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

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma

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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffit Cancer Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St Luke's University Hospital and Health Network
  • Utah
    • Salt Lake City, Utah, United States, 84112-5550
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with surgically resected melanoma receiving adjuvant therapy with HDI or PEG IFN thherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Intron A, HDI; High-dose interferon alfa (Intron A, HDI)
Sylatron; Pegylated alfa-interferon 2b (Sylatron, PEG IFN)

What is the study measuring?

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 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.	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	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").	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.	Baseline-week 1, Week 3, week 13 week 25, week 50

Collaborators and Investigators

• Sponsor: St. Luke's Hospital and Health Network, Pennsylvania
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Neil Belman, DO, St. Luke's Hospital and Health Network, Pennsylvania

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: November 11, 2013
• First Posted (Estimated): November 18, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Melanoma, Stage III, adjuvant, Quality of Life
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: Merck MISP 50422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES