Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms
Conditions
Keywords
Remote patient monitoring, Metastatic cancer
Brief summary
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.
Detailed description
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.
Interventions
DEVICECONTINUUM+ CONNECT remote monitoring
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.
Sponsors
Centre Paul Strauss
Continuum Plus Santé
Plateforme nationale qualité de vie et cancer
WeShare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients aged ≥ 18 years with a solid tumor (only breast, lung, colorectal, prostate cancer) at the metastatic stage followed on an outpatient basis; 2. Patients initiating oral and/or injectable anticancer treatment, whatever the line of treatment, administered on an outpatient basis including day hospitalization; 3. Patients who have given their written, free and informed consent; 4. Patients with life expectancy of more than 3 months; 5. Patients able to complete questionnaires according to the investigator's judgment, and to use the CONTINUUM+ CONNECT electronic application either alone or accompanied by a professional (home nurse); 6. Patients affiliated to a social security scheme or beneficiaries of such a scheme.
Exclusion criteria
1. Patients receiving home hospitalization care or being hospitalized at the time of treatment initiation; 2. Patients receiving concomitant radiotherapy; 3. Patients using another remote monitoring application; 4. Patients enrolled in another clinical trial; 5. Patients protected by law.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At 3 months (± 15 days) post-inclusion | Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At 3 months (± 15 days) post-inclusion | 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) |
| Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months) | At 3 months (± 15 days) post-inclusion | Difference according to intervention group regarding all dimensions of EORTC QLQ-C30 questionnaires |
| Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months) | At 6 months (± 15 days) post-inclusion | Difference according to intervention group regarding all dimensions of EORTC QLQ-C30 questionnaires |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group | At 3 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-BR23 |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group | At 3 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-LC13 |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group | At 3 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-PR25 |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group | At 3 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-CR29 |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group | At 6 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-BR23 |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group | At 6 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-LC13 |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group | At 6 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-PR25 |
| Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group | At 6 months (± 15 days) post-inclusion | Difference on specific symptom scales QLQ-CR29 |
| Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion | At 3 months (± 15 days) 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. |
| Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion | At 6 months (± 15 days) 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. |
| Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion | At 3 months (± 15 days) post-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 |
| Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion | At 6 months (± 15 days) post-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 |
| Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning | Through out the study, up to 10 months. At least once per professional | Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution |
| Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning | At 3 months (± 15 days) post-inclusion | Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution |
Countries
France
Contacts
STUDY_CHAIRPhilippe BARTHELEMY, MD
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed