Metastatic/Advanced Renal Cell Carcinoma
Conditions
Keywords
sunitinib, call center, management of patients, nurses, metastatic renal carcinoma
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)..
Interventions
OTHERBest supportive care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
OTHERcall 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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction | 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 | Baseline up to 6 months | — |
| Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment | 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 | 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 | 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 | 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 With At Least 1 Unplanned Hospitalization | 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 Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | 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 | 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 | 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 Consultation | 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 With at Least 1 Sunitinib Dose Reduction | 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. |
| Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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. |
| Number of Participants Who Were Adherent as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Call Center Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks. | 42 |
| Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks. | 27 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Doctor choice | 1 | 0 |
| Overall Study | Participant choice | 1 | 0 |
| Overall Study | Progressive disease | 4 | 8 |
| Overall Study | Toxicity | 6 | 5 |
Baseline characteristics
| Characteristic | Call Center | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 10.3 | 65.6 years STANDARD_DEVIATION 9.2 | 66.6 years STANDARD_DEVIATION 9.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 30 Participants | 22 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 42 | 3 / 27 |
| other Total, other adverse events | 42 / 42 | 27 / 27 |
| serious Total, serious adverse events | 12 / 42 | 15 / 27 |
Outcome results
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | 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 | 34 Participants |
| Standard of Care | 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 | 14 Participants |
Secondary
Average Sunitinib Dose Reduction
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Call Center | Average Sunitinib Dose Reduction | 12.5 milligram per day (mg/day) | Standard Deviation 0 |
| Standard of Care | Average Sunitinib Dose Reduction | 12.5 milligram per day (mg/day) | Standard Deviation 0 |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Call Center | Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score | 0.1 Units on a scale | Standard Deviation 0.5 |
| Standard of Care | Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score | 0.2 Units on a scale | Standard Deviation 0.4 |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Call Center | Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment | 10.5 days | Standard Deviation 11.5 |
| Standard of Care | Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment | 16.6 days | Standard Deviation 19.4 |
Secondary
Mean Duration of Sunitinib Treatment
Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Call Center | Mean Duration of Sunitinib Treatment | 4.8 Months | Standard Deviation 1.9 |
| Standard of Care | Mean Duration of Sunitinib Treatment | 4.2 Months | Standard Deviation 1.9 |
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.
Time frame: At the end of the study (At Month 6)
Population: Analysis population: participants who were investigated by the doctors, who met study eligibility criteria, had received at least 1 dose of Sunitinib and were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center. Here, 'Number analyzed' = participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Call Center | Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Satisfaction with the advice | 1.2 Units on a scale | Standard Deviation 0.9 |
| Call Center | Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Satisfaction with care | 1.1 Units on a scale | Standard Deviation 1.1 |
| Call Center | Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Satisfaction with the service | 1.2 Units on a scale | Standard Deviation 0.9 |
| Call Center | Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Overall satisfaction with support in management | 1.2 Units on a scale | Standard Deviation 0.9 |
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.
Time frame: At the end of the study (At Month 6)
Population: Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Call Center | Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Satisfaction with the advice | 0.4 Units on a scale | Standard Deviation 1.1 |
| Call Center | Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Satisfaction with care | -0.6 Units on a scale | Standard Deviation 1.2 |
| Call Center | Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Overall satisfaction of participant care | 0.1 Units on a scale | Standard Deviation 1.4 |
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.
Time frame: Baseline up to 6 months
Population: Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Call Center | Number of Investigating Physicians Who Reported Themselves Being Satisfied or Very Satisfied With the Management By the Telephone Call Center | 7 Physicians |
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
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Call Center | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 1 Cycle | 6 Participants |
| Call Center | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 3 Cycles | 7 Participants |
| Call Center | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 2 Cycles | 1 Participants |
| Call Center | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 4 Cycles | 28 Participants |
| Standard of Care | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 2 Cycles | 7 Participants |
| Standard of Care | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 1 Cycle | 3 Participants |
| Standard of Care | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 4 Cycles | 12 Participants |
| Standard of Care | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | 3 Cycles | 5 Participants |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Call Center | Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction | Adverse Event | 12 Participants |
| Call Center | Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction | Unknown | 0 Participants |
| Standard of Care | Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction | Adverse Event | 3 Participants |
| Standard of Care | Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction | Unknown | 1 Participants |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Call Center | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Toxicity | 6 Participants |
| Call Center | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Doctor's Choice | 1 Participants |
| Call Center | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Participant Choice | 1 Participants |
| Call Center | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Death | 1 Participants |
| Call Center | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Progressive Disease | 4 Participants |
| Standard of Care | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Death | 1 Participants |
| Standard of Care | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Progressive Disease | 8 Participants |
| Standard of Care | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Toxicity | 5 Participants |
| Standard of Care | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Participant Choice | 0 Participants |
| Standard of Care | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Doctor's Choice | 0 Participants |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Call Center | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Surgery | 1 Participants |
| Call Center | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Doctor choice | 6 Participants |
| Call Center | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Omission | 4 Participants |
| Call Center | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Other | 2 Participants |
| Call Center | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | AE | 19 Participants |
| Standard of Care | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Other | 1 Participants |
| Standard of Care | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | AE | 7 Participants |
| Standard of Care | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Surgery | 0 Participants |
| Standard of Care | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Omission | 0 Participants |
| Standard of Care | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Doctor choice | 1 Participants |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants Who Permanently Discontinued Sunitinib Treatment | 13 Participants |
| Standard of Care | Number of Participants Who Permanently Discontinued Sunitinib Treatment | 14 Participants |
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.
