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

April 2, 2026 updated by: Resilience

Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1458

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Aix-en-Provence, France, 13080
        • Recruiting
        • Hôpital Privé de Provence
        • Contact:
      • Aix-en-Provence, France, 13100
        • Recruiting
        • Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis
        • Contact:
      • Aurillac, France, 15000
        • Recruiting
        • Centre Hospitalier Henri Mondor-Aurillac
        • Contact:
      • Bayonne, France, 64100
        • Recruiting
        • Centre Hospitalier de la Cote Basque
        • Contact:
      • Caen, France, 14033
        • Recruiting
        • Centre Hospitalier Universitaire de Caen Normandie
        • Contact:
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand
        • Contact:
      • La Tronche, France, 38700
        • Recruiting
        • Centre Hospitalier Universitaire Grenoble - Alpes
        • Contact:
      • Lille, France, 59037
        • Recruiting
        • Centre Hospitalier Universitaire De Lille
        • Contact:
      • Lille, France, 59000
        • Recruiting
        • GHICL Hôpital Saint Vincent de Paul
        • Contact:
      • Lyon, France, 69008
        • Recruiting
        • Hôpital Privé Jean Mermoz - Institut de Cancérologie
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone
        • Contact:
      • Nantes, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire De Nantes
        • Contact:
      • Nantes, France, 44200
        • Recruiting
        • Hôpital Privé du Confluent
        • Contact:
      • Nice, France, 06000
      • Nîmes, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire de Nîmes
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • AP-HP Hôpitaux Universitaires La Pitié Salpêtrière
        • Contact:
      • Quimper, France, 29000
        • Recruiting
        • Clinique Mutualiste Bretagne Occidentale
        • Contact:
      • Saint-Etienne, France, 42100
        • Recruiting
        • Hôpital Privé de la Loire (HPL) - Saint Etienne
        • Contact:
      • Saint-Nazaire, France, 44606
      • Saint-Pierre, France, 97448
        • Recruiting
        • Centre Hospitalier Universitaire Sud Réunion
        • Contact:
      • Soyaux, France, 16800
      • Toulon, France, 83056
        • Recruiting
        • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
        • Contact:
      • Toulouse, France, 31076
        • Recruiting
        • Clinique Pasteur
        • Contact:
      • Valenciennes, France, 59300
        • Recruiting
        • Clinique Teissier
        • Contact:
      • Valenciennes, France, 59300
        • Recruiting
        • Centre de cancerologie Les Dentellieres
        • Contact:
      • Villejuif, France, 94805
  • Germany
      • Augsburg, Germany, 86156
      • Bad Saarow, Germany, 15526
      • Bochum, Germany, 44791
        • Recruiting
        • Katholisches Klinikum Bochum UK St. Josef - Hospital
        • Contact:
      • Hamburg, Germany, 20246
        • Recruiting
        • UK Hamburg- Eppendorf (UKE)
        • Contact:
      • Hanover, Germany, 30625
      • Hösbach, Germany, 63768
      • Kiel, Germany, 24105
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel
        • Contact:
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
        • Contact:
      • München, Germany, 81737
      • Tübingen, Germany, 72076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote Symptoms Monitoring with Resilience PRO
Resilience PRO will be added on top of conventional care
Device: Resilience PRO
The patient will use Resilience PRO remote symptoms monitoring.
No Intervention: Usual care without Remote Symptoms Monitoring
Conventional care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related quality of life
Time Frame: 3 months
EORTC QLQ-C30
3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience from patients
Time Frame: 12 months
Patient experience and usability of the RPM system survey (Patient-Reported Experience Measures PREMs)
12 months
Experience from HCP
Time Frame: 12 months
Healthcare Professionals Experience survey.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Resilience

Collaborators

UNICANCER
Sanoia

Investigators

  • Principal Investigator: Florian Scotté, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-102
  • 2024-A01584-43 (ID RCB) (Other Identifier: Agence Nationale de Sécurité du Médicament (ANSM))
  • N° Eudamed: CIV-25-01-050834 (Other Identifier: Agence Nationale de Sécurité du Médicament (ANSM))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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