Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only (RC-102)

Resilience

Status and phase

Enrolling

Phase 3

Conditions

Cancer

Treatments

Device: Resilience PRO

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06867705

2024-A01584-43 (ID RCB) (Other Identifier)

N° Eudamed: CIV-25-01-050834 (Other Identifier)

RC-102

Details and patient eligibility

About

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.

Full description

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

Enrollment

1,458 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: Adults ≥ 18 years.
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

Age: Patients under 18 years of age.
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