Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-07

Study Completion Date

2018-07-25

Brief Summary

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100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center

Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).

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Detailed Description

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RENACALL is a prospective intermediate care study whose main aim is to evaluate the impact of a therapy management platform on the management of patients suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with Sutent®.

100 mRCC patients treated receiving first line Sutent® treatment shall be included in the study, and shall benefit both from conventional follow-up and from additional therapy management platform-based follow-up. Platform follow-up shall consist in regular phone calls to accompany patients in their real life home management of their treatment with sunitinib (prevention, advice and guidance of patients towards options)..

Conditions

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Metastatic/Advanced Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center

Best supportive care

Intervention Type OTHER

BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life

call center

Intervention Type OTHER

Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.

Interventions

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Best supportive care

BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life

Intervention Type OTHER

call center

Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Man or woman aged 18 or over;

* Patient suffering from a/mRCC, receiving sunitinib first-line treatment, as per SPC recommendations;
* Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic effects due to radiotherapy or surgical procedure prior to initiation of sunitinib;
* Patient who can be monitored for 6 months.
* Female patient of child-bearing age using a form of contraception during treatment with Sunitinib and for at least 28 days after termination of treatment with Sunitinib;
* Patient having signed his/her consent form;
* Patient affiliated with a social security scheme.

* Patient participating in a clinical trial during sunitinib treatment;
* Patient managed by a home hospitalisation service during sunitinib treatment;
* Patient taking part in therapeutic education programmes, or benefiting from nursing consultation, or from any other significant treatment support and likely to impact adverse event management.
* Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation;
* Patient refusing the use of his/her personal data.
* Patient with an ECOG performance status upon inclusion \> 2;
* Patient presenting with a serum creatinine level \>1.5 times the upper limit of the normal level;
* Patient presenting with a bilirubin level \> 2 mg/dl, aspartate transaminase (ASAT) or alanine transaminase (ALAT) \>2.5 times the upper limit of the normal value, or \>5 times the upper limit of the normal value in the presence of liver metastases upon initiation of sunitinib treatment.
* Patients who are staff members of a centre involved in the study, or close to one of the staff members of a centre directly involved in conducting the study, or patients employed by Pfizer and involved in conducting the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No