Contact information
Type
Scientific
Contact name
Dr PFM Stalmeier
ORCID ID
Contact details
Radboud University Nijmegen MC
MTA 138
PO Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3610592
p.stalmeier@mta.umcn.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Dutch Cancer Society 2001-2379; NTR63
Study information
Scientific title
Acronym
Study hypothesis
How many and which patients want to choose their own radiation dose?
Ethics approval(s)
Ethics committee CWOM number 0012-0284. Ethics approval date 16 March 2001.
Study design
Non randomised controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Prostate cancer
Intervention
Control group is usual care (150 patients). Intervention group is usual care plus decision aid (150 patients).
Intervention type
Other
Primary outcome measure
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 measures
1. Substitute preferences of physicians
2. Quality of life measures
3. Decision evaluation measures
4. Coping measures
5. Knowledge measures
6. Treatment preferences
Overall study start date
01/01/2001
Overall study end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with prostate cancer referred for radiotherapy with curative intent are eligible.
Participant type(s)
Patient
Age group
Not Specified
Sex
Male
Target number of participants
300
Participant exclusion criteria
Labile personality structure, as assessed by the physicians, and lack of understanding of the Dutch language.
Recruitment start date
01/01/2001
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Study participating centre
Radboud University Nijmegen MC
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
Dutch Cancer Society (The Netherlands)
Sponsor details
PO 75508
Amsterdam
1070 AM
Netherlands
+31 (0)20 5700500
rc@kwfkankerbestrijding.nl
Sponsor type
Charity
Website
ROR
Funders
Funder type
Charity
Funder name
Dutch Cancer Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 20/07/2007 | Yes | No |