Quality of Life Model for Older Patients With AML

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04380441
• Other study ID #: MCC-20585
• Status: Active, not recruiting
• Start date: July 8, 2020
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Est. completion date: November 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• AML, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials website