To evaluate the compliance with and perceptions of treatment, as well as health-related
quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG
IFN therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01986712.
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
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationSt. Luke's Hospital and Health Network, Pennsylvania
