Prospective minimally interventional clinical trial of the Prostate Cancer Decision Aid to determine the reduction of decisional conflict and the strengthening of health literacy in patients with newly diagnosed, locally treatable prostate cancer
Phase 4
Recruiting
- Conditions
- Malignant neoplasm of prostateC61
- Registration Number
- DRKS00034308
- Lead Sponsor
- Philipps-Universität Marburg, Klinik für Urologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 500
Inclusion Criteria
Histologically confirmed prostate carcinoma before the start of primary therapy
- Age >18 years
- Proficiency in the German language
- Consent to participate in the study
- Ability to use a digital device with at least one relative
- Internet access and e-mail address available
Exclusion Criteria
- Age < 18 years
- Patients not able to give consent
- Patients under legal care
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of the decisional conflict (score of the Decisional Conflict Scale) by 12.5 points
- Secondary Outcome Measures
Name Time Method - Patient knowledge about prostate cancer (score of the test to assess the level of knowledge about prostate cancer)<br>- Emotional stress (score of the distress thermometer)<br>- Patient preference (questionnaire - What can you imagine? - multiple choice)<br>- Usability of the Prostate cancer decision aid<br>- Recording of possible side effects and risks