Clinical trial NCT02187042: 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
Official title: EVALUATION OF 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 SUNITINIB, VERSUS STANDARD FOLLOW-UP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic/Advanced Renal Cell Carcinoma
Keywords: sunitinib
call center
management of patients
nurses
metastatic renal carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The 100 metastatic and/or advanced patients of the study will come from the population of patients under the care of French renal cell carcinoma oncologists

Brief summary: 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).

Detailed description: 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)..

Eligibility criteria: 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.

Non-inclusion criteria

* 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

Primary outcomes:
measure: Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Number of Participants With at Least 1 Sunitinib Dose Reduction
timeFrame: Baseline up to 6 months
measure: Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction
timeFrame: Baseline up to 6 months
measure: Average Sunitinib Dose Reduction
timeFrame: Baseline up to 6 months
measure: Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment
timeFrame: Baseline up to 6 months
measure: Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment
timeFrame: Baseline up to 6 months
measure: Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption
timeFrame: Baseline up to 6 months
measure: Number of Participants Who Permanently Discontinued Sunitinib Treatment
timeFrame: Baseline up to 6 months
measure: Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation
timeFrame: Baseline up to 6 months
measure: Mean Duration of Sunitinib Treatment
timeFrame: Baseline up to 6 months
measure: Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles
timeFrame: Baseline up to 6 months
measure: Number of Participants With At Least 1 Unplanned Hospitalization
timeFrame: Baseline up to 6 months
measure: Number of Participants With At Least 1 Unplanned Consultation
timeFrame: Baseline up to 6 months
measure: Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)
timeFrame: Baseline up to 6 months
measure: Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score
timeFrame: Baseline up to 6 months
measure: Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response
timeFrame: Baseline up to 6 months
measure: Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
timeFrame: At the end of the study (At Month 6)
measure: Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center
timeFrame: At the end of the study (At Month 6)
measure: Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
timeFrame: At the end of the study (At Month 6)
measure: Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center
timeFrame: Baseline up to 6 months
measure: Total Number of Calls (Planned and Unplanned)
timeFrame: Baseline up to 6 months
measure: Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call
timeFrame: First call made anytime from baseline up to 6 months
measure: Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call
timeFrame: First call made anytime from baseline up to 6 months
measure: Number of Telephone Calls Describing Actions Taken by Call Center
timeFrame: Baseline up to 6 months
measure: Number of Telephone Calls Where Participants Declared Adverse Events
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: CHU de la Timone
state: Cedex 5
city: Strasbourg
country: France
facility: CHU Strasbourg
state: Cedex
city: Annecy Cedex
country: France
facility: Centre Hospitalier d'Annecy
city: Cabestany
country: France
facility: Centre Catalan Urologie Andrologie
city: Chambery
country: France
facility: Centre hospitalier de Chambery
city: Lille
country: France
facility: Hopital prive La Louviere
city: Metz
country: France
facility: Clinique Claude Bernard Chimiotherapie Ambulatoire
city: Montpellier cedex 05
country: France
facility: CRLC Val d'Aurelle
city: Nancy
country: France
facility: Polyclinique Gentilly
city: Nancy
country: France
facility: Polyclinique de Gentilly Service Oncologie Médicale
city: Quimper Cedex
country: France
facility: CHI de Cornouailles - Oncologie hospitalisation
city: Valenciennes
country: France
facility: Hopital Jean BERNARD - Tours - 7eme etage
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: