nctId: NCT06379880 id: 2023-031 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 overallStatus: RECRUITING date: 2024-04-25 date: 2024-11-25 date: 2025-02-25 date: 2024-04-23 date: 2024-04-29 name: Institut de cancérologie Strasbourg Europe class: OTHER name: Continuum Plus Santé name: Plateforme nationale qualité de vie et cancer name: WeShare 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. conditions: Prostatic Neoplasms conditions: Lung Neoplasms conditions: Breast Neoplasms conditions: Colorectal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 506 type: ESTIMATED name: CONTINUUM+ CONNECT remote monitoring 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 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 measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months) measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months) measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group measure: Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion measure: Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion measure: Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning measure: Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sainte-Catherine, Institut du Cancer Avignon-Provence status: NOT_YET_RECRUITING city: Avignon zip: 84918 country: France name: Julien GRENIER, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: Polyclinique de Blois status: NOT_YET_RECRUITING city: Blois zip: 41260 country: France name: Yann MOTTAZ, MD role: CONTACT name: Yann MOTTAZ, Md role: PRINCIPAL_INVESTIGATOR lat: 47.58333 lon: 1.33333 facility: Pôle Santé République status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Pierre DALLOZ, MD role: CONTACT name: Pierre DALLOZ, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: centre Georges François Leclerc status: NOT_YET_RECRUITING city: Dijon zip: 21079 country: France name: Leila BENGRINE, MD role: CONTACT name: Leila BENGRINE, MD role: PRINCIPAL_INVESTIGATOR lat: 47.31667 lon: 5.01667 facility: Chu Dupuytren status: NOT_YET_RECRUITING city: Limoges zip: 87042 country: France name: Tiffany DARBAS, MD role: CONTACT name: Tiffany DARBAS, MD role: PRINCIPAL_INVESTIGATOR lat: 45.83153 lon: 1.25781 facility: Centre d'oncologie de Gentilly status: RECRUITING city: Nancy zip: 54100 country: France name: Laurene GAVOILLE, MD role: CONTACT name: Laurene GAVOILLE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA status: NOT_YET_RECRUITING city: Plérin zip: 22190 country: France name: Jérôme MARTIN-BABAU, MD role: CONTACT name: Jérôme MARTIN-BABAU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.54249 lon: -2.77983 facility: Institut Jean Godinot status: RECRUITING city: Reims zip: 51100 country: France name: Christelle JOUANNAUD, MD role: CONTACT name: Christelle JOUANNAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 49.25 lon: 4.03333 facility: CHU de Saint-Etienne status: NOT_YET_RECRUITING city: Saint-Priest-en-Jarez zip: 42270 country: France name: Pierre CORNILLON, MD role: CONTACT name: Pierre CORNILLON, MD role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 facility: Institut de cancérologie Strasbourg Europe status: RECRUITING city: Strasbourg zip: 67033 country: France name: Manon VOEGELIN role: CONTACT name: Philippe BARTHELEMY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Hôpitaux Universitaires de Strasbourg status: NOT_YET_RECRUITING city: Strasbourg zip: 67091 country: France name: Bertrand MENNECIER, MD role: CONTACT name: Bertrand MENNECIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False