Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer
NCT ID: NCT00740961
Last Updated: 2020-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
63 participants
OBSERVATIONAL
2008-03-31
2011-09-30
Brief Summary
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PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.
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Detailed Description
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* Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.
* Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.
* Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.
* Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.
OUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Patients are followed for 1 year for chemotherapy adherence and survival.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
compliance monitoring
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
systemic chemotherapy
Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer
medical chart review
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
study of socioeconomic and demographic variables
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
survey administration
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
cognitive assessment
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
psychosocial assessment and care
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
compliance monitoring
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
medical chart review
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
study of socioeconomic and demographic variables
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
survey administration
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
cognitive assessment
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
psychosocial assessment and care
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Interventions
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compliance monitoring
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
systemic chemotherapy
Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer
medical chart review
A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
study of socioeconomic and demographic variables
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
survey administration
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
cognitive assessment
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
psychosocial assessment and care
Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed breast or colon cancer
* Newly diagnosed disease
* Any stage disease
* Undergoing treatment at the Ireland Cancer Center, University Hospitals Case Medical Center Site
* Scheduled to start a new chemotherapy regimen (objective II only)
* Not concurrently enrolled in a GEM trial (objectives II, III, and IV)
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Understands English
* Menopausal status not specified
PRIOR CONCURRENT THERAPY:
* See Diseases Characteristics
65 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Cynthia Owusu, MD, MSC
Role: STUDY_CHAIR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
UH-LUICC
Mentor, Ohio, United States
UH-Chagrin Highlands
Orange, Ohio, United States
UH-Green Road
South Euclid, Ohio, United States
UH-Westlake
Westlake, Ohio, United States
Countries
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Other Identifiers
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CASE8Y07
Identifier Type: -
Identifier Source: org_study_id
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