Clinical trial NCT05298293: Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma
Official title: Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diffuse Large B Cell Lymphoma
Keywords: ONCOLAXY web-application
electronic Patient Reported Outcomes
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Resilience
name: Incyte Corporation
First posted: 2022-03-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Description of events
timeFrame: 29 months
measure: Delay of taking care of event
timeFrame: 29 months
measure: Description of emergency entry
timeFrame: 29 months
measure: Description of hospitalisations
timeFrame: 29 months
measure: Description of dose/intensity of RCHOP regimen
timeFrame: 29 months
measure: Description of treatment interruptions
timeFrame: 29 months
measure: Description of the quality of life
timeFrame: 29 months
measure: Description of anxiety
timeFrame: 29 months
measure: Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application
timeFrame: 29 months
measure: Overall survival
timeFrame: 29 months
measure: Progression Free survival
timeFrame: 29 months
measure: Event-free survival
timeFrame: 29 months
measure: Description of health care team satisfaction by a specific questionnaire dedicated to the use of the web-application
timeFrame: 29 months
measure: Description of face-to-face consultations
timeFrame: 29 months
measure: Description of teleconsultations
timeFrame: 29 months
measure: Description of drug prescriptions
timeFrame: 29 months
measure: Description of nursing prescription
timeFrame: 29 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Le Mans
country: France
facility: Clinique Victor Hugo/Centre Jean Bernard/ILC
city: Nantes
country: France
facility: Hôpital Privée du Confluent
city: Saint-Nazaire
country: France
facility: Centre Hospitalier de St Nazaire
city: Strasbourg
country: France
facility: Centre de radiothérapie de Robertsau
Study officials:
affiliation: Hôpital Privée du Confluent
name: Katell LE DÛ, MD
role: PRINCIPAL_INVESTIGATOR
References: