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Trial record 1 of 1 for:    NCT02187042
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187042
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date July 8, 2014
First Posted Date July 10, 2014
Results First Submitted Date July 25, 2019
Results First Posted Date October 24, 2019
Last Update Posted Date October 24, 2019
Actual Study Start Date October 7, 2015
Actual Primary Completion Date July 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2019)
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 [ Time Frame: Baseline up to 6 months ]
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.
Original Primary Outcome Measures
 (submitted: July 8, 2014)
Percentage of patients who presented at least one adverse event of grade 3 or 4 (linked or not to sunitinib) [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures
 (submitted: October 1, 2019)
  • Number of Participants With at Least 1 Sunitinib Dose Reduction [ Time Frame: Baseline up to 6 months ]
    Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.
  • Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction [ Time Frame: Baseline up to 6 months ]
    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.
  • Average Sunitinib Dose Reduction [ Time Frame: Baseline up to 6 months ]
  • Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment [ Time Frame: Baseline up to 6 months ]
    Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
  • Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment [ Time Frame: Baseline up to 6 months ]
    Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
  • Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption [ Time Frame: Baseline up to 6 months ]
    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.
  • Number of Participants Who Permanently Discontinued Sunitinib Treatment [ Time Frame: Baseline up to 6 months ]
    Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
  • Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation [ Time Frame: Baseline up to 6 months ]
    Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
  • Mean Duration of Sunitinib Treatment [ Time Frame: Baseline up to 6 months ]
    Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.
  • Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles [ Time Frame: Baseline up to 6 months ]
    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
  • Number of Participants With At Least 1 Unplanned Hospitalization [ Time Frame: Baseline up to 6 months ]
    Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.
  • Number of Participants With At Least 1 Unplanned Consultation [ Time Frame: Baseline up to 6 months ]
    Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.
  • Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) [ Time Frame: Baseline up to 6 months ]
    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.
  • Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score [ Time Frame: Baseline up to 6 months ]
    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.
  • Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response [ Time Frame: Baseline up to 6 months ]
    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.
  • Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire [ Time Frame: At the end of the study (At Month 6) ]
    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.
  • Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center [ Time Frame: At the end of the study (At Month 6) ]
    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.
  • Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire [ Time Frame: At the end of the study (At Month 6) ]
    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.
  • Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center [ Time Frame: Baseline up to 6 months ]
    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.
  • Total Number of Calls (Planned and Unplanned) [ Time Frame: Baseline up to 6 months ]
    1 participant can call more than once during the study.
  • Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call [ Time Frame: First call made anytime from baseline up to 6 months ]
    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.
  • Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call [ Time Frame: First call made anytime from baseline up to 6 months ]
    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.
  • Number of Telephone Calls Describing Actions Taken by Call Center [ Time Frame: Baseline up to 6 months ]
    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.
  • Number of Telephone Calls Where Participants Declared Adverse Events [ Time Frame: Baseline up to 6 months ]
    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.
Original Secondary Outcome Measures
 (submitted: July 8, 2014)
  • Percentage of patients who needed at least one dose reduction of sunitinib [ Time Frame: 6 months ]
  • Percentage of patients who needed at least one interruption of treatment by sunitinib [ Time Frame: 6 months ]
  • Percentage of patients who discontinued sunitinib before the end of the study [ Time Frame: 6 months ]
  • Percentage of patients who needed unplanned hospitalisations [ Time Frame: 6 months ]
  • Percentage of patients who needed unplanned consultations [ Time Frame: 6 months ]
  • Patient adherence to sunitinib [ Time Frame: Week 6, 12 and 24 ]
    Morisky questionnaire
  • Overall response rate [ Time Frame: 6 months ]
  • Patients and doctors satisfaction to the call center [ Time Frame: 6 months ]
    Self-administered questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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)..

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Metastatic/Advanced Renal Cell Carcinoma
Intervention
  • 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.
Study Groups/Cohorts All patients
Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
Interventions:
  • Other: Best supportive care
  • Other: call center
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 26, 2018)
70
Original Estimated Enrollment
 (submitted: July 8, 2014)
220
Actual Study Completion Date July 25, 2018
Actual Primary Completion Date July 25, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02187042
Other Study ID Numbers A6181213
RENACALL ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2019