<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/NCT03013946</url>
  </required_header>
  <id_info>
    <org_study_id>AIO-NZK-0115/ass</org_study_id>
    <secondary_id>2016-000399-28</secondary_id>
    <nct_id>NCT03013946</nct_id>
  </id_info>
  <brief_title>Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy</brief_title>
  <acronym>PREPARE</acronym>
  <official_title>A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AIO-Studien-gGmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Crolll Gmbh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AIO-Studien-gGmbH</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>
      The primary objective of the trial is to determine the effect of a 24-week concomitant&#xD;
      coaching on patient reported outcomes of patients receiving standard treatment for mRCC with&#xD;
      sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of our study is to define the benefit of proactive coaching in mRCC, when compared&#xD;
      to a reactive approach, which is considered the standard of care.&#xD;
&#xD;
      Patients in the Coaching Arm A will be trained continuously at personal interactions of coach&#xD;
      and patient (Face-to Face meetings as well as telephone contacts). The patient is educated on&#xD;
      nature and severity of treatment emergent Adverse events (TEAE) of sunitinib or a combination&#xD;
      of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.&#xD;
&#xD;
      Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and&#xD;
      Arm B non Coaching).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 18, 2024</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QoL assessment during sunitinib treatment: questionnaire</measure>
    <time_frame>24 weeks from randomization</time_frame>
    <description>Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) according to RECIST 1.1 criteria</measure>
    <time_frame>up to one year from randomization</time_frame>
    <description>Objective Response Rate (ORR) according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>up to 36 months from randomization</time_frame>
    <description>Overall Survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival (PFS)</measure>
    <time_frame>up to 36 months from randomization</time_frame>
    <description>progression-free survival (PFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of treatment (coaching and cancer treatment)</measure>
    <time_frame>Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization</time_frame>
    <description>Duration of treatment (coaching and cancer treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dose density of sunitinib</measure>
    <time_frame>24 weeks from randomization</time_frame>
    <description>dose density of sunitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients receiving treatment beyond progression</measure>
    <time_frame>up to 36 months from randomization</time_frame>
    <description>Rate of patients receiving treatment beyond progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Further cancer treatment</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Further cancer treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first subsequent therapy (TFST)</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Time to first subsequent therapy (TFST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):</measure>
    <time_frame>24 weeks from randomization</time_frame>
    <description>% of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Emergent Adverse Events according to CTC 4.03:</measure>
    <time_frame>24 weeks from randomization</time_frame>
    <description>Frequency/incidence, severity, percentage reduction, time-to-event of ADRs, AEs and specific TEAEs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)&#xD;
change of grade 3/4 ADRs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of comorbidities</measure>
    <time_frame>at inclusion</time_frame>
    <description>Charlson Comorbidity Index (CCI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">430</enrollment>
  <condition>Renal Cell Carcinoma, Metastatic</condition>
  <condition>Renal Cell Cancer, Recurrent</condition>
  <arm_group>
    <arm_group_label>Arm A (Coaching)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Concomitant coaching (24 weeks) Pro-active TEAE (Treatment emergent adverse events) management Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (Control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Concomitant coaching</intervention_name>
    <description>The corner stones of the pro-active coaching are as follows:&#xD;
Patient education:&#xD;
Information on nature and severity of treatment emergent AEs&#xD;
information about remedies for TEAEs&#xD;
propagation and explanation of tests and treatment decisions&#xD;
Patient instruction on self-care and preventive measures&#xD;
Preemptive AE treatment strategies&#xD;
Supervision of reported ADR severity, ADR mitigation strategies according to recommendations of the PREPARE protocol and cancer treatment modification by treating physician in close collaboration with the coach</description>
    <arm_group_label>Arm A (Coaching)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent and any locally-required authorization (EU Data Privacy&#xD;
             Directive in the EU) obtained from the subject prior to performing any&#xD;
             protocol-related procedures, including screening evaluations&#xD;
&#xD;
          2. Age ≥ 18 years at time of study entry&#xD;
&#xD;
          3. Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative&#xD;
             intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment&#xD;
             with sunitinib&#xD;
&#xD;
          4. Intended first-line treatment with sunitinib&#xD;
&#xD;
          5. Documented progressive disease within 6 months prior to study inclusion&#xD;
&#xD;
          6. Patients with measurable disease (at least one uni-dimensionally measurable target&#xD;
             lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid&#xD;
             Tumors (RECIST 1.1) as well as non-measurable disease are eligible.&#xD;
&#xD;
          7. Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and&#xD;
             palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and&#xD;
             patient recovered from toxic effects.&#xD;
&#xD;
          8. Female subjects must either be of non-reproductive potential (ie, post-menopausal by&#xD;
             history: ≥60 years old and no menses for ≥1 year without an alternative medical cause;&#xD;
             OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of&#xD;
             bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.&#xD;
&#xD;
          9. Subject is willing to receive additional concomitant coaching and able to comply with&#xD;
             the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the&#xD;
             duration of the study including scheduled visits, examinations and follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative&#xD;
             radiotherapy)&#xD;
&#xD;
          2. Previous malignancy (other than mRCC) which either progresses or requires active&#xD;
             treatment.&#xD;
&#xD;
             Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a&#xD;
             or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1].&#xD;
&#xD;
          3. CNS metastases, unless local therapy has been completed for at least 3 month and&#xD;
             patient does not require the use of steroids.&#xD;
&#xD;
          4. Chronic liver disease with Child-Pugh B or C score&#xD;
&#xD;
          5. Female subjects who are pregnant, breast-feeding or male or female patients of&#xD;
             reproductive potential who are not employing an effective method of birth control&#xD;
             (failure rate of less than 1% per year)&#xD;
&#xD;
          6. Any condition that, in the opinion of the investigator, would interfere with&#xD;
             evaluation of the concomitant coaching or QoL assessments or interpretation of patient&#xD;
             safety or study results&#xD;
&#xD;
          7. Participation in another clinical study with an investigational product during the&#xD;
             last 30 days before inclusion&#xD;
&#xD;
          8. Any previous treatment with a tyrosine kinase inhibitor for metastatic disease.&#xD;
             Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that&#xD;
             relapse occurred at least 6 months after last exposure&#xD;
&#xD;
          9. Previous enrollment or randomization in the present study (does not include screening&#xD;
             failure).&#xD;
&#xD;
         10. Involvement in the planning and/or conduct of the study (applies to both Pfizer staff&#xD;
             and/or staff of sponsor and study site)&#xD;
&#xD;
         11. Patient who might be affiliated or otherwise dependent on the sponsor, site or the&#xD;
             investigator&#xD;
&#xD;
         12. Patient who has been incarcerated or involuntarily institutionalized by court order or&#xD;
             by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].&#xD;
&#xD;
         13. Patients who are unable to consent because they do not understand the nature,&#xD;
             significance and implications of the clinical trial and therefore cannot form a&#xD;
             rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].&#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>Viktor Grünwald, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Essen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mischo Kursar, Dr.</last_name>
    <phone>+49 30 8145 344</phone>
    <phone_ext>67</phone_ext>
    <email>Mischo.Kursar@aio-studien-ggmbh.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Johanna Homfeld</last_name>
    <phone>+49 30 8145344</phone>
    <phone_ext>72</phone_ext>
    <email>johanna.homfeld@aio-studien-ggmbh.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Brüder Regensburg</name>
      <address>
        <city>Regensburg</city>
        <state>Bayern</state>
        <zip>93049</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heribert Stauder, MD</last_name>
      <phone>09413693309</phone>
      <email>heribert.stauder@barmherzige-regensburg.de</email>
    </contact>
    <contact_backup>
      <last_name>heribert.stauder@barmherzige-regensburg.de</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Severine Banek, Dr.</last_name>
      <phone>069 630180072</phone>
      <email>severine.banek@kgu.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Fulda</name>
      <address>
        <city>Fulda</city>
        <state>Hessen</state>
        <zip>36043</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Heinz-Gert Höffkes, Prof.</last_name>
      <phone>0926162480</phone>
      <email>hoeffkes.tumorklinik@klinikum-fulda.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen</name>
      <address>
        <city>Göttingen</city>
        <state>Niedersachsen</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Arne Strauß, Dr.</last_name>
      <phone>055160823</phone>
      <email>astrauss@med.uni-goettingen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hämatologisch-Onkologische Praxis Stolberg</name>
      <address>
        <city>Stolberg</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52222</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Matthias Groschek, MD</last_name>
      <email>m.groschek@onkologie-stolberg.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus</name>
      <address>
        <city>Bonn</city>
        <state>Nordrhein-Westphalen</state>
        <zip>53113</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yon-Dschun Ko, Prof.</last_name>
      <phone>0228 5432203</phone>
      <email>yon-dschun.ko@johanniter-kliniken.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen (AöR)</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westphalen</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Viktor Grünwald, Prof.</last_name>
      <phone>0201723-2637</phone>
      <email>viktor.gruenwald@uk-essen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland-Pfalz</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rene Mager, Dr.</last_name>
      <phone>06131172041</phone>
      <email>rene.mager@unimedizin-mainz.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Brüder Trier</name>
