Clinical trial NCT00499785: Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Official title: Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-11
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute leukemia \>= 60 years of age

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.

Eligibility 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

Primary outcomes:
measure: feasibility of administering a functional assessment in clinical situation
timeFrame: 72 hours of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi D. Klepin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Bayard L. Powell, MD
role: PRINCIPAL_INVESTIGATOR
References: