Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|ClinicalTrials.gov Identifier: NCT00459524|
Recruitment Status : Completed
First Posted : April 12, 2007
Last Update Posted : August 1, 2012
- 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.
|Condition or disease||Intervention/treatment|
|Acute Myelogenous Leukemia Myelodysplastic Syndrome||Behavioral: Questionnaire Behavioral: Neurocognitive Testing|
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.
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|Official Title:||Longitudinal Assessment of Neurocognitive Function and Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Undergoing Treatment|
|Study Start Date :||April 2004|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2009|
AML and MDS Patients
Questionnaires taking about 30 minutes to complete.
Other Name: SurveyBehavioral: Neurocognitive Testing
Neurocognitive testing lasting 30 minutes. Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears.
- Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL)) [ Time Frame: Interval testing will be approximately at 1 month, 3 months, and 6 months. ]
- Effects of therapy on the ability to think, quality of life, the ability to perform everyday tasks, and how often side effects occur. [ Time Frame: 6 Years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459524
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Christina A. Meyers, PhD||M.D. Anderson Cancer Center|