Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Psychosocial Effects of Cancer and Its Treatment
Conditions
Keywords
cognitive/functional effects, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III colon cancer
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. 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.
Interventions
DRUGchemotherapy
OTHERmedical chart review
OTHERquestionnaire administration
PROCEDUREadjuvant therapy
PROCEDUREassessment of therapy complications
PROCEDUREcognitive assessment
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities | — |
Secondary
| Measure | 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 | — |
| 3-year disease-free survival | — |
Outcome results
None listed