Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma

Not Applicable

• Conditions: Renal Carcinoma Metastatic; Kidney Neoplasms; Renal Cancer
• Interventions: Other: Electronic PRO in daily clinical practice

• Registration Number: NCT03062410
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

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 Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-05-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26
• Primary Completion: 2019-11-04
• Study Completion: 2020-02-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic PRO	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.

Primary Outcome Measures

Name	Time	Method
Rate of filled questionnaires at 12-months	12 months	Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.

Secondary Outcome Measures

Name	Time	Method
Effectiveness	24 months	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
Exhaustiveness	24 months	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
Acceptability	24 months	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)
Physician satisfaction	12 months

Trial Locations

Locations (8)

Centre de lutte contre le cancer Georges François Leclerc; 🇫🇷 Dijon, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Besançon; 🇫🇷 Besançon, France

Hôpital privé Sainte Marie; 🇫🇷 Chalon-sur-Saône, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France

Centre de lutte contre le cancer Jean Godinot; 🇫🇷 Reims, France

Groupe hospitaliser St-Vincent; 🇫🇷 Strasbourg, France

Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France