Testing the effectiveness of a multi-criteria values clarification methods for patients with localized prostate cancer

Recruiting

Conditions: Shared decision making, Values clarification methods, decision aid, analytichierarchy process, prostate cancer

Registration Number: NL-OMON22110

Lead Sponsor: Elisabeth-Tweesteden Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

Men that are newly diagnosed with localized early staged prostate cancer. ‘Early stage’ prostate cancer is defined by a T1c-T2c tumour with a maximum PSA-score of 20 and a maximum Gleason-score of 7.

- Patients are eligible for active surveillance and active treatment.

Exclusion Criteria

- Patients with advanced cancer; the decision aid is not suitable for decisions involved in a more advanced stage of the cancer (any score higher than mentioned as inclusion criteria).

- If the urologist judges the patient is not in the right condition to participate, the patient will not be approached.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Disease-specific knowledge<br /><br>- Decisional Conflict (special interest: informed subscale) = subjective knowledge<br /><br>- Value congruence by measuring indicated preferences, changes in preferences<br /><br>- Decision quality

Secondary Outcome Measures

Name	Time	Method
Patients’ evaluation of the AHP- model (acceptability)<br /><br>- Consistency of patient’s answers<br /><br>- Reduction of proportion of patients who did not indicate a specific preferred treatment option after use of the DA by adding the AHP model to the existing DA.<br /><br>- Satisfaction with decision (making)<br /><br>- Satisfaction with treatment<br /><br>- Preparation for decision making - Decisional regret<br /><br>- Demographics<br /><br>- Health skills (numeracy and literacy)