Clinical trial · Observational
Quality of Life Model for Older Patients With AML
Development of a Quality of Life Decision-Making Model for Older Patients With Acute Myeloid Leukemia
NCT04380441CI-TRIAL-00111891active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Difference in Quality of Life score between patients receiving intensive versus non-intensive chemotherapy
- timeFrame
- At baseline and at 30, 60, 90 and 180 days post treatment
- description
- 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.
- measure
- Difference in Quality of Life score between patients with varying disease characteristics
- timeFrame
- At baseline and at 30, 60, 90 and 180 days post treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.