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Trial Title:
Improving Care Pathway Using Simplified Digital Tools for Oncology Patients: a Multicenter "Before-and-after" Study
NCT ID:
NCT05968027
Condition:
Oncology
Adverse Event
Numeric Application
Care Telemonitoring
Compliance, Treatment
Patient Reported Outcome (PRO)
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Nouveal numeric application "Onco'nect"
Description:
A remote monitoring application, Onco'nect® (smartphone /tablet /PC), in partnership with
the company Nouveal facilitates communication between patients undergoing Intra Vascular
(IV) chemotherapy and the care team. A questionnaire before and after each session can be
used to alert the oncology department and adapt patient management.
Arm group label:
Onco'nect post-deployment
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 (I.V.) chemotherapy
or oral anti-cancer treatments.
The preliminary study on the use of the digital solution Onco'nect 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, Onco'nect was deployed to all institution's
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 Onco'nect 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 Onco'nect 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
- Onco'nect pre-deployment (12 months): period covering the year prior to the actual
implementation of the solution in each centre; patients receiving I.V. chemotherapy
during the first 6 months of the period will be included, in order to assess
follow-up at 6 months.
- Onco'nect deployment: this period corresponds to the implementation of the solution
in the centre's 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 I.V. chemotherapy during the first 6 months of the
period will be included, in order to be able to evaluate the 6-month follow-up.
Criteria for eligibility:
Study pop:
Patients treated with IV chemotherapy and monitored in the medical oncology departments
of participating centres (AP-HP): CHU Henri Mondor Créteil (HMN), CHU Pitié Salpêtrière
Paris (PSL), CHU Bichat Paris (BCT), CHU Saint Antoine (SAT) and CHU Georges Pompidou
(HEGP).
Sampling method:
Probability Sample
Criteria:
Inclusion criteria
- Age >=18 years
- Initiation of I.V. chemotherapy for solid cancer of any location or metastatic
status:
- Either over a period of 12 months before Onco'nect is deployed, covering the year
preceding the actual implementation of the solution in each centre.
- Or over a period of 12 months post-deployment of Onco'nect, covering the year
following the implementation of the solution within the centre.
- Non-opposition to the study and to the processing of their medical data.
Exclusion criteria
- Any known difficulty in understanding or reading French that might invalidate the
relevance of applying questionnaires
- Known cognitive or psychiatric disorder preventing the protocol from being carried
out
- Patient under legal protection
- Patient included in the article 51 programme
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Start date:
January 2, 2024
Completion date:
July 2, 2025
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
Nouveal
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05968027
