Prostatic NeoplasmsFEGALANCT06379880
Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution
A study testing CONTINUUM+ CONNECT remote monitoring in people with Prostatic Neoplasms and Lung Neoplasms, run by Centre Paul Strauss at 13 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Neoplasms, Lung Neoplasms, Breast Neoplasms
- What is being tested?
- CONTINUUM+ CONNECT remote monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 13 sitesFrance
- Study dates
- 25 Apr 2024to 26 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Sainte-Catherine, Institut du Cancer Avignon-Provence
Avignon, 84918
Polyclinique de Blois
Blois, 41260
Pôle Santé République
Clermont-Ferrand, 63000
centre Georges François Leclerc
Dijon, 21079
Chu Dupuytren
Limoges, 87042
Centre Hospitalier de Morlaix
Morlaix, 29600
Centre d'oncologie de Gentilly
Nancy, 54100
Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA
Plérin, 22190
Institut Jean Godinot
Reims, 51100
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Centre Paul Strauss
Strasbourg, 67033
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, De, 54519
About this study
Official title: Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA
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.
Read the 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.
- Being tested
- CONTINUUM+ CONNECT remote monitoring
- Keywords
- Remote patient monitoring, Metastatic cancer
- Medical subject headings
- Prostatic Neoplasms, Lung Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients using CONTINUUM+ CONNECT remote monitoring solution | Experimental | Not described Receives: Device: CONTINUUM+ CONNECT remote monitoring |
| Patients with conventional follow-up without remote monitoring application. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Difference on specific symptom scales QLQ-LC13
Measured: At 3 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group
Difference on specific symptom scales QLQ-PR25
Measured: At 3 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group
Difference on specific symptom scales QLQ-CR29
Measured: At 3 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group
Difference on specific symptom scales QLQ-BR23
Measured: At 6 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group
Difference on specific symptom scales QLQ-LC13
Measured: At 6 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group
Difference on specific symptom scales QLQ-PR25
Measured: At 6 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group
Difference on specific symptom scales QLQ-CR29
Measured: At 6 months (± 15 days) post-inclusion
Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion
Percentage of patients with at least one adverse event (graded 3 or 4 according to NCI-CTCAE V5.0) at evaluation visit at 3 months.
Measured: At 3 months (± 15 days) post-inclusion
Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion
Percentage of patients with at least one adverse event (graded 3 or 4 according to NCI-CTCAE V5.0) at Follow-up (FU) visit at 6 months.
Measured: At 6 months (± 15 days) post-inclusion
Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion
Percentage of patients that required at least one unscheduled hospitalization due to their cancer and/or treatment during the 3 months following their enrollment in the trial based on patient's medical record
Measured: At 3 months (± 15 days) post-inclusion
Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion
Percentage of patients that required at least one unscheduled hospitalization due to their cancer during the 6 months following their enrollment in the trial based on patient's medical record
Measured: At 6 months (± 15 days) post-inclusion
Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning
Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution
Measured: Through out the study, up to 10 months. At least once per professional
Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning
Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution
Measured: At 3 months (± 15 days) post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start25 Apr 2024
- Primary completion7 Nov 2025
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Collaborators
- Continuum Plus Santé, Plateforme nationale qualité de vie et cancer, WeShare
- Responsible party
- Sponsor
- Investigators
- Philippe BARTHELEMY, MD, Study chair, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379880
- Sponsor's protocol ID
- 2023-031
- Other IDs
- 2024-A00120-47
- Acronym
- FEGALA
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA
- ClinicalTrials.gov ID
- NCT06379880
- Acronym / sponsor ID
- FEGALA / 2023-031
- Keywords
- Remote patient monitoring, Metastatic cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Collaborators
- Continuum Plus Santé, Plateforme nationale qualité de vie et cancer, WeShare
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients using CONTINUUM+ CONNECT remote monitoring solution | Experimental | Device: CONTINUUM+ CONNECT remote monitoring |
| Patients with conventional follow-up without remote monitoring application. | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONTINUUM+ CONNECT remote monitoringCONTINUUM+ 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. | Device | Patients using CONTINUUM+ CONNECT remote monitoring solution |
Primary outcome
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
Time frame: At 3 months (± 15 days) post-inclusion
Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group
17 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
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)
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)
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
Time frame: 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
Time frame: At 3 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group
Time frame: At 3 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group
Time frame: At 3 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group
Time frame: At 6 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group
Time frame: At 6 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group
Time frame: At 6 months (± 15 days) post-inclusion
Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group
Time frame: At 6 months (± 15 days) post-inclusion
Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion
Time frame: At 3 months (± 15 days) post-inclusion
Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion
Time frame: At 6 months (± 15 days) post-inclusion
Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion
Time frame: At 3 months (± 15 days) post-inclusion
Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion
Time frame: At 6 months (± 15 days) post-inclusion
Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning
Time frame: Through out the study, up to 10 months. At least once per professional
Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning
Time frame: At 3 months (± 15 days) post-inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe BARTHELEMY, MD study chair
Hôpitaux Universitaires de Strasbourg
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONTINUUM+ CONNECT remote monitoring in people with Prostatic Neoplasms and Lung Neoplasms, run by Centre Paul Strauss at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At 3 months (± 15 days) post-inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.