Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma
QUANARIE
Heath Related Quality of Life Assessment for Patients With Advanced or Metastatic Renal Cell Carcinoma Treated With Tyrosine Kinase Inhibitor Using Electronic Patient Reported Outcome in Daily Clinical Practice.
1 other identifier
interventional
56
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2020
CompletedJuly 26, 2018
July 1, 2018
2.5 years
February 20, 2017
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Exhaustiveness
24 months
Acceptability
24 months
Effectiveness
24 months
Physician satisfaction
12 months
Other Outcomes (5)
Time to occurrence of grade 2 toxicity according to the NCI schedule CTCAE v4
24 months
Survival under HRQoL deterioration
24 months
Time to treatment failure (TTF)
24 months
- +2 more other outcomes
Study Arms (1)
Electronic PRO
OTHERAll 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
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
You may qualify if:
- Patient with renal clear cells carcinoma, histologically or cytologically confirmed, locally advanced nonresectable or metastatic who initiate an oral treatment by ITK anti-VEGF (Pazopanib or Sunitinib.)
- 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
You may not qualify if:
- Prior systemic treatment for metastatic renal cancer other than immunotherapy. Pretreatment or concomitant treatment with Biphosphonate or Denosumab is allowed.
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CHU de Besançon
Besançon, 25030, France
Hôpital privé Sainte Marie
Chalon-sur-Saône, 71100, France
Centre de lutte contre le cancer Georges François Leclerc
Dijon, 21000, France
Hôpital Nord Franche-Comté
Montbéliard, 25200, France
Centre de lutte contre le cancer Jean Godinot
Reims, 51100, France
Groupe hospitaliser St-Vincent
Strasbourg, 67000, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000, France
Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Related Publications (1)
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.
PMID: 30717745DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume MOUILLET, MD
Centre Hospitalier Universitairede Besançon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
February 23, 2017
Study Start
May 4, 2017
Primary Completion
November 4, 2019
Study Completion
February 4, 2020
Last Updated
July 26, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share