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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00499785
First received: July 10, 2007
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  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
Cognitive/Functional Effects
Depression
Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • feasibility of administering a functional assessment in clinical situation [ Time Frame: 72 hours of admission ] [ Designated as safety issue: No ]
    Assessment of physical and cognitive function via a set of physical and congnitive tests


Enrollment: 11
Study Start Date: June 2007
Study Completion Date: January 2012
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients admitted with acute 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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with acute leukemia >= 60 years of age

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
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heidi D. Klepin, MD Comprehensive Cancer Center of Wake Forest University
Principal Investigator: Bayard L. Powell, MD Comprehensive Cancer Center of 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

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00499785     History of Changes
Other Study ID Numbers: CDR0000555118, CCCWFU-22A07, CCCWFU-IRB00002562
Study First Received: July 10, 2007
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013