NCT05377957

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
OTHER	Quality of life questionnaires	Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
OTHER	Discrete choice experiment	Assessment of patient preferences for outcomes of proton therapy and enucleation
OTHER	Shared decision-making analysis	Assessment of shared decision-making from the perspective of the patient (by questionnaire), physician (by questionnaire) and a neutral observer (by audiotape), combined with patient-reported satisfaction and regret of the treatment decision (by questionnaire)
OTHER	Impact of side-effects analysis	Assessment of the impact of side-effects by questionnaire

Timeline

• Start date: 2019-03-05
• Primary completion: 2028-04-01
• Completion: 2031-04-01
• First posted: 2022-05-17
• Last updated: 2026-04-15

Locations

1 site across 1 country: Netherlands