NCT02853409已完成不适用
Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 628
- 试验地点
- 14
- 主要终点
- Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
研究概览
简要总结
The purpose of this study is to evaluate possible changes in quality of life related to health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥ 18 years old
- •Symptomatic prostate cancer patients who present symptoms due to prostate cancer disease
- •Capacity to comply with the protocol
- •Patient with an expected survival > 12 months
排除标准
- •Patients who are also participating in any other clinical study
- •Patient with other malignant diseases, apart from prostate cancer
结局指标
主要结局
Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
时间窗: 12 months
次要结局
- Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)(12 months)
- Quality of life using EQ-5D questionnaire(12 months)
- Socio-demographic characteristics (percentage of patients (a) living married or living with a partner, (b) had completed primary studies, (c) retired or pensioners, (d) patients had a family history of PrCa)(12 months)
- Anthropometric Characteristics - Body Mass Index(Baseline)
- Prostate-specific Antigen (PSA)(Baseline, 12 months)
- Testosterone level(Baseline, 12 months)
- Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)(12 months)
- Change in general health status perception (from either patient or physician perspective)(12 months)
- Digital rectal examination(Baseline, 12 months)
研究者
研究点 (14)
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