Clinical Trials Directory

Trials / Completed

CompletedNCT00769951

Study of Physical and Mental Health of Older Patients With Newly Diagnosed Cancer

The Geriatric-Oncology Database: A Resource for Advancing Research in Older Cancer Patients

Status
Completed
Phase
Study type
Observational
Enrollment
46 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

Interventions

TypeNameDescription
OTHERmedical chart reviewData will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
OTHERquestionnaire administrationPatients 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.
PROCEDUREcognitive assessmentPatients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
PROCEDUREpsychosocial assessment and carePatients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
PROCEDUREquality-of-life assessmentPatients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.

Timeline

Start date
2008-02-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2008-10-09
Last updated
2020-07-27

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00769951. Inclusion in this directory is not an endorsement.