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

January 23, 2025 updated by: Neil Belman, St. Luke's Hospital and Health Network, Pennsylvania

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN
Time Frame: baseline -week 1, week 3, week 13, week 25, week 50

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
Time Frame: baseline-week 1, week 3, week 13, week 25, week 50
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
Time Frame: baseline-week 1, week 3, week 13, week 25, week 50
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)
Time Frame: Baseline-week 1, Week 3, week 13 week 25, week 50

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merck MISP 50422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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