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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

NTR6379.

Trial name or title Shared decision making in patients with Castration‐Resistant Prostate Cancer ‐ the impact of implementation of a treatment decision aid in CRPC patients
Methods RCT
Participants Inclusion criteria
  • Men who 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

Interventions Decision aid with value clarification exercise
Outcomes Primary outcomes
  • Objective knowledge

  • Informed choice


Secondary outcomes
  • 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)

Starting date September 2016
Contact information Prof. Dr. J. J. M. Takkenberg, +31 (0)10 7035413, j.j.m.takkenberg@erasmusmc.nl
Notes