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.
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
Study Type
OBSERVATIONAL
Enrollment
50
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
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
Time frame: 1 year
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 questionnaire (CCSQ). The CCSQ measures the construct "chemotherapy convenience and satisfaction" and includes 10 questions \[scores from 0 ("not at all") to 4 ("very much"), maximum possible summative score = 40\]. Higher scores signify a better outcome. Minimum possible summative score = 0.
Time frame: baseline -week 1, week 3, week 13, week 25, week 50
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
Time frame: baseline-week 1, week 3, week 13, week 25, week 50
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN
To examine reasons for patients' choice of treatment HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option (percentage answering "very important", "somewhat important", or "not important" for "frequency", "toxicity", "effectiveness", "convenience", and "length").
Time frame: baseline-week 1, week 3, week 13, week 25, week 50
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM)
To compare QOL for patients on standard HDI versus PEG IFN using the Functional Assessment of Cancer Therapy - biologic response modifier, questionnaire (FACT-BRM). The FACT-BRM measures the construct "Functional Assessment of Cancer Therapy" and includes 40 questions \[scores from 0 ("not at all") to 4 ("very much"), maximum possible summative score = 160\]. Due to the nature of their items, the Social/Family Well-Being and Functional Well-Being subscale scores were reverse coded. For the summative score, higher scores signify a worse outcome. Minimum possible summative score = 0.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline-week 1, Week 3, week 13 week 25, week 50