Understanding How Uveal Melanoma and Its Treatment Affect Your Life
Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
In Plain English
This study, called PROQEM, is designed to understand how an eye melanoma diagnosis and treatment affect your quality of life over five years. You're not receiving a new treatment in this study—instead, you're helping researchers learn about the real-world impact of the disease and standard treatments (like proton therapy or eye removal surgery) on patients like you. This information will help doctors better support future patients. If you join, you'll be asked to fill out questionnaires before your treatment and then at regular intervals (3, 6, 12, 24, 36, and 60 months after treatment). These questionnaires ask about how you're feeling emotionally, how well you're functioning in daily life, any eye symptoms you're experiencing, and how the diagnosis and treatment have affected your relationships and work. There's also a special sub-study (PROQEM-pco) for patients who have a choice between two different treatments—this part focuses on helping doctors understand how to better involve you in making that decision and whether you feel satisfied with your choice afterward. This is an observational study, meaning researchers are watching and documenting your experience rather than testing a new drug or procedure. Your honest feedback helps create a clearer picture of what patients actually go through, which can improve care for others in the future.
What This Trial Does
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.
How It Works
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.
Who Can Join
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
Treatments
Quality of life questionnaires (OTHER)
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Discrete choice experiment (OTHER)
Assessment of patient preferences for outcomes of proton therapy and enucleation
Shared decision-making analysis (OTHER)
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)
Impact of side-effects analysis (OTHER)
Assessment of the impact of side-effects by questionnaire
Trial Sites (1)
Leiden University Medical Center
Leiden, South Holland, Netherlands
Nanda Horeweg, MD PhD · n.horeweg@lumc.nl
Recruiting