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Prostate Cancer E-Health-Tutorial (PROCET)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Online tutorial
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UrologieZentrum Bern
  • Urologische Universitätsklinik Basel, Kantonsspital Basselland
  • Urologie, Kantonsspital Graubünden
  • Klinik für Urologie, Luzerner Kantonsspital
  • Klinik für Urologie, Kantonsspital St. Gallen
  • Urologisches Kompetenzzentrum soH
  • Urologische Klinik, Kantonsspital Münsterlingen
  • Klinik für Urologie, Stadtspital Triemli

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Online Tutorial

Outcomes

Primary Outcome Measures

information needs (own scale)
questionnaire developed in line with contents of the online tutorial

Secondary Outcome Measures

Decision Quality: decisional conflict (Decisional Conflict Scale)
Decision Quality: decision regret (Decision Regret Scale)
Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)
Role in decision making: Actual Role (Actual Role in Decision Making Scale)
Preparation for Decision Making (Preparation for Decision Making Scale)

Full Information

First Posted
July 16, 2015
Last Updated
April 21, 2017
Sponsor
Zurich University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02503748
Brief Title
Prostate Cancer E-Health-Tutorial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zurich University of Applied Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Online Tutorial
Intervention Type
Other
Intervention Name(s)
Online tutorial
Intervention Description
website informing about treatment options in localized prostate cancer
Primary Outcome Measure Information:
Title
information needs (own scale)
Description
questionnaire developed in line with contents of the online tutorial
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Decision Quality: decisional conflict (Decisional Conflict Scale)
Time Frame
1 month
Title
Decision Quality: decision regret (Decision Regret Scale)
Time Frame
4 months
Title
Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)
Time Frame
1 month
Title
Role in decision making: Actual Role (Actual Role in Decision Making Scale)
Time Frame
4 months
Title
Preparation for Decision Making (Preparation for Decision Making Scale)
Time Frame
1 month

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Schaffert, lic. phil.
Organizational Affiliation
Zurich University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
UrologieZentrum Bern
City
Bern
State/Province
BE
ZIP/Postal Code
3000
Country
Switzerland
Facility Name
Urologische Universitätsklinik Basel, Kantonsspital Basselland
City
Liestal
State/Province
BL
ZIP/Postal Code
4410
Country
Switzerland
Facility Name
Urologie, Kantonsspital Graubünden
City
Chur
State/Province
GR
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Klinik für Urologie, Luzerner Kantonsspital
City
Luzern
State/Province
LU
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Klinik für Urologie, Kantonsspital St. Gallen
City
St. Gallen
State/Province
SG
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Urologisches Kompetenzzentrum soH
City
Olten
State/Province
SO
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Urologische Klinik, Kantonsspital Münsterlingen
City
Münsterlingen
State/Province
TG
ZIP/Postal Code
8596
Country
Switzerland
Facility Name
Klinik für Urologie, Stadtspital Triemli
City
Zürich
State/Province
ZH
ZIP/Postal Code
8036
Country
Switzerland

12. IPD Sharing Statement

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Prostate Cancer E-Health-Tutorial

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