Prospective Registration of Patient Data and Quality of Life in Eye Melanoma Patients

Last updated: March 10, 2025
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Treatment

Impact of side-effects analysis

Quality of life questionnaires

Discrete choice experiment

Clinical Study ID

NCT05377957
PROQEM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Clinical or pathological diagnosis of a melanoma of the choroid or ciliary body

  • No signs of metastasis after staging procedures with at least an X-thorax, bloodtest and an ultrasound of the liver

  • Treatment by brachytherapy, proton therapy or enucleation

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 500
Treatment Group(s): 4
Primary Treatment: Impact of side-effects analysis
Phase:
Study Start date:
March 05, 2019
Estimated Completion Date:
September 01, 2030

Study 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.

Connect with a study center

  • Leiden University Medical Center

    Leiden, Zuid-Holland 2333ZA
    Netherlands

    Active - Recruiting

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