Prostate Cancer E-Health-Tutorial (PROCET): Multicenter, One-armed Intervention Study to Evaluate an Online Tutorial for Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 16
- 主要终点
- information needs (own scale)
研究概览
简要总结
In a participatory process involving urologists and former patients, the project team has developed an online information system ("tutorial") for patients with localized prostate cancer. In this field test, relevant outcomes are measured and the tutorial will be tested for its clinical applicability.
详细描述
Prostate cancer is the most common cancer in men: In Switzerland, every year about 6,000 men are diagnosed with prostate cancer. Men with prostate cancer at an early stage are confronted with a difficult decision: they are faced with different treatment alternatives, each with its own advantages and disadvantages. That is why a comprehensive information delivery and processing is extremely important for patients to make an informed decision.
Therefore, an online platform has been developed in collaboration with urologists and former patients. This online platform is designed to cover the individual information needs of patients with early prostate cancer. Additionally, the software aims at facilitating cooperation between patients and doctors and at increasing the satisfaction of patients with their treatment decision.
In this study, the online platform will now to be tested in clinical practice, and data will be collected for the benefit of the platform: Can the online platform actually satisfy the indivudal information needs, facilitate the therapy decision and support the cooperation between doctors and patients?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Medical Inclusion Criteria:
- •tumor stage: clinical stage T1 or T2
- •PSA level <20 (PSA = Prostata-specific antigen)
- •Gleason score <8
- •age ≤ 75 years
- •Assumed life expectancy ≥ 10 years
- •Other inclusion criteria due to the study design and the type of intervention are the following:
- •patients have to be diagnosed in one of the trial sites
- •Internet-enabled device in the patient's household / basal user knowledge of this device
- •signing of the consent form
排除标准
- •Impaired judgment
- •Insufficient ability to read and understand German
- •Emotional problems
结局指标
主要结局
information needs (own scale)
时间窗: 4 months
questionnaire developed in line with contents of the online tutorial
次要结局
- Decision Quality: decisional conflict (Decisional Conflict Scale)(1 month)
- Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)(1 month)
- Decision Quality: decision regret (Decision Regret Scale)(4 months)
- Role in decision making: Actual Role (Actual Role in Decision Making Scale)(4 months)
- Preparation for Decision Making (Preparation for Decision Making Scale)(1 month)
研究者
René Schaffert
lic.phil.
Zurich University of Applied Sciences