Trial Information

A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer

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.