      <address>
        <city>Trier</city>
        <state>Rheinland-Pfalz</state>
        <zip>54292</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nina Heidger, Dr.</last_name>
      <phone>06512082401</phone>
      <email>n.heidger@bk-trier.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Magdeburg A.ö.R.</name>
      <address>
        <city>Magdeburg</city>
        <state>Sachsen-Anhalt</state>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Janitzky, Dr.</last_name>
      <phone>03916724770</phone>
      <email>andreas.janitzky@med.ovgu.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Urologische Arztpraxis Dr. Ralf Eckert</name>
      <address>
        <city>Wittenberg</city>
        <state>Sachsen-Anhalt</state>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ralf Eckert, Dr.</last_name>
      <phone>03475250059</phone>
      <email>urologiestudie.eckert@web.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Schulze</name>
      <address>
        <city>Markkleeberg</city>
        <state>Sachsen</state>
        <zip>04416</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Matthias Schulze, Dr.</last_name>
      <phone>03413542755</phone>
      <email>info@praxis-schulze.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23562</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nils Gilbert, Dr.</last_name>
      <phone>045150043601</phone>
      <email>Nils.Gilbert@uksh.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>FEK - Friedrich-Ebert-Krankenhaus Neumünster</name>
      <address>
        <city>Neumünster</city>
        <state>Schleswig-Holstein</state>
        <zip>24534</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stefan Mahlmann, Dr.</last_name>
      <phone>043214055037</phone>
      <email>stefan.mahlmann@fek.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Katholisches Krankenhaus St. Johann Nepomuk Erfurt</name>
      <address>
        <city>Erfurt</city>
        <state>Thüringen</state>
        <zip>99097</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum St. Marien Amberg</name>
      <address>
        <city>Amberg</city>
        <zip>92224</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ludwig Fischer von Weikersthal, Dr.med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Onkologisches Versorgungszentrum</name>
      <address>
        <city>Berlin</city>
        <zip>10407</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fritz Maiwirth, Dr.med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum Neukölln</name>
      <address>
        <city>Berlin</city>
        <zip>12351</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maike de Wit, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>BAG Onkologische Gemeinschaftspraxis</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lutz Jacobasch, Dr.med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Johannes Mohm, Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manfred Wirth, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>MVZ für Hämato/Onkologie Essen gGmbH</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ulla Frfr. von Verschuer, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>MVZ Onkologische Kooperation Harz</name>
      <address>
        <city>Goslar</city>
        <zip>38642</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark-Oliver Zahn, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Onkologische Schwerpunktpraxis Göttingen</name>
      <address>
        <city>Göttingen</city>
        <zip>37073</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michael Metz, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philipp Ivanyi, Dr.</last_name>
      <phone>+49 511 532</phone>
      <phone_ext>2301</phone_ext>
      <email>Ivanyi.Philipp@mh-hannover.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Urologie Herzberg</name>
      <address>
        <city>Herzberg</city>
        <zip>37412</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thorsten Werner</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IDGGQ Institut für medizinische Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung</name>
      <address>
        <city>Kaiserslautern</city>
        <zip>67655</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Richard Hansen, Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin</name>
      <address>
        <city>Landshut</city>
        <zip>84028</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ursula Vehling-Kaiser, Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis für Hämatologie u. Onkologie PD Dr. Jan Schröder</name>
      <address>
        <city>Mühlheim</city>
        <zip>45468</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jan Schröder, PD Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Martin Bögemann, PD Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg 5. Medizinische Klinik</name>
      <address>
        <city>Nürnberg</city>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marinela Augustin, Dr.med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wissenschaftskontor Nord GmbH &amp; Co KG</name>
      <address>
        <city>Rostock</city>
        <zip>18107</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Hübner, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Onkologische Schwerpunktpraxis</name>
      <address>
        <city>Singen</city>
        <zip>78224</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulrich Banhardt, Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>MVZ Kloster Paradiese GbR/Onkologiezentrum Soest</name>
      <address>
        <city>Soest</city>
        <zip>59494</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anke Wortmann, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Therapy-Coaching, Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03013946
org study id: AIO-NZK-0115/ass
secondary id: 2016-000399-28
nct id: NCT03013946
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the trial is to determine the effect of a 24-week concomitant
      coaching on patient reported outcomes of patients receiving standard treatment for mRCC with
      sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line
      therapy.
