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Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia


N/A
60 Years
N/A
Not Enrolling
Both
Cognitive/Functional Effects, Depression, Leukemia

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Trial Information

Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous 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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

feasibility of administering a functional assessment in clinical situation

Outcome Description:

Assessment of physical and cognitive function via a set of physical and congnitive tests

Outcome Time Frame:

72 hours of admission

Safety Issue:

No

Principal Investigator

Heidi D. Klepin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000555118

NCT ID:

NCT00499785

Start Date:

June 2007

Completion Date:

January 2012

Related Keywords:

  • Cognitive/Functional Effects
  • Depression
  • Leukemia
  • 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)
  • Depression
  • Depressive Disorder
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096