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

Completed

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT01986712

Run by

St. Luke's Hospital and Health Network, Pennsylvania

People needed

50

Starts

2013-12-01

Expected to finish

2019-09-17

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moffit Cancer Center — Tampa, Florida, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• St Luke's University Hospital and Health Network — Bethlehem, Pennsylvania, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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