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临床试验/NCT03563924
NCT03563924Unknown不适用

Allo - Cancer - Thrombosis

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 100 人开始时间: 2018年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Percentage of patients with appropriate care of venous thromboembolism

研究概览

简要总结

Management of venous thromboembolism (VTE) in patients with cancer is complex and require the intervention of many specialized health professionals, in hospital but also at home and during follow-up.

The AlloTC project aims to integrate the management of VTE within the multidisciplinary care pathway of the patient with cancer, in order to improve the management of VTE in patients with cancer: optimize treatments and follow-up with appropriate anticoagulants, monitor the implementation of good clinical practice, promote patient involvement and adherence.

The objective of this monocentric study is to evaluate the efficiency of the integration of the therapeutic management of VTE into a specific management of patient with cancer and to set up a specialized "AlloTC" team that coordinates this course of care.

For that purpose, the management of VTE and outcome of patients with cancer and VTE will be compared between two periods : traditional management and management with the "AlloTC" team.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cancer or haematological malignancies
  • Venous thromboembolism diagnosis (symptomatic or not)

排除标准

  • Life expectancy ≤ 3 months
  • Inability to understand or sign consent
  • Inability to read or understand the French language

结局指标

主要结局

Percentage of patients with appropriate care of venous thromboembolism

时间窗: at 6 months

Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines

次要结局

  • Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan ''(at 6 months)
  • Percentage of patients who had at least 1 session of specialized therapeutic education(at 6 months)
  • Number of complications(at 6 months)
  • Number of calls from health professionals to the AlloTC team(at 6 months)
  • Number of patients referred to the coordinating nurse in Oncology service(at 6 months)
  • Caregiver satisfaction survey concerning on the AlloTC team and care path(at 6 months)
  • Hospitalization duration in the AlloTC cohort(at 6 months)
  • Number of patients lost to follow-up(at 6 months)
  • Assessment of the quality of life of the patient(at 6 months)
  • Percentage of patients with appropriate care of venous thromboembolism(at 3 months)
  • Number of patients evaluated at multidisciplinary meeting(at 6 months)
  • Patient satisfaction survey concerning the AlloTC team and care path(at 6 months)
  • Number of patients accessing the venous thromboembolism information documents.(at 6 months)
  • Number of hospitalizations in the AlloTC cohort(at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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