protocolSection identificationModule nctId: NCT06379880, orgStudyIdInfo id: 2023-031, secondaryIdInfos id: 2024-A00120-47, type: OTHER, domain: ID-RCB Number, briefTitle: Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution, acronym: FEGALA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2025-02-25, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Institut de cancérologie Strasbourg Europe, class: OTHER, collaborators name: Continuum Plus Santé, collaborators name: Plateforme nationale qualité de vie et cancer, collaborators name: WeShare, descriptionModule briefSummary: FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring., conditionsModule conditions: Prostatic Neoplasms, conditions: Lung Neoplasms, conditions: Breast Neoplasms, conditions: Colorectal Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 506, type: ESTIMATED, armsInterventionsModule interventions name: CONTINUUM+ CONNECT remote monitoring, outcomesModule primaryOutcomes measure: Effect of the CONTINUUM+ CONNECT solution on the results in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings who did not require assistance in self-assessment, secondaryOutcomes measure: Effect of CONTINUUM+ CONNECT solution on the results at 3 months (± 15 days) post-inclusion in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings, secondaryOutcomes measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months), secondaryOutcomes measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months), secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group, secondaryOutcomes measure: Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion, secondaryOutcomes measure: Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion, secondaryOutcomes measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion, secondaryOutcomes measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion, secondaryOutcomes measure: Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning, secondaryOutcomes measure: Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sainte-Catherine, Institut du Cancer Avignon-Provence, status: NOT_YET_RECRUITING, city: Avignon, zip: 84918, country: France, contacts name: Julien GRENIER, MD, role: CONTACT, geoPoint lat: 43.94834, lon: 4.80892, locations facility: Polyclinique de Blois, status: NOT_YET_RECRUITING, city: Blois, zip: 41260, country: France, contacts name: Yann MOTTAZ, MD, role: CONTACT, contacts name: Yann MOTTAZ, Md, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.58333, lon: 1.33333, locations facility: Pôle Santé République, status: RECRUITING, city: Clermont-Ferrand, zip: 63000, country: France, contacts name: Pierre DALLOZ, MD, role: CONTACT, contacts name: Pierre DALLOZ, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: centre Georges François Leclerc, status: NOT_YET_RECRUITING, city: Dijon, zip: 21079, country: France, contacts name: Leila BENGRINE, MD, role: CONTACT, contacts name: Leila BENGRINE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Chu Dupuytren, status: NOT_YET_RECRUITING, city: Limoges, zip: 87042, country: France, contacts name: Tiffany DARBAS, MD, role: CONTACT, contacts name: Tiffany DARBAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Centre d'oncologie de Gentilly, status: RECRUITING, city: Nancy, zip: 54100, country: France, contacts name: Laurene GAVOILLE, MD, role: CONTACT, contacts name: Laurene GAVOILLE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA, status: NOT_YET_RECRUITING, city: Plérin, zip: 22190, country: France, contacts name: Jérôme MARTIN-BABAU, MD, role: CONTACT, contacts name: Jérôme MARTIN-BABAU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.54249, lon: -2.77983, locations facility: Institut Jean Godinot, status: RECRUITING, city: Reims, zip: 51100, country: France, contacts name: Christelle JOUANNAUD, MD, role: CONTACT, contacts name: Christelle JOUANNAUD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.25, lon: 4.03333, locations facility: CHU de Saint-Etienne, status: NOT_YET_RECRUITING, city: Saint-Priest-en-Jarez, zip: 42270, country: France, contacts name: Pierre CORNILLON, MD, role: CONTACT, contacts name: Pierre CORNILLON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.47501, lon: 4.37614, locations facility: Institut de cancérologie Strasbourg Europe, status: RECRUITING, city: Strasbourg, zip: 67033, country: France, contacts name: Manon VOEGELIN, role: CONTACT, contacts name: Philippe BARTHELEMY, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Hôpitaux Universitaires de Strasbourg, status: NOT_YET_RECRUITING, city: Strasbourg, zip: 67091, country: France, contacts name: Bertrand MENNECIER, MD, role: CONTACT, contacts name: Bertrand MENNECIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False