Condition category
Cancer
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
28/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2001

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with prostate cancer referred for radiotherapy with curative intent are eligible.

Participant type

Patient

Age group

Not Specified

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17634489

Publication citations

  1. Results

    Stalmeier PF, van Tol-Geerdink JJ, van Lin EN, Schimmel E, Huizenga H, van Daal WA, Leer JW, Doctors' and patients' preferences for participation and treatment in curative prostate cancer radiotherapy., J. Clin. Oncol., 2007, 25, 21, 3096-3100, doi: 10.1200/JCO.2006.07.4955.

Additional files

Editorial Notes