Randomized Controlled Trial of Remote Symptoms Monitoring with Resilience PRO Compared to Care As Usual Only

Phase 3

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06867705
• Lead Sponsor: Resilience

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2025-02-21
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-03-24
• Primary Completion: 2027-01
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1458

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health-Related quality of life	3 months	EORTC QLQ-C30

Secondary Outcome Measures

Name	Time	Method
Health-economic evaluation	12 months	The outcome is measured in QALYs. These are calculated from the EQ-5D-5L questionnaire scores.
Overall survival	36 months