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

NCT ID: NCT00499785

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Cognitive/Functional Effects Depression Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients admitted with acute leukemia

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heidi D. Klepin, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Bayard L. Powell, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CCCWFU-22A07

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-IRB00002562

Identifier Type: -

Identifier Source: secondary_id

CDR0000555118

Identifier Type: -

Identifier Source: org_study_id

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