability to understand the study and submit informed&#xD;
             consent (ex.: dementia and severe mental illness / disability)&#xD;
&#xD;
          -  lack of capability to fill out electronic questionnaires&#xD;
&#xD;
          -  poor self-care and/or compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mia Sommer, MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalborg University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mia Sommer, MHsc</last_name>
    <phone>0045 9766 0896</phone>
    <email>m.sommer@rn.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aalborg University Hospital, Department of Hematology</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mia Sommer, MHSc</last_name>
      <phone>+45 9766 0896</phone>
      <email>m.sommer@rn.dk</email>
    </contact>
    <contact_backup>
      <last_name>Lise T Elkjær</last_name>
      <phone>+45 9766 3871</phone>
      <email>lit@rn.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Mia Sommer, MHSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>March 1, 2018</last_update_submitted>
  <last_update_submitted_qc>March 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
    <investigator_full_name>Mia Sommer</investigator_full_name>
    <investigator_title>Clinical Research Nurse, ph.d. student</investigator_title>
  </responsible_party>
  <keyword>Patient-reported outcomes, Health-related QoL, Internet-based tool</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03031106
org study id: TVO
nct id: NCT03031106
lead sponsor: 
has dmc: No
The aim of this study is to adjust and test an existing internet-based tool for collecting
      patient-reported outcome measures and to use the internet-based tool in an multidisciplinary
      follow-up of patients treated for malignant hematological diseases. The patient-reported
      outcome measurements will be used in describing the patients' health-related quality of life
      (HRQoL) and to investigate whether the HRQol will increase due to participation in
      multidisciplinary follow-up.
observational model: Case-Only
time perspective: Prospective
measure: Health-Related Quality of Life (HRQoL) - General
time frame: HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
description: Patients will be asked to electronically fill out questionnaires before each consultation.
The questionnaire that will be used to measure HRQoL is SF-36. SF-36 is a generic questionnaire which can be used to assess HRQoL in the general public.
measure: Health-Related Quality of Life (HRQoL) - Disease specific
time frame: HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
description: Patients will be asked to electronically fill out questionnaires before each consultation.
The questionnaire that will be used to measure HRQoL is EORTC C30 QLQ. EORTC C30 QLQ is a disease specific questionnaire which can be used to assess HRQoL in patients diagnosed with cancer
measure: Symptoms of depression and anxiety
time frame: Symptoms of depression and anxiety will be assessed every 2, 3, 4 or 6 month, up to 18 months
description: Data on symptoms of depression and anxiety will be collected before and after each consultation using an international validated questionnaire.
The questionnaire which will be used is:
Hospital Depression and Anxiety Scale (HADS)
measure: Symptoms of hematological disease
time frame: Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months
description: Data on symptoms of disease will be collected before each consultation using an international validated questionnaire.
The questionnaire which will be used is:
Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mia Sommer, MHSc
role: Principal Investigator
affiliation: Aalborg University Hospital
last name: Mia Sommer, MHsc
phone: 0045 9766 0896
email: m.sommer@rn.dk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University Hospital
investigator full name: Mia Sommer
investigator title: Clinical Research Nurse, ph.d. student
mesh term: Hematologic Neoplasms
mesh term: Hematologic Diseases
sharing ipd: Undecided