Remote monitoring solution for patients with metastatic cancer

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

This study tests if a new remote monitoring system can help improve the quality of life for patients with metastatic breast, lung, colorectal, and prostate cancer compared to regular check-ups.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 506 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut de cancérologie Strasbourg Europe (other)
• Locations: 11 sites (Avignon and 10 other locations)
• Trial ID: NCT06379880 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of the CONTINUUM+ CONNECT remote monitoring platform on the quality of life and health of patients with metastatic cancer. It involves a multicenter, randomized, prospective design where patients will be monitored remotely through questionnaires regarding their health status. The study compares outcomes at three months between patients using this remote monitoring solution and those receiving conventional monitoring. The focus is on four types of cancer: breast, lung, colorectal, and prostate.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with metastatic breast, lung, colorectal, or prostate cancer who are able to use the remote monitoring application.

Not a fit: Patients currently hospitalized or receiving home hospitalization care may not benefit from this remote monitoring solution.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients with metastatic cancer by providing timely health monitoring and interventions.

How similar studies have performed: Other studies have shown promising results with remote monitoring in cancer care, indicating potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Avignon and 10 other locations

• Sainte-Catherine, Institut du Cancer Avignon-Provence — Avignon, France (NOT_YET_RECRUITING)
• Polyclinique de Blois — Blois, France (NOT_YET_RECRUITING)
• Pôle Santé République — Clermont-Ferrand, France (RECRUITING)
• centre Georges François Leclerc — Dijon, France (NOT_YET_RECRUITING)
• Chu Dupuytren — Limoges, France (NOT_YET_RECRUITING)
• Centre d'oncologie de Gentilly — Nancy, France (RECRUITING)
• Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA — Plérin, France (NOT_YET_RECRUITING)
• Institut Jean Godinot — Reims, France (RECRUITING)
• CHU de Saint-Etienne — Saint-Priest-en-Jarez, France (NOT_YET_RECRUITING)
• Institut de cancérologie Strasbourg Europe — Strasbourg, France (RECRUITING)
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Manon VOEGELIN

Conditions: Prostatic Neoplasms, Lung Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Remote patient monitoring, Metastatic cancer