Quality of Life Model for Older Patients With AML

N/AActive Not RecruitingNCT04380441

H. Lee Moffitt Cancer Center and Research Institute206 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

206

Conditions

AML, Adult Acute Myeloid Leukemia

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At baseline and at 30, 60, 90 and 180 days post treatment

Data from ClinicalTrials.gov

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