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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769951
• Other study ID #: CASE9Y07
• Status: Completed
• Start date: February 2008
• Est. completion date: September 2011

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight Changes
• Cognitive/Functional Effects
• Depression
• Hematopoietic/Lymphoid Cancer
• Malnutrition
• Pain
• Psychosocial Effects of Cancer and Its Treatment
• Unspecified Adult Solid Tumor, Protocol Specific
• Weight Changes

Intervention

Other:
• medical chart review
Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
• questionnaire administration
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.

Procedure:
• cognitive assessment
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
• psychosocial assessment and care
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
• quality-of-life assessment
Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	UHHS Chagrin Highlands Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a Geriatric-Oncology database		Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
Primary	Enhancement of the Geriatric-Oncology database by linking it to the Central Medicare Services Database and the Ohio Death Files		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.