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临床试验/NCT04158726
NCT04158726已完成不适用

Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia

Carevive Systems, Inc.2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.

研究概览

简要总结

Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Thus, in this study, the investigators seek to describe the feasibility of using this shorter GA tool, the mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.

详细描述

This outcomes study has a two-part intervention that includes 1) provider education and 2) patient and provider use of Carevive Treatment Care Planning technology. The provider education component of the intervention highlights evidenced guidelines and investigational agents in the treatment of AML in older adults. The Carevive CPS will be used for the second component of the intervention. The results of this study will provide important information about drivers of treatment decision-making and practice patterns, feasibility of a technology platform to incorporate important, but under-utilized components of value-based care into practice, and healthcare utilization data.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • All participants must be adults ages 18 years of age or older.
  • Patient participants must have a diagnosis of AML.
  • Patients may be newly diagnosed, needing a new line of therapy and have not yet made a treatment decision, or on treatment and being assessed for potential new treatment
  • All participants must be able to understand English.

排除标准

  • Any patient who cannot understand written or spoken English.
  • Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

结局指标

主要结局

The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.

时间窗: 3 months

Clinical outcomes include time on treatment, adherence to the prescribed treatment, quality of life (QoL), and patient side effects. Providers will review results of the mGA at a treatment decision visit and indicate if the mGA results influenced the treatment selection. Chart abstraction will be conducted at a 3-month post treatment planning visit time point to confirm treatment given. Baseline and 3-month QoL and symptom assessment measures will be collected and change over time will be analyzed. Comparisons of change in QoL and symptoms over 3 months, total time on treatment, and adherence among fit, intermediate, and frail groups will be made.

次要结局

  • Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),(3 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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