Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00499785

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Leukemia	Other: medical chart review Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Observational
Official Title:	Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility of the functional assessment program
Overall survival
Length of hospitalization
Early death defined as death within 30 days of chemotherapy initiation

Estimated Enrollment:	40
Study Start Date:	June 2007
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499785

Locations

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

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Heidi D. Klepin, MD	Wake Forest University
Principal Investigator:	Bayard L. Powell, MD	Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000555118, CCCWFU-22A07, CCCWFU-IRB00002562
Study First Received:	July 10, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00499785 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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)

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Depression
Acute Myeloid Leukemia, Adult

Leukemia, Myeloid
Depressive Disorder
Congenital Abnormalities
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on May 07, 2009