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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00769951
Enrollment
46
Registered
2008-10-09
Start date
2008-02-29
Completion date
2011-09-30
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERmedical chart review

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

OTHERquestionnaire 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.

PROCEDUREcognitive assessment

Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.

PROCEDUREpsychosocial assessment and care

Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.

PROCEDUREquality-of-life assessment

Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Creation of a Geriatric-Oncology databaseData will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
Enhancement of the Geriatric-Oncology database by linking it to the Central Medicare Services Database and the Ohio Death FilesAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026