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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02537743

Acronym

PROKidney

Enrollment

Registered

2015-09-02

Start date

2015-08-19

Completion date

2021-02-19

Last updated

2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Patient Reported Outcomes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed renal cell carcinoma * Start of the first line systemic treatment * Ability to read and understand German * Written informed consent

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results