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OpenTrials
Completed

NCT Number: NCT02503748

Prostate Cancer E-Health-Tutorial

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.

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Key information

Age range

Up to 75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urologische Universitätsklinik Basel, Kantonsspital Basselland, Liestal, Basel-Landschaft, Switzerland

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About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online tutorial

Other

website informing about treatment options in localized prostate cancer

Primary outcomes

  1. information needs (own scale)

    Time frame: 4 months

    questionnaire developed in line with contents of the online tutorial

Secondary outcomes

  1. Decision Quality: decisional conflict (Decisional Conflict Scale)

    Time frame: 1 month

  2. Decision Quality: decision regret (Decision Regret Scale)

    Time frame: 4 months

  3. Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)

    Time frame: 1 month

  4. Role in decision making: Actual Role (Actual Role in Decision Making Scale)

    Time frame: 4 months

  5. Preparation for Decision Making (Preparation for Decision Making Scale)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Zurich University of Applied Sciences

Other

Registry information

Official study title

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

Acronym: PROCET

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2015
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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