NCT00873600WithdrawnNot Applicable
A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
- Determine the effect of a 1-year geriatric evaluation and management (GEM) program on adherence to adjuvant chemotherapy (defined as tolerance and timely completion of planned dose) in patients with newly diagnosed breast or colon cancer.
Secondary
- Evaluate the effect of a 1-year GEM program on the health-related quality of life and functional, cognitive, and mental status of these patients.
- Evaluate the effect of a 1-year GEM program on 3-year disease-free survival of these patients.
- Compare the number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization to a GEM program vs no program.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
Secondary Outcomes
- Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization
- 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
- 3-year disease-free survival
Investigators
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