Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986712
Recruitment Status : Active, not recruiting
First Posted : November 18, 2013
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sanjiv Agarwala, MD, St. Luke's Hospital and Health Network, Pennsylvania

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.

Condition or disease
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

Layout table for study information
Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : December 2013
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Interferon

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Compare Quality of Life (Qol)for patients on HDI versus PEG IFN [ Time Frame: 1 year ]
    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)

  2. Assess the frequency of Grade 3 and Grade 4 Toxicities [ Time Frame: 1 year ]
    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

  3. Examine the Reasons for Patients' Choice of Treatment with HDI versus PEG IFN [ Time Frame: 1 year ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986712


Locations
Layout table for location information
United States, Florida
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Pennsylvania
St Luke's University Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18015
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
Sponsors and Collaborators
Sanjiv Agarwala, MD
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Sanjiv Agarwala, MD St. Luke's Hospital and Health Network, Pennsylvania
Layout table for additonal information
Responsible Party: Sanjiv Agarwala, MD, Chief of Medical Oncology, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT01986712    
Other Study ID Numbers: Merck MISP 50422
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Sanjiv Agarwala, MD, St. Luke's Hospital and Health Network, Pennsylvania:
Melanoma, Stage III, adjuvant, Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas