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

NTR4554.

Trial name or title Prostate Cancer Patient‐centered Care (PCPCC): impact of a treatment decision aid in a pragmatic, cluster randomized controlled trial
Methods RCT
Participants 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

Interventions The 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.
Outcomes Primary outcomes
  • Decisional conflict (short term)

  • Decisional regret

  • Treatment satisfaction (long term).


Secondary outcomes
  • Decision‐making role

  • Knowledge about prostate cancer

  • Satisfaction with information

  • Preparation for decision making

  • Health‐related quality of life

  • Personality (anxiety, depression, optimism) and skills measures (self‐efficacy, health literacy, numeracy)

Starting date May 2014
Contact information M. Cuypers, +31 13 466 28 55, M.Cuypers@uvt.nl
Notes