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

May 25, 2017 updated by: Wake Forest University Health Sciences

Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with acute leukemia >= 60 years of age

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients admitted with acute leukemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of administering a functional assessment in clinical situation
Time Frame: 72 hours of admission
Assessment of physical and cognitive function via a set of physical and congnitive tests
72 hours of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 10, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 11, 2007

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000555118
  • CCCWFU-22A07
  • CCCWFU-IRB00002562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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