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Completed

NCT Number: NCT02794636

Interferon Toxicities in Melanoma Treatment

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.

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Key information

Conditions

Stage III Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy

    Time frame: 180 days prior to the index date

  2. Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy

    Time frame: 180 days after the index date

  3. Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy

    Time frame: 180 days prior to the index date

  4. Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy

    Time frame: 180 days after the index date

  5. Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy

    Time frame: 180 days prior to the index date

  6. Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy

    Time frame: 180 days after the index date

Secondary outcomes

  1. Pre-IFN treatment period Health care costs related to depression

    Time frame: 180 days prior to the index date

  2. Post-IFN treatment period Health care costs related to depression

    Time frame: 180 days after the index date

  3. Pre-IFN treatment period Health care costs related to fatigue

    Time frame: 180 days prior to the index date

  4. Post-IFN treatment period Health care costs related to fatigue

    Time frame: 180 days after the index date

  5. Pre-IFN treatment period Health care costs related to myalgia

    Time frame: 180 days prior to the index date

  6. Post-IFN treatment period Health care costs related to myalgia

    Time frame: 180 days after the index date

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: ITMT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2016
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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