Quality of Life Model for Older Patients With AML

NCT04380441 | Active Not Recruiting

• 1 other identifier: MCC-20585
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

AML, Adult; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Malignant Hematology Department or Senior Adult Oncology Division at Moffitt Cancer Center in Tampa, Florida.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sara Tinsley, PhD, APRN

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: July 8, 2020
• Primary Completion: November 30, 2023
• Study Completion: March 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (1)