Clinical trial NCT06867705: Randomized Controlled Trial of Remote Symptoms Monitoring with Resilience PRO Compared to Care As Usual Only
Official title: Digital Monitoring with Patient-Reported Outcomes in Cancer Care: a Randomized Controlled Trial RC - 102 (Resilience Care - 102)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cancer
Keywords: Remote Patient Monitoring
Remote Symptom Monitoring
Digital medicine
Resilience PRO
Resilience
PRO
Patient-reported Outcomes
Lead sponsor: Resilience
Sponsor class: INDUSTRY
Collaborators: name: UNICANCER
name: Sanoia
First posted: 2025-03-10
Enrollment: 1458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Health-Related quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Health-economic evaluation
timeFrame: 12 months
measure: Overall survival
timeFrame: 36 months
Other outcomes:
measure: Experience from patients
timeFrame: 12 months
measure: Experience from HCP
timeFrame: 12 months
Locations:
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Florian Scotté, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: