<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/NCT02204111</url>
  </required_header>
  <id_info>
    <org_study_id>YonLife-2014</org_study_id>
    <nct_id>NCT02204111</nct_id>
  </id_info>
  <brief_title>Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma</brief_title>
  <acronym>YonLife</acronym>
  <official_title>Patient Directed Intervention Towards a Multidimensional Recommendation Guideline to Improve the Quality of Life for Patients With Soft Tissue Sarcoma Under Palliative Treatment With Trabectedin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GWT-TUD GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PharmaMar</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GWT-TUD GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to compare quality of life (QoL) between patients&#xD;
      suffering from soft tissue sarcoma, receiving a multidimensional intervention with those&#xD;
      receiving standard treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Health related QoL, measured by total score of FACT-G</measure>
    <time_frame>change to baseline at 9 weeks</time_frame>
    <description>assessed by the patient using standard questionnaire (FACT-G) via tablet-PC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dimensions of QoL (scales of FACT-G)</measure>
    <time_frame>baseline, 3, 6, 9, 21, 35 and 61 weeks</time_frame>
    <description>assessed by the patient using standard questionnaire (FACT-G) via tablet-PC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression (HADS)</measure>
    <time_frame>baseline, 9, 21, 35 and 61 weeks</time_frame>
    <description>assessed by the patient using standard questionnaire (HADS) via tablet-PC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with care (IN-PATSAT32)</measure>
    <time_frame>baseline, 9, 21, 35 and 61 weeks</time_frame>
    <description>assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anorexia and cachexia related impact on QoL (FAACT)</measure>
    <time_frame>baseline, 9, 21, 35 and 61 weeks</time_frame>
    <description>assessed by the patient using standard questionnaire (FAACT) via tablet-PC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain and pain related interference (BPI)</measure>
    <time_frame>baseline, 9, 21, 35 and 61 weeks</time_frame>
    <description>assessed by the patient using standard questionnaire (BPI) via tablet-PC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of cancer-related symptoms (MDASI)</measure>
    <time_frame>baseline, 3, 6, 9, 21, 35 and 61 weeks</time_frame>
    <description>assessed by the patient using standard questionnaire (MDASI) via tablet-PC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>baseline up to 61 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>baseline up to 61 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">77</enrollment>
  <condition>Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>Control Cluster</arm_group_label>
    <description>Care as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Cluster</arm_group_label>
    <description>Care as usual and patient directed, multidimensional treatment proposals</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes</description>
    <arm_group_label>Treatment Cluster</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of advanced or metastatic soft tissue sarcoma&#xD;
&#xD;
          -  Treatment with trabectedin in an in-label prescription&#xD;
&#xD;
          -  Age at least 18 years (inclusive) at the first visit&#xD;
&#xD;
          -  Patients with a life expectancy of at least 6 months&#xD;
&#xD;
          -  The informed consent form must be signed before any study specific tests or procedures&#xD;
             are done&#xD;
&#xD;
          -  Confirmation of the subject's health insurance coverage prior to the first visit&#xD;
&#xD;
          -  Ability to understand and follow study-related instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ECOG PS &gt;2&#xD;
&#xD;
          -  Estimated life expectancy of less than 6 months&#xD;
&#xD;
          -  Patients with STS not receiving trabectedin&#xD;
&#xD;
          -  Contraindications according to the local SmPC of Yondelis®&#xD;
&#xD;
          -  Subject is in custody by order of an authority or a court of law&#xD;
&#xD;
          -  Exclusion periods from other studies or simultaneous participation in other clinical&#xD;
             studies&#xD;
&#xD;
          -  Previous assignment to treatment during this study&#xD;
&#xD;
          -  Close affiliation with the investigator (e.g. a close relative) or persons working at&#xD;
             the study site&#xD;
&#xD;
          -  Subject is an employee of GWT-TUD GmbH or Pharma Mar S.A.&#xD;
&#xD;
          -  Criteria which in the opinion of the investigator preclude participation for&#xD;
             scientific reasons, for reasons of compliance, or for reasons of the subject's safety&#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>Markus Schuler, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Carl Gustav Carus, Dresden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Carl Gustav Carus, MK I</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hannover Medical School</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Koeln</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Muenster</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>November 7, 2018</last_update_submitted>
  <last_update_submitted_qc>November 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palliative Treatment</keyword>
  <keyword>Trabectedin</keyword>
  <keyword>Patient Reported Outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT02204111
org study id: YonLife-2014
nct id: NCT02204111
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of the study is to compare quality of life (QoL) between patients
      suffering from soft tissue sarcoma, receiving a multidimensional intervention with those
      receiving standard treatment.
observational model: Case-Control
time perspective: Prospective
measure: Health related QoL, measured by total score of FACT-G
time frame: change to baseline at 9 weeks
description: assessed by the patient using standard questionnaire (FACT-G) via tablet-PC
measure: Dimensions of QoL (scales of FACT-G)
time frame: baseline, 3, 6, 9, 21, 35 and 61 weeks
description: assessed by the patient using standard questionnaire (FACT-G) via tablet-PC
measure: Anxiety and depression (HADS)
time frame: baseline, 9, 21, 35 and 61 weeks
description: assessed by the patient using standard questionnaire (HADS) via tablet-PC
measure: Satisfaction with care (IN-PATSAT32)
time frame: baseline, 9, 21, 35 and 61 weeks
description: assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC
measure: Anorexia and cachexia related impact on QoL (FAACT)
time frame: baseline, 9, 21, 35 and 61 weeks
description: assessed by the patient using standard questionnaire (FAACT) via tablet-PC
measure: Intensity of pain and pain related interference (BPI)
time frame: baseline, 9, 21, 35 and 61 weeks
description: assessed by the patient using standard questionnaire (BPI) via tablet-PC
measure: Severity of cancer-related symptoms (MDASI)
time frame: baseline, 3, 6, 9, 21, 35 and 61 weeks
description: assessed by the patient using standard questionnaire (MDASI) via tablet-PC
measure: progression free survival
time frame: baseline up to 61 weeks
measure: Overall survival
time frame: baseline up to 61 weeks
arm group label: Control Cluster
description: Care as usual
arm group label: Treatment Cluster
description: Care as usual and patient directed, multidimensional treatment proposals
intervention type: Other
intervention name: Intervention
description: Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes
arm group label: Treatment Cluster
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Markus Schuler, Dr. med.
role: Principal Investigator
affiliation: University Hospital Carl Gustav Carus, Dresden
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Sarcoma