Clinical trial NCT01986712: A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Melanoma, Stage III, adjuvant, Quality of Life
Lead sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with surgically resected melanoma receiving adjuvant therapy with HDI or PEG IFN thherapy

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

Eligibility 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

Primary outcomes:
measure: Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
timeFrame: 1 year
Secondary outcomes:
measure: Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN
timeFrame: baseline -week 1, week 3, week 13, week 25, week 50
measure: Assess the Frequency of Grade 3 and Grade 4 Toxicities
timeFrame: baseline-week 1, week 3, week 13, week 25, week 50
measure: Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN
timeFrame: baseline-week 1, week 3, week 13, week 25, week 50
measure: Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM)
timeFrame: Baseline-week 1, Week 3, week 13 week 25, week 50
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffit Cancer Center
state: Florida
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Bethlehem
country: United States
facility: St Luke's University Hospital and Health Network
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: St. Luke's Hospital and Health Network, Pennsylvania
name: Neil Belman, DO
role: PRINCIPAL_INVESTIGATOR
References: