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 Overview
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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.

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

Official Title
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An Observational Pilot Study to Compare the Compliance With and Health Related Quality of Life During Therapy With Standard High-Dose Interferon Alfa (Intron A, HDI) Versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) in Patients With Surgically Resected Melanoma

Conditions
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Melanoma

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intron A, HDI<br>High-dose interferon alfa (Intron A, HDI) | |
| Sylatron<br>Pegylated alfa-interferon 2b (Sylatron, PEG IFN) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Compliance with Standard High Dose Interferon (HDI) versus Sylatron | To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Quality of Life (Qol)for patients on HDI versus PEG IFN | To compare QOL for patients on standard HDI versus PEG IFN using chemotherapy convenience and satisfaction questionaire (CCSQ) and to evaluate the treatment-related side effects that may impact the patients health-related QOL using Functional Assessment of Cancer Therapy of Biologic Response Modifier (FACT-BRM) | 1 year | 
| Assess the frequency of Grade 3 and Grade 4 Toxicities | 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 | 1 year | 
| Examine the Reasons for Patients' Choice of Treatment with HDI versus PEG IFN | To examine reasons for patients' choice of treatment HDI versus PEG IFN, for those case in which patients are presented with a choice of either treatment option | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Stage III, adjuvant, Quality of Life