Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myelogenous Leukemia Myelodysplastic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Questionnaire

AML and MDS Patients

Questionnaire

Intervention Type BEHAVIORAL

Questionnaires taking about 30 minutes to complete.

Neurocognitive Testing

Intervention Type BEHAVIORAL

Neurocognitive testing lasting 30 minutes. Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears.

Interventions

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Questionnaire

Questionnaires taking about 30 minutes to complete.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey

Eligibility Criteria

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Inclusion Criteria

1. Patients with newly diagnosed AML or MDS. Patients who fail an MDS/AML therapy and receive other therapies may be asked to continue participation in this neurocognitive study.
2. Patients who are 18 years of age or older.
3. Patients who are seen in the MDACC adult Leukemia clinic. Patients who do not enroll onto therapy protocols are also eligible.
4. Patients must sign the informed consent.