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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
121
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
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Bavaria, Germany
QoL assessment during sunitinib treatment: questionnaire
Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.
Time frame: 24 weeks from randomization
Objective Response Rate (ORR) according to RECIST 1.1 criteria
Objective Response Rate (ORR) according to RECIST 1.1 criteria
Time frame: up to one year from randomization
Overall Survival (OS)
Overall Survival (OS)
Time frame: up to 36 months from randomization
progression-free survival (PFS)
progression-free survival (PFS)
Time frame: up to 36 months from randomization
Duration of treatment (coaching and cancer treatment)
Duration of treatment (coaching and cancer treatment)
Time frame: Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization
dose density of sunitinib
dose density of sunitinib
Time frame: 24 weeks from randomization
Rate of patients receiving treatment beyond progression
Rate of patients receiving treatment beyond progression
Time frame: up to 36 months from randomization
Further cancer treatment
Further cancer treatment
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Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany
Universitätsklinikum Essen (AöR)
Essen, Nordrhein-Westphalen, Germany
Hämatologisch-Onkologische Praxis Stolberg
Stolberg, North Rhine-Westphalia, Germany
Krankenhaus Barmherzige Brüder Trier
Trier, Rhineland-Palatinate, Germany
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Saxony-Anhalt, Germany
Urologische Arztpraxis Dr. Ralf Eckert
Wittenberg, Saxony-Anhalt, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Klinikum St. Marien Amberg
Amberg, Germany
...and 12 more locations
Time frame: up to 36 months
Time to first subsequent therapy (TFST)
Time to first subsequent therapy (TFST)
Time frame: up to 36 months
Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):
% of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)
Time frame: 24 weeks from randomization
Treatment Emergent Adverse Events according to CTC 4.03:
* 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
Time frame: 24 weeks from randomization
Assessment of comorbidities
Charlson Comorbidity Index (CCI)
Time frame: at inclusion