Diffuse Large B Cell LymphomaEMILYNCT05298293
Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma
A study testing ONCOLAXY Follow-up in people with Diffuse Large B Cell Lymphoma, run by Weprom at 5 sites in France.
Trial summary
Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- ONCOLAXY Follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Jul 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient with untreated large B cell lymphoma requiring a first line treatment by RCHOP or R-mini-CHOP
- Patient aged 18 years or older at the time of signing Informed Consent Form
- Additional Intrathecal or/and intravenous treatment with Methotrexate allowed, if indicated
- Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
- Patient with internet access (or has someone at home who can help send patients' symptoms or complete the form)
- Patient enrolled in social security
- Patient has given his written consent ahead of any specific protocol procedure
Who cannot join
- Patient with symptomatic brain metastases,
- Patient deprived of their liberty, under guardianship or trusteeship
- Patient is being treated for another cancer and has not been cured
- Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
- Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
- Patient is pregnant or breastfeeding
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Katell LE DÛ, MD contact
5 sites in 1 country
France5 sites
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077
Olivier FITOUSSI, MD, o.fitoussi@bordeauxnord.com
Olivier FITOUSSI, MD
Clinique Victor Hugo/Centre Jean Bernard/ILC
Le Mans, 72000
Marielle LE GOFF, MD, m.legoff@ilcgroupe.fr
Marielle LE GOFF, MD
Hôpital Privée du Confluent
Nantes, 44200
Katell LE DÛ, MD, dr.ledu@groupeconfluent.fr
Katell LE DÛ, MD
Centre Hospitalier de St Nazaire
Saint-Nazaire, 44600
Elsa LESTANG, MD, e.lestang@ch-saintnazaire.fr
Elsa LESTANG, MD
Centre de radiothérapie de Robertsau
Strasbourg, 67000
Frédéric MALOISEL, MD, fmaloisel@solcrr.org
Frédéric MALOISEL, MD
About this study
Official title: Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment
Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- ONCOLAXY Follow-up
- Keywords
- ONCOLAXY web-application, electronic Patient Reported Outcomes
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONCOLAXY Follow-upDevice
The operation of Oncolaxy© is based on the principle of e-PRO (electronic patient reported outcome) which is able to assess the symptoms declared by patients treated for cancer, to detect an evolution, a recurrence or the toxicity of a therapy. Alerts are sent to the healthcare team if the algorithm detects suspicious symptoms or worsening of these symptoms.
Oncolaxy© records symptoms using an electronic questionnaire that allows them to be graded. Questionnaires are sent out on a regular basis. The algorithm analyzes the responses and processes them taking into account the score of the response and its evolution over time. The combination of the results makes it possible to send information to the healthcare teams in charge of the patient that will alert them, enlighten them and help them guide their decisions which remain under their sole control. The summary of the results can be viewed at any time on a dashboard.
| Study group | Role | What they receive |
|---|---|---|
| ONCOLAXY follow-up | Experimental | patients will make a regular assessment of symptoms via an electronic questionnaire Receives: Device: ONCOLAXY Follow-up |
| Standard follow-up | No intervention | patients will have the standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of events
The events will be collected (CTCAE V5.0) per patient
Measured: 29 months
Delay of taking care of event
The period of management of event will be evaluated between the date of the event and the first action realize to manage this event (patient contact, consultation, hospitalization, prescription, etc.) incremented in the source file
Measured: 29 months
Description of emergency entry
The number of emergency visits (consultation or hospitalization in the suites) per arm
Measured: 29 months
Description of hospitalisations
The number and average length of stay of hospitalizations per patient and per arm
Measured: 29 months
Description of dose/intensity of RCHOP regimen
The dose of treatment received compared to the theoretical dose will assess the dose / intensity
Measured: 29 months
Description of treatment interruptions
The number of patients having had a treatment interruption will be recorded out of the total number of patients
Measured: 29 months
Description of the quality of life
Quality of life will be evaluated by the Quality of Life Questionnaire-C30 (QLQ-C30). QLQ-C30 is a generic questionnaire for cancer patients. Score will be calculated according to EORTC guidelines. The scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. QoL with QLQ-C30 will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months. Score will be calculated according to EORTC guidelines
Measured: 29 months
Description of anxiety
Anxiety will be evaluated by the State-Trait Anxiety Inventory Form Y (STAI-Y scale). STAI-Y is a specific questionnaire for which reflects the current emotional state (STAI-form Y-A) which makes it possible to assess the nervousness and anxiety of the patient. The scores range from 20 to 80; Higher score is worse.
