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

PHASE3TerminatedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

January 18, 2017

Primary Completion Date

January 16, 2024

Study Completion Date

January 16, 2024

Conditions
Renal Cell Carcinoma, MetastaticRenal Cell Cancer, Recurrent
Interventions
BEHAVIORAL

Concomitant coaching

"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"

Trial Locations (22)

10407

Onkologisches Versorgungszentrum, Berlin

12351

Vivantes Klinikum Neukölln, Berlin

18107

Wissenschaftskontor Nord GmbH & Co KG, Rostock

23562

Universitätsklinikum Schleswig-Holstein, Lübeck

30625

Medizinische Hochschule Hannover, Hanover

37075

Universitätsmedizin Göttingen, Göttingen

38642

MVZ Onkologische Kooperation Harz, Goslar

39120

Universitätsklinikum Magdeburg A.ö.R., Magdeburg

45136

MVZ für Hämato/Onkologie Essen gGmbH, Essen

45147

Universitätsklinikum Essen (AöR), Essen

52222

Hämatologisch-Onkologische Praxis Stolberg, Stolberg

54292

Krankenhaus Barmherzige Brüder Trier, Trier

59494

MVZ Kloster Paradiese GbR/Onkologiezentrum Soest, Soest

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

78224

Onkologische Schwerpunktpraxis, Singen

84028

Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin, Landshut

90419

Klinikum Nürnberg 5. Medizinische Klinik, Nuremberg

92224

Klinikum St. Marien Amberg, Amberg

93049

Krankenhaus Barmherzige Brüder Regensburg, Regensburg

Unknown

Urologische Arztpraxis Dr. Ralf Eckert, Wittenberg

01307

BAG Onkologische Gemeinschaftspraxis, Dresden

Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie, Dresden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Crolll Gmbh

OTHER

lead

AIO-Studien-gGmbH

OTHER

NCT03013946 - 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 | Biotech Hunter | Biotech Hunter