Myelodysplastic Syndrome Clinical Trial
Official title:
Longitudinal Assessment of Neurocognitive Function and Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Undergoing Treatment
Primary Objectives:
- To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the
quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia
(AML) or high-risk myelodysplastic syndrome (MDS) receiving different therapies,
chemotherapy (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or
R115777 + low-dose ara-C, or decitabine, or STI + low-dose ara-C).
- To determine whether there is a correlation between the number of packed red blood cell
(PRBC) transfusions and cognitive scores and/or QOL.
You will participate in a series of neurocognitive tests. For these tests, you will be asked
to complete certain tasks that require the use of your hands, eyes, and ears. The
neurocognitive testing will take about 30 minutes.
You will answer some questionnaires about disease symptoms and your quality of life. It will
take about 30 minutes to complete the questionnaires.
You will participate in these neurocognitive tests and fill out the questionnaires before
you begin cancer therapy. Your interval testing will coincide with your clinic visit
evaluations, which will be approximately at 1 month, 3 months, and 6 months. If you do not
receive therapy, you will be asked to complete the neurocognitive tests at baseline and then
again on your follow up clinic visit evaluations, which will be approximately at 3 months
and at 6 months. You may be asked to continue your participation in these neurocognitive
tests and fill out questionnaires approximately every 3 months thereafter.
This is an investigational study. About 306 patients will take part in this study. All will
be enrolled at UTMDACC.
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Observational Model: Case-Only, Time Perspective: Prospective
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