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

Primary Purpose

Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Electronic PRO in daily clinical practice

About this trial

This is an interventional other trial for Renal Carcinoma Metastatic focused on measuring Health Related Quality of Life, Routine clinical practice, Electronic Patient Reported Outcome, EORTC QLQ-C30, Pazopanib, Sunitinib, Tyrosine Kinase Inhibitor anti-VEGF, Patient Reported Outcome, Supportive Care, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

CHU de Besançon
Hôpital privé Sainte MarieRecruiting
Centre de lutte contre le cancer Georges François LeclercRecruiting
Hôpital Nord Franche-ComtéRecruiting
Centre de lutte contre le cancer Jean GodinotRecruiting
Groupe hospitaliser St-VincentRecruiting
Hôpitaux Universitaires de StrasbourgRecruiting
Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de LorraineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Electronic PRO

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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)

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

Physician satisfaction

Full Information

NCT ID

NCT03062410

First Posted

February 20, 2017

Last Updated

July 24, 2018

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT03062410

Brief Title

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

Acronym

QUANARIE

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 4, 2017 (Actual)

Primary Completion Date

November 4, 2019 (Anticipated)

Study Completion Date

February 4, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer

Keywords

Health Related Quality of Life, Routine clinical practice, Electronic Patient Reported Outcome, EORTC QLQ-C30, Pazopanib, Sunitinib, Tyrosine Kinase Inhibitor anti-VEGF, Patient Reported Outcome, Supportive Care, Quality of Life

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electronic PRO

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Electronic PRO in daily clinical practice

Intervention Description

Primary Outcome Measure Information:

Title

Rate of filled questionnaires at 12-months

Description

Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Exhaustiveness

Description

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

Time Frame

24 months

Title

Acceptability

Description

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)

Time Frame

24 months

Title

Effectiveness

Description

Time Frame

24 months

Title

Physician satisfaction

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Time to occurrence of grade 2 toxicity according to the NCI schedule CTCAE v4

Description

Defined as the time elapse between the inclusion date and the date of occurrence of grade 2 toxicity.

Time Frame

24 months

Title

Survival under HRQoL deterioration

Description

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

Time Frame

24 months

Title

Time to treatment failure (TTF)

Description

Defined as the time interval between the date of inclusion and death, tumor progression or definitive cessation of TKI treatment from any cause.

Time Frame

24 months

Title

Progression-free survival (PFS):

Description

Defined as the time interval between the date of inclusion and the date of first progression of the disease or death from any cause.

Time Frame

24 months

Title

Overall Survival (OS):

Description

Defined as the time interval between the date of inclusion and the date of death from any cause.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guillaume MOUILLET, MD

Phone

0033370632266

gmouillet@chu-besancon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Astrid POZET

Phone

0033370632179

apozet@chu-besancon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillaume MOUILLET, MD

Organizational Affiliation

Centre Hospitalier Universitairede Besançon

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Besançon

City

Besançon

ZIP/Postal Code

25030

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Hôpital privé Sainte Marie

City

Chalon-sur-Saône

ZIP/Postal Code

71100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erika Viel, MD

Phone

0033385488989

Facility Name

Centre de lutte contre le cancer Georges François Leclerc

City

Dijon

ZIP/Postal Code

21000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sylvain Ladoire, MD

Phone

0033380737506

sladoire@cgfl.fr

Facility Name

Hôpital Nord Franche-Comté

City

Montbéliard

ZIP/Postal Code

25200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume Mouillet, MD

mouillet.guillaume@gmail.com

Facility Name

Centre de lutte contre le cancer Jean Godinot

City

Reims

ZIP/Postal Code

51100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Christophe Eymard, MD

Facility Name

Groupe hospitaliser St-Vincent

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louis-Marie Dourthe, MD

lm.dourthe@solcrr.org

Facility Name

Hôpitaux Universitaires de Strasbourg

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe Barthelemy, MD

philippe.barthelemy@chru-strasbourg.fr

Facility Name

Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine

City

Vandœuvre-lès-Nancy

ZIP/Postal Code

54519

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lionnel Geoffrois, MD

l.geoffrois@nancy.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30717745

Citation

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.

Results Reference

derived

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

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