Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia (DOSE)
The purpose of this study is to describe patient characteristics, treatment patterns, and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy (EST).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Dosing and Outcomes Study of Erythropoietic Stimulating Therapies|
- To document patient characteristics and patterns of clinical management [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.
- To assess the relationships between patient characteristics, treatment patterns and outcomes [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- To measure economic impacts, and quality of life [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2003|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Patients with chemotherapy induced anemia||
Other: Patients with chemotherapy induced anemia
Physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the database. Patients will have to fill the questionaire at the time of enrollment and baseline.
The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (DOSE) is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with EST; eg, epoetin alfa or darbepoetin alfa. The planned duration of the DOSE Registry is three years. Based on initial results, the registry sponsor may elect to extend the duration of the registry.This study does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on baseline patient characteristics, treatment patterns, and clinical outcomes. Baseline determinations will include patient demographics, tumor and treatment type, hematologic parameters, and patient reported outcomes. Data will be collected over the 16-week study period with regard to EST treatment, hematologic outcomes and patient reported outcomes.