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

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
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
Leukemia, Myeloid, Acute
Behavioral Symptoms
Mental Disorders
Mood Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 29, 2014