The goal of our study is to define the benefit of proactive coaching in mRCC, when compared
      to a reactive approach, which is considered the standard of care.

      Patients in the Coaching Arm A will be trained continuously at personal interactions of coach
      and patient (Face-to Face meetings as well as telephone contacts). The patient is educated on
      nature and severity of treatment emergent Adverse events (TEAE) of sunitinib or a combination
      of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.

      Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and
      Arm B non Coaching).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: QoL assessment during sunitinib treatment: questionnaire
time frame: 24 weeks from randomization
description: Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.
measure: Objective Response Rate (ORR) according to RECIST 1.1 criteria
time frame: up to one year from randomization
description: Objective Response Rate (ORR) according to RECIST 1.1 criteria
measure: Overall Survival (OS)
time frame: up to 36 months from randomization
description: Overall Survival (OS)
measure: progression-free survival (PFS)
time frame: up to 36 months from randomization
description: progression-free survival (PFS)
measure: Duration of treatment (coaching and cancer treatment)
time frame: Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization
description: Duration of treatment (coaching and cancer treatment)
measure: dose density of sunitinib
time frame: 24 weeks from randomization
description: dose density of sunitinib
measure: Rate of patients receiving treatment beyond progression
time frame: up to 36 months from randomization
description: Rate of patients receiving treatment beyond progression
measure: Further cancer treatment
time frame: up to 36 months
description: Further cancer treatment
measure: Time to first subsequent therapy (TFST)
time frame: up to 36 months
description: Time to first subsequent therapy (TFST)
measure: Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):
time frame: 24 weeks from randomization
description: % of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)
measure: Treatment Emergent Adverse Events according to CTC 4.03:
time frame: 24 weeks from randomization
description: Frequency/incidence, severity, percentage reduction, time-to-event of ADRs, AEs and specific TEAEs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)
change of grade 3/4 ADRs
measure: Assessment of comorbidities
time frame: at inclusion
description: Charlson Comorbidity Index (CCI)
arm group label: Arm A (Coaching)
arm group type: Experimental
description: Concomitant coaching (24 weeks) Pro-active TEAE (Treatment emergent adverse events) management Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15
arm group label: Arm B (Control)
arm group type: No Intervention
description: Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15
intervention type: Behavioral
intervention name: Concomitant coaching
description: The corner stones of the pro-active coaching are as follows:
Patient education:
Information on nature and severity of treatment emergent AEs
information about remedies for TEAEs
propagation and explanation of tests and treatment decisions
Patient instruction on self-care and preventive measures
Preemptive AE treatment strategies
Supervision of reported ADR severity, ADR mitigation strategies according to recommendations of the PREPARE protocol and cancer treatment modification by treating physician in close collaboration with the coach
arm group label: Arm A (Coaching)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Viktor Grünwald, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Essen
last name: Mischo Kursar, Dr.
phone: +49 30 8145 344
phone ext: 67
email: Mischo.Kursar@aio-studien-ggmbh.de
last name: Johanna Homfeld
phone: +49 30 8145344
phone ext: 72
email: johanna.homfeld@aio-studien-ggmbh.de
facility: 
status: Recruiting
contact: 
contact backup: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
sharing ipd: No