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

February 2, 2026 updated by: Centre Paul Strauss

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
411

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Avignon, France, 84918
        • Sainte-Catherine, Institut du Cancer Avignon-Provence
      • Blois, France, 41260
        • Polyclinique De Blois
      • Clermont-Ferrand, France, 63000
        • Pole Santé République
      • Dijon, France, 21079
        • Centre Georges François 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: At 3 months (± 15 days) post-inclusion
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: At 3 months (± 15 days) post-inclusion
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)
Time Frame: At 3 months (± 15 days) post-inclusion
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)
Time Frame: At 6 months (± 15 days) post-inclusion
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
Time Frame: At 3 months (± 15 days) post-inclusion
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
Time Frame: At 3 months (± 15 days) post-inclusion
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
Time Frame: At 3 months (± 15 days) post-inclusion
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
Time Frame: At 3 months (± 15 days) post-inclusion
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
Time Frame: At 6 months (± 15 days) post-inclusion
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
Time Frame: At 6 months (± 15 days) post-inclusion
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
Time Frame: At 6 months (± 15 days) post-inclusion
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
Time Frame: At 6 months (± 15 days) post-inclusion
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
Time Frame: At 3 months (± 15 days) 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
Time Frame: At 6 months (± 15 days) 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
Time Frame: At 3 months (± 15 days) post-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
Time Frame: At 6 months (± 15 days) post-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
Time Frame: Through out the study, up to 10 months. At least once per professional
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
Time Frame: At 3 months (± 15 days) post-inclusion
Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution
At 3 months (± 15 days) post-inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Paul Strauss

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Continuum Plus Santé
Plateforme nationale qualité de vie et cancer
WeShare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Philippe BARTHELEMY, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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