Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
RC-102
Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)
3 other identifiers
interventional
1,458
2 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started Apr 2025
Typical duration for phase_3 cancer
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
August 1, 2025
July 1, 2025
1.8 years
February 21, 2025
July 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-Related quality of life
EORTC QLQ-C30
3 months
Secondary Outcomes (2)
Health-economic evaluation
12 months
Overall survival
36 months
Other Outcomes (2)
Experience from patients
12 months
Experience from HCP
12 months
Study Arms (2)
Remote Symptoms Monitoring with Resilience PRO
EXPERIMENTALResilience PRO will be added on top of conventional care
Usual care without Remote Symptoms Monitoring
NO INTERVENTIONConventional care only
Interventions
The patient will use Resilience PRO remote symptoms monitoring.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Resiliencelead
- UNICANCERcollaborator
- Sanoiacollaborator
Study Sites (28)
Hôpital Privé de Provence
Aix-en-Provence, 13080, France
Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, 13100, France
Centre Hospitalier Henri Mondor-Aurillac
Aurillac, 15000, France
Centre Hospitalier de la Côte Basque
Bayonne, 64100, France
Centre Hospitalier Universitaire de Caen Normandie
Caen, 14033, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63003, France
Centre Hospitalier Universitaire Grenoble - Alpes
La Tronche, 38700, France
GHICL Hôpital Saint Vincent de Paul
Lille, 59000, France
Centre Hospitalier Universitaire de Lille
Lille, 59037, France
Hôpital Privé Jean Mermoz - Institut de Cancérologie
Lyon, 69008, France
AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone
Marseille, 13005, France
Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
Hôpital Privé du Confluent
Nantes, 44200, France
Centre Hospitalier Universitaire de Nice
Nice, 06000, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029, France
AP-HP Hôpitaux Universitaires La Pitié Salpêtrière
Paris, 75013, France
Clinique Mutualiste Bretagne Occidentale
Quimper, 29000, France
Hôpital Privé de la Loire (HPL) - Saint Etienne
Saint-Etienne, 42100, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606, France
Centre Hospitalier Universitaire Sud Réunion
Saint-Pierre, 97448, France
Centre Clinical Elsan
Soyaux, 16800, France
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, 83056, France
Clinique Pasteur
Toulouse, 31076, France
Centre de Cancérologie Les Dentellières
Valenciennes, 59300, France
Clinique Teissier
Valenciennes, 59300, France
Gustave Roussy
Villejuif, 94805, France
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel
Kiel, 24105, Germany
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
Lübeck, 23538, Germany
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Florian Scotté, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
March 10, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
August 1, 2025
Record last verified: 2025-07