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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms
• Intervention / Treatment: Device: CONTINUUM+ CONNECT remote 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.

• Study Type: Interventional
• Enrollment (Actual): 411
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84918
    • Sainte-Catherine, Institut du Cancer Avignon-Provence
  • Blois, France, 41260
    • Polyclinique de Blois
  • Clermont-Ferrand, France, 63000
    • Pôle Santé République
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc
  • Limoges, France, 87042
    • Chu Dupuytren
  • Morlaix, France, 29600
    • Centre Hospitalier de Morlaix
  • Nancy, France, 54100
    • Centre d'oncologie de Gentilly
  • Plérin, France, 22190
    • Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA
  • Reims, France, 51100
    • Institut Jean Godinot
  • Saint-Priest-en-Jarez, France, 42270
    • Chu de Saint-Etienne
  • Strasbourg, France, 67091
    • Hopitaux universitaires de Strasbourg
  • Strasbourg, France, 67033
    • Centre Paul Strauss
  • De
    • Vandœuvre-lès-Nancy, De, France, 54519
      • Institut de Cancerologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients using CONTINUUM+ CONNECT remote monitoring solution	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.
No Intervention: Patients with conventional follow-up without remote monitoring application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Paul Strauss
• Collaborators: Continuum Plus Santé; Plateforme nationale qualité de vie et cancer; WeShare
• Investigators: Study Chair: Philippe BARTHELEMY, MD, Hopitaux universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Actual): November 7, 2025
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic cancer; Remote patient monitoring
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Neoplastic Processes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: 2023-031; 2024-A00120-47 (Other Identifier: ID-RCB Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No