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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00499785
Other study ID # CDR0000555118
Secondary ID CCCWFU-22A07CCCW
Status Completed
Phase N/A
First received July 10, 2007
Last updated May 25, 2017
Start date June 2007
Est. completion date January 2012

Study information

Verified date October 2015
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date January 2012
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender All
Age group 60 Years to 120 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary feasibility of administering a functional assessment in clinical situation Assessment of physical and cognitive function via a set of physical and congnitive tests 72 hours of admission
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