NCT02503748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

July 16, 2015

Last Update Submit

April 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • information needs (own scale)

    questionnaire developed in line with contents of the online tutorial

    4 months

Secondary Outcomes (5)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

Online Tutorial

Other: Online tutorial

Interventions

website informing about treatment options in localized prostate cancer

Intervention

Eligibility Criteria

AgeUp to 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Impaired judgment
  • Insufficient ability to read and understand German
  • Emotional problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Urologische Universitätsklinik Basel, Kantonsspital Basselland

Liestal, Basel-Landschaft, 4410, Switzerland

Location

UrologieZentrum Bern

Bern, Canton of Bern, 3000, Switzerland

Location

Klinik für Urologie, Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Urologisches Kompetenzzentrum soH

Olten, Canton of Solothurn, 4600, Switzerland

Location

Klinik für Urologie, Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Klinik für Urologie, Stadtspital Triemli

Zurich, Canton of Zurich, 8036, Switzerland

Location

Urologie, Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

Location

Urologische Klinik, Kantonsspital Münsterlingen

Münsterlingen, Thurgau, 8596, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • René Schaffert, lic. phil.

    Zurich University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lic.phil.

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 21, 2015

Study Start

July 1, 2015

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations