A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma

St. Luke's Hospital and Health Network

Status

Completed

Conditions

Melanoma

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01986712

Merck MISP 50422

Details and patient eligibility

About

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.

Full 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 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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is male or female at least 18 years of age
Patient has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
Patient is willing and able to give written informed consent
Patient is willing to comply with all study requirements

Exclusion criteria

Patient is unable or unwilling to complete QoL questionaire or compliance diary
Patient has a history of anaphylaxis due to any interferon alpha product
Patient has autoimmune hepatitis
Patient has decompensated liver disease (Child-Pugh score>6 ( Class B and C)
Patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements