Clinical trial NCT02503748: Prostate Cancer E-Health-Tutorial
Official title: Prostate Cancer E-Health-Tutorial (PROCET): Multicenter, One-armed Intervention Study to Evaluate an Online Tutorial for Patients With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 53
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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?

Eligibility criteria: 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

Primary outcomes:
measure: information needs (own scale)
timeFrame: 4 months
Secondary outcomes:
measure: Decision Quality: decisional conflict (Decisional Conflict Scale)
timeFrame: 1 month
measure: Decision Quality: decision regret (Decision Regret Scale)
timeFrame: 4 months
measure: Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)
timeFrame: 1 month
measure: Role in decision making: Actual Role (Actual Role in Decision Making Scale)
timeFrame: 4 months
measure: Preparation for Decision Making (Preparation for Decision Making Scale)
timeFrame: 1 month
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: UrologieZentrum Bern
state: BE
city: Liestal
country: Switzerland
facility: Urologische Universitätsklinik Basel, Kantonsspital Basselland
state: BL
city: Chur
country: Switzerland
facility: Urologie, Kantonsspital Graubünden
state: GR
city: Luzern
country: Switzerland
facility: Klinik für Urologie, Luzerner Kantonsspital
state: LU
city: St. Gallen
country: Switzerland
facility: Klinik für Urologie, Kantonsspital St. Gallen
state: SG
city: Olten
country: Switzerland
facility: Urologisches Kompetenzzentrum soH
state: SO
city: Münsterlingen
country: Switzerland
facility: Urologische Klinik, Kantonsspital Münsterlingen
state: TG
city: Zürich
country: Switzerland
facility: Klinik für Urologie, Stadtspital Triemli
state: ZH
Study officials:
affiliation: Zurich University of Applied Sciences
name: René Schaffert, lic. phil.
role: PRINCIPAL_INVESTIGATOR
References: