Clinical trial NCT02794636: Interferon Toxicities in Melanoma Treatment
Official title: Analysis of the Clinical and Economic Impact of Adverse Events and Medication-related Toxicities Associated With Interferon (IFN) Treatment for Patients With Stage III Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage III Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-06-09
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health plan enrollees whose data are reflected in the Truven Health MarketScan Commercial and Medicare Supplemental database. This database captures clinical utilization, expenditures and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations

Brief summary: The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. The date of the first observed claim will be defined as the index date
* Patients with a melanoma diagnosis based on two medical claims prior to the index date
* Patients with a procedure code for melanoma-related lymph node dissection before the index date
* Patients ≥ 18 years of age on or before the index date
* Patients with continuous benefit enrollment for at least 180 days before and after the index date

Exclusion Criteria:

* Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
* Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
* Patients who received systemic chemotherapy during the pre- or post-index period

Primary outcomes:
measure: Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy
timeFrame: 180 days prior to the index date
measure: Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy
timeFrame: 180 days after the index date
measure: Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy
timeFrame: 180 days prior to the index date
measure: Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy
timeFrame: 180 days after the index date
measure: Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy
timeFrame: 180 days prior to the index date
measure: Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy
timeFrame: 180 days after the index date
Secondary outcomes:
measure: Pre-IFN treatment period Health care costs related to depression
timeFrame: 180 days prior to the index date
measure: Post-IFN treatment period Health care costs related to depression
timeFrame: 180 days after the index date
measure: Pre-IFN treatment period Health care costs related to fatigue
timeFrame: 180 days prior to the index date
measure: Post-IFN treatment period Health care costs related to fatigue
timeFrame: 180 days after the index date
measure: Pre-IFN treatment period Health care costs related to myalgia
timeFrame: 180 days prior to the index date
measure: Post-IFN treatment period Health care costs related to myalgia
timeFrame: 180 days after the index date
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: