|- candidate number||26914|
|- NTR Number||NTR6585|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-apr-2017|
|- Secondary IDs||CZ 201600197 |
|- Public Title||Transmurale zorg Prostaatkanker, van diagnose tot en met nazorg|
|- Scientific Title||Transmural Care for Prostate cancer |
|- hypothesis||1. Decision aid for patients and their family doctors on PSA testing will increase quality of decision (increase knowledge and decrease decisional conflict)|
2. Substitution of parts of care after prostatectomy from urologists to general practitioners will lower the use of specialist care and will not negatively affect patients' satisfaction
|- Healt Condition(s) or Problem(s) studied||Prostate cancer, Decision-making, Follow-up, Collaboration between family doctors and general practitioners|
|- Inclusion criteria||1. Healthy men who consider PSA testing.|
2. Men who had prostatectomy for localized prostate cancer
|- Exclusion criteria||Insufficient knowledge of the Dutch language.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-feb-2016|
|- planned closingdate||1-mei-2018|
|- Target number of participants||200|
|- Interventions||1. Men who consider PSA testing will be counseled by their family doctor using a decision aid. These patients will be compared to men who receive usual care from their family doctor with regard to PSA testing (without decision aid).|
2. Some follow-up visits after radical prostatectomy (at 6, 9, 18 and 30 months or more) will be scheduled at the family doctor instead of the urologist. These patients will be compared to patients who have all follow-up visits at the Urology department.
|- Primary outcome||Satisfaction of patients. |
Use of specialist care (Urology)
|- Secondary outcome||Patient knowledge|
Decisional conflict score
Number of PSA tests ordered.
|- Timepoints||1. After consultation with the family doctor|
2. 6 and 9 months after prostatectomy
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Julia van Tol-Geerdink|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Julia van Tol-Geerdink|
|- Sponsor/Initiator ||Canisius Wilhelmina Hospital, Radboud University Medical Center Nijmegen, Maashospital Pantein|
(Source(s) of Monetary or Material Support)
|- Brief summary||This project focuses on the collaboration between first and second line care for prostate cancer. Our aim is to set up and evaluate new working arrangements between urologists and general practitioners across the spectrum of the care path, from diagnosis to aftercare.|
1. For the diagnostic phase, a decision aid will be introduced to help patients and their general practitioners to decide on whether or not to perform a PSA test. And in case PSA is tested, decision trees are set up for the general practitioners on when to refer or retest.
2. For the aftercare after prostatectomy, substitution of care from urologist to general practitioner is set up for some of the follow-up visits, i.e. at 6, 9, 18 and 30 months or more after surgery.
To evaluate the new methods, questionnaires are sent out to men in the diagnostic phase and men in the aftercare phase. Satisfaction, knowledge and decisional conflict of men receiving care according to the new protocols will be compared to that of men in usual care. In addition, the number of PSA tests ordered and the use of specialist care will be assessed.
|- Main changes (audit trail)|
|- RECORD||29-apr-2017 - 12-aug-2017|