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low accrual
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RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Patients without cancer | non-cancer patients, seeking care at out-patient clinics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compliance monitoring | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of impaired domains on Comprehensive Geriatric Assessment (CGA) | at baseline and 12 months later. | |
| Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities | Patients are followed for 1 year for chemotherapy adherence and survival. | |
| Vulnerable Elders Survey scores | at baseline and 12 months later. | |
| Functional decline | at baseline and 12 months later. | |
| Time to death | Patients are followed for 1 year for chemotherapy adherence and survival. |
| Measure | Description | Time Frame |
|---|---|---|
| Scores of individual battery of tools included in the CGA | at baseline and 12 months later |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast or colon cancer
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:
PRIOR CONCURRENT THERAPY:
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Primary Care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Owusu, MD, MSC | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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Approximately 13mls of blood will be drawn at each of the three time-points for testing for biologic correlates of frailty (pre study, mid-study and post-study).
|
| systemic chemotherapy | Drug | Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer |
|
| medical chart review | Other | 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 | Other | 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 | Other | 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 | Procedure | 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 | Procedure | 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. |
|
| UH-LUICC | Mentor | Ohio | 44060 | United States |
| UH-Chagrin Highlands | Orange | Ohio | 44122 | United States |
| UH-Green Road | South Euclid | Ohio | 44121 | United States |
| UH-Westlake | Westlake | Ohio | 44145 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D000073216 | Mental Status and Dementia Tests |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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