Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol

Guillaume Mouillet, Joëlle Fritzsch, Sophie Paget-Bailly, Astrid Pozet, Ikram Es-Saad, Aurelia Meurisse, Dewi Vernerey, Kristina Mouyabi, Diane Berthod, Franck Bonnetain, Amélie Anota, Antoine Thiery-Vuillemin, Guillaume Mouillet, Joëlle Fritzsch, Sophie Paget-Bailly, Astrid Pozet, Ikram Es-Saad, Aurelia Meurisse, Dewi Vernerey, Kristina Mouyabi, Diane Berthod, Franck Bonnetain, Amélie Anota, Antoine Thiery-Vuillemin

Abstract

Background: Two main therapies, pazopanib and sunitinib, are used in the first-line setting for metastatic renal cell carcinoma (mRCC). These two tyrosine kinase inhibitors (TKI) are equally effective in terms of survival; however, they frequently induce adverse events. In this setting, Health-Related Quality of life (HRQoL) is a key element in the choice between these two treatments and the evaluation of treatment effectiveness. It could be of interest to evaluate HRQoL in daily clinical practice to aid adequate therapy choice and management. Currently, the development of information and communication technology may allow HRQoL monitoring in routine practice. The objective of the QUANARIE study is to evaluate the use of HRQoL assessment in daily clinical practice for patients with mRCC treated with TKI using electronic patient-reported outcomes (e-PRO). The present article describes the key elements of the study protocol.

Methods: The QUANARIE study is an interventional, prospective, multicentre trial. Patients diagnosed with mRCC initiating sunitinib or pazopanib treatment will be invited to complete the EORTC QLQ-C30 questionnaire, nine additional questions from the EORTC items library, and the EuroQoL EQ-5D, prior to each visit with the physician. Questionnaires will be completed by patients using tablets and/or computer terminals via the e-PRO software. The physician will have real-time access to a visual summary of the HRQoL evaluation. The primary objective is to assess the proportion of patients having good compliance with Routine Electronic Monitoring of HRQoL (REMOQOL) during the first 12 months. Physicians' satisfaction with REMOQOL will be assessed as a secondary objective. We hypothesise that 80% of patients having good compliance with REMOQOL would be meaningful. A sample size of 56 patients would be needed.

Discussion: The results of this study will show whether REMOQOL is feasible on a large scale and whether patients are receptive to this new practice. This study will also determine how real-time multidimensional evaluation of patient perception can help physicians in their daily practice and how they used it in conjunction with other clinical information to manage patient care.

Trial registration: ClinicalTrials.gov; Identifier: NCT03062410 ; First Posted: February 23, 2017; Last Update Posted: August 9, 2017.

Keywords: Health-related quality of life; Patient-reported outcome,sunitinib,pazopanib; Renal cell carcinoma.

Conflict of interest statement

Ethics approval and consent to participate

The QUANARIE trial was reviewed and approved by the local ethics committee (Comité de protection des personnes EST-II, Besançon) on the 24th October 2016. Approval from the National Authority for the Safety of Medicines and Health Products (Agence nationale de sécurité du medicament et des produits de santé (ANSM)) was obtained on the 16th December 2016. The QUANARIE study is registered with the Clinical Trials Registry (ClinicalTrials.org; Identifier: NCT03062410).

All participants will provide written informed consent in accordance with the Declaration of Helsinki.

Consent for publication

All authors have read the manuscript and given consent for its publication.

Competing interests

A.T.-V. and G.M. received honoraria from Novartis, Pfizer, Roche, BMS, and Ipsen. A.A. received travel fees from Novartis and Roche. The other authors have stated that they have no conflicts of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
ePRO with the CHES software. Questionnaires are completed by patients using tablets and/or computer terminals via the CHES software (Computer-Based Health Evaluation System; https://ches.pro/index.php/ches) prior to each consultation at the oncology centre (waiting room) or at home via a secured portal. The physician will have real-time access to a visual summary of the HRQOL evaluation

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