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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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-02-14

No results posted yet for this study

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.

Conditions

  • Renal Cell Carcinoma, Metastatic
  • Renal 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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Crolll Gmbh

    collaborator OTHER

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Viktor Grünwald, Prof. Dr. · Universitätsklinikum Essen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-18
Primary Completion
2024-01-16
Completion
2024-01-16

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013946 on ClinicalTrials.gov