Prostate CancerPROCETNCT02503748
Prostate Cancer E-Health-Tutorial
A study testing Online tutorial in people with Prostate Cancer, run by Zurich University of Applied Sciences at 8 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Online tutorial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 8 sitesSwitzerland
- Study dates
- Jul 2015to 15 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Impaired judgment
- Insufficient ability to read and understand German
- Emotional problems
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Switzerland8 sites
UrologieZentrum Bern
Bern, Canton of Bern, 3000
Urologie, Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Urologische Universitätsklinik Basel, Kantonsspital Basselland
Liestal, Basel-Landschaft, 4410
Klinik für Urologie, Luzerner Kantonsspital
Lucerne, Canton of Lucerne, 6000
Urologische Klinik, Kantonsspital Münsterlingen
Münsterlingen, Thurgau, 8596
Urologisches Kompetenzzentrum soH
Olten, Canton of Solothurn, 4600
Klinik für Urologie, Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Klinik für Urologie, Stadtspital Triemli
Zurich, Canton of Zurich, 8036
About this study
Official title: 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.
Read the 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?
- Conditions
- Prostate Cancer
- Being tested
- Online tutorial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online tutorialOther
website informing about treatment options in localized prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Online Tutorial Receives: Other: Online tutorial |
What is being measured
The primary outcome is the main question the study is designed to answer.
information needs (own scale)
questionnaire developed in line with contents of the online tutorial
Measured: 4 months
Secondary outcomes (5)
Decision Quality: decisional conflict (Decisional Conflict Scale)
Measured: 1 month
Decision Quality: decision regret (Decision Regret Scale)
Measured: 4 months
Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)
Measured: 1 month
Role in decision making: Actual Role (Actual Role in Decision Making Scale)
Measured: 4 months
Preparation for Decision Making (Preparation for Decision Making Scale)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, René Schaffert, Zurich University of Applied Sciences
- Investigators
- René Schaffert, lic. phil., Principal investigator, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503748
- Sponsor's protocol ID
- ZH 2015-132
- Acronym
- PROCET
- Status last verified
- Apr 2017
- First submitted
- 16 Jul 2015
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer E-Health-Tutorial (PROCET): Multicenter, One-armed Intervention Study to Evaluate an Online Tutorial for Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02503748
- Acronym / sponsor ID
- PROCET / ZH 2015-132
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Online tutorialOnline Tutorial |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Impaired judgment
- Insufficient ability to read and understand German
- Emotional problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online tutorialwebsite informing about treatment options in localized prostate cancer | Other | Intervention |
Primary outcome
information needs (own scale)
Time frame: 4 months
questionnaire developed in line with contents of the online tutorial
5 secondary outcomes
Decision Quality: decisional conflict (Decisional Conflict Scale)
Time frame: 1 month
Decision Quality: decision regret (Decision Regret Scale)
Time frame: 4 months
Role in decision making: Preferred Role (Preferred Role in Decision Making Scale)
Time frame: 1 month
Role in decision making: Actual Role (Actual Role in Decision Making Scale)
Time frame: 4 months
Preparation for Decision Making (Preparation for Decision Making Scale)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
Related trials for Prostate Cancer
Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
RecruitingEarly Phase 1
FTT PET/CT in Metastatic Prostate Cancer
Prostate Cancer Metastatic
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingPhase 2
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Recurrent Prostate Cancer
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Schaffert, lic. phil. principal investigator
Zurich University of Applied Sciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online tutorial in people with Prostate Cancer, run by Zurich University of Applied Sciences at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
information needs (own scale) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.