Breast Cancer Clinical Trial
Official title:
A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer
Verified date | March 2015 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma, including one of the following: - Breast cancer (female), meeting the following criteria: - Stage I-III (T1-4, N0-3, M0) disease - Has undergone complete surgical removal of invasive cancer by mastectomy or lumpectomy - Has undergone either sentinel lymph node dissection or axillary lymph node dissection with adequate TNM staging - Colon cancer (male or female), meeting the following criteria: - Stage I-III (T1-3, any N, M0) disease - Has undergone appropriate surgical resection with TNM staging - Newly diagnosed disease - Scheduled to receive chemotherapy - Agrees to receive chemotherapy AND is able to receive chemotherapy within 3 months after surgery - No distant metastases - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Menopausal status not specified - Life expectancy = 6 months - Fluent in English - Not living in a nursing home - No end-stage disease - No severe dementia - No other clinically active malignancy within the past 5 years or within 3 months after diagnosis of current malignancy PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior chemotherapy for the malignancy - More than 1 year since prior treatment on an inpatient/outpatient geriatric evaluation and management unit |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities | Yes | ||
Secondary | 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 | No | ||
Secondary | Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization | No | ||
Secondary | 3-year disease-free survival | No |
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