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.
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 Type
OBSERVATIONAL
Enrollment
500
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Assessment of patient preferences for outcomes of proton therapy and enucleation
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)
Leiden University Medical Center
Leiden, South Holland, Netherlands
Uveal melanoma-related quality of life
EORTC QLQ-OPT30
Time frame: 5 years
Health-related quality of life
EORTC QLQ-C30
Time frame: 5 years
General quality of life
EQ-5D-5L
Time frame: 5 years
Impact of the diagnosis and treatment of uveal melanoma on mental health
Impact of events scale
Time frame: 2 years
Patient preferences for outcomes of proton therapy and enucleation
Discrete choice experiment
Time frame: Cross-sectional at baseline
Shared decision-making
Audiotape, iSHARE, satisfaction with decision scale, decision regret scale
Time frame: 1 year
Impact of side-effects of treatment for uveal melanoma
Questionnaire specifically developed for uveal melanoma
Time frame: 3 years
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Assessment of the impact of side-effects by questionnaire