Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 5 центров

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