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

Completed

• Conditions: Depression; Leukemia; Cognitive/Functional Effects

• Registration Number: NCT00499785
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Primary Completion: 2009-01
• Study Completion: 2012-01
• Status Verified: 2015-10
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States