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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


N/A
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

Longitudinal Assessment of Neurocognitive Function and Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Undergoing Treatment


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.


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.

Exclusion Criteria:

1) Not applicable

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL))

Outcome Time Frame:

Interval testing will be approximately at 1 month, 3 months, and 6 months.

Safety Issue:

No

Principal Investigator

Christina A. Meyers, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0060

NCT ID:

NCT00459524

Start Date:

April 2004

Completion Date:

March 2009

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Quality of Life
  • Questionnaire
  • Survey
  • Neurocognitive Function
  • AML
  • MDS
  • QOL
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030