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

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.

Study Overview

• Status: Recruiting
• Conditions: Uveal Melanoma
• Intervention / Treatment: Other: Quality of life questionnaires; Other: Discrete choice experiment; Other: Shared decision-making analysis; Other: Impact of side-effects analysis

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Nanda Horeweg, MD PhD; Phone Number: +31725165539; Email: n.horeweg@lumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333ZA
      • Recruiting
      • Leiden University Medical Center
      • Contact: Nanda Horeweg, MD PhD; Phone Number: +31725165539; Email: n.horeweg@lumc.nl
      • Principal Investigator: Coen RN Rasch, MD PhD
      • Principal Investigator: Gré PM Luyten, MD PhD
      • Principal Investigator: Marina Marinkovic, MD
      • Sub-Investigator: Arwen H Pieterse, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brachytherapy; Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy	Other: Quality of life questionnaires; 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
Proton therapy; Uveal melanoma patients treated with proton therapy	Other: Quality of life questionnaires; 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; Other: Discrete choice experiment; Assessment of patient preferences for outcomes of proton therapy and enucleation; Other Names: DCE; Other: Shared 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); Other Names: Audiotape; iSHARE; Satisfaction with decision scale; Decision regret scale; Other: Impact of side-effects analysis; Assessment of the impact of side-effects by questionnaire
Enucleation; Uveal melanoma patients treated with enucleation	Other: Quality of life questionnaires; 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; Other: Discrete choice experiment; Assessment of patient preferences for outcomes of proton therapy and enucleation; Other Names: DCE; Other: Shared 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); Other Names: Audiotape; iSHARE; Satisfaction with decision scale; Decision regret scale; Other: Impact of side-effects analysis; Assessment of the impact of side-effects by questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preferences for outcomes of proton therapy and enucleation	Discrete choice experiment	Cross-sectional at baseline
Shared decision-making	Audiotape, iSHARE, satisfaction with decision scale, decision regret scale	1 year
Impact of side-effects of treatment for uveal melanoma	Questionnaire specifically developed for uveal melanoma	3 years

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Study Chair: Nanda Horeweg, Md PhD, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Brachytherapy; Uveal Melanoma; Shared decision-making; Proton therapy; Patient preferences; Enucleation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: PROQEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PROQEM study adheres to the FAIR principles of data stewardship. Due to privacy regulations the data of the PROQEM study will not be made publicly accessible, but can be made available upon request.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Data available upon reasonable request. A research proposal should be send to the chief investigator. Subject to ethical approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No