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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01986712
• Other study ID #: Merck MISP 50422
• Status: Active, not recruiting
• First received: October 23, 2013
• Last updated: April 17, 2018
• Start date: December 2013
• Est. completion date: March 2022

Study information

• Verified date: April 2018
• Source: St. Luke's Hospital and Health Network, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: March 2022
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	St Luke's University Hospital and Health Network	Bethlehem	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Moffit Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sanjiv Agarwala, MD	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 questionaire (CCSQ) and to evaluate the treatment-related side effects that may impact the patients health-related QOL using Functional Assessment of Cancer Therapy of Biologic Response Modifier (FACT-BRM)	1 year
Secondary	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	1 year
Secondary	Examine the Reasons for Patients' Choice of Treatment with HDI versus PEG IFN	To examine reasons for patients' choice of treatment HDI versus PEG IFN, for those case in which patients are presented with a choice of either treatment option	1 year