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Clinical Trials/NCT04158726
NCT04158726
Completed
Not Applicable

Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia

Carevive Systems, Inc.1 site in 1 country47 target enrollmentApril 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myeloid Leukemia
Sponsor
Carevive Systems, Inc.
Enrollment
47
Locations
1
Primary Endpoint
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 26, 2019
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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