Study of Physical and Mental Health of Older Patients With Newly Diagnosed Cancer
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|ClinicalTrials.gov Identifier: NCT00769951|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : October 2, 2015
RATIONALE: Gathering information from older patients with newly diagnosed cancer may help doctors learn more about the risks of functional decline.
PURPOSE: This studying is looking at the physical and mental health of older patients with newly diagnosed cancer.
|Condition or disease||Intervention/treatment|
|Cognitive/Functional Effects Depression Hematopoietic/Lymphoid Cancer Malnutrition Pain Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific Weight Changes||Other: medical chart review Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- To create a Geriatric-Oncology database of patients 65 years of age and older with newly diagnosed cancer who have been identified as being at increased risk of functional decline and mortality within a year.
- To enhance the Geriatric-Oncology Database by linking it to the Central Medicare Services (CMS) Database and the Ohio Death Files.
OUTLINE: This is a multicenter study.
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. The assessments include the Lawton's nine-item Instrumental Activities of Daily Living (IADL); the Katz's Activity of Daily Living (ADL); the Timed Up and Go Test; the Karnofsky Physician-Rated Performance Rating Scale (KPS); the number of falls in the past 6 months; the Mini Nutritional Assessment (MNA); the Body Mass Index; the percent of unintentional weight loss in the past 6 months; the Medical Outcomes Study (MOS) Social Support Subscale (emotional/information and tangible subscales); the MOS Social Activity Limitations Measures; the Charlson Comorbidity Index; the Cumulative Index Rating Scale Geriatrics (CIRS-G); the ACE-27; the Folstein's Mini-Mental State Examination (MMSE); the Geriatric Depression Scale (GDS); the Functional Pain Scale; and a list of medications.
Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years. At completion of 1 and 3 years of follow up, the Geriatric-Oncology Database will be linked to the Central Medicare and Medicaid Services (CMS) Database and the Ohio Death Files.
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||The Geriatric-Oncology Database: A Resource for Advancing Research in Older Cancer Patients|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Other: medical chart review
- Creation of a Geriatric-Oncology database [ Time Frame: Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years. ]
- Enhancement of the Geriatric-Oncology database by linking it to the Central Medicare Services Database and the Ohio Death Files [ Time Frame: At completion of 1 and 3 years of follow up, the Geriatric-Oncology Database will be linked to the Central Medicare and Medicaid Services (CMS) Database and the Ohio Death Files. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769951
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|UHHS Chagrin Highlands Medical Center|
|Cleveland, Ohio, United States, 44122|
|Study Chair:||Cynthia Owusu, MD, MSC||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|