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: * Step 1. Collection of ePRO * Step 2. Intelligent analysis and alerts * Step 3. Adapted care
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,458
The patient will use Resilience PRO remote symptoms monitoring.
Hôpital Privé de Provence
Aix-en-Provence, France
RECRUITINGCentre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, France
RECRUITINGCentre Hospitalier Henri Mondor-Aurillac
Aurillac, France
RECRUITINGCentre Hospitalier de la Côte Basque
Bayonne, France
Health-Related quality of life
EORTC QLQ-C30
Time frame: 3 months
Health-economic evaluation
The outcome is measured in QALYs. These are calculated from the EQ-5D-5L questionnaire scores.
Time frame: 12 months
Overall survival
Time frame: 36 months
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Centre Hospitalier Universitaire de Caen Normandie
Caen, France
RECRUITINGCentre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCentre Hospitalier Universitaire Grenoble - Alpes
La Tronche, France
RECRUITINGGHICL Hôpital Saint Vincent de Paul
Lille, France
RECRUITINGCentre Hospitalier Universitaire de Lille
Lille, France
RECRUITINGHôpital Privé Jean Mermoz - Institut de Cancérologie
Lyon, France
RECRUITING...and 26 more locations