Prostate Cancer E-Health-Tutorial

Prostate Cancer Clinical Trial

— PROCET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503748
• Other study ID #: ZH 2015-132
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: April 21, 2017
• Start date: July 2015
• Est. completion date: February 15, 2017

Study information

• Verified date: April 2017
• Source: Zurich University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Online tutorial
website informing about treatment options in localized prostate cancer

Locations

Country	Name	City	State
Switzerland	UrologieZentrum Bern	Bern	BE
Switzerland	Urologie, Kantonsspital Graubünden	Chur	GR
Switzerland	Urologische Universitätsklinik Basel, Kantonsspital Basselland	Liestal	BL
Switzerland	Klinik für Urologie, Luzerner Kantonsspital	Luzern	LU
Switzerland	Urologische Klinik, Kantonsspital Münsterlingen	Münsterlingen	TG
Switzerland	Urologisches Kompetenzzentrum soH	Olten	SO
Switzerland	Klinik für Urologie, Kantonsspital St. Gallen	St. Gallen	SG
Switzerland	Klinik für Urologie, Stadtspital Triemli	Zürich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	information needs (own scale)	questionnaire developed in line with contents of the online tutorial	4 months
Secondary	Decision Quality: decisional conflict (Decisional Conflict Scale)		1 month
Secondary	Decision Quality: decision regret (Decision Regret Scale)		4 months
Secondary	Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)		1 month
Secondary	Role in decision making: Actual Role (Actual Role in Decision Making Scale)		4 months
Secondary	Preparation for Decision Making (Preparation for Decision Making Scale)		1 month