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Shared decision making in patients with Castration-Resistant Prostate Cancer


- candidate number27119
- NTR NumberNTR6379
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2017
- Secondary IDsNW2016-55 METZ Brabant/16.280
- Public TitleShared decision making in patients with Castration-Resistant Prostate Cancer
- Scientific TitleShared decision making in patients with Castration-Resistant Prostate Cancer - The impact of implementation of a treatment decision aid in CRPC patients
- ACRONYMSDM CRPC
- hypothesisThe use of a web-based decision aid with value clarification exercises will improve patients' knowledge and will give patients realistic expectations of risks and benefits. Addition of the G8 (frailty instrument) and the Timed Up and Go-test as supportive screening tools will help clinicians to recognize frail patients who might require adapted treatment.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Shared decision making
- Inclusion criteria- Men that are newly diagnosed with CRPC. CRPC is defined as any cancer progression under maximal hormonal treatment with anti-androgens and/or LHRH agonist or antagonist (when three consecutive rises of PSA are observed at castrate serum levels of testosterone (< 50 ng/dL or <1.7 nmol/L) and/or progression of osseous lesions is shown))
- Patients are eligible for at least two treatment options
- Patients have to be able to make use of a computer with internet-access in order to make use of the web-based decision aid
- Patients have to be able to complete a Dutch questionnaire
- Exclusion criteria- In the case of a second opinion the patient will not be included if the first opinion was obtained in one of the other involved hospitals and vice versa
- Patients who do not have sufficient knowledge of the Dutch language
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate31-jan-2018
- Target number of participants168
- InterventionsDecision aid with value clarification exercise
- Primary outcome- Objective knowledge
- Informed choice
- Secondary outcome- Correlation between G8 score and treatment decision
- Correlation between TUG-test and treatment decision
- Quality of life
- Anxiety
- Value clarification
- Satisfaction with decision making, information and treatment
- Preparation for decision making
- Healthcare providers' evaluation of decision aid
- Partner involvement in SDM
- Treatment outcome (e.g. dose reductions, treatment delays, treatment discontinuation, treatment switch, and death)
- TimepointsThe effectiveness of the decision aid will be assessed with questionnaires before and after implementation. Participants are asked to complete a questionnaire at four different point in time: shortly after being diagnosed (T0 = baseline), at the point of decision making (T1), and at follow up 3 and 6 months.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Promovendus Isabel de Angst
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J.M. Takkenberg
- Sponsor/Initiator Elisabeth-Twee Steden ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summaryWe will conduct a stepped wedge randomized controlled trial. Each hospital will start as control (standard care) and will switch randomly to the implementation of the decision aid at consecutive time points. The effectiveness of the decision aid will be assessed with questionnaires before and after implementation. Participants are asked to complete a questionnaire at four different points in time: shortly after being diagnosed (T0 = baseline), at the point of decision making (T1), and at follow up 3 and 6 months.
- Main changes (audit trail)
- RECORD20-apr-2017 - 21-jun-2017


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