STAI-Y will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months.
Measured: 29 months
Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application
Patient satisfaction will be evaluated by a specific self-evaluation (specific questionnaire dedicated to the use of the web-application) at the end of treatment, 12th and 24th months follow-up visits. The scores range from 14 to 70; Higher score is better.
Measured: 29 months
Overall survival
Overall survival will be calculated from the date of randomization to the date of death due to any cause or the date last known to be alive if patient is censored
Measured: 29 months
Progression Free survival
Progression Free survival will be calculated from the date of randomization to the date of first progression of disease based on Investigator assessment per Lugano classification or the date of death or censored at the date of the last valid tumor assessment
Measured: 29 months
Event-free survival
Event-free survival will be defined as the time between the date of treatment initiation and the date of the first event (relapse, death, unplanned hospitalizations) demonstrated or the date of death if the patient died or the date of the last news if the patient is censored,
Measured: 29 months
Description of health care team satisfaction by a specific questionnaire dedicated to the use of the web-application
Health care team satisfaction will be evaluated by a specific questionnaire (specific questionnaire dedicated to the use of the web-application) at the 6th and 12th of use of application. The scores range from 8 to 33; Higher score is worse.
Measured: 29 months
Description of face-to-face consultations
In the application arm the number of face-to-face consultations triggered by an alert
Measured: 29 months
Description of teleconsultations
In the application arm the number of teleconsultations triggered by an alert
Measured: 29 months
Description of drug prescriptions
In the application arm the number of drug prescription triggered by an alert
Measured: 29 months
Description of nursing prescription
In the application arm the number of nursing prescription triggered by an alert
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Resilience, Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Katell LE DÛ, MD, Principal investigator, Hôpital Privée du Confluent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298293
- Sponsor's protocol ID
- WP-2022-01
- Other IDs
- 2021-A02957-34
- Acronym
- EMILY
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment
- ClinicalTrials.gov ID
- NCT05298293
- Acronym / sponsor ID
- EMILY / WP-2022-01
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- ONCOLAXY web-application, electronic Patient Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Resilience, Incyte Corporation
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Mar 2022 (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.
Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONCOLAXY follow-up | Experimental | Device: ONCOLAXY Follow-uppatients will make a regular assessment of symptoms via an electronic questionnaire |
| Standard follow-up | No intervention | –patients will have the standard follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with untreated large B cell lymphoma requiring a first line treatment by RCHOP or R-mini-CHOP
- Patient aged 18 years or older at the time of signing Informed Consent Form
- Additional Intrathecal or/and intravenous treatment with Methotrexate allowed, if indicated
- Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
- Patient with internet access (or has someone at home who can help send patients' symptoms or complete the form)
Key exclusion criteria (6 listed)
- Patient with symptomatic brain metastases,
- Patient deprived of their liberty, under guardianship or trusteeship
- Patient is being treated for another cancer and has not been cured
- Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
- Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
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 |
|---|---|---|
| ONCOLAXY Follow-upThe operation of Oncolaxy© is based on the principle of e-PRO (electronic patient reported outcome) which is able to assess the symptoms declared by patients treated for cancer, to detect an evolution, a recurrence or the toxicity of a therapy. Alerts are sent to the healthcare team if the algorithm detects suspicious symptoms or worsening of these symptoms. Oncolaxy© records symptoms using an electronic questionnaire that allows them to be graded. Questionnaires are sent out on a regular basis. The algorithm analyzes the responses and processes them taking into account the score of the response and its evolution over time. The combination of the results makes it possible to send information to the healthcare teams in charge of the patient that will alert them, enlighten them and help them guide their decisions which remain under their sole control. The summary of the results can be viewed at any time on a dashboard. | Device | ONCOLAXY follow-up |
