Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379880
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-11
Brief Title:
Impact on Quality of Life and Health of the CONTINUUM CONNECT Remote Monitoring Solution
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Institut de cancérologie Strasbourg Europe
Study Overview
Official Title:
Impact on Quality of Life and Health of the CONTINUUM CONNECT Remote Monitoring Solution Prospective Randomized Multicenter Trial FEGALA
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEGALA
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00120-47 | OTHER | ID-RCB Number | None |