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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-09-17

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intron A, HDI

High-dose interferon alfa (Intron A, HDI)

No interventions assigned to this group

Sylatron

Pegylated alfa-interferon 2b (Sylatron, PEG IFN)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No