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Clinical Trials/NCT01986712
NCT01986712CompletedNot Applicable

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

St. Luke's Hospital and Health Network, Pennsylvania4 sites in 1 country50 target enrollmentStarted: December 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
4
Primary Endpoint
Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Neil Belman

Dr. Neil Belman

St. Luke's Hospital and Health Network, Pennsylvania

Study Sites (4)

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