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Evaluation of information provision and treatment decision making for men with early-stage prostate cancer.


- candidate number17629
- NTR NumberNTR4554
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2014
- Secondary IDsNW2014-03 METC Brabant
- Public TitleEvaluation of information provision and treatment decision making for men with early-stage prostate cancer.
- Scientific TitleProstate Cancer Patient-centered Care (PCPCC): impact of a treatment decision aid in a pragmatic, cluster randomized controlled trial.
- ACRONYMPCPCC
- hypothesisWe expect that the decision aid will support patients in deciding about prostate cancer treatment by decreasing decisional conflict and regret. We also expect and an improvement of treatment satisfaction and health-related quality of life.
- Healt Condition(s) or Problem(s) studiedProstatic neoplasms, Prostate cancer
- Inclusion criteria- Men that are newly diagnosed with early stage prostate cancer;
- Tumour stage T1 or T2;
- Maximum PSA-score of 20;
- Maximum Gleason-score of 7;
- Patients who are eligible for at least two treatment options;
- Patients (in the intervention arm) have to be able to make use of a computer with internet-access in order make use of the web-based decision aid.
- Patients have to be able to read and understand Dutch language.
- Exclusion criteria- Patients with advanced cancer;
- If the urologist judges the patient is not in the right condition to participate;
- In the case of a second opinion when the other involved hospital also uses a decision aid from this or an other study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2014
- planned closingdate1-jun-2016
- Target number of participants400
- InterventionsThe control group will receive usual care; information provision and provided decisional support will be given according to the hospital standards.
In addition to usual care, the intervention group will be granted access to an online decision aid, providing patients with structured information on the risks and benefits of the different treatment options and offer value-clarification tasks. A summary is obtained to discuss with their physician during the following consultation.
- Primary outcomeDecisional conflict (short term), decisional regret and treatment satisfaction (long term). All measured by questionnaires.
- Secondary outcomeDecision making role, knowledge about prostate cancer, statisfaction with information, preparation for decision making, health-related quality of life, and personality (anxiety, depression, optimism) and skills measures (self-efficacy, health literacy, numeracy). All measured by questionnaires.
- TimepointsT0: Registration; after diagnosis, but before a treatment decision is made (no questionnaire).
T1: After treatment decision making (approximately two weeks after registration)
T2: Follow-up after 6 months
T3: Follow-up after 12 months
- Trial web sitewww.prostaatkeuzehulp.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. M. Cuypers
- CONTACT for SCIENTIFIC QUERIESMSc. M. Cuypers
- Sponsor/Initiator Tilburg University, St. Elisabeth Hospital, Tilburg
- Funding
(Source(s) of Monetary or Material Support)
CZ Fonds
- Publications
- Brief summaryAt an early stage, prostate cancer patients are often eligible for more than one treatment option, including active surveillance. In terms of long-time survival no treatment option is superior. To choose the most suitable treatment, a patient has to weigh his personal preferences against the risk involved to the cancer and the occurrence of side-effects from treatment. To stimulate shared decision making between a patient and his physician, decision aids (DA's) have proven to be a valuable tool but routine use in clinical practice is lagging behind. For this study an existing prostate cancer treatment DA is adjusted to Dutch context for use at minimal effort and optimal support in clinical consultation. This has resulted in an innovative, web based DA. The aim of this study is to investigate the effectiveness of this tool as well as implementation in clinical practice.
Country of recruitment: The Netherlands
- Main changes (audit trail)
- RECORD1-mei-2014 - 26-mei-2014


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