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NCT Number: NCT05298293

Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Description of events

    Time frame: 29 months

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

  2. Delay of taking care of event

    Time frame: 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

  3. Description of emergency entry

    Time frame: 29 months

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

  4. Description of hospitalisations

    Time frame: 29 months

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

  5. Description of dose/intensity of RCHOP regimen

    Time frame: 29 months

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

  6. Description of treatment interruptions

    Time frame: 29 months

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

  7. Description of the quality of life

    Time frame: 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

  8. Description of anxiety

    Time frame: 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.

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

    Time frame: 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.

  10. Overall survival

    Time frame: 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

  11. Progression Free survival

    Time frame: 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

  12. Event-free survival

    Time frame: 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,

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

    Time frame: 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.

  14. Description of face-to-face consultations

    Time frame: 29 months

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

  15. Description of teleconsultations

    Time frame: 29 months

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

  16. Description of drug prescriptions

    Time frame: 29 months

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

  17. Description of nursing prescription

    Time frame: 29 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Katell LE DÛ, MD

CONTACT

[email protected]

Magali BALAVOINE

CONTACT

[email protected]

2 41 68 29 70 ext. +33

Sponsors and collaborators

Lead sponsor

Weprom

Other

Collaborators

  • Incyte Corporation
  • Resilience

Registry information

Official study title

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

Acronym: EMILY

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2022
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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