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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00769951
First received: October 8, 2008
Last updated: September 20, 2011
Last verified: September 2011
  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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Other: medical chart review
    Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
    Other: 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.
    Procedure: psychosocial assessment and care
    Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
    Procedure: quality-of-life assessment
    Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinics

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769951

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
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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 April 17, 2014