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

NCT00769951 | Completed DMC

• 1 other identifier: CASE9Y07
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Creation of a Geriatric-Oncology database

  Data 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 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.

Interventions

medical chart review OTHER

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

questionnaire administration OTHER

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.

cognitive assessment PROCEDURE

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

psychosocial assessment and care PROCEDURE

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

quality-of-life assessment PROCEDURE

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinics

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Depression; Hematologic Neoplasms; Malnutrition; Pain; Body Weight Changes

Interventions

Mental Status and Dementia Tests; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cynthia Owusu, MD, MSC

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

US (2)