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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00499785

Enrollment

Registered

2007-07-11

Start date

2007-06-30

Completion date

2012-01-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive/Functional Effects, Depression, Leukemia

Keywords

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)

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
feasibility of administering a functional assessment in clinical situation	72 hours of admission	Assessment of physical and cognitive function via a set of physical and congnitive tests

Countries

United States

Outcome results