Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution

Breast Neoplasms Clinical Trial

— FEGALA  

Official title:

Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379880
• Other study ID #: 2023-031
• Secondary ID: 2024-A00120-47
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: February 25, 2025

Study information

• Verified date: April 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Manon VOEGELIN
• Phone: (0)3 68 33 95 23
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 506
• Est. completion date: February 25, 2025
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Lung Neoplasms
• Neoplasms
• Prostatic Neoplasms

Intervention

Device:
• CONTINUUM+ 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.

Locations

Country	Name	City	State
France	Sainte-Catherine, Institut du Cancer Avignon-Provence	Avignon
France	Polyclinique de Blois	Blois
France	Pôle Santé République	Clermont-Ferrand
France	centre Georges François Leclerc	Dijon
France	Chu Dupuytren	Limoges
France	Centre d'oncologie de Gentilly	Nancy
France	Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA	Plérin
France	Institut Jean Godinot	Reims
France	CHU de Saint-Etienne	Saint-Priest-en-Jarez
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (4)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	Continuum Plus Santé, Plateforme nationale qualité de vie et cancer, WeShare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group	At 3 months (± 15 days) post-inclusion
Secondary	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	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)	At 3 months (± 15 days) post-inclusion
Secondary	Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months)	Difference according to intervention group regarding all dimensions of EORTC QLQ-C30 questionnaires	At 3 months (± 15 days) post-inclusion
Secondary	Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months)	Difference according to intervention group regarding all dimensions of EORTC QLQ-C30 questionnaires	At 6 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group	Difference on specific symptom scales QLQ-BR23	At 3 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group	Difference on specific symptom scales QLQ-LC13	At 3 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group	Difference on specific symptom scales QLQ-PR25	At 3 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group	Difference on specific symptom scales QLQ-CR29	At 3 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group	Difference on specific symptom scales QLQ-BR23	At 6 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group	Difference on specific symptom scales QLQ-LC13	At 6 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group	Difference on specific symptom scales QLQ-PR25	At 6 months (± 15 days) post-inclusion
Secondary	Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group	Difference on specific symptom scales QLQ-CR29	At 6 months (± 15 days) post-inclusion
Secondary	Frequency of grade 3 - 4 adverse events present at 3 months 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.	At 3 months (± 15 days) post-inclusion
Secondary	Frequency of grade 3 - 4 adverse events present at 6 months 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.	At 6 months (± 15 days) post-inclusion
Secondary	Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following 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	At 3 months (± 15 days) post-inclusion
Secondary	Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following 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	At 6 months (± 15 days) post-inclusion
Secondary	Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning	Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution	Through out the study, up to 10 months. At least once per professional
Secondary	Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning	Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution	At 3 months (± 15 days) post-inclusion