Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia

NCT04158726 | Completed

• 1 other identifier: 422 AML GA
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months

Secondary Outcomes (1)

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

  3 months

Other Outcomes (2)

• Satisfaction (usability, acceptability, feasibility and utility) of incorporating electronic mGA into routine clinical care will be evaluated at baseline and each clinic visit.A comprehensive survey will be utilized to capture these outcomes.

  3 months

• Change in the hematologists' knowledge, skills and attitudes from baseline following continuing education modules viewed by providers.

  3 months

Interventions

modified Geriatric Assessment (mGA) BEHAVIORAL

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Carevive Systems, Inc.: lead

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Debbie Wujcik, PhD,RN

  Carevive Systems, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 12, 2019
• Study Start: April 26, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)