|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN97145188 |
|
Date of registration:
|
12/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Patient involvement in prostate cancer treatment decisions
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
01/01/2001 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN97145188 |
|
Study type:
|
Interventional |
|
Study design:
|
Non randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
PFM
Stalmeier |
|
Address:
|
Radboud University Nijmegen MC
MTA 138
PO Box 9101
6500 HB
Nijmegen
Netherlands |
|
Telephone:
|
+31 (0)24 3610592 |
|
Email:
|
p.stalmeier@mta.umcn.nl |
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
Age maximum:
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
Prostate cancer
Cancer
Prostate cancer
|
|
Intervention(s)
|
|
Control group is usual care (150 patients). Intervention group is usual care plus decision aid (150 patients).
|
|
Primary Outcome(s)
|
|
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(s)
|
1. Substitute preferences of physicians
2. Quality of life measures
3. Decision evaluation measures
4. Coping measures
5. Knowledge measures
6. Treatment preferences
|
|
Secondary ID(s)
|
|
Dutch Cancer Society 2001-2379; NTR63
|
|
Source(s) of Monetary Support
|
|
Dutch Cancer Society
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|