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

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00769951
Collaborator
National Cancer Institute (NCI) (NIH)
46
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43
23
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: cognitive assessment
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment

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.

Study Design

Study Type:
Observational
Actual Enrollment :
46 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Geriatric-Oncology Database: A Resource for Advancing Research in Older Cancer Patients
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Creation of a Geriatric-Oncology database [Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.]

  2. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106-5065
2 UHHS Chagrin Highlands Medical Center Cleveland Ohio United States 44122

Sponsors and Collaborators

  • Case Comprehensive Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Cynthia Owusu, MD, MSC, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00769951
Other Study ID Numbers:
  • CASE9Y07
First Posted:
Oct 9, 2008
Last Update Posted:
Jul 27, 2020
Last Verified:
Jul 1, 2020

Study Results

No Results Posted as of Jul 27, 2020