NCT04694924招募中不适用
Promoting Quality of Care: a Prospective Cohort Study of Localized and Locally Advanced Prostate Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 4
- 主要终点
- Assessment of systematically reporting a standardized set of predefined clinical parameters
研究概览
简要总结
This study aims to evaluate the use of a digital solution, integrated into the electronic health record, for prospective and structured reporting of clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathology confirmed diagnosis of localized or locally advanced prostate cancer
- •Being able to speak, read and understand Dutch, French, or English
- •Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and is willing to participate in the study.
排除标准
- •Patients with prior treatment for prostate malignancies will be excluded.
- •Dementia, mental alteration, or psychiatric pathology that can compromise informed consent from the patient and/ or adherence to the protocol and the monitoring of the trial
- •Patients who cannot submit themselves to following the protocol for psychological reasons, social, family, or geographical.
- •Persons deprived of liberty or under guardianship
结局指标
主要结局
Assessment of systematically reporting a standardized set of predefined clinical parameters
时间窗: up to 10 years after diagnosis
The proportion of patients who are enrolled in the registry over the total localized and locally advanced prostate cancer patients
Assessment of systematically collecting a predefined set of patient-reported outcomes
时间窗: up to 10 years after diagnosis
The proportion of patients who completed all questionnaires over the total of questionnaires send.
次要结局
- Occurence of disease recurrence/progression(up to 10 years after diagnosis)
- General quality of life(at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis)
- Prostate cancer specific quality of life(at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis)
- Overall Survival (OS)(up to 10 years after diagnosis)
- Prostate Cancer (PC)-related Mortality (PM)(up to 10 years after diagnosis)
研究者
研究点 (4)
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