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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00499785 |
RATIONALE: Learning about physical ability and mental function over time in older patients with acute myeloid leukemia may help doctors learn about the long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is assessing physical and mental status in older patients with newly diagnosed acute myeloid leukemia.
Condition | Intervention |
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Cancer-Related Problem/Condition Leukemia |
Other: medical chart review Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care |
Study Type: | Observational |
Official Title: | Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia |
Estimated Enrollment: | 40 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective study.
At baseline, patients complete questionnaires including the Vulnerable Elders Survey (functional status), the Mini-Mental Status Exam (cognition), and the Center for Epidemiologic Studies-Depression. Patients also undergo physical function testing via the Short Physical Performance Battery and hand grip strength. Further information parameters are obtained by periodic medical chart reviews.
Patients are followed every 3 months for up to 2 years.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 |
Principal Investigator: | Heidi D. Klepin, MD | Wake Forest University |
Principal Investigator: | Bayard L. Powell, MD | Wake Forest University |
Study ID Numbers: | CDR0000555118, CCCWFU-22A07, CCCWFU-IRB00002562 |
Study First Received: | July 10, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00499785 History of Changes |
Health Authority: | United States: Federal Government |
depression cognitive/functional effects untreated adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Leukemia Acute Myelocytic Leukemia Depression Acute Myeloid Leukemia, Adult |
Leukemia, Myeloid Depressive Disorder Congenital Abnormalities Leukemia, Myeloid, Acute |
Leukemia Neoplasms Neoplasms by Histologic Type Leukemia, Myeloid Leukemia, Myeloid, Acute |