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Clinical Trials/NCT02503748
NCT02503748
Completed
N/A

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

Zurich University of Applied Sciences8 sites in 1 country53 target enrollmentJuly 2015
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Zurich University of Applied Sciences
Enrollment
53
Locations
8
Primary Endpoint
information needs (own scale)
Status
Completed
Last Updated
9 years ago

Overview

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?

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
February 15, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Zurich University of Applied Sciences
Responsible Party
Principal Investigator
Principal Investigator

René Schaffert

lic.phil.

Zurich University of Applied Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

information needs (own scale)

Time Frame: 4 months

questionnaire developed in line with contents of the online tutorial

Secondary Outcomes

  • 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)

Study Sites (8)

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