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Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma (EMILY)

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ONCOLAXY Follow-up
Sponsored by
Weprom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diffuse Large B Cell Lymphoma focused on measuring ONCOLAXY web-application, electronic Patient Reported Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient with untreated large B cell lymphoma requiring a first line treatment by RCHOP or R-mini-CHOP
  2. Patient aged 18 years or older at the time of signing Informed Consent Form
  3. Additional Intrathecal or/and intravenous treatment with Methotrexate allowed, if indicated
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
  5. Patient with internet access (or has someone at home who can help send patients' symptoms or complete the form)
  6. Patient enrolled in social security
  7. Patient has given his written consent ahead of any specific protocol procedure

Exclusion Criteria:

  1. Patient with symptomatic brain metastases,
  2. Patient deprived of their liberty, under guardianship or trusteeship
  3. Patient is being treated for another cancer and has not been cured
  4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
  5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
  6. Patient is pregnant or breastfeeding

Sites / Locations

  • Polyclinique Bordeaux Nord Aquitaine
  • Clinique Victor Hugo/Centre Jean Bernard/ILC
  • Hôpital Privée du Confluent
  • Centre Hospitalier de St Nazaire
  • Centre de radiothérapie de Robertsau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ONCOLAXY follow-up

Standard follow-up

Arm Description

patients will make a regular assessment of symptoms via an electronic questionnaire

patients will have the standard follow-up

Outcomes

Primary Outcome Measures

Description of events
The events will be collected (CTCAE V5.0) per patient
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
Description of emergency entry
The number of emergency visits (consultation or hospitalization in the suites) per arm
Description of hospitalisations
The number and average length of stay of hospitalizations per patient and per arm
Description of dose/intensity of RCHOP regimen
The dose of treatment received compared to the theoretical dose will assess the dose / intensity
Description of treatment interruptions
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
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
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
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
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
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
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
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
In the application arm the number of face-to-face consultations triggered by an alert
Description of teleconsultations
In the application arm the number of teleconsultations triggered by an alert
Description of drug prescriptions
In the application arm the number of drug prescription triggered by an alert
Description of nursing prescription
In the application arm the number of nursing prescription triggered by an alert

Secondary Outcome Measures

Full Information

First Posted
March 7, 2022
Last Updated
March 25, 2022
Sponsor
Weprom
Collaborators
Resilience Care, Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05298293
Brief Title
Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma
Acronym
EMILY
Official Title
Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weprom
Collaborators
Resilience Care, Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
ONCOLAXY web-application, electronic Patient Reported Outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ONCOLAXY follow-up
Arm Type
Experimental
Arm Description
patients will make a regular assessment of symptoms via an electronic questionnaire
Arm Title
Standard follow-up
Arm Type
No Intervention
Arm Description
patients will have the standard follow-up
Intervention Type
Device
Intervention Name(s)
ONCOLAXY Follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Description of events
Description
The events will be collected (CTCAE V5.0) per patient
Time Frame
29 months
Title
Delay of taking care of event
Description
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
Time Frame
29 months
Title
Description of emergency entry
Description
The number of emergency visits (consultation or hospitalization in the suites) per arm
Time Frame
29 months
Title
Description of hospitalisations
Description
The number and average length of stay of hospitalizations per patient and per arm
Time Frame
29 months
Title
Description of dose/intensity of RCHOP regimen
Description
The dose of treatment received compared to the theoretical dose will assess the dose / intensity
Time Frame
29 months
Title
Description of treatment interruptions
Description
The number of patients having had a treatment interruption will be recorded out of the total number of patients
Time Frame
29 months
Title
Description of the quality of life
Description
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
Time Frame
29 months
Title
Description of anxiety
Description
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.
Time Frame
29 months
Title
Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application
Description
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.
Time Frame
29 months
Title
Overall survival
Description
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
Time Frame
29 months
Title
Progression Free survival
Description
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
Time Frame
29 months
Title
Event-free survival
Description
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,
Time Frame
29 months
Title
Description of health care team satisfaction by a specific questionnaire dedicated to the use of the web-application
Description
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.
Time Frame
29 months
Title
Description of face-to-face consultations
Description
In the application arm the number of face-to-face consultations triggered by an alert
Time Frame
29 months
Title
Description of teleconsultations
Description
In the application arm the number of teleconsultations triggered by an alert
Time Frame
29 months
Title
Description of drug prescriptions
Description
In the application arm the number of drug prescription triggered by an alert
Time Frame
29 months
Title
Description of nursing prescription
Description
In the application arm the number of nursing prescription triggered by an alert
Time Frame
29 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali BALAVOINE
Phone
2 41 68 29 70
Ext
+33
Email
m.balavoine@ilcgroupe.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Katell LE DÛ, MD
Email
dr.ledu@groupeconfluent.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katell LE DÛ, MD
Organizational Affiliation
Hôpital Privée du Confluent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier FITOUSSI, MD
Email
o.fitoussi@bordeauxnord.com
First Name & Middle Initial & Last Name & Degree
Olivier FITOUSSI, MD
Facility Name
Clinique Victor Hugo/Centre Jean Bernard/ILC
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marielle LE GOFF, MD
Email
m.legoff@ilcgroupe.fr
First Name & Middle Initial & Last Name & Degree
Marielle LE GOFF, MD
Facility Name
Hôpital Privée du Confluent
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katell LE DÛ, MD
Email
dr.ledu@groupeconfluent.fr
First Name & Middle Initial & Last Name & Degree
Katell LE DÛ, MD
Facility Name
Centre Hospitalier de St Nazaire
City
Saint-Nazaire
ZIP/Postal Code
44600
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa LESTANG, MD
Email
e.lestang@ch-saintnazaire.fr
First Name & Middle Initial & Last Name & Degree
Elsa LESTANG, MD
Facility Name
Centre de radiothérapie de Robertsau
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric MALOISEL, MD
Email
fmaloisel@solcrr.org
First Name & Middle Initial & Last Name & Degree
Frédéric MALOISEL, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

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