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

NCT06379880 | Completed

• 2 other identifiers: 2023-0312024-A00120-47
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Lung Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms

Keywords

Remote patient monitoring; Metastatic cancer

Outcome Measures

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

  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 Outcomes (17)

• 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

  At 3 months (± 15 days) post-inclusion

• Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months)

  At 3 months (± 15 days) post-inclusion

• Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months)

  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

  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

  At 3 months (± 15 days) post-inclusion

Study Arms (2)

Patients using CONTINUUM+ CONNECT remote monitoring solution

EXPERIMENTAL

Device: CONTINUUM+ CONNECT remote monitoring

Patients with conventional follow-up without remote monitoring application.

NO INTERVENTION

Interventions

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.

Patients using CONTINUUM+ CONNECT remote monitoring solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Paul Strauss: lead
• Continuum Plus Santé: collaborator
• WeShare: collaborator
• Plateforme nationale qualité de vie et cancer: collaborator

Study Sites (13)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, De, 54519, France

Location

Sainte-Catherine, Institut du Cancer Avignon-Provence

Avignon, 84918, France

Location

Polyclinique de Blois

Blois, 41260, France

Location

Pôle Santé République

Clermont-Ferrand, 63000, France

Location

centre Georges François Leclerc

Dijon, 21079, France

Location

Chu Dupuytren

Limoges, 87042, France

Location

Centre Hospitalier de Morlaix

Morlaix, 29600, France

Location

Centre d'oncologie de Gentilly

Nancy, 54100, France

Location

Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA

Plérin, 22190, France

Location

Institut Jean Godinot

Reims, 51100, France

Location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Centre Paul Strauss

Strasbourg, 67033, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Lung Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe BARTHELEMY, MD

  Hôpitaux Universitaires de Strasbourg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 23, 2024
• Study Start: April 25, 2024
• Primary Completion: November 7, 2025
• Study Completion: January 26, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (13)