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.
QUANARIE study is an interventional, prospective, multicenter trial involving 9 french oncological centers. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
56
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.
CHU de Besançon
Besançon, France
ACTIVE_NOT_RECRUITINGHôpital privé Sainte Marie
Chalon-sur-Saône, France
RECRUITINGCentre de lutte contre le cancer Georges François Leclerc
Dijon, France
RECRUITINGHôpital Nord Franche-Comté
Montbéliard, France
RECRUITINGCentre de lutte contre le cancer Jean Godinot
Reims, France
RECRUITINGGroupe hospitaliser St-Vincent
Strasbourg, France
RECRUITINGHôpitaux Universitaires de Strasbourg
Strasbourg, France
RECRUITINGCentre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
RECRUITINGRate of filled questionnaires at 12-months
Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.
Time frame: 12 months
Exhaustiveness
Number of new cases for each center, initiating a treatment per ITK molecule compared to the number of patients to whom the intervention was proposed
Time frame: 24 months
Acceptability
Number of patients who agreed to participate in this study compared to the number of refusals on all patients, by center and by molecule type (Sunitinib or Pazopanib)
Time frame: 24 months
Effectiveness
Description of the toxicities collected by physicians according to the NCI CTCAE V4 compared to the toxicities reported by patients according to the 8 symptomatic dimensions of the QLC-C30 questionnaire and 9 items from EORTC Item Bank exploring 6 supplementary symptomatic dimensions
Time frame: 24 months
Physician satisfaction
Time frame: 12 months
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