No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Primary outcome measure is choice acceptance. At the end of the interview, the patient is asked whether he wants to choose one of the two treatment options, or whether he wants to leave the decision to the physician. The response to this question is choice acceptance. Choice acceptance is confirmed by telephone 2 days later. This measure is obtained about 10 days after the first consultation.
Secondary outcome
1. Substitute preferences of physicians,
2. quality of life measures,
3. decision evaluation measures,
4. coping measures,
5. knowledge measures,
6. treatment preferences.
Background summary
Do patients with prostate cancer want to choose between radiotherapeutic radiation dose levels after being informed with a decision aid?
Prospective trial with a time series format, that is a control-intervention-control group design. The main research question is answered in a prospective design.
The evaluation of the the decision aid is done in a controlled design.
The control group receives usual care. Accrual of the control group is before and after the accrual of the intervention group.
Study objective
More hopeful and autonomous patients will want to participate more often. Physicians are not capable to guess patient preferences.
The patients in the decision aid group will be better informed. The well-being of patients in the decision aid and control groups will be equal.
Study design
N/A
Intervention
Intervention group is usual care plus decision aid (150 patients).
Control group is usual care (150 patients), not receiving a decision aid.
Geert Grooteplein 14A
Room 0.10
P.F.M. Stalmeier
Geert Grooteplein 14A
Nijmegen
The Netherlands
+31 (0)24 3610592
p.stalmeier@mta.umcn.nl
Geert Grooteplein 14A
Room 0.10
P.F.M. Stalmeier
Geert Grooteplein 14A
Nijmegen
The Netherlands
+31 (0)24 3610592
p.stalmeier@mta.umcn.nl
Inclusion criteria
Patients with prostate cancer referred for radiotherapy with curative intent are eligible.
Exclusion criteria
Labile personality structure, as assessed by the physicians, and lack of understanding 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 | NL36 |
| NTR-old | NTR63 |
| Other | : Dutch Cancer Society 2001-2379 |
| ISRCTN | ISRCTN97145188 |