Outpatient Health Care Program for Older Patients Receiving Chemotherapy for Newly Diagnosed Breast Cancer or Colon Cancer
|ClinicalTrials.gov Identifier: NCT00873600|
Recruitment Status : Withdrawn (No accrual)
First Posted : April 1, 2009
Last Update Posted : March 19, 2015
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Cognitive/Functional Effects Colorectal Cancer Psychosocial Effects of Cancer and Its Treatment||Drug: chemotherapy Other: medical chart review Other: questionnaire administration Procedure: adjuvant therapy Procedure: assessment of therapy complications Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- 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.
- 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|
|Actual Enrollment :||0 participants|
|Observational Model:||Case Control|
|Official Title:||A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer|
|Study Start Date :||October 2007|
- Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
- 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
- 3-year disease-free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873600
|Principal Investigator:||Cynthia Owusu, MD, MSC||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|