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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Device: ONCOLAXY Follow-up

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali BALAVOINE; Phone Number: +33 2 41 68 29 70; Email: m.balavoine@ilcgroupe.fr
• Study Contact Backup: Name: Katell LE DÛ, MD; Email: dr.ledu@groupeconfluent.fr

Study Locations

• France
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine
    • Contact: Olivier FITOUSSI, MD; Email: o.fitoussi@bordeauxnord.com
    • Principal Investigator: Olivier FITOUSSI, MD
  • Le Mans, France, 72000
    • Clinique Victor Hugo/Centre Jean Bernard/ILC
    • Contact: Marielle LE GOFF, MD; Email: m.legoff@ilcgroupe.fr
    • Principal Investigator: Marielle LE GOFF, MD
  • Nantes, France, 44200
    • Hôpital Privée du Confluent
    • Principal Investigator: Katell Le Dû, MD
    • Contact: Katell LE DÛ, MD; Email: dr.ledu@groupeconfluent.fr
  • Saint-Nazaire, France, 44600
    • Centre Hospitalier de St Nazaire
    • Contact: Elsa LESTANG, MD; Email: e.lestang@ch-saintnazaire.fr
    • Principal Investigator: Elsa LESTANG, MD
  • Strasbourg, France, 67000
    • Centre de radiothérapie de Robertsau
    • Contact: Frédéric MALOISEL, MD; Email: fmaloisel@solcrr.org
    • Principal Investigator: Frédéric MALOISEL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONCOLAXY follow-up; patients will make a regular assessment of symptoms via an electronic questionnaire	Device: ONCOLAXY Follow-up; 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.
No Intervention: Standard follow-up; patients will have the standard follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of events	The events will be collected (CTCAE V5.0) per patient	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	29 months
Description of emergency entry	The number of emergency visits (consultation or hospitalization in the suites) per arm	29 months
Description of hospitalisations	The number and average length of stay of hospitalizations per patient and per arm	29 months
Description of dose/intensity of RCHOP regimen	The dose of treatment received compared to the theoretical dose will assess the dose / intensity	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	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	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.	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.	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	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	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,	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.	29 months
Description of face-to-face consultations	In the application arm the number of face-to-face consultations triggered by an alert	29 months
Description of teleconsultations	In the application arm the number of teleconsultations triggered by an alert	29 months
Description of drug prescriptions	In the application arm the number of drug prescription triggered by an alert	29 months
Description of nursing prescription	In the application arm the number of nursing prescription triggered by an alert	29 months

Collaborators and Investigators

• Sponsor: Weprom
• Collaborators: Incyte Corporation; Resilience Care
• Investigators: Principal Investigator: Katell LE DÛ, MD, Hôpital Privée du Confluent

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ONCOLAXY web-application; electronic Patient Reported Outcomes
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: WP-2022-01; 2021-A02957-34 (Other Identifier: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No