C61
Conditions
Interventions
Group 1: With 60,000 new diagnoses per year prostate cancer is the most common malignant disease in German men (Robert Koch Institute, 2016). There are various methods of treating prostate cancer, for
Sponsors
Urologische Universitätsklinik Heidelberg
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Histologically confirmed prostate adenocarcinoma, clinically not metastasized (cM0 or cMx), PSA < 100 ng/ml, age 18 - 80 years, internet access and e-mail address available
Exclusion criteria
Exclusion criteria: Lack of consent or lack of agreement ability to participate in the study, completed decision making for primary treatment, previous primary treatment, participation in another study on prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment decision: stronger guideline conform use of deferred treatment startegies after 14 months. The treatment decision is recorded at the 14-month follow-up by the study physician using predefined categories (watchful waiting; active surveillance; radical prostatectomy; percutaneous radiation therapy; brachytherapy; others). | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Knowledge: Knowledge Score (brief version) - measurement after use of intervention/control b) Acceptance: Acceptability e-scale - measurement after use of intervention/control c) Decision conflict: Decisional conflict scale (DCS) - measurement in follow-up after 1 month d) Doctor-patient communication: Man Son Hing scale - measurement in follow-up after 1 month e) Fear & Depressiveness: Patient Health Questionnaire-4 (PHQ-4) - Measurement after use of intervention/control and in follow-up after 1 and 14 months f) regret of the treatment decision: Decision regret scale (DRS) - measurement in follow-up after 14 months g) Quality of life: Expanded Prostate Cancer Index Composite (EPIC-26; 2 domains: incontinence and sexuality) - measurement in follow-up after 14 months | — |
Countries
Germany
Contacts
Public ContactElke Hempel
SMG Forschungsgesellschaft mbH
Outcome results
None listed