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

July 24, 2018 updated by: Centre Hospitalier Universitaire de Besancon

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Active, not recruiting
        • CHU de Besancon
      • Chalon-sur-Saône, France, 71100
        • Recruiting
        • Hôpital privé sainte Marie
        • Contact:
          • Erika Viel, MD
          • Phone Number: 0033385488989
      • Dijon, France, 21000
        • Recruiting
        • Centre de Lutte Contre le Cancer Georges Francois Leclerc
        • Contact:
      • Montbéliard, France, 25200
      • Reims, France, 51100
        • Recruiting
        • Centre de lutte contre le cancer Jean Godinot
      • Strasbourg, France, 67000
      • Strasbourg, France, 67000
        • Recruiting
        • Groupe hospitaliser St-Vincent
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of filled questionnaires at 12-months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exhaustiveness
Time Frame: 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
24 months
Acceptability
Time Frame: 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)
24 months
Effectiveness
Time Frame: 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
24 months
Physician satisfaction
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to occurrence of grade 2 toxicity according to the NCI schedule CTCAE v4
Time Frame: 24 months
Defined as the time elapse between the inclusion date and the date of occurrence of grade 2 toxicity.
24 months
Survival under HRQoL deterioration
Time Frame: 24 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)
Time Frame: 24 months
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):
Time Frame: 24 months
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):
Time Frame: 24 months
Defined as the time interval between the date of inclusion and the date of death from any cause.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Guillaume MOUILLET, MD, Centre Hospitalier Universitairede Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2017

Primary Completion (Anticipated)

November 4, 2019

Study Completion (Anticipated)

February 4, 2020

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/2016/54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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