This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.
This is a non-interventional, observational study with the primary objective to assess and describe "real world" patterns of care in the treatment of patients with unresectable or metastatic melanoma. A sample size of 1,600 prospective patients will provide sufficient information to explore this primary objective. There will be no forced number of patients enrolled into a specific treatment cohort. Setting or controlling specific treatment enrollment cohort counts would invalidate the results of the primary objective of the study. No primary hypothesis is being tested.
Study Type
OBSERVATIONAL
Enrollment
408
Patterns of Care
To assess the selection and sequencing of drugs and practice patterns used to treat unresectable and metastatic melanoma (e.g. immune checkpoint agents, targeted agents, or combination therapies) in a real-world setting. Reasons for initial treatment decisions across and between drug classes, changes in treatment, and discontinuation will be recorded (e.g. lack of benefit, safety, cost, or other barriers to care).
Time frame: Up to 5 years
Demographics
Baseline characteristics (age, gender, race/ethnicity)
Time frame: Up to 5 years
Overall Survival
To estimate overall survival in patients receiving therapy for unresectable or metastatic melanoma some statistical measurements and actual survival will be used.
Time frame: Up to 5 years
Disease Characteristics
Disease characteristics (date of diagnosis, disease stage, performance status)
Time frame: Up to 5 years
Healthcare Resource
To compare and describe healthcare utilization, imputed costs, and impact of initial treatment choice on lifetime or periodic costs. Due to potential differences between in patterns of care among various regions, region-specific analyses may be conducted for healthcare resource utilization.
Time frame: up to 5 years
Functional Assessments of Cancer Therapy-Melanoma (FACT-M)
Time frame: Up to 12 months
European Quality of Life-5 Dimensions (EQ-5D)
Time frame: Up to 12 months
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Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Pacific Shores Medical Group
Long Beach, California, United States
Cancer Care Associates
Redondo Beach, California, United States
University of Colorado
Aurora, Colorado, United States
21st Century Oncology
Jacksonville, Florida, United States
Cancer Specialits, LLC D/B/A
Jacksonville, Florida, United States
Lakeland Regional Health
Lakeland, Florida, United States
Watson Clinical Center for Research, INC
Lakeland, Florida, United States
UF Health Cancer Center at Orlando Health
Longwood, Florida, United States
...and 56 more locations
Work Productivity and Activity Impairment: General Health (WPAI:GH)
Time frame: Up to 12 months
The Caregiver Quality of Life Index - Cancer (CQOLC)
Time frame: Up to 12 months