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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uveal Melanoma

Intervention / Treatment
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* Other: Quality of life questionnaires
* Other: Discrete choice experiment
* Other: Shared decision-making analysis
* Other: Impact of side-effects analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brachytherapy<br>Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy | Other: Quality of life questionnaires<br>* Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis<br>* Other names: Impact of events scale;|
| Proton therapy<br>Uveal melanoma patients treated with proton therapy | Other: Quality of life questionnaires<br>* Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis<br>* Other names: Impact of events scale;Other: Discrete choice experiment<br>* Assessment of patient preferences for outcomes of proton therapy and enucleation<br>* Other names: DCE;Other: Shared decision-making analysis<br>* 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)<br>* Other names: Decision regret scale;Other: Impact of side-effects analysis<br>* Assessment of the impact of side-effects by questionnaire<br>|
| Enucleation<br>Uveal melanoma patients treated with enucleation | Other: Quality of life questionnaires<br>* Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis<br>* Other names: Impact of events scale;Other: Discrete choice experiment<br>* Assessment of patient preferences for outcomes of proton therapy and enucleation<br>* Other names: DCE;Other: Shared decision-making analysis<br>* 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)<br>* Other names: Decision regret scale;Other: Impact of side-effects analysis<br>* Assessment of the impact of side-effects by questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enucleation, Uveal Melanoma, Quality of Life, Shared decision-making, Patient preferences, Brachytherapy, Proton therapy