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Clinical Trial 18922
Cancer Type: Cutaneous
Study Type: Other
Phase of Study: Phase IV
A US Multisite Observational Study in Patients with Unresectable and Metastatic Melanoma: the OPTIMIzE Study
The purpose of this study is to collect information about post-approval or "real world" experience on the treatment and management of unresectable or metastatic melanoma. This observational study will follow the regulator medical care of patients who have unresectable or metastatic melanoma and related conditions, the treatments given for this disease, and document the burden of disease on those who provide care to those patients.
Primary Objectives: 1) To describe patterns of care for patients receiving therapy for unresectable or metastatic melanoma (dosing, duration, regimen, indication, treatment rationales, switching rate, and reasons for treatment discontinuation). 2) To describe the patient demographic and clinical characteristics of patients receiving therapy for unresectable or metastatic melanoma. 3) To estimate overall survival (OS) in patients receiving therapy for unresectable or metastatic melanoma. Secondary Objectives: 1) To describe real-world use of healthcare resources in the treatment of unresectable or metastatic melanoma (ie, identify resource utilization across the treatment strategies). 2) To measure patient-reported outcomes using the European Quality of Life-5 Dimensions (EQ-5D), Functional Assessment of Cancer Therapy -Melanoma (FACT-M), and work productivity specific questions. 3) To characterize caregiver burden, described as number of hours spent by caregivers providing informal medical care and other services related to the patient's illness, and impact on caregiver quality of life. Exploratory Objectives: 1) Describe the occurrence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) to characterize changes in treatment patterns, as well as their treatment/management and outcomes, in a real world setting. 2) Assess the influence of patient demographic and clinical characteristics on the incidence and severity of treatment-related AEs.