RecruitingNCT05377957

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


Sponsor

Leiden University Medical Center

Enrollment

500 participants

Start Date

Mar 5, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • None

Interventions

OTHERQuality of life questionnaires

Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis

OTHERDiscrete choice experiment

Assessment of patient preferences for outcomes of proton therapy and enucleation

OTHERShared 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)

OTHERImpact of side-effects analysis

Assessment of the impact of side-effects by questionnaire


Locations(1)

Leiden University Medical Center

Leiden, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05377957


Related Trials