Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06867705
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1458}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Experience from patients', 'timeFrame': '12 months', 'description': 'Patient experience and usability of the RPM system survey (Patient-Reported Experience Measures PREMs)'}, {'measure': 'Experience from HCP', 'timeFrame': '12 months', 'description': 'Healthcare Professionals Experience survey.'}], 'primaryOutcomes': [{'measure': 'Health-Related quality of life', 'timeFrame': '3 months', 'description': 'EORTC QLQ-C30'}], 'secondaryOutcomes': [{'measure': 'Health-economic evaluation', 'timeFrame': '12 months', 'description': 'The outcome is measured in QALYs. These are calculated from the EQ-5D-5L questionnaire scores.'}, {'measure': 'Overall survival', 'timeFrame': '36 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remote Patient Monitoring', 'Remote Symptom Monitoring', 'Digital medicine', 'Resilience PRO', 'Resilience', 'PRO', 'Patient-reported Outcomes'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ec.europa.eu/tools/eudamed/#/screen/search-device/4295460b-cbc2-49a2-8f50-cb1d9dbf2453', 'label': 'EUDAMED - European Database on Medical Devices'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question it aims to answer is:\n\n\\- 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.\n\nParticipants 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.', 'detailedDescription': '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).\n\nResilience 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:\n\n* Step 1. Collection of ePRO\n* Step 2. Intelligent analysis and alerts\n* Step 3. Adapted care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Adults ≥ 18 years.\n* Informed Consent: Patient giving signed informed consent to participate in the RC - 102 clinical study.\n* Diagnosis: Patients with cancer at any stage.\n* Systemic Treatment\n* Remote Monitoring Eligibility: Access to a smartphone\n* Language: Ability to understand and communicate in the language(s) in which the trial is conducted.\n\nExclusion Criteria:\n\n* Age: Patients under 18 years of age.\n* Life Expectancy: Patients with a life expectancy of less than 6 months as estimated by the treating physician.\n* Concurrent remote monitoring\n* HSCT or CAR-T Therapy\n* Cognitive Impairment\n* Pregnancy or breastfeeding\n* Subject under administrative or judicial control'}, 'identificationModule': {'nctId': 'NCT06867705', 'acronym': 'RC-102', 'briefTitle': 'Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only', 'organization': {'class': 'INDUSTRY', 'fullName': 'Resilience'}, 'officialTitle': 'Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)', 'orgStudyIdInfo': {'id': 'RC-102'}, 'secondaryIdInfos': [{'id': '2024-A01584-43 (ID RCB)', 'type': 'OTHER', 'domain': 'Agence Nationale de Sécurité du Médicament (ANSM)'}, {'id': 'N° Eudamed: CIV-25-01-050834', 'type': 'OTHER', 'domain': 'Agence Nationale de Sécurité du Médicament (ANSM)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Symptoms Monitoring with Resilience PRO', 'description': 'Resilience PRO will be added on top of conventional care', 'interventionNames': ['Device: Resilience PRO']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care without Remote Symptoms Monitoring', 'description': 'Conventional care only'}], 'interventions': [{'name': 'Resilience PRO', 'type': 'DEVICE', 'description': 'The patient will use Resilience PRO remote symptoms monitoring.', 'armGroupLabels': ['Remote Symptoms Monitoring with Resilience PRO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13080', 'city': 'Aix-en-Provence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Salima DELLYS', 'role': 'CONTACT', 'email': 's.dellys@hpp13.com', 'phone': '+33.(0)4.84.49.60.43'}], 'facility': 'Hôpital Privé de Provence', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '13100', 'city': 'Aix-en-Provence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabila Akkache', 'role': 'CONTACT', 'email': 'nakkache@ch-aix.fr', 'phone': '+33.(0)4.42.33.50.46'}], 'facility': "Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '15000', 'city': 'Aurillac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Manon MONCET', 'role': 'CONTACT', 'email': 'm.moncet@ch-aurillac.fr', 'phone': '+33 (0)4 71 46 56 00'}], 'facility': 'Centre Hospitalier Henri Mondor-Aurillac', 'geoPoint': {'lat': 44.92539, 'lon': 2.43983}}, {'zip': '64100', 'city': 'Bayonne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle Vignes', 'role': 'CONTACT', 'email': 'evignes@ch-cotebasque.fr', 'phone': '+33.(0)5.59.44.37.62'}], 'facility': 'Centre Hospitalier de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '14033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Justine Lecache', 'role': 'CONTACT', 'email': 'lecache-j@chu-caen.fr', 'phone': '+33.(0)2.31.06.20.10'}], 'facility': 'Centre Hospitalier Universitaire de Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Céline Bonhomme', 'role': 'CONTACT', 'email': 'cbonhomme@chu-clermontferrand.fr', 'phone': '+33.(0)4.73.75.00.74'}], 'facility': 'Centre Hospitalier Universitaire de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38700', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amandine Ramond', 'role': 'CONTACT', 'email': 'aramond@chu-grenoble.fr', 'phone': '+33.