Outpatient Health Care Program for Older Patients Receiving Chemotherapy for Newly Diagnosed Breast Cancer or Colon Cancer
March 17, 2015 updated by: Case Comprehensive Cancer Center
A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer
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.
Study Overview
Status
Withdrawn
Conditions
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.
OUTLINE: Patients are stratified according to tumor site (breast vs colon). Patients are randomized to 1 of 2 arms.
- Arm I (intervention): Patients complete health-related quality-of-life (QOL) and comprehensive geriatric assessment questionnaires at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months to assess functional status (i.e., activities of daily living), comorbidity (i.e., medical problems), medications, mood and memory, nutrition, and social support from family members and friends. Patients receive a home visit from a social worker and visit the Senior Adult Oncology clinic within 1 month after the first course of chemotherapy. The clinic staff develops an individualized care plan for the patient and communicates the results of the assessment questionnaires and their recommendations (e.g., medication and/or specialty referrals) to the patient's primary care provider and oncologist. The staff meets weekly to monitor and update the patient care plan. Patients are followed in the Senior Adult Oncology clinic at least every 3 months for 1 year. Follow-up telephone calls and in-home visits are also conducted as needed. Patients are also assessed prior to each course of chemotherapy for toxicities related to the chemotherapy.
- Arm II (control): Patients complete a health-related QOL questionnaire at baseline, within 30 days after chemotherapy or at 6 months, and then at 12-13 months. Patients receive oncology and primary care by their usual health care providers.
After completion of the study intervention, patients' medical charts are reviewed periodically for up to 2 years.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Primary care clinic
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
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Secondary Outcome Measures
Outcome Measure |
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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
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Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization
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3-year disease-free survival
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Owusu, MD, MSC, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (Estimate)
April 1, 2009
Study Record Updates
Last Update Posted (Estimate)
March 19, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE4Y07 (Other Identifier: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.