Prostate Cancer E-Health-Tutorial

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Online tutorial

• Registration Number: NCT02503748
• Lead Sponsor: Zurich University of Applied Sciences

Brief Summary

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

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?

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Online tutorial	Online Tutorial

Primary Outcome Measures

Name	Time	Method
information needs (own scale)	4 months	questionnaire developed in line with contents of the online tutorial

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Klinik für Urologie, Luzerner Kantonsspital; 🇨🇭 Luzern, LU, Switzerland

Klinik für Urologie, Stadtspital Triemli; 🇨🇭 Zürich, ZH, Switzerland

Urologische Universitätsklinik Basel, Kantonsspital Basselland; 🇨🇭 Liestal, BL, Switzerland

Klinik für Urologie, Kantonsspital St. Gallen; 🇨🇭 St. Gallen, SG, Switzerland

Urologisches Kompetenzzentrum soH; 🇨🇭 Olten, SO, Switzerland

Urologische Klinik, Kantonsspital Münsterlingen; 🇨🇭 Münsterlingen, TG, Switzerland

UrologieZentrum Bern; 🇨🇭 Bern, BE, Switzerland

Urologie, Kantonsspital Graubünden; 🇨🇭 Chur, GR, Switzerland