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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518991-30-00 | EU Trial (CTIS) Number |
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The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment
Patients receive the combination of Cabozantinib and Nivolumab as indicated in the label.
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance, based on patient reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital monitoring under Cabozantinib and nivolumab treatments | Experimental | During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report. The digital telemonitoring platform is used to facilitate the monitoring of signs and symptoms of treatment-specific Adverse Events. The platform integrates an algorithm to define patient risk based on responses to data collected on platform. The self-reported information on the mobile digital device allows to "classify" patients ("correct", "compromised", "to be monitored", or "critical) and to create some alerts. Some actions may be undertaken depending on these alerts, with adjustments of the management of treatments |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cabozantinib and nivolumab | Drug | cabozantinib and nivolumab according to the labelling indication, namely:
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with adjustment of treatments management | rate of patients with adjustment of treatments management including any unplanned action guided by weekly digital monitoring of self-reported symptoms: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment | within the first 3 months of the combined treatment (cabozantinib and nivolumab) |
| Measure | Description | Time Frame |
|---|---|---|
| - The evolution of self-reported symptoms | report regular follow-up of self-reported symptoms on the digital platform | during the first 6 months of the combination (cabozantinb and nivolumab) |
| - To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence LOBBEDEZ | Contact | +33231455002 | f.joly@baclesse.unicancer.fr | |
| Romain LEVARD, MD | Contact | +33231455002 | r.levard@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Annecy | Not yet recruiting | Annecy | France |
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|
Follow-up of number of grade 3-4 of self-reported symptoms after modification of treatment management induced by remote follow-up at 3 months |
| during the first 3 months of the combination (cabozantinib and nivolumab) |
| - To characterize and evaluate regular follow-up of patients self-reported fatigue | Score of self-reported fatigue by the questionnaire Facit-F (score between 0 and 160) | During the first 6 months of combination (cabozantinib and nivolumab) |
| - To have a longitudinal assessment of general health-related quality of life (QoL) | - The evolution of general health-related quality of life with the score of FSKI-10 questionnaire (score between 0 and 40) | During the first 6 months of combination (cabozantinib and nivolumab) |
| - To assess the feasibility of regular follow-up of PROs in real life | The levels of satisfaction and difficulties encountered by patients using the digital monitoring with the French validated version of the self-questionnaire F-SUS System Usability Scale (score between 0 and 50) | At 3 and 6 months after initiation of combination (cabozantinib and nivolumab) |
| - To characterize and describe warning adverse reactions | - The characterization and description of warning adverse reactions that may require therapeutic adaptation | During the first 6 months of the combination (cabozantinib and nivolumab) |
| - To characterize alerts issued by digital monitoring | Follow-up of number of alerts issued by digital monitoring | During the first 6 months of the combination (cabozantinib and nivolumab) |
| To have a longitudinal assessment of anxiety/depression and pain | The evolution of anxiety/depression with HADS scale (score between 0 and 56) | During the first 6 months of combination (cabozantinib and nivolumab) |
| To characterize alerts issued by digital monitoring | Follow-up on the type of alerts (dose adjustment or treatment discontinuation) | During the first 6 months of combination (cabozantinib and nivolumab) |
| Institut Sainte Catherine | Recruiting | Avignon | France |
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| Centre Hospitalier de Bayeux | Not yet recruiting | Bayeux | France |
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| CH Boulogne sur Mer | Not yet recruiting | Boulogne-sur-Mer | France |
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| Centre François Baclesse | Recruiting | Caen | France |
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| Polyclinique du Parc Elsan | Not yet recruiting | Caen | France |
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| Institut Andrée Dutreix | Not yet recruiting | Coudekerque-Branche | France |
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| Ghpso Creil | Not yet recruiting | Creil | France |
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| Centre Hospitalier de Lorient | Not yet recruiting | Lorient | France |
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| Centre Léon Bérard | Not yet recruiting | Lyon | France |
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| GHR Mulhouse Sud Alsace | Recruiting | Mulhouse | France |
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| Centre Antoine Lacassagne | Not yet recruiting | Nice | France |
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| CHU | Not yet recruiting | Saint-Etienne | France |
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| Hôpital FOCH | Not yet recruiting | Suresnes | France |
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| Centre Hospitalier de Tours | Not yet recruiting | Tours | France |
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| Centre d'oncologie St Yves | Not yet recruiting | Vannes | France |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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