Primary outcome
Description of events
Time frame: 29 months
The events will be collected (CTCAE V5.0) per patient
Delay of taking care of event
Time frame: 29 months
The period of management of event will be evaluated between the date of the event and the first action realize to manage this event (patient contact, consultation, hospitalization, prescription, etc.) incremented in the source file
Description of emergency entry
Time frame: 29 months
The number of emergency visits (consultation or hospitalization in the suites) per arm
Description of hospitalisations
Time frame: 29 months
The number and average length of stay of hospitalizations per patient and per arm
Description of dose/intensity of RCHOP regimen
Time frame: 29 months
The dose of treatment received compared to the theoretical dose will assess the dose / intensity
Description of treatment interruptions
Time frame: 29 months
The number of patients having had a treatment interruption will be recorded out of the total number of patients
Description of the quality of life
Time frame: 29 months
Quality of life will be evaluated by the Quality of Life Questionnaire-C30 (QLQ-C30). QLQ-C30 is a generic questionnaire for cancer patients. Score will be calculated according to EORTC guidelines. The scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. QoL with QLQ-C30 will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months. Score will be calculated according to EORTC guidelines
Description of anxiety
Time frame: 29 months
Anxiety will be evaluated by the State-Trait Anxiety Inventory Form Y (STAI-Y scale). STAI-Y is a specific questionnaire for which reflects the current emotional state (STAI-form Y-A) which makes it possible to assess the nervousness and anxiety of the patient. The scores range from 20 to 80; Higher score is worse. STAI-Y will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months.
Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application
Time frame: 29 months
Patient satisfaction will be evaluated by a specific self-evaluation (specific questionnaire dedicated to the use of the web-application) at the end of treatment, 12th and 24th months follow-up visits. The scores range from 14 to 70; Higher score is better.
Overall survival
Time frame: 29 months
Overall survival will be calculated from the date of randomization to the date of death due to any cause or the date last known to be alive if patient is censored
Progression Free survival
Time frame: 29 months
Progression Free survival will be calculated from the date of randomization to the date of first progression of disease based on Investigator assessment per Lugano classification or the date of death or censored at the date of the last valid tumor assessment
Event-free survival
Time frame: 29 months
Event-free survival will be defined as the time between the date of treatment initiation and the date of the first event (relapse, death, unplanned hospitalizations) demonstrated or the date of death if the patient died or the date of the last news if the patient is censored,
Description of health care team satisfaction by a specific questionnaire dedicated to the use of the web-application
Time frame: 29 months
Health care team satisfaction will be evaluated by a specific questionnaire (specific questionnaire dedicated to the use of the web-application) at the 6th and 12th of use of application. The scores range from 8 to 33; Higher score is worse.
Description of face-to-face consultations
Time frame: 29 months
In the application arm the number of face-to-face consultations triggered by an alert
Description of teleconsultations
Time frame: 29 months
In the application arm the number of teleconsultations triggered by an alert
Description of drug prescriptions
Time frame: 29 months
In the application arm the number of drug prescription triggered by an alert
Description of nursing prescription
Time frame: 29 months
In the application arm the number of nursing prescription triggered by an alert
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Katell LE DÛ, MD contact
Katell LE DÛ, MD principal investigator
Hôpital Privée du Confluent
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONCOLAXY Follow-up in people with Diffuse Large B Cell Lymphoma, run by Weprom at 5 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali BALAVOINE (2 41 68 29 70 ext. +33, m.balavoine@ilcgroupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of events (time frame: 29 months). The study lists 17 primary outcomes in all. 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 5 Apr 2022.