Quality of Life Model for Older Patients With AML

Study Overview
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Brief Summary
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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.

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

Conditions
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AML, Adult, Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Quality of Life score between patients receiving intensive versus non-intensive chemotherapy | 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. | At baseline and at 30, 60, 90 and 180 days post treatment | 
| Difference in Quality of Life score between patients with varying disease characteristics | 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. | At baseline and at 30, 60, 90 and 180 days post treatment |