No registrations found.
ID
Source
Brief title
Health condition
Shared decision making, decision aid, prostate cancer, CRPC
Sponsors and support
Postbus 90151
5000 LC Tilburg
Delfland 17
1062 EA Amsterdam
Intervention
Outcome measures
Primary outcome
- Objective knowledge
- Informed choice
Secondary outcome
- Correlation between G8 score and treatment decision
- Correlation between TUG-test and treatment decision
- Quality of life
- Anxiety
- Value clarification
- Satisfaction with decision making, information and treatment
- Preparation for decision making
- Healthcare providers' evaluation of decision aid
- Partner involvement in SDM
- Treatment outcome (e.g. dose reductions, treatment delays, treatment discontinuation, treatment switch, and death)
Background summary
We will conduct a stepped wedge randomized controlled trial. Each hospital will start as control (standard care) and will switch randomly to the implementation of the decision aid at consecutive time points. The effectiveness of the decision aid will be assessed with questionnaires before and after implementation. Participants are asked to complete a questionnaire at four different points in time: shortly after being diagnosed (T0 = baseline), at the point of decision making (T1), and at follow up 3 and 6 months.
Study objective
The use of a web-based decision aid with value clarification exercises will improve patients' knowledge and will give patients realistic expectations of risks and benefits. Addition of the G8 (frailty instrument) and the Timed Up and Go-test as supportive screening tools will help clinicians to recognize frail patients who might require adapted treatment.
Study design
The effectiveness of the decision aid will be assessed with questionnaires before and after implementation. Participants are asked to complete a questionnaire at four different point in time: shortly after being diagnosed (T0 = baseline), at the point of decision making (T1), and at follow up 3 and 6 months.
Intervention
Decision aid with value clarification exercise
Isabel de Angst
Postbus 90151
Tilburg 5000 LC
The Netherlands
i.deangst@etz.nl
Isabel de Angst
Postbus 90151
Tilburg 5000 LC
The Netherlands
i.deangst@etz.nl
Inclusion criteria
- Men that are newly diagnosed with CRPC. CRPC is defined as any cancer progression under maximal hormonal treatment with anti-androgens and/or LHRH agonist or antagonist (when three consecutive rises of PSA are observed at castrate serum levels of testosterone (< 50 ng/dL or <1.7 nmol/L) and/or progression of osseous lesions is shown))
- Patients are eligible for at least two treatment options
- Patients have to be able to make use of a computer with internet-access in order to make use of the web-based decision aid
- Patients have to be able to complete a Dutch questionnaire
Exclusion criteria
- In the case of a second opinion the patient will not be included if the first opinion was obtained in one of the other involved hospitals and vice versa
- Patients who do not have sufficient knowledge of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6223 |
| NTR-old | NTR6379 |
| Other | METZ Brabant/16.280 : NW2016-55 |