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van CCT (UK)

van CCT (UK)

Choice between stoma and neobladder after bladder removal for bladder cancer

- candidate number27475
- NTR NumberNTR6460
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jun-2017
- Secondary IDsKUN 2014-6945 KWF (Dutch Cancer Society)
- Public TitleChoice between stoma and neobladder after bladder removal for bladder cancer
- Scientific TitleDEcision aid for Diversion of Urine after CysTectomy
- hypothesisDecision aid will increase patient knowledge and reduce decisional conflict compared to usual care
- Healt Condition(s) or Problem(s) studiedCystectomy, Choice, Stoma, Bladder carinoma
- Inclusion criteriaPatients who have a choice between stoma and neobladder after cystectomy
- Exclusion criteriaInsufficient knowledge of the Dutch language
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate1-mrt-2018
- Target number of participants60
- InterventionsPatients who had a choice between a stoma and a neobladder were presented with a webbased decision aid. Patients filled out a questionnaire. Their answers were compared to those of patients receiving usual care (without decision aid).
- Primary outcome* Patient knowledge on the risks and benefits of stoma and neobladder
* Decisional Conflict score
- Secondary outcomeTreatment choice (stoma or neobladder)Perceived role in decision
- TimepointsQuestionnaires were filled out after the decision was made, but before cystectomy took place
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Julia van Tol-Geerdink
- CONTACT for SCIENTIFIC QUERIESDr. Julia van Tol-Geerdink
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society, Ipsen BV
- Publications
- Brief summaryAfter bladder removal for bladder cancer, urine needs to be diverted by a stoma or a neobladder. Each option has different pros and cons for quality of life. Current guidelines ask for patient involvement in this decision. To help patients and their doctors to reach a treatment choice that best fits the individual patient, a decision aid is developed and evaluated.
- Main changes (audit trail)
- RECORD29-jun-2017 - 9-jul-2017

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