Quality of Life Model for Older Patients With AML

Development of a Quality of Life Decision-Making Model for Older Patients With Acute Myeloid Leukemia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04380441

Enrollment

206

Registered

2020-05-08

Start date

2020-07-08

Completion date

2027-07-01

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, AML, Adult

Brief summary

The purpose of this study is to describe the differences in quality of life (QOL) among newly diagnosed patients diagnosed with acute myeloid leukemia (AML) to help design a patient decision-making QOL model for aligning patients' choice of treatment with what matters the most to them.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* 60 years of age or older * Newly diagnosed with pathology-confirmed diagnosis of Acute Myeloid Leukemia * Within 7 days of starting a new treatment * Must be able to read and speak English at the 8th grade level

Exclusion criteria

* Under 60 years of age * Other malignancy, dementia, traumatic brain injury or individuals with central nervous system involvement of their leukemia

Design outcomes

Primary

Measure	Time frame	Description
Difference in Quality of Life score between patients receiving intensive versus non-intensive chemotherapy	At baseline and at 30, 60, 90 and 180 days post treatment	Difference in Quality of Life between newly diagnosed AML patients 60 years of age and older receiving intensive versus non-intensive chemotherapy. Quality of Life will be measured using the Functional Assessment of Cancer Therapy, Leukemia Version (FACT-Leu), a 44-item self reported leukemia specific questionnaire. The FACT-Leu uses a 0-4 Likert scale, 0=not at all and 4=very much. Positive items receive scores from 0-4 points, and negative items are scored from 4-0 points.The FACT-Leu scores are obtained by summing item responses coded so that larger scores indicate better QOL. The leukemia subscale has been validated. A meaningful clinical change for the FACT-Leu is a 13-17 point difference out of a maximum score of 176.
Difference in Quality of Life score between patients with varying disease characteristics	At baseline and at 30, 60, 90 and 180 days post treatment	Difference in Quality of Life score between patients with varying disease characteristics such as age, performance status, functional status, comorbidity, fatigue, symptoms, blast percentage, transfusion dependence and cytogenic risk group. Quality of Life will be measured using the Functional Assessment of Cancer Therapy, Leukemia Version (FACT-Leu), a 44-item self reported leukemia specific questionnaire. The FACT-Leu uses a 0-4 Likert scale, 0=not at all and 4=very much. Positive items receive scores from 0-4 points, and negative items are scored from 4-0 points. The FACT-Leu scores are obtained by summing item responses coded so that larger scores indicate better QOL. The leukemia subscale has been validated. A meaningful clinical change for the FACT-Leu is a 13-17 point difference out of a maximum score of 176.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSara Tinsley, PhD, APRN

Moffitt Cancer Center

Outcome results