Metastatic/Advanced Renal Cell Carcinoma Clinical Trial
— RENACALLOfficial 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
| Verified date | October 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | July 25, 2018 |
| Est. primary completion date | July 25, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier d'Annecy | Annecy Cedex | |
| France | Centre Catalan Urologie Andrologie | Cabestany | |
| France | Centre hospitalier de Chambery | Chambery | |
| France | Hopital prive La Louviere | Lille | |
| France | CHU de la Timone | Marseille | Cedex 5 |
| France | Clinique Claude Bernard Chimiotherapie Ambulatoire | Metz | |
| France | CRLC Val d'Aurelle | Montpellier cedex 05 | |
| France | Polyclinique de Gentilly Service Oncologie Médicale | Nancy | |
| France | Polyclinique Gentilly | Nancy | |
| France | CHI de Cornouailles - Oncologie hospitalisation | Quimper Cedex | |
| France | CHU Strasbourg | Strasbourg | Cedex |
| France | Hopital Jean BERNARD - Tours - 7eme etage | Valenciennes | |
| France | Centre Alexis Vautrin | Vandoeuvre les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | Average Sunitinib Dose Reduction | Baseline up to 6 months | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Mean Duration of Sunitinib Treatment | Total mean duration (in months) of sunitinib treatment is reported in this outcome measure. | Baseline up to 6 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | Total Number of Calls (Planned and Unplanned) | 1 participant can call more than once during the study. | Baseline up to 6 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |