RecruitingPhase 3NCT06867705

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

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


Sponsor

Resilience

Enrollment

1,458 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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Interventions

DEVICEResilience PRO

The patient will use Resilience PRO remote symptoms monitoring.


Locations(36)

Hôpital Privé de Provence

Aix-en-Provence, France

Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis

Aix-en-Provence, France

Centre Hospitalier Henri Mondor-Aurillac

Aurillac, France

Centre Hospitalier de la Côte Basque

Bayonne, France

Centre Hospitalier Universitaire de Caen Normandie

Caen, France

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

Centre Hospitalier Universitaire Grenoble - Alpes

La Tronche, France

GHICL Hôpital Saint Vincent de Paul

Lille, France

Centre Hospitalier Universitaire de Lille

Lille, France

Hôpital Privé Jean Mermoz - Institut de Cancérologie

Lyon, France

AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone

Marseille, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

Hôpital Privé du Confluent

Nantes, France

Centre Hospitalier Universitaire de Nice

Nice, France

Centre Hospitalier Universitaire de Nîmes

Nîmes, France

AP-HP Hôpitaux Universitaires La Pitié Salpêtrière

Paris, France

Clinique Mutualiste Bretagne Occidentale

Quimper, France

Hôpital Privé de la Loire (HPL) - Saint Etienne

Saint-Etienne, France

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

Centre Hospitalier Universitaire Sud Réunion

Saint-Pierre, France

Centre Clinical Elsan

Soyaux, France

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, France

Clinique Pasteur

Toulouse, France

Centre de Cancérologie Les Dentellières

Valenciennes, France

Clinique Teissier

Valenciennes, France

Gustave Roussy

Villejuif, France

University Hospital Augsburg - UKA

Augsburg, Germany

Helios Klinikum Bad Saarow

Bad Saarow, Germany

Katholisches Klinikum Bochum UK St. Josef - Hospital

Bochum, Germany

UK Hamburg- Eppendorf (UKE)

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

MVZ Aschaffenburg-Alzenau

Hösbach, Germany

Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel

Kiel, Germany

Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck

Lübeck, Germany

Onkomedeor MVZ Perlach

München, Germany

Universitätsklinikum Tuebingen

Tübingen, Germany

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NCT06867705


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