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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE4Y07 | Other Identifier | Case Comprehensive Cancer Center |
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No accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Gathering health information from older patients undergoing chemotherapy may help doctors plan better treatment and improve the quality of life for these patients.
PURPOSE: This randomized clinical trial is studying how well an outpatient health care program works for older patients receiving chemotherapy for newly diagnosed breast cancer or colon cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to tumor site (breast vs colon). Patients are randomized to 1 of 2 arms.
After completion of the study intervention, patients' medical charts are reviewed periodically for up to 2 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy | Drug | |||
| medical chart review | Other | |||
| questionnaire administration | Other | |||
| adjuvant therapy | Procedure | |||
| assessment of therapy complications | Procedure | |||
| cognitive assessment | Procedure | |||
| psychosocial assessment and care | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in comprehensive geriatric assessment scores and quality-of-life scores from baseline to post-chemotherapy and from baseline to 12 months following randomization | ||
| Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma, including one of the following:
Breast cancer (female), meeting the following criteria:
Colon cancer (male or female), meeting the following criteria:
Newly diagnosed disease
Scheduled to receive chemotherapy
No distant metastases
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 | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| quality-of-life assessment | Procedure |
| 3-year disease-free survival |
| 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 |
|---|---|
| D004358 | Drug Therapy |
| D017024 | Chemotherapy, Adjuvant |
| D000073216 | Mental Status and Dementia Tests |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| 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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