Prostate Cancer E-Health-Tutorial

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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Prostate Cancer E-Health-Tutorial (PROCET): Multicenter, One-armed Intervention Study to Evaluate an Online Tutorial for Patients With Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Online tutorial


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Impaired judgment Insufficient ability to read and understand German Emotional problems

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Online Tutorial | Other: Online tutorial<br>* website informing about treatment options in localized prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| information needs (own scale) | questionnaire developed in line with contents of the online tutorial | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Quality: decisional conflict (Decisional Conflict Scale) |  | 1 month | 
| Decision Quality: decision regret (Decision Regret Scale) |  | 4 months | 
| Role in decision making: Preferred Role (Preferred Role in Decision Making Scale) |  | 1 month | 
| 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 |