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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Renal Cell Carcinoma, Metastatic
• Renal Cell Cancer, Recurrent

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-18
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2017-01-09
• Last updated: 2025-02-14

Locations

22 sites across 1 country: Germany