Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
100

Summary

Conditions
Melanoma
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 sta...

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 patients' 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

Tracking Information

NCT #
NCT01986712
Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Sanjiv Agarwala, MD St. Luke's Hospital and Health Network, Pennsylvania