Study of Physical and Mental Health of Older Patients With Newly Diagnosed Cancer
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Geriatric-Oncology Database: A Resource for Advancing Research in Older Cancer Patients |
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 46 |
| Study Start Date: | February 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
-
Other: medical chart review
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Primary care clinics
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00769951 History of Changes |
| Other Study ID Numbers: | CASE9Y07, P30CA043703, CASE9Y07 |
| Study First Received: | October 8, 2008 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Case Comprehensive Cancer Center:
|
pain depression weight changes cognitive/functional effects |
malnutrition psychosocial effects of cancer and its treatment unspecified adult solid tumor, protocol specific hematopoietic/lymphoid cancer |
Additional relevant MeSH terms:
|
Body Weight Changes Depression Depressive Disorder Malnutrition Body Weight |
Signs and Symptoms Behavioral Symptoms Mood Disorders Mental Disorders Nutrition Disorders |
ClinicalTrials.gov processed this record on May 23, 2013