Long Term Quality of Life in Melanoma Patients in Netherlands

Bristol-Myers Squibb89 enrolled

Overview

Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Interventions

Non-InterventionalOTHER

Non-Interventional

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria- * Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration) * Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort Exclusion Criteria * Insufficient understanding of the Dutch language * Other anticancer treatment after ipilimumab or during study entry * Disease recurrence during the study Other protocol defined inclusion/exclusion criteria could apply

Locations (1)

Local Institution

Amsterdam, Netherlands

Outcomes

Primary Outcomes

European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)

EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).