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

NCT05377957 | Active Not Recruiting

• 1 other identifier: PROQEM
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveal Melanoma

Keywords

Uveal Melanoma; Quality of Life; Shared decision-making; Patient preferences; Brachytherapy; Proton therapy; Enucleation

Outcome Measures

Primary Outcomes (4)

• Uveal melanoma-related quality of life

  EORTC QLQ-OPT30

  5 years

• Health-related quality of life

  EORTC QLQ-C30

  5 years

• General quality of life

  EQ-5D-5L

  5 years

• Impact of the diagnosis and treatment of uveal melanoma on mental health

  Impact of events scale

  2 years

Secondary Outcomes (3)

• Patient preferences for outcomes of proton therapy and enucleation

  Cross-sectional at baseline

• Shared decision-making

  1 year

• Impact of side-effects of treatment for uveal melanoma

  3 years

Study Arms (3)

Brachytherapy

Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy

Other: Quality of life questionnaires

Proton therapy

Uveal melanoma patients treated with proton therapy

Other: Quality of life questionnaires; Other: Discrete choice experiment; Other: Shared decision-making analysis; Other: Impact of side-effects analysis

Enucleation

Uveal melanoma patients treated with enucleation

Other: Quality of life questionnaires; Other: Discrete choice experiment; Other: Shared decision-making analysis; Other: Impact of side-effects analysis

Interventions

Quality of life questionnaires OTHER

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

Also known as: EORTC-QLQ-C30, EORTC-QLQ-OPT30, EQ-5D-5L, Impact of events scale

Brachytherapy; Enucleation; Proton therapy

Discrete choice experiment OTHER

Assessment of patient preferences for outcomes of proton therapy and enucleation

Also known as: DCE

Enucleation; Proton therapy

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)

Also known as: Audiotape, iSHARE, Satisfaction with decision scale, Decision regret scale

Enucleation; Proton therapy

Impact of side-effects analysis OTHER

Assessment of the impact of side-effects by questionnaire

Enucleation; Proton therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with uveal melanoma who will be treated with brachytherapy, proton therapy or enucleation with curative intent

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Uveal Melanoma; Patient Preference

Interventions

Tape Recording

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Nanda Horeweg, Md PhD

  Leiden University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, department of radiation oncology

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 17, 2022
• Study Start: March 5, 2019
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After completion of the analysis and publication of the secondary endpoints by the PROQEM research group; until 15 years after the last publication.
• Access Criteria: Data available upon reasonable request. A research proposal should be send to the chief investigator. Subject to ethical approval.

Locations

NL (1)