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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Start Date
April 1, 2004
Primary Completion Date
March 1, 2009
Completion Date
March 1, 2009
Last Updated
August 1, 2012
104
ACTUAL participants
Questionnaire
BEHAVIORAL
Neurocognitive Testing
BEHAVIORAL
Lead Sponsor
M.D. Anderson Cancer Center
NCT03520647
NCT06859424
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