Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

NCT ID: NCT05298293

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-12-01

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ONCOLAXY follow-up

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

Group Type: EXPERIMENTAL

ONCOLAXY Follow-up

Intervention Type: DEVICE

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.

Standard follow-up

patients will have the standard follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Resilience

INDUSTRY

Sponsor Role: collaborator

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Weprom

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katell LE DÛ, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privée du Confluent

Locations

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Clinique Victor Hugo/Centre Jean Bernard/ILC

Le Mans, , France

Hôpital Privée du Confluent

Nantes, , France

Centre Hospitalier de St Nazaire

Saint-Nazaire, , France

Centre de radiothérapie de Robertsau

Strasbourg, , France

Countries

France

Central Contacts

Magali BALAVOINE

Role: CONTACT

m.balavoine@ilcgroupe.fr

2 41 68 29 70 ext. +33

Katell LE DÛ, MD

Role: CONTACT

dr.ledu@groupeconfluent.fr

Facility Contacts

Olivier FITOUSSI, MD

Role: primary

o.fitoussi@bordeauxnord.com

Marielle LE GOFF, MD

Role: primary

m.legoff@ilcgroupe.fr

Katell LE DÛ, MD

Role: primary

dr.ledu@groupeconfluent.fr

Elsa LESTANG, MD

Role: primary

e.lestang@ch-saintnazaire.fr

Frédéric MALOISEL, MD

Role: primary

fmaloisel@solcrr.org

Other Identifiers

2021-A02957-34

Identifier Type: OTHER

Identifier Source: secondary_id

WP-2022-01

Identifier Type: -

Identifier Source: org_study_id