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Prostate Cancer E-Health-Tutorial (PROCET)

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ClinicalTrials.gov Identifier: NCT02503748
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
René Schaffert, 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Online tutorial Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : July 2015
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention
Online Tutorial
Other: Online tutorial
website informing about treatment options in localized prostate cancer




Primary Outcome Measures :
  1. information needs (own scale) [ Time Frame: 4 months ]
    questionnaire developed in line with contents of the online tutorial


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503748


Locations
Switzerland
UrologieZentrum Bern
Bern, BE, Switzerland, 3000
Urologische Universitätsklinik Basel, Kantonsspital Basselland
Liestal, BL, Switzerland, 4410
Urologie, Kantonsspital Graubünden
Chur, GR, Switzerland, 7000
Klinik für Urologie, Luzerner Kantonsspital
Luzern, LU, Switzerland, 6000
Klinik für Urologie, Kantonsspital St. Gallen
St. Gallen, SG, Switzerland, 9007
Urologisches Kompetenzzentrum soH
Olten, SO, Switzerland, 4600
Urologische Klinik, Kantonsspital Münsterlingen
Münsterlingen, TG, Switzerland, 8596
Klinik für Urologie, Stadtspital Triemli
Zürich, ZH, Switzerland, 8036
Sponsors and Collaborators
Zurich University of Applied Sciences
Investigators
Principal Investigator: René Schaffert, lic. phil. Zurich University of Applied Sciences

Responsible Party: René Schaffert, lic.phil., Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT02503748     History of Changes
Other Study ID Numbers: ZH 2015-132
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases