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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic PRO | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic PRO in daily clinical practice | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to occurrence of grade 2 toxicity according to the NCI schedule CTCAE v4 | Defined as the time elapse between the inclusion date and the date of occurrence of grade 2 toxicity. | 24 months |
| Survival under HRQoL deterioration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume MOUILLET, MD | Contact | 0033370632266 | gmouillet@chu-besancon.fr | |
| Astrid POZET | Contact | 0033370632179 | apozet@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume MOUILLET, MD | Centre Hospitalier Universitairede Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Active, not recruiting | Besançon | 25030 | France | ||
| Hôpital privé Sainte Marie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30717745 | Derived | Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, Es-Saad I, Meurisse A, Vernerey D, Mouyabi K, Berthod D, Bonnetain F, Anota A, Thiery-Vuillemin A. 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. Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1. |
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|
| 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 | 24 months |
| Physician satisfaction | 12 months |
Assessed by the QLQ-C30 questionnaire and defined by the time between the inclusion date and the first clinically significant minimal deterioration (MCID) at the baseline score without clinically significant improvement or death from any cause
| 24 months |
| Time to treatment failure (TTF) | Defined as the time interval between the date of inclusion and death, tumor progression or definitive cessation of TKI treatment from any cause. | 24 months |
| Progression-free survival (PFS): | Defined as the time interval between the date of inclusion and the date of first progression of the disease or death from any cause. | 24 months |
| Overall Survival (OS): | Defined as the time interval between the date of inclusion and the date of death from any cause. | 24 months |
| Recruiting |
| Chalon-sur-Saône |
| 71100 |
| France |
|
| Centre de lutte contre le cancer Georges François Leclerc | Recruiting | Dijon | 21000 | France |
|
| Hôpital Nord Franche-Comté | Recruiting | Montbéliard | 25200 | France |
|
| Centre de lutte contre le cancer Jean Godinot | Recruiting | Reims | 51100 | France |
|
| Groupe hospitaliser St-Vincent | Recruiting | Strasbourg | 67000 | France |
|
| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
|
| Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54519 | France |
|
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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