Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Description of events — 29 months
  The events will be collected (CTCAE V5.0) per patient
• Delay of taking care of event — 29 months
  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
• Description of emergency entry — 29 months
  The number of emergency visits (consultation or hospitalization in the suites) per arm
• Description of hospitalisations — 29 months
  The number and average length of stay of hospitalizations per patient and per arm
• Description of dose/intensity of RCHOP regimen — 29 months
  The dose of treatment received compared to the theoretical dose will assess the dose / intensity
• Description of treatment interruptions — 29 months
  The number of patients having had a treatment interruption will be recorded out of the total number of patients
• Description of the quality of life — 29 months
  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
• Description of anxiety — 29 months
  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.
• Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application — 29 months
  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.
• Overall survival — 29 months
  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
• Progression Free survival — 29 months
  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
• Event-free survival — 29 months
  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,
• Description of health care team satisfaction by a specific questionnaire dedicated to the use of the web-application — 29 months
  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.
• Description of face-to-face consultations — 29 months
  In the application arm the number of face-to-face consultations triggered by an alert
• Description of teleconsultations — 29 months
  In the application arm the number of teleconsultations triggered by an alert
• Description of drug prescriptions — 29 months
  In the application arm the number of drug prescription triggered by an alert
• Description of nursing prescription — 29 months
  In the application arm the number of nursing prescription triggered by an alert

Trial sites (5)

More Weprom trials in France

Other trials for the same condition