Quality of Life Model for Older Patients With AML

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

AML, Adult Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Difference in Quality of Life score between patients receiving intensive versus non-intensive chemotherapy

Time frame: 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

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 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2027
First posted: May 8, 2020
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting