Clinical trial NCT05377957: Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
Official title: Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveal Melanoma
Keywords: Uveal Melanoma
Quality of Life
Shared decision-making
Patient preferences
Brachytherapy
Proton therapy
Enucleation
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with uveal melanoma who will be treated with brachytherapy, proton therapy or enucleation with curative intent

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.

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.

Eligibility 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

Primary outcomes:
measure: Uveal melanoma-related quality of life
timeFrame: 5 years
measure: Health-related quality of life
timeFrame: 5 years
measure: General quality of life
timeFrame: 5 years
measure: Impact of the diagnosis and treatment of uveal melanoma on mental health
timeFrame: 2 years
Secondary outcomes:
measure: Patient preferences for outcomes of proton therapy and enucleation
timeFrame: Cross-sectional at baseline
measure: Shared decision-making
timeFrame: 1 year
measure: Impact of side-effects of treatment for uveal melanoma
timeFrame: 3 years
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Nanda Horeweg, Md PhD
role: STUDY_CHAIR
References: