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


N/A
65 Years
N/A
Not Enrolling
Both
Cognitive/Functional Effects, Depression, Hematopoietic/Lymphoid Cancer, Malnutrition, Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific, Weight Changes

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed cancer

- Any stage disease

- At increased risk for functional decline and mortality within the next year as per
the Vulnerable Elders Survey (VES-13) screening tool (score ≥ 3)

- Seeking care at the Ireland Cancer Center (University hospitals and all other
satellite sites)

- Patients with a pre-existing cancer diagnosis and a geriatric syndrome referred
directly to the Senior Adult Oncology Program by their providers for a
geriatric-oncology consultative evaluation are not eligible

PATIENT CHARACTERISTICS:

- Able to speak and comprehend English

- Able to understand and willing to sign a written informed consent

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Creation of a Geriatric-Oncology database

Outcome Time Frame:

Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.

Safety Issue:

No

Principal Investigator

Cynthia Owusu, MD, MSC

Investigator Role:

Study Chair

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE9Y07

NCT ID:

NCT00769951

Start Date:

February 2008

Completion Date:

September 2011

Related Keywords:

  • Cognitive/Functional Effects
  • Depression
  • Hematopoietic/Lymphoid Cancer
  • Malnutrition
  • Pain
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Weight Changes
  • pain
  • depression
  • weight changes
  • cognitive/functional effects
  • malnutrition
  • psychosocial effects of cancer and its treatment
  • unspecified adult solid tumor, protocol specific
  • hematopoietic/lymphoid cancer
  • Body Weight Changes
  • Depression
  • Depressive Disorder
  • Malnutrition

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122