NCT02537743

Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma

Open-labeled, Multicenter, Non-interventional, Prospective PRO Registry for Patients With First Line Treatment for Advanced RCC Using a Tablet-technology Based Digital Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: iOMEDICO AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE Renal Cell Carcinoma population

Detailed description

The PRO Kidney project will recruit a representative cohort of patients with advanced renal cell carcinoma (RCC) treated with systemic antiproliferative therapies such as TKIs, mTOR inhibitors, cytokines, antiVEGF or immune therapy. The aim of this study is to collect data on the effectiveness and patients´quality of life on preference in the real life setting. Patient Reported Outcomes ( PRO) are assessed by a questionnaire consisting Functional Assessment of Cancer Therapy ( FACT) Kidney Syndrome Index 19 (FKSI 19) completed by four questions assessing ailments about changes in skin of hands/feet, taste, color of hair and mouth scores. 13 Questions about Fatigue assessed with the Functional Assessment of Chronic IIlness Disease.

Conditions

• Renal Cell Carcinoma

Timeline

• Start date: 2015-08-19
• Primary completion: 2021-02-19
• Completion: 2021-02-19
• First posted: 2015-09-02
• Last updated: 2021-03-25

Locations

1 site across 1 country: Germany