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

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Uveal Melanoma

Treatments: Other: Discrete choice experiment; Other: Impact of side-effects analysis; Other: Quality of life questionnaires; Other: Shared decision-making analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05377957

PROQEM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Brachytherapy

Description:

Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy

Treatment:

Other: Quality of life questionnaires

Proton therapy

Description:

Uveal melanoma patients treated with proton therapy

Treatment:

Other: Shared decision-making analysis

Other: Quality of life questionnaires

Other: Impact of side-effects analysis

Other: Discrete choice experiment

Enucleation

Description:

Uveal melanoma patients treated with enucleation

Treatment:

Other: Shared decision-making analysis

Other: Quality of life questionnaires

Other: Impact of side-effects analysis

Other: Discrete choice experiment