NCT03336138已完成不适用
Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 18
- 主要终点
- dose-relative intensity (RDI)
研究概览
简要总结
The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
- •a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
- •Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
- •accepting the study
排除标准
- •Patient with another type of lymphoma (including transformed follicular forms)
- •Patient having already started his treatment.
- •Life expectancy <3 months.
- •Carcinologic history
- •Serum positive for HIV or hepatitis B virus (HBV).
研究组 & 干预措施
AMA group
Active Comparator
Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)
干预措施: AMA (Assistance for ambulatory patients) (Other)
Control group
No Intervention
Patient with standard follow-up with no specific assistance for ambulatory patients
结局指标
主要结局
dose-relative intensity (RDI)
时间窗: through study completion, an average of 2 years
reduction of RDI
次要结局
未报告次要终点
研究者
研究点 (18)
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