|- candidate number||0|
|- NTR Number||NTR63|
|- Date ISRCTN created||12-sep-2005|
|- date ISRCTN requested||15-aug-2005|
|- Date Registered NTR||6-jul-2005|
|- Secondary IDs||Dutch Cancer Society 2001-2379 |
|- Public Title||Patient involvement in prostate cancer treatment decisions.|
|- Scientific Title||Patient involvement in prostate cancer treatment decisions.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- 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. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2001|
|- planned closingdate||31-dec-2006|
|- Target number of participants||300|
|- Interventions||Intervention group is usual care plus decision aid (150 patients).|
Control group is usual care (150 patients), not receiving a decision aid.
|- 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.
|- Trial web site||http://www.ebp-umcn.org/home.htm go to \departments\medical techology assesment\staff\stalmeier|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.F.M. Stalmeier|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.F.M. Stalmeier|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||28-jul-2005 - 14-sep-2009|