(0)4.76.76.57.55'}], 'facility': 'Centre Hospitalier Universitaire Grenoble - Alpes', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine CUNISSE', 'role': 'CONTACT', 'email': 'Cunisse.Catherine@ghicl.net', 'phone': '+33.(0)3.20.87.45.32'}], 'facility': 'GHICL Hôpital Saint Vincent de Paul', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jeremy DRUGEON', 'role': 'CONTACT', 'email': 'Jeremy.DRUGEON@chu-lille.fr', 'phone': '+33.(0)3.20.44.54.61'}], 'facility': 'Centre Hospitalier Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gaëlle Le Guludec', 'role': 'CONTACT', 'email': 'gaelle.leguludec@ramsaysante.fr', 'phone': '+33 (0)4 37 53 87 26'}], 'facility': 'Hôpital Privé Jean Mermoz - Institut de Cancérologie', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie Moureau', 'role': 'CONTACT', 'email': 'nathalie.moureau@ap-hm.fr', 'phone': '+33 (0)4 91 38 73 77'}], 'facility': 'AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Celine LEREBOURG', 'role': 'CONTACT', 'email': 'celine.lerebourg@chu-nantes.fr', 'phone': '+33.(0)2.40.16.59.30'}], 'facility': 'Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44200', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emma CADET', 'role': 'CONTACT', 'email': 'ECADET@vivalto-sante.com', 'phone': '+33 (0) 02 28 25 56 87'}], 'facility': 'Hôpital Privé du Confluent', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Enora Valle', 'role': 'CONTACT', 'email': 'enora.valle@hospigrandouest.fr', 'phone': '+33 (0)4 92 03 82 80'}], 'facility': 'Centre Hospitalier Universitaire de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Shanice Roriz', 'role': 'CONTACT', 'email': 'shanice.roriz@chu-nimes.fr', 'phone': '+33 (0)4 66 68 33 01'}], 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': "Direction de la Recherche Clinique et de l'Innovation", 'role': 'CONTACT', 'email': 'promotion-externe-industrielle.drc@aphp.fr', 'phone': '+33 (0)1 42 16 03 81'}], 'facility': 'AP-HP Hôpitaux Universitaires La Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '29000', 'city': 'Quimper', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine Mas', 'role': 'CONTACT', 'email': 'karine.mas@hospigrandouest.fr', 'phone': '+33 (0)2 57 23 05 68'}], 'facility': 'Clinique Mutualiste Bretagne Occidentale', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '42100', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandy MESSAOUDENE', 'role': 'CONTACT', 'email': 'sandy.messaoudene@ramsaysante.fr', 'phone': '+33 (0)4 77 42 29 51'}], 'facility': 'Hôpital Privé de la Loire (HPL) - Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '44606', 'city': 'Saint-Nazaire', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Enora Valle', 'role': 'CONTACT', 'email': 'enora.valle@hospigrandouest.fr', 'phone': '+33.(0)2.72.27.53.34'}], 'facility': "Clinique Mutualiste de l'Estuaire", 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '97448', 'city': 'Saint-Pierre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sara MIKOLASEK', 'role': 'CONTACT', 'email': 'sara.mikolasek@chu-reunion.fr', 'phone': '+262 (0)2 62 35 90 00'}], 'facility': 'Centre Hospitalier Universitaire Sud Réunion', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '16800', 'city': 'Soyaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corine Bustreau', 'role': 'CONTACT', 'email': 'corine.bustreau@elsan.care', 'phone': '+33 (0)5 45 69 68 32'}], 'facility': 'Centre Clinical Elsan', 'geoPoint': {'lat': 45.64052, 'lon': 0.19752}}, {'zip': '83056', 'city': 'Toulon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charline Genin', 'role': 'CONTACT', 'email': 'charline.genin@ch-toulon.fr', 'phone': '+33.(0)4.94.14.52.90'}], 'facility': 'Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '31076', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Bringer', 'role': 'CONTACT', 'email': 'sbringer@groupeorion.fr', 'phone': '+33.(0)5.67.20.44.01'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '59300', 'city': 'Valenciennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie Vermoesen', 'role': 'CONTACT', 'email': 'svermoesen@lesdentellieres.com', 'phone': '+33.(0)3.66.22.70.54'}], 'facility': 'Centre de Cancérologie Les Dentellières', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '59300', 'city': 'Valenciennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marielle Fery', 'role': 'CONTACT', 'email': 'mfery@ahnac.com', 'phone': '+33 (0)3 27 14 24 34'}], 'facility': 'Clinique Teissier', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabrina Ikene', 'role': 'CONTACT', 'email': 'Sabrina.IKENE@gustaveroussy.fr', 'phone': '+33.(0)1.42.11.40.53'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '24105', 'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Emilia Prieß', 'role': 'CONTACT', 'email': 'Emilia.Priess@uksh.de', 'phone': '+49 (0) 451 500 -44355'}], 'facility': 'Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '23538', 'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Emilia Prieß', 'role': 'CONTACT', 'email': 'Emilia.Priess@uksh.de', 'phone': '+49 (0) 451 500 -44355'}], 'facility': 'Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'centralContacts': [{'name': 'Resilience', 'role': 'CONTACT', 'email': 'support@resilience.care', 'phone': '+33 805 69 65 61'}], 'overallOfficials': [{'name': 'Florian Scotté, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Resilience', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UNICANCER', 'class': 'OTHER'}, {'name': 'Sanoia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}