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Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma

NCT03062410 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-07-26

No results posted yet for this study

Summary

Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide to evaluate treatment efficiency. In contrast Health Related Quality of Life (HRQOL) assessment is often restricted to clinical trial. It could be of particular interest to evaluate HRQOL in daily clinical practice in order to adequately choose and manage first line therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in daily clinical practice of the HRQoL data using standardized questionnaires could strengthen management of symptoms : improve symptom control, improve patient-clinician communication, satisfaction with care and well-being of the patient and in fine the overall survival.

The objective of the QUANARIE Study is to assess the use of HRQOL assessment in daily clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using electronic patient reported outcome (PRO).

Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to clinicians, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on patient reported outcomet.

Conditions

  • Renal Carcinoma Metastatic
  • Kidney Neoplasms
  • Renal Cancer

Interventions

OTHER

Electronic PRO in daily clinical practice

All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Guillaume MOUILLET, MD · Centre Hospitalier Universitairede Besançon

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2019-11-04
Completion
2020-02-04

Countries

  • France

Study Locations

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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 NCT03062410 on ClinicalTrials.gov