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Patient involvement in the choice between surgery and radiation for prostate cancer: what about regret?


- candidate number3419
- NTR NumberNTR1334
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jun-2008
- Secondary IDsKWF 2007-3809 
- Public TitlePatient involvement in the choice between surgery and radiation for prostate cancer: what about regret?
- Scientific TitlePatient involvement in the choice between prostatectomy and radiotherapy for prostate cancer: What about regret?
- ACRONYMPITCH
- hypothesisWe hypothesise that regret is affected by adverse outcomes of the cancer treatment and not by patient involvement in the treatment choice.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1. Primary localized prostate cancer (T1T2)
- Exclusion criteria1. Contra-indication for surgery
2. Aged over 70 years
3. Mental or cognitive problems
4. Inadequate knowledge of Dutch language
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2008
- planned closingdate1-apr-2012
- Target number of participants300
- InterventionsThe control group will receive usual care, i.e. the physician will discuss the options with the patients.
The intervention group will receive usual care plus structured information on the risks and benefits of the different treatment options by means of a purpose-built decision aid (DA) presented by a researcher. The use of DAs has been shown to increase the level of patient participation in treatment decisions.
- Primary outcome- Process regret
- Option regret
- Outcome regret
- Secondary outcome- Patient preferences
- Reasons underlying these preferences
- Anxiety and Depression
- Health-related Quality of Life
- Timepoints- Baseline (before information on treatments)
- Pre-treatment (after information)
- 6 months after treatment choice
- 12 months after treatment choice
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Julia van Tol-Geerdink
- CONTACT for SCIENTIFIC QUERIESDr. Julia van Tol-Geerdink
- Sponsor/Initiator KWF Kankerbestrijding
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryFor primary localized prostate cancer different treatment options are available. The most frequently applied treatments are radical prostatectomy, external beam radiation therapy and brachytherapy. These treatments yield comparable results for tumor control, but they differ strongly in the procedure and their profile of side effects. The effect of involving patients into this treatment choice by means of a decision aid is the topic of this study.
- Main changes (audit trail)
- RECORD2-jun-2008 - 6-aug-2017


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