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Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00499785
First received: July 10, 2007
Last updated: July 11, 2012
Last verified: July 2012

July 10, 2007
July 11, 2012
June 2007
January 2009   (final data collection date for primary outcome measure)
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
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Complete list of historical versions of study NCT00499785 on ClinicalTrials.gov Archive Site
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Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous 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.

OBJECTIVES:

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients with acute leukemia >= 60 years of age

  • Cognitive/Functional Effects
  • Depression
  • Leukemia
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patients admitted with acute leukemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
January 2012
January 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00499785
CDR0000555118, CCCWFU-22A07, CCCWFU-IRB00002562
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Heidi D. Klepin, MD Comprehensive Cancer Center of Wake Forest University
Principal Investigator: Bayard L. Powell, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP