Spots Global Cancer Trial Database for Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients

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Trial Identification

Brief Title: Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients

Official Title: Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients

Study ID: NCT05377957

Conditions

Uveal Melanoma

Interventions

Quality of life questionnaires

Discrete choice experiment

Shared decision-making analysis

Impact of side-effects analysis

Study Description

Brief Summary: PROQEM is a prospective cohort study among patients diagnosed with uveal melanoma to assess quality of life before and in the first five years after treatment.

Detailed Description: PROQEM is a prospective observational cohort study wherein patients with uveal melanoma are registered at diagnosis and are requested to fill in an array of questionaires before treatment and at 3, 6, 12, 24, 36 and 60 months after treatment. A comprehensive overview of the impact of their disease and treatment on quality of life is obtained by systematic assessment of the psychological impact of the initial diagnosis, eye symptoms, physical, emotional, social and role functioning. In addition, the PROQEM has a substudy called the PROQEM-pco (Preferences, Choices and Outcomes) for the subgroup of patients who are eligible for both proton therapy and enucleation. They are invited to participate in research on patient preferences and shared decision-making. The consultations wherein the treatment decision is made are audiotaped and data on perceived shared decision-making, preferences, decision satisfaction and -regret are collected by questionaires at baseline and in the first 36 months after treatment.