Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
This study has been completed.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 10, 2007 | ||||||||
| Last Updated Date | July 11, 2012 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00499785 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia | ||||||||
| Official Title ICMJE | Inpatient Functional and Cognitive Assessment in Older Adults With Acute Myelogenous Leukemia | ||||||||
| Brief 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | patients with acute leukemia >= 60 years of age |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | patients admitted with acute leukemia | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 11 | ||||||||
| Completion Date | January 2012 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||||||
| Ages | 60 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00499785 | ||||||||
| Other Study ID Numbers ICMJE | CDR0000555118, CCCWFU-22A07, CCCWFU-IRB00002562 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Comprehensive Cancer Center of Wake Forest University | ||||||||
| Study Sponsor ICMJE | Comprehensive Cancer Center of Wake Forest University | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Comprehensive Cancer Center of Wake Forest University | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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