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 (RENACALL)

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

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).

Study Overview

• Status: Completed
• Conditions: Metastatic/Advanced Renal Cell Carcinoma
• Intervention / Treatment: Other: Best supportive care; Other: call center

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)..

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Annecy Cedex, France, 74011
    • Centre Hospitalier d'Annecy
  • Cabestany, France, 66330
    • Centre Catalan Urologie Andrologie
  • Chambery, France, 73000
    • Centre Hospitalier de Chambery
  • Lille, France, 59042
    • Hôpital privé La Louvière
  • Metz, France, 57000
    • Clinique Claude Bernard Chimiotherapie Ambulatoire
  • Montpellier cedex 05, France, 34295
    • CRLC Val d'Aurelle
  • Nancy, France, 54100
    • Polyclinique de Gentilly Service Oncologie Médicale
  • Nancy, France, 54000
    • Polyclinique Gentilly
  • Quimper Cedex, France, 29107
    • CHI de Cornouailles - Oncologie hospitalisation
  • Valenciennes, France, 59300
    • Hopital Jean BERNARD - Tours - 7eme etage
  • Vandoeuvre les Nancy, France, 54511
    • Centre Alexis Vautrin
  • Cedex
    • Strasbourg, Cedex, France, 67091
      • CHU Strasbourg
  • Cedex 5
    • Marseille, Cedex 5, France, 13335
      • CHU de la Timone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center	Other: Best supportive care; BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.	Baseline up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least 1 Sunitinib Dose Reduction	Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.	Baseline up to 6 months
Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction	Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.	Baseline up to 6 months
Average Sunitinib Dose Reduction		Baseline up to 6 months
Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment	Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.	Baseline up to 6 months
Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment	Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.	Baseline up to 6 months
Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption	Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.	Baseline up to 6 months
Number of Participants Who Permanently Discontinued Sunitinib Treatment	Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.	Baseline up to 6 months
Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation	Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.	Baseline up to 6 months
Mean Duration of Sunitinib Treatment	Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.	Baseline up to 6 months
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles	Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped	Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Hospitalization	Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.	Baseline up to 6 months
Number of Participants With At Least 1 Unplanned Consultation	Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.	Baseline up to 6 months
Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)	MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.	Baseline up to 6 months
Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score	MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.	Baseline up to 6 months
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response	ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.	Baseline up to 6 months
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire	Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.	At the end of the study (At Month 6)
Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center	Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.	At the end of the study (At Month 6)
Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire	Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.	At the end of the study (At Month 6)
Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center	Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.	Baseline up to 6 months
Total Number of Calls (Planned and Unplanned)	1 participant can call more than once during the study.	Baseline up to 6 months
Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call	Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported.	First call made anytime from baseline up to 6 months
Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call	Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported.	First call made anytime from baseline up to 6 months
Number of Telephone Calls Describing Actions Taken by Call Center	In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.	Baseline up to 6 months
Number of Telephone Calls Where Participants Declared Adverse Events	In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.	Baseline up to 6 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2015
• Primary Completion (Actual): July 25, 2018
• Study Completion (Actual): July 25, 2018

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: sunitinib; nurses; call center; management of patients; metastatic renal carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: A6181213; RENACALL (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.