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NCT Number: NCT06379880

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

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.

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Key information

Conditions

Prostatic Neoplasms Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy, De, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged ≥ 18 years with a solid tumor (only breast, lung, colorectal, prostate cancer) at the metastatic stage followed on an outpatient basis;
  • Patients initiating oral and/or injectable anticancer treatment, whatever the line of treatment, administered on an outpatient basis including day hospitalization;
  • Patients who have given their written, free and informed consent;
  • Patients with life expectancy of more than 3 months;
  • 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);
  • Patients affiliated to a social security scheme or beneficiaries of such a scheme.

Exclusion criteria

  • Patients receiving home hospitalization care or being hospitalized at the time of treatment initiation;
  • Patients receiving concomitant radiotherapy;
  • Patients using another remote monitoring application;
  • Patients enrolled in another clinical trial;
  • Patients protected by law.

Treatment and study plan

CONTINUUM+ CONNECT remote monitoring

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Collaborators

  • Continuum Plus Santé
  • Plateforme nationale qualité de vie et cancer
  • WeShare

Registry information

Official study title

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

Acronym: FEGALA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 23, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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