Spots Global Cancer Trial Database for 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
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Trial Identification
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
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
Study ID: NCT03013946
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Krankenhaus Barmherzige BrĂŒder Regensburg, Regensburg, Bayern, Germany
UniversitÀtsklinikum Frankfurt, Frankfurt am Main, Hessen, Germany
Klinikum Fulda, Fulda, Hessen, Germany
UniversitÀtsmedizin Göttingen, Göttingen, Niedersachsen, Germany
HĂ€matologisch-Onkologische Praxis Stolberg, Stolberg, Nordrhein-Westfalen, Germany
Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Bonn, Nordrhein-Westphalen, Germany
UniversitÀtsklinikum Essen (AöR), Essen, Nordrhein-Westphalen, Germany
UniversitÀtsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany
Krankenhaus Barmherzige BrĂŒder Trier, Trier, Rheinland-Pfalz, Germany
UniversitÀtsklinikum Magdeburg A.ö.R., Magdeburg, Sachsen-Anhalt, Germany
Urologische Arztpraxis Dr. Ralf Eckert, Wittenberg, Sachsen-Anhalt, Germany
Praxis Dr. Schulze, Markkleeberg, Sachsen, Germany
UniversitĂ€tsklinikum Schleswig-Holstein, LĂŒbeck, Schleswig-Holstein, Germany
FEK - Friedrich-Ebert-Krankenhaus NeumĂŒnster, NeumĂŒnster, Schleswig-Holstein, Germany
Katholisches Krankenhaus St. Johann Nepomuk Erfurt, Erfurt, ThĂŒringen, Germany
Klinikum St. Marien Amberg, Amberg, , Germany
Onkologisches Versorgungszentrum, Berlin, , Germany
Vivantes Klinikum Neukölln, Berlin, , Germany
BAG Onkologische Gemeinschaftspraxis, Dresden, , Germany
Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex FachĂ€rzte fĂŒr Innere Medizin HĂ€matologie und Internistische Onkologie, Dresden, , Germany
UniversitÀtsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
MVZ fĂŒr HĂ€mato/Onkologie Essen gGmbH, Essen, , Germany
MVZ Onkologische Kooperation Harz, Goslar, , Germany
Onkologische Schwerpunktpraxis Göttingen, Göttingen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Urologie Herzberg, Herzberg, , Germany
IDGGQ Institut fĂŒr medizinische Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. QualitĂ€tssicherung, Kaiserslautern, , Germany
Tagesklinik Landshut HĂ€matologie, Onkologie Palliativmedizin, Landshut, , Germany
Gemeinschaftspraxis fĂŒr HĂ€matologie u. Onkologie PD Dr. Jan Schröder, MĂŒhlheim, , Germany
UniversitĂ€tsklinikum MĂŒnster, MĂŒnster, , Germany
Klinikum NĂŒrnberg 5. Medizinische Klinik, NĂŒrnberg, , Germany
Wissenschaftskontor Nord GmbH & Co KG, Rostock, , Germany
Onkologische Schwerpunktpraxis, Singen, , Germany
MVZ Kloster Paradiese GbR/Onkologiezentrum Soest, Soest, , Germany
Contact Details
Name: Viktor GrĂŒnwald, Prof. Dr.
Affiliation: UniversitÀtsklinikum Essen
Role: PRINCIPAL_INVESTIGATOR
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