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

Uveal Melanoma Clinical Trial

— PROQEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377957
• Other study ID #: PROQEM
• Status: Recruiting
• Start date: March 5, 2019
• Est. completion date: January 1, 2030

Study information

• Verified date: October 2023
• Source: Leiden University Medical Center
• Contact: Nanda Horeweg, MD PhD
• Phone: +31725165539
• Email: n.horeweg[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma

Intervention

Other:
• Quality of life questionnaires
Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis
• Discrete choice experiment
Assessment of patient preferences for outcomes of proton therapy and enucleation
• 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)
• Impact of side-effects analysis
Assessment of the impact of side-effects by questionnaire

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uveal melanoma-related quality of life	EORTC QLQ-OPT30	5 years
Primary	Health-related quality of life	EORTC QLQ-C30	5 years
Primary	General quality of life	EQ-5D-5L	5 years
Primary	Impact of the diagnosis and treatment of uveal melanoma on mental health	Impact of events scale	2 years
Secondary	Patient preferences for outcomes of proton therapy and enucleation	Discrete choice experiment	Cross-sectional at baseline
Secondary	Shared decision-making	Audiotape, iSHARE, satisfaction with decision scale, decision regret scale	1 year
Secondary	Impact of side-effects of treatment for uveal melanoma	Questionnaire specifically developed for uveal melanoma	3 years