Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT00499785
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
11 participants
OBSERVATIONAL
2007-06-30
2012-01-31
Brief Summary
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PURPOSE: This clinical trial is assessing physical and mental status in older patients with newly diagnosed acute myeloid leukemia.
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Detailed Description
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Primary
* Test the feasibility of pre-treatment, bedside assessment of functional and cognitive status in older adults with newly diagnosed acute myeloid leukemia (AML).
Secondary
* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients admitted with acute leukemia
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed newly diagnosed acute myeloid leukemia
* Planned induction chemotherapy
* Inpatient status
PATIENT CHARACTERISTICS:
* No requirement for intensive care unit support
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior therapy for acute myeloid leukemia
60 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Heidi D. Klepin, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Bayard L. Powell, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU-22A07
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-IRB00002562
Identifier Type: -
Identifier Source: secondary_id
CDR0000555118
Identifier Type: -
Identifier Source: org_study_id
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