Clinical trial NCT00769951: Study of Physical and Mental Health of Older Patients With Newly Diagnosed Cancer
Official title: The Geriatric-Oncology Database: A Resource for Advancing Research in Older Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive/Functional Effects
Depression
Hematopoietic/Lymphoid Cancer
Malnutrition
Pain
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Weight Changes
Keywords: pain
depression
weight changes
cognitive/functional effects
malnutrition
psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
hematopoietic/lymphoid cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-10-09
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinics

Brief 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.

Eligibility 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

Primary outcomes:
measure: Creation of a Geriatric-Oncology database
timeFrame: Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
measure: Enhancement of the Geriatric-Oncology database by linking it to the Central Medicare Services Database and the Ohio Death Files
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Cynthia Owusu, MD, MSC
role: STUDY_CHAIR
References: