Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Quality of Life

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Avelumab

Axitinib

Sunitinib

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

Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

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

Concomitant coaching

Mischo Kursar, Dr.

Johanna Homfeld

Heribert Stauder, MD

heribert.stauder@barmherzige-regensburg.de

Severine Banek, Dr.

Heinz-Gert Höffkes, Prof.

Arne Strauß, Dr.

Matthias Groschek, MD

Yon-Dschun Ko, Prof.

Viktor Grünwald, Prof.

Rene Mager, Dr.

Nina Heidger, Dr.

Andreas Janitzky, Dr.

Ralf Eckert, Dr.

Matthias Schulze, Dr.

Nils Gilbert, Dr.

Stefan Mahlmann, Dr.

Ludwig Fischer von Weikersthal, Dr.med.

Fritz Maiwirth, Dr.med.

Maike de Wit, Prof. Dr.

Lutz Jacobasch, Dr.med.

Johannes Mohm, Dr. med.

Manfred Wirth, Prof. Dr.

Ulla Frfr. von Verschuer, Dr.

Mark-Oliver Zahn, Dr.

Michael Metz, Dr.

Philipp Ivanyi, Dr.

Thorsten Werner

Richard Hansen, Dr. med.

Ursula Vehling-Kaiser, Dr. med.

Jan Schröder, PD Dr.

Martin Bögemann, PD Dr.

Marinela Augustin, Dr.med.

Andreas Hübner, Dr.

Ulrich Banhardt, Dr. med.

Anke Wortmann, Dr.

Viktor Grünwald, Prof. Dr.

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).

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

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

Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.

Objective Response Rate (ORR) according to RECIST 1.1 criteria

Duration of treatment (coaching and cancer treatment)

Rate of patients receiving treatment beyond progression

% of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)

* 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

Pfizer

Crolll Gmbh

AIO-Studien-gGmbH

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT03013946	Renal Cell Carc... Renal Cell Canc...	Concomitant coa...	18 Years -	AIO-Studien-gGmbH
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	NCT03013946	Renal Cell Carc... Renal Cell Canc...	Concomitant coa...	18 Years -	AIO-Studien-gGmbH

Spots Global Cancer Trial Database for concomitant coaching