Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Uveal melanoma-related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Brachytherapy
Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy
干预措施: Quality of life questionnaires (Other)
Proton therapy
Uveal melanoma patients treated with proton therapy
干预措施: Quality of life questionnaires (Other)
Proton therapy
Uveal melanoma patients treated with proton therapy
干预措施: Discrete choice experiment (Other)
Proton therapy
Uveal melanoma patients treated with proton therapy
干预措施: Shared decision-making analysis (Other)
Proton therapy
Uveal melanoma patients treated with proton therapy
干预措施: Impact of side-effects analysis (Other)
Enucleation
Uveal melanoma patients treated with enucleation
干预措施: Quality of life questionnaires (Other)
Enucleation
Uveal melanoma patients treated with enucleation
干预措施: Discrete choice experiment (Other)
Enucleation
Uveal melanoma patients treated with enucleation
干预措施: Shared decision-making analysis (Other)
Enucleation
Uveal melanoma patients treated with enucleation
干预措施: Impact of side-effects analysis (Other)
结局指标
主要结局
Uveal melanoma-related quality of life
时间窗: 5 years
EORTC QLQ-OPT30
Health-related quality of life
时间窗: 5 years
EORTC QLQ-C30
General quality of life
时间窗: 5 years
EQ-5D-5L
Impact of the diagnosis and treatment of uveal melanoma on mental health
时间窗: 2 years
Impact of events scale
次要结局
- Shared decision-making(1 year)
- Patient preferences for outcomes of proton therapy and enucleation(Cross-sectional at baseline)
- Impact of side-effects of treatment for uveal melanoma(3 years)
研究者
Nanda Horeweg
Senior researcher, department of radiation oncology
Leiden University Medical Center