Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma
- Conditions
- Renal Cell Carcinoma
- Registration Number
- NCT02537743
- Lead Sponsor
- iOMEDICO AG
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- Histologically confirmed renal cell carcinoma
- Start of the first line systemic treatment
- Ability to read and understand German
- Written informed consent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measure (Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population) 24 months Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures (Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life) 24 months Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life
Trial Locations
- Locations (1)
Multiple sites all over Germany
🇩🇪Multiple Locations, Germany