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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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
Investigators
Neil Belman
Dr. Neil Belman
St. Luke's Hospital and Health Network, Pennsylvania
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
Time Frame: 1 year
To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy
Secondary Outcomes
- Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN(baseline -week 1, week 3, week 13, week 25, week 50)
- Assess the Frequency of Grade 3 and Grade 4 Toxicities(baseline-week 1, week 3, week 13, week 25, week 50)
- Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN(baseline-week 1, week 3, week 13, week 25, week 50)
- Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM)(Baseline-week 1, Week 3, week 13 week 25, week 50)