Trial Title:
Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution
NCT ID:
NCT06379880
Condition:
Prostatic Neoplasms
Lung Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Conditions: Keywords:
Remote patient monitoring
Metastatic cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
CONTINUUM+ CONNECT remote monitoring
Description:
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.
Arm group label:
Patients using CONTINUUM+ CONNECT remote monitoring solution
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sainte-Catherine, Institut du Cancer Avignon-Provence
Address:
City:
Avignon
Zip:
84918
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Julien GRENIER, MD
Facility:
Name:
Polyclinique de Blois
Address:
City:
Blois
Zip:
41260
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Yann MOTTAZ, MD
Investigator:
Last name:
Yann MOTTAZ, Md
Email:
Principal Investigator
Facility:
Name:
Pôle Santé République
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre DALLOZ, MD
Investigator:
Last name:
Pierre DALLOZ, MD
Email:
Principal Investigator
Facility:
Name:
centre Georges François Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Leila BENGRINE, MD
Investigator:
Last name:
Leila BENGRINE, MD
Email:
Principal Investigator
Facility:
Name:
Chu Dupuytren
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Tiffany DARBAS, MD
Investigator:
Last name:
Tiffany DARBAS, MD
Email:
Principal Investigator
Facility:
Name:
Centre d'oncologie de Gentilly
Address:
City:
Nancy
Zip:
54100
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurene GAVOILLE, MD
Investigator:
Last name:
Laurene GAVOILLE, MD
Email:
Principal Investigator
Facility:
Name:
Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA
Address:
City:
Plérin
Zip:
22190
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jérôme MARTIN-BABAU, MD
Investigator:
Last name:
Jérôme MARTIN-BABAU, MD
Email:
Principal Investigator
Facility:
Name:
Institut Jean Godinot
Address:
City:
Reims
Zip:
51100
Country:
France
Status:
Recruiting
Contact:
Last name:
Christelle JOUANNAUD, MD
Investigator:
Last name:
Christelle JOUANNAUD, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Saint-Etienne
Address:
City:
Saint-Priest-en-Jarez
Zip:
42270
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre CORNILLON, MD
Investigator:
Last name:
Pierre CORNILLON, MD
Email:
Principal Investigator
Facility:
Name:
Institut de cancérologie Strasbourg Europe
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Manon VOEGELIN
Investigator:
Last name:
Philippe BARTHELEMY, MD
Email:
Principal Investigator
Facility:
Name:
Hôpitaux Universitaires de Strasbourg
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Bertrand MENNECIER, MD
Investigator:
Last name:
Bertrand MENNECIER, MD
Email:
Principal Investigator
Start date:
April 25, 2024
Completion date:
February 25, 2025
Lead sponsor:
Agency:
Institut de cancérologie Strasbourg Europe
Agency class:
Other
Collaborator:
Agency:
Continuum Plus Santé
Agency class:
Other
Collaborator:
Agency:
Plateforme nationale qualité de vie et cancer
Agency class:
Other
Collaborator:
Agency:
WeShare
Agency class:
Other
Source:
Institut de cancérologie Strasbourg Europe
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06379880
