Patient involvement in prostate cancer treatment decisions

ISRCTN	ISRCTN97145188
DOI	https://doi.org/10.1186/ISRCTN97145188
Protocol serial number	Dutch Cancer Society 2001-2379; NTR63
Sponsor	Dutch Cancer Society (The Netherlands)
Funder	Dutch Cancer Society

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr PFM Stalmeier
Scientific

Radboud University Nijmegen MC
MTA 138
PO Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)24 3610592
Email	p.stalmeier@mta.umcn.nl

Primary study design	Interventional
Study design	Non randomised controlled trial
Secondary study design	Non randomised controlled trial
Scientific title
Study objectives	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.
Health condition(s) or problem(s) studied	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(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.
Key secondary outcome measure(s)	1. Substitute preferences of physicians 2. Quality of life measures 3. Decision evaluation measures 4. Coping measures 5. Knowledge measures 6. Treatment preferences
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	300
Key inclusion criteria	Patients with prostate cancer referred for radiotherapy with curative intent are eligible.
Key exclusion criteria	Labile personality structure, as assessed by the physicians, and lack of understanding of the Dutch language.
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2006

Radboud University Nijmegen MC

Nijmegen
6500 HB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	20/07/2007		Yes	No