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NCT Number: NCT05377957

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life questionnaires

Other

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

Discrete choice experiment

Other

Assessment of patient preferences for outcomes of proton therapy and enucleation

Other names: DCE

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)

Other names: Audiotape, iSHARE, Satisfaction with decision scale, Decision regret scale

Impact of side-effects analysis

Other

Assessment of the impact of side-effects by questionnaire

Primary outcomes

  1. Uveal melanoma-related quality of life

    Time frame: 5 years

    EORTC QLQ-OPT30

  2. Health-related quality of life

    Time frame: 5 years

    EORTC QLQ-C30

  3. General quality of life

    Time frame: 5 years

    EQ-5D-5L

  4. Impact of the diagnosis and treatment of uveal melanoma on mental health

    Time frame: 2 years

    Impact of events scale

Secondary outcomes

  1. Patient preferences for outcomes of proton therapy and enucleation

    Time frame: Cross-sectional at baseline

    Discrete choice experiment

  2. Shared decision-making

    Time frame: 1 year

    Audiotape, iSHARE, satisfaction with decision scale, decision regret scale

  3. Impact of side-effects of treatment for uveal melanoma

    Time frame: 3 years

    Questionnaire specifically developed for uveal melanoma

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: PROQEM

Important dates

Study start
2019
Primary completion
2028
Study completion
2031
First posted
May 17, 2022
Registry last updated
Apr 15, 2026

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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