PROQEM: Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Brachytherapy Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy |
Other: Quality of life questionnaires
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Other Names:
|
| Proton therapy Uveal melanoma patients treated with proton therapy |
Other: Quality of life questionnaires
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Other Names:
Other: Discrete choice experiment
Assessment of patient preferences for outcomes of proton therapy and enucleation
Other Names:
Other: Shared decision-making analysis
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)
Other Names:
Other: Impact of side-effects analysis
Assessment of the impact of side-effects by questionnaire
|
| Enucleation Uveal melanoma patients treated with enucleation |
Other: Quality of life questionnaires
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Other Names:
Other: Discrete choice experiment
Assessment of patient preferences for outcomes of proton therapy and enucleation
Other Names:
Other: Shared decision-making analysis
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)
Other Names:
Other: Impact of side-effects analysis
Assessment of the impact of side-effects by questionnaire
|
Outcome Measures
Primary Outcome Measures
- Uveal melanoma-related quality of life [5 years]
EORTC QLQ-OPT30
- Health-related quality of life [5 years]
EORTC QLQ-C30
- General quality of life [5 years]
EQ-5D-5L
- Impact of the diagnosis and treatment of uveal melanoma on mental health [2 years]
Impact of events scale
Secondary Outcome Measures
- Patient preferences for outcomes of proton therapy and enucleation [Cross-sectional at baseline]
Discrete choice experiment
- Shared decision-making [1 year]
Audiotape, iSHARE, satisfaction with decision scale, decision regret scale
- Impact of side-effects of treatment for uveal melanoma [3 years]
Questionnaire specifically developed for uveal melanoma
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Leiden University Medical Center | Leiden | Zuid-Holland | Netherlands | 2333ZA |
Sponsors and Collaborators
- Leiden University Medical Center
Investigators
- Study Chair: Nanda Horeweg, Md PhD, Leiden University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PROQEM