No registrations found.
ID
Source
Brief title
Health condition
prostate cancer
prostaatkanker
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Process regret
- Option regret
- Outcome regret
Secondary outcome
- Patient preferences
- Reasons underlying these preferences
- Anxiety and Depression
- Health-related Quality of Life
Background summary
For primary localized prostate cancer different treatment options are available. The most frequently applied treatments are radical prostatectomy, external beam radiation therapy and brachytherapy. These treatments yield comparable results for tumor control, but they differ strongly in the procedure and their profile of side effects. The effect of involving patients into this treatment choice by means of a decision aid is the topic of this study.
Study objective
We hypothesise that regret is affected by adverse outcomes of the cancer treatment and not by patient involvement in the treatment choice.
Study design
- Baseline (before information on treatments)
- Pre-treatment (after information)
- 6 months after treatment choice
- 12 months after treatment choice
Intervention
The control group will receive usual care, i.e. the physician will discuss the options with the patients.
The intervention group will receive usual care plus structured information on the risks and benefits of the different treatment options by means of a purpose-built decision aid (DA) presented by a researcher. The use of DAs has been shown to increase the level of patient participation in treatment decisions.
Julia van Tol-Geerdink
Nijmegen 6500 HB
The Netherlands
024-3614515
julia.vantol-geerdink@radboudumc.nl
Julia van Tol-Geerdink
Nijmegen 6500 HB
The Netherlands
024-3614515
julia.vantol-geerdink@radboudumc.nl
Inclusion criteria
1. Primary localized prostate cancer (T1T2)
Exclusion criteria
1. Contra-indication for surgery
2. Aged over 70 years
3. Mental or cognitive problems
4. Inadequate knowledge of 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 | NL1288 |
| NTR-old | NTR1334 |
| Other | : KWF 2007-3809 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |