The goal of the proposed multi-center randomized trial, which in May 1995 was increased to include 892 patients (rather than the 2/95 figure of 654 patients) is to assess the relative safety, costs, and effects on patient well-being of two alternative treatment settings for the antibiotic therapy of low-risk cancer patients with fever and neutropenia. Early discharge to home antibiotic therapy will be compared to the usual pattern of care, which is to keep patients in the hospital until fever and neutropenia have resolved, in a multi-center limited-access randomized trial within the Cancer and Leukemia Group B (CALGB). To achieve this goal, 892 cancer patients with fever and neutropenia will be identified for low risk of medical complications using a prospectively validated clinical prediction rule. These patients will enrolled in a randomized, multi-center study comparing conventional, in-hospital therapy with a program, previously piloted in 30 patients at the Dana-Farber Cancer Institute (DFCI), of early discharge to home antibiotic therapy and careful medical follow-up, with medical, economic, and quality of life outcomes. The study will be conducted through the CALGB, with patients enrolled at six main member sites, which are major tertiary care cancer referral centers, and six Community Clinical Oncology Program (CCOP) sites, which are community hospitals whose clinical investigation programs are supported by the National Cancer Institute. Two participating home care companies have agreed to provide home therapy without cost to the patients, to designate a nurse at each study site to provide care and, to collect data, and to provide care to Medicare patients at cost. The study hypothesis is that the positive effects of added freedom, comfort, and familiarity in the home setting will balance or outweigh the increased burden of transportation, minor medical tasks and potential anxiety resulting from reduced medical surveillance among home-treated patients. Consequently, home-treated patients will have equal or improved quality of life measurements compared to those treated in hospitals. The study will take place over five years, with an initial six-month start-up period, four years for patient accrual and follow-up, and the remaining time for data analysis. Eligibility of patients will be assessed at approximately 36 hours after presentation to hospital for fever and neutropenia. In response to 2/95 questions, the project team has clarified that it will not allow multiple enrollments of the same patient into the study (for multiple episodes of fever and neutropenia). This will avoid any biases related to underlying conditions in patients that carry across episodes. Patients randomized to the home antibiotics arm will be discharged as soon as antibiotics can be made available at home -- in nearly all cases on the day of randomization, but at least within 48 hours after the randomization. A number of required laboratory studies for both baseline and antibiotic monitoring are outlined. The visiting nurse will take vital signs daily. Oral temperatures and systemic blood pressure will be monitored using equipment provided by the participating home care company, and will be recorded by the patient daily within 30 minutes of awakening and returning to bed, and at 10am, 2pm, 6pm, and 10pm under the supervision of the study nurse. As noted, patients assigned to home antibiotic care will be examined daily by the study nurse under the supervision of a physician familiar with the study. Patients will be evaluated by a physician in specified circumstances. Conditions requiring hospital readmission for patients assigned to home care are also specified. The period of observation extends until the resolution of fever and neutropenia, the discontinuation of antibiotics, and the resolutions of any complications arising during the period of fever and neutropenia. All patients entered into the study will be treated with broad spectrum antibiotics intravenously until neutropenia has resolved.
| Talcott, James A; Yeap, Beow Y; Clark, Jack A et al. (2011) Safety of early discharge for low-risk patients with febrile neutropenia: a multicenter randomized controlled trial. J Clin Oncol 29:3977-83 |
| Hendricks, Ann M; Loggers, Elizabeth Trice; Talcott, James A (2011) Costs of home versus inpatient treatment for fever and neutropenia: analysis of a multicenter randomized trial. J Clin Oncol 29:3984-9 |
| Talcott, J A (2000) Out-patient management of febrile neutropenia. Int J Antimicrob Agents 16:169-71 |
