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

Centre Paul Strauss

Status: Completed

Conditions: Lung Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Colorectal Neoplasms

Treatments: Device: CONTINUUM+ CONNECT remote monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06379880

2023-031

2024-A00120-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 411 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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411 participants in 2 patient groups

Patients using CONTINUUM+ CONNECT remote monitoring solution

Experimental group

Treatment:

Device: CONTINUUM+ CONNECT remote monitoring

Patients with conventional follow-up without remote monitoring application.

No Intervention group