Leiden University Medical Center
Leiden, South Holland, 2333ZA, Netherlands
NCT Number: NCT05377957
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Leiden, South Holland, 2333ZA, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
Other names: EORTC-QLQ-C30, EORTC-QLQ-OPT30, EQ-5D-5L, Impact of events scale
Assessment of patient preferences for outcomes of proton therapy and enucleation
Other names: DCE
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: Audiotape, iSHARE, Satisfaction with decision scale, Decision regret scale
Assessment of the impact of side-effects by questionnaire
Time frame: 5 years
EORTC QLQ-OPT30
Time frame: 5 years
EORTC QLQ-C30
Time frame: 5 years
EQ-5D-5L
Time frame: 2 years
Impact of events scale
Time frame: Cross-sectional at baseline
Discrete choice experiment
Time frame: 1 year
Audiotape, iSHARE, satisfaction with decision scale, decision regret scale
Time frame: 3 years
Questionnaire specifically developed for uveal melanoma
Leiden University Medical Center
Other
Acronym: PROQEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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