Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

NCT05298293 | Not Yet Recruiting

• 2 other identifiers: WP-2022-012021-A02957-34
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

ONCOLAXY web-application; electronic Patient Reported Outcomes

Outcome Measures

Primary Outcomes (17)

• Description of events

  The events will be collected (CTCAE V5.0) per patient

  29 months

• Delay of taking care of event

  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

  29 months

• Description of emergency entry

  The number of emergency visits (consultation or hospitalization in the suites) per arm

  29 months

• Description of hospitalisations

  The number and average length of stay of hospitalizations per patient and per arm

  29 months

• Description of dose/intensity of RCHOP regimen

  The dose of treatment received compared to the theoretical dose will assess the dose / intensity

  29 months

• Description of treatment interruptions

  The number of patients having had a treatment interruption will be recorded out of the total number of patients

  29 months

• Description of the quality of life

  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

  29 months

• Description of anxiety

  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.

  29 months

• Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application

  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.

  29 months

• Overall survival

  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

  29 months

• Progression Free survival

  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

  29 months

• Event-free survival

  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,

  29 months

• Description of health care team satisfaction by a specific questionnaire dedicated to the use of the web-application

  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.

  29 months

• Description of face-to-face consultations

  In the application arm the number of face-to-face consultations triggered by an alert

  29 months

• Description of teleconsultations

  In the application arm the number of teleconsultations triggered by an alert

  29 months

• Description of drug prescriptions

  In the application arm the number of drug prescription triggered by an alert

  29 months

• Description of nursing prescription

  In the application arm the number of nursing prescription triggered by an alert

  29 months

Study Arms (2)

ONCOLAXY follow-up

EXPERIMENTAL

patients will make a regular assessment of symptoms via an electronic questionnaire

Device: ONCOLAXY Follow-up

Standard follow-up

NO INTERVENTION

patients will have the standard follow-up

Interventions

ONCOLAXY Follow-up DEVICE

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.

ONCOLAXY follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weprom: lead
• Resilience: collaborator
• Incyte Corporation: collaborator

Study Sites (5)

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

Location

Clinique Victor Hugo/Centre Jean Bernard/ILC

Le Mans, 72000, France

Location

Hôpital Privée du Confluent

Nantes, 44200, France

Location

Centre Hospitalier de St Nazaire

Saint-Nazaire, 44600, France

Location

Centre de radiothérapie de Robertsau

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Katell LE DÛ, MD

  Hôpital Privée du Confluent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali BALAVOINE

CONTACT

2 41 68 29 70; m.balavoine@ilcgroupe.fr

Katell LE DÛ, MD

CONTACT

dr.ledu@groupeconfluent.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 28, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)