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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01584-43 (ID RCB) | Other Identifier | Agence Nationale de Sécurité du Médicament (ANSM) | |
| N° Eudamed: CIV-25-01-050834 | Other Identifier | Agence Nationale de Sécurité du Médicament (ANSM) |
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| Name | Class |
|---|---|
| UNICANCER | OTHER |
| Sanoia | OTHER |
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The goal of this clinical trial is to learn if Resilience PRO, a digital solution performing remote symptoms monitoring, can improve the quality of life of patients with a diagnosis of cancer receiving systemic anticancer treatment.
The main question it aims to answer is:
- Do patients with a diagnosis of cancer receiving systemic anticancer therapy and using Resilience PRO have an improved quality of life? Researchers will compare patients using Resilience PRO plus care as usual to patients receiving care as usual only.
Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. Participants both in the control arm and in the intervention arm will further receive care as usual.
Resilience PRO is a digital medical device (dMD CE marked, class IIa) that enables the remote monitoring of patients diagnosed with cancer receiving anticancer systemic therapy. Resilience PRO has been positively evaluated by the French health authorities (HAS, Haute Autorité de Santé) and is registered on the French LATM list (Liste des Activités de Télésurveillance Médicale).
Resilience PRO is a software medical device prescribed by cancer treating physicians to collect electronic patient-reported outcomes (ePRO). The Resilience PRO workflow comprises the following steps:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Symptoms Monitoring with Resilience PRO | Experimental | Resilience PRO will be added on top of conventional care |
|
| Usual care without Remote Symptoms Monitoring | No Intervention | Conventional care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilience PRO | Device | The patient will use Resilience PRO remote symptoms monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related quality of life | EORTC QLQ-C30 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-economic evaluation | The outcome is measured in QALYs. These are calculated from the EQ-5D-5L questionnaire scores. | 12 months |
| Overall survival | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Experience from patients | Patient experience and usability of the RPM system survey (Patient-Reported Experience Measures PREMs) | 12 months |
| Experience from HCP | Healthcare Professionals Experience survey. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Resilience | Contact | +33 805 69 65 61 | support@resilience.care |
| Name | Affiliation | Role |
|---|---|---|
| Florian Scotté, MD, PhD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé de Provence | Recruiting | Aix-en-Provence | 13080 | France |
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| Label | URL |
|---|---|
| EUDAMED - European Database on Medical Devices | View source |
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| 12 months |
| Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis | Recruiting | Aix-en-Provence | 13100 | France |
|
| Centre Hospitalier Henri Mondor-Aurillac | Recruiting | Aurillac | 15000 | France |
|
| Centre Hospitalier de la Côte Basque | Recruiting | Bayonne | 64100 | France |
|
| Centre Hospitalier Universitaire de Caen Normandie | Recruiting | Caen | 14033 | France |
|
| Centre Hospitalier Universitaire de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
|
| Centre Hospitalier Universitaire Grenoble - Alpes | Recruiting | La Tronche | 38700 | France |
|
| GHICL Hôpital Saint Vincent de Paul | Recruiting | Lille | 59000 | France |
|
| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59037 | France |
|
| Hôpital Privé Jean Mermoz - Institut de Cancérologie | Recruiting | Lyon | 69008 | France |
|
| AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone | Recruiting | Marseille | 13005 | France |
|
| Centre Hospitalier Universitaire de Nantes | Recruiting | Nantes | 44093 | France |
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| Hôpital Privé du Confluent | Recruiting | Nantes | 44200 | France |
|
| Centre Hospitalier Universitaire de Nice | Recruiting | Nice | 06000 | France |
|
| Centre Hospitalier Universitaire de Nîmes | Recruiting | Nîmes | 30029 | France |
|
| AP-HP Hôpitaux Universitaires La Pitié Salpêtrière | Recruiting | Paris | 75013 | France |
|
| Clinique Mutualiste Bretagne Occidentale | Recruiting | Quimper | 29000 | France |
|
| Hôpital Privé de la Loire (HPL) - Saint Etienne | Recruiting | Saint-Etienne | 42100 | France |
|
| Clinique Mutualiste de l'Estuaire | Recruiting | Saint-Nazaire | 44606 | France |
|
| Centre Hospitalier Universitaire Sud Réunion | Recruiting | Saint-Pierre | 97448 | France |
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| Centre Clinical Elsan | Recruiting | Soyaux | 16800 | France |
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| Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer | Recruiting | Toulon | 83056 | France |
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| Clinique Pasteur | Recruiting | Toulouse | 31076 | France |
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| Centre de Cancérologie Les Dentellières | Recruiting | Valenciennes | 59300 | France |
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| Clinique Teissier | Recruiting | Valenciennes | 59300 | France |
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| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
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| University Hospital Augsburg - UKA | Recruiting | Augsburg | 86156 | Germany |
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| Helios Klinikum Bad Saarow | Recruiting | Bad Saarow | 15526 | Germany |
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| Katholisches Klinikum Bochum UK St. Josef - Hospital | Recruiting | Bochum | 44791 | Germany |
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| UK Hamburg- Eppendorf (UKE) | Recruiting | Hamburg | 20246 | Germany |
|
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
|
| MVZ Aschaffenburg-Alzenau | Recruiting | Hösbach | 63768 | Germany |
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| Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel | Recruiting | Kiel | 24105 | Germany |
|
| Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck | Recruiting | Lübeck | 23538 | Germany |
|
| Onkomedeor MVZ Perlach | Recruiting | München | 81737 | Germany |
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| Universitätsklinikum Tuebingen | Recruiting | Tübingen | 72076 | Germany |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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