PMID- 30717745
OWN - NLM
STAT- MEDLINE
DCOM- 20190318
LR  - 20240329
IS  - 1477-7525 (Electronic)
IS  - 1477-7525 (Linking)
VI  - 17
IP  - 1
DP  - 2019 Feb 4
TI  - 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.
PG  - 25
LID - 10.1186/s12955-019-1085-1 [doi]
LID - 25
AB  - 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.
FAU - Mouillet, Guillaume
AU  - Mouillet G
AUID- ORCID: 0000-0002-2288-7461
AD  - Department of Medical Oncology, University Hospital of Besancon, Boulevard 
      Fleming, F-25000, Besancon, France. gmouillet@chu-besancon.fr.
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France. gmouillet@chu-besancon.fr.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France. 
      gmouillet@chu-besancon.fr.
FAU - Fritzsch, Joelle
AU  - Fritzsch J
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
FAU - Paget-Bailly, Sophie
AU  - Paget-Bailly S
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
FAU - Pozet, Astrid
AU  - Pozet A
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
FAU - Es-Saad, Ikram
AU  - Es-Saad I
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
FAU - Meurisse, Aurelia
AU  - Meurisse A
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
FAU - Vernerey, Dewi
AU  - Vernerey D
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
FAU - Mouyabi, Kristina
AU  - Mouyabi K
AD  - Clinical Research and Innovation Office, University Hospital of Besancon, 
      F-25000, Besancon, France.
FAU - Berthod, Diane
AU  - Berthod D
AD  - Department of Medical Oncology, University Hospital of Besancon, Boulevard 
      Fleming, F-25000, Besancon, France.
FAU - Bonnetain, Franck
AU  - Bonnetain F
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
FAU - Anota, Amelie
AU  - Anota A
AD  - Methodological and Quality of Life Unit, University Hospital of Besancon, 
      F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
AD  - French National Platform Quality of Life and Cancer, Besancon, France.
FAU - Thiery-Vuillemin, Antoine
AU  - Thiery-Vuillemin A
AD  - Department of Medical Oncology, University Hospital of Besancon, Boulevard 
      Fleming, F-25000, Besancon, France.
AD  - INSERM, EFS BFC, UMR1098, Interactions Hote-Greffon-Tumeur/Ingenierie Cellulaire 
      et Genique, University Bourgogne Franche-Comte, F-25000, Besancon, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT03062410
GR  - PHRCI-2016/GIRCI/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20190204
PL  - England
TA  - Health Qual Life Outcomes
JT  - Health and quality of life outcomes
JID - 101153626
RN  - 0 (Indazoles)
RN  - 7RN5DR86CK (pazopanib)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (Protein-Tyrosine Kinases)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Young Adult
MH  - *Carcinoma, Renal Cell/drug therapy/pathology/psychology
MH  - Indazoles
MH  - *Kidney Neoplasms/drug therapy/pathology/psychology
MH  - Patient Reported Outcome Measures
MH  - Prospective Studies
MH  - *Protein Kinase Inhibitors/therapeutic use
MH  - Protein-Tyrosine Kinases/antagonists & inhibitors
MH  - *Pyrimidines/therapeutic use
MH  - *Quality of Life
MH  - *Sulfonamides/therapeutic use
MH  - *Sunitinib/therapeutic use
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Multicenter Studies as Topic
PMC - PMC6360763
OTO - NOTNLM
OT  - Health-related quality of life
OT  - Patient-reported outcome,sunitinib,pazopanib
OT  - Renal cell carcinoma
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The QUANARIE trial was reviewed and 
      approved by the local ethics committee (Comite de protection des personnes 
      EST-II, Besancon) on the 24th October 2016. Approval from the National Authority 
      for the Safety of Medicines and Health Products (Agence nationale de securite du 
      medicament et des produits de sante (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.
EDAT- 2019/02/06 06:00
MHDA- 2019/03/19 06:00
PMCR- 2019/02/04
CRDT- 2019/02/06 06:00
PHST- 2018/07/27 00:00 [received]
PHST- 2019/01/07 00:00 [accepted]
PHST- 2019/02/06 06:00 [entrez]
PHST- 2019/02/06 06:00 [pubmed]
PHST- 2019/03/19 06:00 [medline]
PHST- 2019/02/04 00:00 [pmc-release]
AID - 10.1186/s12955-019-1085-1 [pii]
AID - 1085 [pii]
AID - 10.1186/s12955-019-1085-1 [doi]
PST - epublish
SO  - Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1.