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Clinical Trial 18686
Cancer Type: Cutaneous
Interventions:PEG-Intron (Peginterferon Alfa 2B); interferon alfa
Study Type: Other
Phase of Study: Phase IV
An Observational Pilot Study to Compare the Compliance with and Health Related Quality of Life during Therapy with Standard High-Dose Interferon Alfa (Intron® A, HDI) versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) in Patients with Surgically Resected Melanoma
The purpose of this study is to evaluate patient cooperation and impression of treatment, as well as to assess the health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing standard High-Dose Interferon Alfa (Intron® A, HDI) versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) therapy.
The primary objective of this study is: To evaluate compliance with the administration of standard HDI versus PEG IFN for patients with melanoma in need of adjuvant therapy. The secondary objectives of this study are: To compare the convenience and satisfaction with chemotherapy for patients on standard HDI versus PEG IFN using a chemotherapy convenience and satisfaction questionnaire (CCSQ) and to evaluate the treatment-related side effects that may impact the patient's HRQOL using the Functional Assessment of Cancer Therapy of Biologic Response Modifier (FACT-BRM). To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on standard HDI versus PEG IFN. To examine reasons for patient's choice of treatment with HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option. To assess Health Resource Utilization on both arms of the study.