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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00120-47 | Other Identifier | ID-RCB Number |
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| Name | Class |
|---|---|
| Continuum Plus Santé | UNKNOWN |
| Plateforme nationale qualité de vie et cancer | UNKNOWN |
| WeShare | UNKNOWN |
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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.
CONTINUUM+ CONNECT is a platform, accessible from a computer, a smartphone or a tablet, allowing remote monitoring of cancer patients followed on an outpatient basis. The remotely monitored patient is invited to answer questionnaires (regarding adverse events, physiological constants and pain) at home. These questionnaires are either completed by the patient himself, if his condition allows it (self-assessment) or completed with the help of a professional on an outpatient basis (hetero-assessment). The data and alerts are transmitted in real time to the healthcare professionals in charge of the patient who analyze them and then determine the course of action to take.
In order to evaluate the impact of remote monitoring by CONTINUUM+ CONNECT on the quality of life and health of patients with metastatic cancer, the present prospective randomized multicenter study will be carried out.
Four main types of cancer will be studied: Breast, Lung, Colorectal and Prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients using CONTINUUM+ CONNECT remote monitoring solution | Experimental |
| |
| Patients with conventional follow-up without remote monitoring application. | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONTINUUM+ CONNECT remote monitoring | Device | CONTINUUM+ CONNECT is a web platform, accessible via the internet, which contains the digital medical device (DMN) Continuum+ alert module. This is a medical software intended for the interpretation of clinical constants, symptoms, adverse events and pain, generating alerts with a view to improving the monitoring of patients undergoing anticancer treatment. The "Continuum+ Alert Module" version 1.0.0 dated 30 April 2021 is CE-marked and will be used in accordance with the manufacturer's instructions for use by patients in the experimental group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group | At 3 months (± 15 days) post-inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group (patients using CONTINUUM+ CONNECT solution (hetero- and self-assessment) or with conventional care) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe BARTHELEMY, MD | Hôpitaux Universitaires de Strasbourg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | De | 54519 | France | ||
| Sainte-Catherine, Institut du Cancer Avignon-Provence |
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| At 3 months (± 15 days) post-inclusion |
| Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months) | Difference according to intervention group regarding all dimensions of EORTC QLQ-C30 questionnaires | At 3 months (± 15 days) post-inclusion |
| Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months) | Difference according to intervention group regarding all dimensions of EORTC QLQ-C30 questionnaires | At 6 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group | Difference on specific symptom scales QLQ-BR23 | At 3 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group | Difference on specific symptom scales QLQ-LC13 | At 3 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group | Difference on specific symptom scales QLQ-PR25 | At 3 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group | Difference on specific symptom scales QLQ-CR29 | At 3 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group | Difference on specific symptom scales QLQ-BR23 | At 6 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group | Difference on specific symptom scales QLQ-LC13 | At 6 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group | Difference on specific symptom scales QLQ-PR25 | At 6 months (± 15 days) post-inclusion |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group | Difference on specific symptom scales QLQ-CR29 | At 6 months (± 15 days) post-inclusion |
| Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion | Percentage of patients with at least one adverse event (graded 3 or 4 according to NCI-CTCAE V5.0) at evaluation visit at 3 months. | At 3 months (± 15 days) post-inclusion |
| Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion | Percentage of patients with at least one adverse event (graded 3 or 4 according to NCI-CTCAE V5.0) at Follow-up (FU) visit at 6 months. | At 6 months (± 15 days) post-inclusion |
| Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion | Percentage of patients that required at least one unscheduled hospitalization due to their cancer and/or treatment during the 3 months following their enrollment in the trial based on patient's medical record | At 3 months (± 15 days) post-inclusion |
| Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion | Percentage of patients that required at least one unscheduled hospitalization due to their cancer during the 6 months following their enrollment in the trial based on patient's medical record | At 6 months (± 15 days) post-inclusion |
| Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning | Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution | Through out the study, up to 10 months. At least once per professional |
| Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning | Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution | At 3 months (± 15 days) post-inclusion |
| Avignon |
| 84918 |
| France |
| Polyclinique de Blois | Blois | 41260 | France |
| Pôle Santé République | Clermont-Ferrand | 63000 | France |
| centre Georges François Leclerc | Dijon | 21079 | France |
| Chu Dupuytren | Limoges | 87042 | France |
| Centre Hospitalier de Morlaix | Morlaix | 29600 | France |
| Centre d'oncologie de Gentilly | Nancy | 54100 | France |
| Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA | Plérin | 22190 | France |
| Institut Jean Godinot | Reims | 51100 | France |
| CHU de Saint-Etienne | Saint-Priest-en-Jarez | 42270 | France |
| Centre Paul Strauss | Strasbourg | 67033 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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