Clinical trial NCT06379880: Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution
Official title: Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Lung Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Keywords: Remote patient monitoring
Metastatic cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: Continuum Plus Santé
name: Plateforme nationale qualité de vie et cancer
name: WeShare
First posted: 2024-04-23
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

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.

Primary outcomes:
measure: 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
timeFrame: At 3 months (± 15 days) post-inclusion
Secondary outcomes:
measure: 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
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months)
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months)
timeFrame: At 6 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group
timeFrame: At 6 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group
timeFrame: At 6 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group
timeFrame: At 6 months (± 15 days) post-inclusion
measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group
timeFrame: At 6 months (± 15 days) post-inclusion
measure: Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion
timeFrame: At 6 months (± 15 days) post-inclusion
measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion
timeFrame: At 3 months (± 15 days) post-inclusion
measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion
timeFrame: At 6 months (± 15 days) post-inclusion
measure: Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning
timeFrame: Through out the study, up to 10 months. At least once per professional
measure: Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning
timeFrame: At 3 months (± 15 days) post-inclusion
Other outcomes:
Locations:
city: Avignon
country: France
facility: Sainte-Catherine, Institut du Cancer Avignon-Provence
city: Blois
country: France
facility: Polyclinique de Blois
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
city: Dijon
country: France
facility: centre Georges François Leclerc
city: Limoges
country: France
facility: Chu Dupuytren
city: Nancy
country: France
facility: Centre d'oncologie de Gentilly
city: Plérin
country: France
facility: Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Institut de cancérologie Strasbourg Europe
name: Philippe BARTHELEMY, MD
role: STUDY_CHAIR
References: