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Not yet recruiting NCT05298293

Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

No phase Interventional Diffuse Large B Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ONCOLAXY Follow-up.
Who it may be relevant to
Registry conditions: Diffuse Large B Cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Description of events [Time frame: 29 months]
  • Delay of taking care of event [Time frame: 29 months]
  • Description of emergency entry [Time frame: 29 months]
  • Description of hospitalisations [Time frame: 29 months]
  • Description of dose/intensity of RCHOP regimen [Time frame: 29 months]
  • Description of treatment interruptions [Time frame: 29 months]
  • Description of the quality of life [Time frame: 29 months]
  • Description of anxiety [Time frame: 29 months]
  • Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application [Time frame: 29 months]
  • Overall survival [Time frame: 29 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 5 centers
  • Polyclinique Bordeaux Nord Aquitaine — Bordeaux
  • Clinique Victor Hugo/Centre Jean Bernard/ILC — Le Mans
  • Hôpital Privée du Confluent — Nantes
  • Centre Hospitalier de St Nazaire — Saint-Nazaire
  • Centre de radiothérapie de Robertsau — Strasbourg

Identifiers

NCT: NCT05298293 · WP-2022-01 · 2021-A02957-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