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

Centre Paul Strauss411 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

411

Conditions

Prostatic Neoplasms Lung Neoplasms Breast Neoplasms Colorectal Neoplasms

Interventions

CONTINUUM+ CONNECT remote monitoringDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, De, France

Sainte-Catherine, Institut du Cancer Avignon-Provence

Avignon, France

Polyclinique de Blois

Blois, France

Outcomes

Primary Outcomes

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

Time frame: At 3 months (± 15 days) post-inclusion

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At 3 months (± 15 days) post-inclusion

Data from ClinicalTrials.gov

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