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Patient involvement in prostate cancer treatment decisions.


- candidate number0
- NTR NumberNTR63
- ISRCTNISRCTN97145188
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR6-jul-2005
- Secondary IDsDutch Cancer Society 2001-2379 
- Public TitlePatient involvement in prostate cancer treatment decisions.
- Scientific TitlePatient involvement in prostate cancer treatment decisions.
- ACRONYMN/A
- hypothesisMore 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) studiedProstate cancer
- Inclusion criteriaPatients with prostate cancer referred for radiotherapy with curative intent are eligible.
- Exclusion criteriaLabile personality structure, as assessed by the physicians, and lack of understanding of the Dutch language.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2001
- planned closingdate31-dec-2006
- Target number of participants300
- InterventionsIntervention group is usual care plus decision aid (150 patients).
Control group is usual care (150 patients), not receiving a decision aid.
- Primary outcomePrimary 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 outcome1. Substitute preferences of physicians,
2. quality of life measures,
3. decision evaluation measures,
4. coping measures,
5. knowledge measures,
6. treatment preferences.
- TimepointsN/A
- Trial web sitehttp://www.ebp-umcn.org/home.htm go to \departments\medical techology assesment\staff\stalmeier
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. P.F.M. Stalmeier
- CONTACT for SCIENTIFIC QUERIESDr. P.F.M. Stalmeier
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryDo 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)
- RECORD28-jul-2005 - 14-sep-2009


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