Prostate Cancer E-Health-Tutorial (PROCET)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Online tutorial

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
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland, 3000
      • UrologieZentrum Bern
  • BL
    • Liestal, BL, Switzerland, 4410
      • Urologische Universitätsklinik Basel, Kantonsspital Basselland
  • GR
    • Chur, GR, Switzerland, 7000
      • Urologie, Kantonsspital Graubünden
  • LU
    • Luzern, LU, Switzerland, 6000
      • Klinik für Urologie, Luzerner Kantonsspital
  • SG
    • St. Gallen, SG, Switzerland, 9007
      • Klinik für Urologie, Kantonsspital St. Gallen
  • SO
    • Olten, SO, Switzerland, 4600
      • Urologisches Kompetenzzentrum soH
  • TG
    • Münsterlingen, TG, Switzerland, 8596
      • Urologische Klinik, Kantonsspital Münsterlingen
  • ZH
    • Zürich, ZH, Switzerland, 8036
      • Klinik für Urologie, Stadtspital Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
information needs (own scale)	questionnaire developed in line with contents of the online tutorial	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Decision Quality: decisional conflict (Decisional Conflict Scale)	1 month
Decision Quality: decision regret (Decision Regret Scale)	4 months
Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)	1 month
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

Collaborators and Investigators

• Sponsor: Zurich University of Applied Sciences
• Investigators: Principal Investigator: René Schaffert, lic. phil., Zurich University of Applied Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 15, 2017

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: ZH 2015-132