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

NCT00459524 | Completed

• 1 other identifier: 2004-0060
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Keywords

Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Leukemia; Quality of Life; Questionnaire; Survey; Neurocognitive Function; AML; MDS; QOL

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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

Study Arms (1)

Questionnaire

AML and MDS Patients

Behavioral: Questionnaire; Behavioral: Neurocognitive Testing

Interventions

Questionnaire BEHAVIORAL

Questionnaires taking about 30 minutes to complete.

Also known as: Survey

Questionnaire

Neurocognitive Testing BEHAVIORAL

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

Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute myelogenous leukemia or myelodysplastic syndrome.

You may qualify if:

• 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.
• Patients who are 18 years of age or older.
• Patients who are seen in the MDACC adult Leukemia clinic. Patients who do not enroll onto therapy protocols are also eligible.
• Patients must sign the informed consent.

You may not qualify if:

• \) Not applicable

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christina A. Meyers, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 12, 2007
• Study Start: April 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)