Time frame: At the end of the study (At Month 6)
Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants Who Reported Themselves Being Satisfied or Very Satisfied With the Management By the Telephone Call Center | 19 Participants |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants Who Were Adherent as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) | 30 Participants |
| Standard of Care | Number of Participants Who Were Adherent as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) | 15 Participants |
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.
Time frame: First call made anytime from baseline up to 6 months
Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call | 33 Participants |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants With at Least 1 Sunitinib Dose Reduction | 12 Participants |
| Standard of Care | Number of Participants With at Least 1 Sunitinib Dose Reduction | 4 Participants |
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.
Time frame: Baseline up to 6 months
Population: Safety population included participants treated with Sunitinib.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment | 27 Participants |
| Standard of Care | Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment | 8 Participants |
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.
Time frame: Baseline up to 6 months
Population: Analysis population included included participants who were treated with sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm call center as per the planned analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants With At Least 1 Unplanned Consultation | 16 Participants |
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.
Time frame: Baseline up to 6 months
Population: Analysis population included participants who were treated with Sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm call center as per the planned analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Call Center | Number of Participants With At Least 1 Unplanned Hospitalization | 9 Participants |
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.
Time frame: First call made anytime from baseline up to 6 months
Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Call Center | Number of Participants With Their Responses as Yes Against the Actions of Investigating Physicians, as Told to Call Center During the First Call | Doctor clearly explained how to take treatment | 31 Participants |
| Call Center | Number of Participants With Their Responses as Yes Against the Actions of Investigating Physicians, as Told to Call Center During the First Call | Participants given documentation about treatment | 31 Participants |
| Call Center | Number of Participants With Their Responses as Yes Against the Actions of Investigating Physicians, as Told to Call Center During the First Call | Doctor explain manage side effect due to treatment | 27 Participants |
| Call Center | Number of Participants With Their Responses as Yes Against the Actions of Investigating Physicians, as Told to Call Center During the First Call | Prescriptions for supportive medical treatments | 27 Participants |
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.
Time frame: Baseline up to 6 months
Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Advice about managing treatment: taking Sunitinib | 266 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Advice about managing treatment:Sunitinib followup | 281 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Advice about managing treatment: Reporting any AE | 341 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | General preventative advice: taking treatments | 263 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | General preventative advice: Lifestyle advice | 278 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | General preventative advice: Food/dietetic advice | 222 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | General preventative advice: Orodental hygiene | 272 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Specific advice for type of AE: skin toxicities | 270 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Specific advice for type of AE: GI disorders | 271 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Specific advice for type of AE: cardiac disorders | 317 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Specific advice for type of AE: infectious problem | 233 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Specific advice for type of AE:preventative advice | 289 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Actions to participants:Do not forget consultation | 134 Telephone calls |
| Call Center | Number of Telephone Calls Describing Actions Taken by Call Center | Actions to participants: additional investigation | 137 Telephone calls |
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.
Time frame: Baseline up to 6 months
Population: Call center full analysis set (FAS) population included all participants who were investigated by doctors, who met the study eligibility criteria and had received at least 1 dose of Sunitinib and were followed up by call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Call Center | Number of Telephone Calls Where Participants Declared Adverse Events | 280 Telephone calls |
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.
Time frame: Baseline up to 6 months
Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Data was collected only for the reporting arm call center as per the planned analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Call Center | Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response | 33.3 Percentage of participants |
Secondary
Total Number of Calls (Planned and Unplanned)
1 participant can call more than once during the study.
Time frame: Baseline up to 6 months
Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Call Center | Total Number of Calls (Planned and Unplanned) | 431 Calls |