Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia|
- feasibility of administering a functional assessment in clinical situation [ Time Frame: 72 hours of admission ] [ Designated as safety issue: No ]Assessment of physical and cognitive function via a set of physical and congnitive tests
|Study Start Date:||June 2007|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|patients admitted with acute leukemia|
- Test the feasibility of pre-treatment, bedside assessment of functional and cognitive status in older adults with newly diagnosed acute myeloid leukemia (AML).
- Obtain preliminary data regarding the predictive value of pre-treatment, bedside assessment of functional and cognitive status on overall survival, length of hospitalization and early death.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499785
|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 Health Sciences|
|Principal Investigator:||Bayard L. Powell, MD||Wake Forest University Health Sciences|