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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499785
• Other study ID #: CDR0000555118
• Secondary ID: CCCWFU-22A07CCCW
• Status: Completed
• Phase: N/A
• First received: July 10, 2007
• Last updated: May 25, 2017
• Start date: June 2007
• Est. completion date: January 2012

Study information

• Verified date: October 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2012
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive/Functional Effects
• Depression
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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