Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 10
- 主要终点
- Description of dose/intensity of RCHOP regimen
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Description of dose/intensity of RCHOP regimen
时间窗: 29 months
The dose of treatment received compared to the theoretical dose will assess the dose / intensity
Description of anxiety
时间窗: 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
时间窗: 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 events
时间窗: 29 months
The events will be collected (CTCAE V5.0) per patient
Description of hospitalisations
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 29 months
In the application arm the number of face-to-face consultations triggered by an alert
Description of treatment interruptions
时间窗: 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
时间窗: 29 months
The number of emergency visits (consultation or hospitalization in the suites) per arm
Description of drug prescriptions
时间窗: 29 months
In the application arm the number of drug prescription triggered by an alert
Description of nursing prescription
时间窗: 29 months
In the application arm the number of nursing prescription triggered by an alert
Delay of taking care of event
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 29 months
In the application arm the number of teleconsultations triggered by an alert
次要结局
未报告次要终点