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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nutrition Disorders
Behavioral Symptoms
Body Weight
Mental Disorders
Mood Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014