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CompletedNCT00769951Updated Jul 27, 2020

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

An observational study in Cognitive/Functional Effects, Depression and Hematopoietic/Lymphoid Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.

Sponsored by Case Comprehensive Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 46 is below the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Primary care clinics

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (actual)

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.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

07

Study locations

2 sites
  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    Cleveland, Ohio 44106-5065, United States
  • UHHS Chagrin Highlands Medical Center
    Cleveland, Ohio 44122, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00769951
Lead sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 9, 2008
Start date
Feb 2008
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jul 27, 2020

Study contacts

Cynthia Owusu, MD, MSC
study chair · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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