Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma
NCT ID: NCT03062410
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2017-05-04
2020-02-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Electronic PRO
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Estimated life expectancy over than 3 months.
* Male or female
* Aged 18 years or older
* Patient able to understand French and to complete study questionnaires (no major cognitive disorders)
* Signed informed consent
* Patient affiliated to or beneficiary of French social security regime
Exclusion Criteria
* Renal carcinoma without clear cell component.
* Psychiatric illness compromising understanding of the information or conducting the study.
* Any acute or chronic disease (eg severe COPD) may affect the patient's ability to receive treatment under study or may make it difficult the interpretation of toxicities or adverse events.
* HIV positive.
* History of active chronic hepatitis including subjects who are carriers of Hepatitis B virus or Hepatitis C virus
* Uncontrolled infection
* History of digestive pathology which could compromise the good absorption of an oral ITK.
* Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 4 months from the last treatment administration.
* Hypersensitivity or contraindication to any of the study drugs (active substance of ITK or any excipients.)
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Guillaume MOUILLET, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitairede Besançon
Locations
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CHU de Besançon
Besançon, , France
Hôpital privé Sainte Marie
Chalon-sur-Saône, , France
Centre de lutte contre le cancer Georges François Leclerc
Dijon, , France
Hôpital Nord Franche-Comté
Montbéliard, , France
Centre de lutte contre le cancer Jean Godinot
Reims, , France
Groupe hospitaliser St-Vincent
Strasbourg, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Erika Viel, MD
Role: primary
Jean-Christophe Eymard, MD
Role: primary
References
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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.
Other Identifiers
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R/2016/54
Identifier Type: -
Identifier Source: org_study_id
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