Evaluation of a patient-oriented decision aid and the German healthcare situation in non-metastatic prostate cancer

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00014627
• Lead Sponsor: rologische Universitätsklinik Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-12
• Study Completion: 2021-11-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 1115

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
a) Knowledge: Knowledge Score (brief version) - measurement after use of intervention/control<br>b) Acceptance: Acceptability e-scale - measurement after use of intervention/control<br>c) Decision conflict: Decisional conflict scale (DCS) - measurement in follow-up after 1 month<br>d) Doctor-patient communication: Man Son Hing scale - measurement in follow-up after 1 month<br>e) Fear & Depressiveness: Patient Health Questionnaire-4 (PHQ-4) - Measurement after use of intervention/control and in follow-up after 1 and 14 months<br>f) regret of the treatment decision: Decision regret scale (DRS) - measurement in follow-up after 14 months<br>g) Quality of life: Expanded Prostate Cancer Index Composite (EPIC-26; 2 domains: incontinence and sexuality) - measurement in follow-up after 14 months