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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459524
• Other study ID #: 2004-0060
• Status: Completed
• Phase: N/A
• First received: April 11, 2007
• Last updated: July 31, 2012
• Start date: April 2004
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Behavioral:
• Questionnaire
Questionnaires taking about 30 minutes to complete.
• 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.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL))		Interval testing will be approximately at 1 month, 3 months, and 6 months.	No
Secondary	Effects of therapy on the ability to think, quality of life, the ability to perform everyday tasks, and how often side effects occur.		6 Years	No

External Links

•   MD Anderson Cancer Center