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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brachytherapy | Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy |
| |
| Proton therapy | Uveal melanoma patients treated with proton therapy |
| |
| Enucleation | Uveal melanoma patients treated with enucleation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life questionnaires | Other | Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with uveal melanoma who will be treated with brachytherapy, proton therapy or enucleation with curative intent
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| Name | Affiliation | Role |
|---|---|---|
| Nanda Horeweg, Md PhD | Leiden University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
The PROQEM study adheres to the FAIR principles of data stewardship. Due to privacy regulations the data of the PROQEM study will not be made publicly accessible, but can be made available upon request.
After completion of the analysis and publication of the secondary endpoints by the PROQEM research group; until 15 years after the last publication.
Data available upon reasonable request. A research proposal should be send to the chief investigator. Subject to ethical approval.
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D013637 | Tape Recording |
| ID | Term |
|---|---|
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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|
| 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 |
|
| 1 year |
| Impact of side-effects of treatment for uveal melanoma | Questionnaire specifically developed for uveal melanoma | 3 years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |