Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05968027
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-07-21
Brief Title:
Improving Care Pathway Using Simplified Digital Tools for Oncology Patients a Multicenter Before-and-after Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Improving Care Pathway Using Simplified Digital Tools for Oncology Patients a Multicenter Before-and-after Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
ONCONECTSAFE
Brief Summary:
Developments in the healthcare sector in general and in oncology in particular mean that patients are increasingly autonomous Outpatient treatment raises the issue of home monitoring One of the solutions proposed by the 2014-2019 Cancer Plan is the development of telemedicine Several programmes have been set up in the medical oncology department at Hôpital Mondor to make patient care more secure and improve the management of undesirable effects of treatment for patients undergoing intravenous IV chemotherapy or oral anti-cancer treatments
The preliminary study on the use of the digital solution Onconect demonstrated the feasibility of using a dematerialised tool for real-time monitoring and management of chemotherapy-induced adverse events in cancer patients undergoing outpatient treatment The tool was used to help AP-HP institution deal with the crisis linked to the COVID epidemic Once it had been configured Onconect was deployed to all institutions hospital groups to ensure that infected patients could remain at home and that patients hospitalised with symptomatic COVID infection could return home
Hypothesis The digital solution Onconect would improve patient compliance and could reduce the occurrence and improve the management of unexpected adverse events
Primary objective
In terms of clinical evaluation the primary objective is to assess the effect of using the Onconect solution for ambulatory oncology follow-up on reducing the rate of occurrence at 6 months follow-up of unexpected and unwanted chemo-induced adverse events
The solution is already on the market and has been integrated or is in the process of being integrated into the care systems of the participating AP-HP establishments The aim of the project is to evaluate its use in routine care and measure the occurrence and management of unexpected and unwanted chemo-induced adverse events in outpatients treated for cancer
This observational study of care pathway using retrospective data aims to include 480 patients in a 18 months period
Three periods of interest will be considered in this before-and-after study
Onconect pre-deployment 12 months period covering the year prior to the actual implementation of the solution in each centre patients receiving IV chemotherapy during the first 6 months of the period will be included in order to assess follow-up at 6 months
Onconect deployment this period corresponds to the implementation of the solution in the centres care pathway Deployment includes interoperability with other operating systems and setting up the collection interfaces for the user
Post-deployment 12 months period covering the year following the implementation of the solution within the centre installation interoperability and configuration validated patients receiving IV chemotherapy during the first 6 months of the period will be included in order to be able to evaluate the 6-month follow-up
The preliminary study on the use of the digital solution Onconect demonstrated the feasibility of using a dematerialised tool for real-time monitoring and management of chemotherapy-induced adverse events in cancer patients undergoing outpatient treatment The tool was used to help AP-HP institution deal with the crisis linked to the COVID epidemic Once it had been configured Onconect was deployed to all institutions hospital groups to ensure that infected patients could remain at home and that patients hospitalised with symptomatic COVID infection could return home
Hypothesis The digital solution Onconect would improve patient compliance and could reduce the occurrence and improve the management of unexpected adverse events
Primary objective
In terms of clinical evaluation the primary objective is to assess the effect of using the Onconect solution for ambulatory oncology follow-up on reducing the rate of occurrence at 6 months follow-up of unexpected and unwanted chemo-induced adverse events
The solution is already on the market and has been integrated or is in the process of being integrated into the care systems of the participating AP-HP establishments The aim of the project is to evaluate its use in routine care and measure the occurrence and management of unexpected and unwanted chemo-induced adverse events in outpatients treated for cancer
This observational study of care pathway using retrospective data aims to include 480 patients in a 18 months period
Three periods of interest will be considered in this before-and-after study
Onconect pre-deployment 12 months period covering the year prior to the actual implementation of the solution in each centre patients receiving IV chemotherapy during the first 6 months of the period will be included in order to assess follow-up at 6 months
Onconect deployment this period corresponds to the implementation of the solution in the centres care pathway Deployment includes interoperability with other operating systems and setting up the collection interfaces for the user
Post-deployment 12 months period covering the year following the implementation of the solution within the centre installation interoperability and configuration validated patients receiving IV chemotherapy during the first 6 months of the period will be included in order to be able to evaluate the 6-month follow-up
Detailed Description:
None
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