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

Recruiting

• Conditions: Uveal Melanoma
• Interventions: Other: Quality of life questionnaires; Other: Discrete choice experiment; Other: Shared decision-making analysis; Other: Impact of side-effects analysis

• Registration Number: NCT05377957
• Lead Sponsor: Leiden University Medical Center

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.

Study Timeline

• Study Start: 2019-03-05
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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, blood test and an ultrasound of the liver
• Treatment by brachytherapy, proton therapy or enucleation

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proton therapy	Discrete choice experiment	Uveal melanoma patients treated with proton therapy
Enucleation	Quality of life questionnaires	Uveal melanoma patients treated with enucleation
Brachytherapy	Quality of life questionnaires	Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy
Proton therapy	Quality of life questionnaires	Uveal melanoma patients treated with proton therapy
Proton therapy	Impact of side-effects analysis	Uveal melanoma patients treated with proton therapy
Enucleation	Discrete choice experiment	Uveal melanoma patients treated with enucleation
Enucleation	Impact of side-effects analysis	Uveal melanoma patients treated with enucleation
Proton therapy	Shared decision-making analysis	Uveal melanoma patients treated with proton therapy
Enucleation	Shared decision-making analysis	Uveal melanoma patients treated with enucleation

Primary Outcome Measures

Name	Time	Method
Uveal melanoma-related quality of life	5 years	EORTC QLQ-OPT30
Health-related quality of life	5 years	EORTC QLQ-C30
General quality of life	5 years	EQ-5D-5L
Impact of the diagnosis and treatment of uveal melanoma on mental health	2 years	Impact of events scale

Secondary Outcome Measures

Name	Time	Method
Shared decision-making	1 year	Audiotape, iSHARE, satisfaction with decision scale, decision regret scale
Patient preferences for outcomes of proton therapy and enucleation	Cross-sectional at baseline	Discrete choice experiment
Impact of side-effects of treatment for uveal melanoma	3 years	Questionnaire specifically developed for uveal melanoma

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands