Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
NCT ID: NCT06867705
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1458 participants
INTERVENTIONAL
2025-04-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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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:
* Step 1. Collection of ePRO
* Step 2. Intelligent analysis and alerts
* Step 3. Adapted care
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Remote Symptoms Monitoring with Resilience PRO
Resilience PRO will be added on top of conventional care
Resilience PRO
The patient will use Resilience PRO remote symptoms monitoring.
Usual care without Remote Symptoms Monitoring
Conventional care only
No interventions assigned to this group
Interventions
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Resilience PRO
The patient will use Resilience PRO remote symptoms monitoring.
Eligibility Criteria
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Inclusion Criteria
* Informed Consent: Patient giving signed informed consent to participate in the RC - 102 clinical study.
* Diagnosis: Patients with cancer at any stage.
* Systemic Treatment
* Remote Monitoring Eligibility: Access to a smartphone
* Language: Ability to understand and communicate in the language(s) in which the trial is conducted.
Exclusion Criteria
* Life Expectancy: Patients with a life expectancy of less than 6 months as estimated by the treating physician.
* Concurrent remote monitoring
* HSCT or CAR-T Therapy
* Cognitive Impairment
* Pregnancy or breastfeeding
* Subject under administrative or judicial control
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Sanoia
OTHER
Resilience
INDUSTRY
Responsible Party
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Principal Investigators
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Florian Scotté, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Hôpital Privé de Provence
Aix-en-Provence, , France
Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, , France
Centre Hospitalier Henri Mondor-Aurillac
Aurillac, , France
Centre Hospitalier de la Côte Basque
Bayonne, , France
Centre Hospitalier Universitaire de Caen Normandie
Caen, , France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
Centre Hospitalier Universitaire Grenoble - Alpes
La Tronche, , France
GHICL Hôpital Saint Vincent de Paul
Lille, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
Hôpital Privé Jean Mermoz - Institut de Cancérologie
Lyon, , France
AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone
Marseille, , France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Hôpital Privé du Confluent
Nantes, , France
Centre Hospitalier Universitaire de Nice
Nice, , France
Centre Hospitalier Universitaire de Nîmes
Nîmes, , France
AP-HP Hôpitaux Universitaires La Pitié Salpêtrière
Paris, , France
Clinique Mutualiste Bretagne Occidentale
Quimper, , France
Hôpital Privé de la Loire (HPL) - Saint Etienne
Saint-Etienne, , France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, , France
Centre Hospitalier Universitaire Sud Réunion
Saint-Pierre, , France
Centre Clinical Elsan
Soyaux, , France
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, , France
Clinique Pasteur
Toulouse, , France
Centre de Cancérologie Les Dentellières
Valenciennes, , France
Clinique Teissier
Valenciennes, , France
Gustave Roussy
Villejuif, , France
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel
Kiel, , Germany
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
Lübeck, , Germany
Countries
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Central Contacts
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Facility Contacts
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Direction de la Recherche Clinique et de l'Innovation
Role: primary
Related Links
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EUDAMED - European Database on Medical Devices
Other Identifiers
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2024-A01584-43 (ID RCB)
Identifier Type: OTHER
Identifier Source: secondary_id
N° Eudamed: CIV-25-01-050834
Identifier Type: OTHER
Identifier Source: secondary_id
RC-102
Identifier Type: -
Identifier Source: org_study_id
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