Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

Not Applicable

Not yet recruiting

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Device: ONCOLAXY Follow-up

• Registration Number: NCT05298293
• Lead Sponsor: Weprom

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-25
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-04-05
• Study Start: 2022-07-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONCOLAXY follow-up	ONCOLAXY Follow-up	patients will make a regular assessment of symptoms via an electronic questionnaire

Primary Outcome Measures

Name	Time	Method
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 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.
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
Description of hospitalisations	29 months	The number and average length of stay of hospitalizations per patient and per arm
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.
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 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 emergency entry	29 months	The number of emergency visits (consultation or hospitalization in the suites) per arm
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
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 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
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
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 teleconsultations	29 months	In the application arm the number of teleconsultations triggered by an alert

Trial Locations

Locations (5)

Clinique Victor Hugo/Centre Jean Bernard/ILC; 🇫🇷 Le Mans, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Hôpital Privée du Confluent; 🇫🇷 Nantes, France

Centre Hospitalier de St Nazaire; 🇫🇷 Saint-Nazaire, France

Centre de radiothérapie de Robertsau; 🇫🇷 Strasbourg, France