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

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 (Estimated)

506

Phase

  • 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 Locations

      • Avignon, France, 84918
        • Not yet recruiting
        • Sainte-Catherine, Institut du Cancer Avignon-Provence
        • Contact:
          • Julien GRENIER, MD
      • Blois, France, 41260
        • Not yet recruiting
        • Polyclinique De Blois
        • Contact:
          • Yann MOTTAZ, MD
        • Principal Investigator:
          • Yann MOTTAZ, Md
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Pole Santé République
        • Contact:
          • Pierre DALLOZ, MD
        • Principal Investigator:
          • Pierre DALLOZ, MD
      • Dijon, France, 21079
        • Not yet recruiting
        • Centre Georges François Leclerc
        • Principal Investigator:
          • Leila BENGRINE, MD
        • Contact:
          • Leila BENGRINE, MD
      • Limoges, France, 87042
        • Not yet recruiting
        • CHU Dupuytren
        • Contact:
          • Tiffany DARBAS, MD
        • Principal Investigator:
          • Tiffany DARBAS, MD
      • Nancy, France, 54100
        • Recruiting
        • Centre d'oncologie de Gentilly
        • Contact:
          • Laurene GAVOILLE, MD
        • Principal Investigator:
          • Laurene GAVOILLE, MD
      • Plérin, France, 22190
        • Not yet recruiting
        • Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA
        • Contact:
          • Jérôme MARTIN-BABAU, MD
        • Principal Investigator:
          • Jérôme Martin-Babau, MD
      • Reims, France, 51100
        • Recruiting
        • Institut Jean Godinot
        • Contact:
          • Christelle JOUANNAUD, MD
        • Principal Investigator:
          • Christelle JOUANNAUD, MD
      • Saint-Priest-en-Jarez, France, 42270
        • Not yet recruiting
        • CHU de Saint-Etienne
        • Principal Investigator:
          • Pierre CORNILLON, MD
        • Contact:
          • Pierre CORNILLON, MD
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg europe
        • Principal Investigator:
          • Philippe BARTHELEMY, MD
        • Contact:
          • Manon VOEGELIN
      • Strasbourg, France, 67091
        • Not yet recruiting
        • Hôpitaux universitaires de Strasbourg
        • Contact:
          • Bertrand MENNECIER, MD
        • Principal Investigator:
          • Bertrand MENNECIER, MD

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

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
Intervention / Treatment
Experimental: Patients using CONTINUUM+ CONNECT remote monitoring solution
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
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

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.

Investigators

  • Study Chair: Philippe BARTHELEMY, MD, Institut de cancérologie Strasbourg europe

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)

April 25, 2024

Primary Completion (Estimated)

November 25, 2024

Study Completion (Estimated)

February 25, 2025

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)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

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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