|- candidate number||24334|
|- NTR Number||NTR5884|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2016|
|- Secondary IDs|| METC 14-4-203 |
|- Public Title||B-Beslist! Testing an Aftercare Decision Aid|
|- Scientific Title||B-Beslist! Testing an Aftercare Decision Aid|
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- Inclusion criteria||- understanding and mastery of the Dutch language|
- above 18 years of age
|- Exclusion criteria||- the development of metastasis |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jun-2015|
|- planned closingdate||1-jun-2016|
|- Target number of participants||100|
|- Interventions||B-beslist! an aftercare decision aid to support curatively treated patients in choosing a more personalized aftercare trajectory|
|- Primary outcome||- choice evaluation|
- SDM-Q-9 (shared decision making)
|- Secondary outcome||- Locus of control|
- medical costs
|- Timepoints||3 time points:|
1 week before choosing an aftercare trajectory
directly after choosing an aftercare trajectory
3 months after choosing an aftercare trajectory
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L. Klaassen|
|- CONTACT for SCIENTIFIC QUERIES|| L. Klaassen|
|- Sponsor/Initiator ||Maastricht University, Maastro Clinic, Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|CZ zorgverzekeringen, VGZ|
|- Brief summary||Testing an aftecare decision aid for curatively treated breast cancer patients.|
Background: To test the effects of a developed decision aid to support curatively treated breast cancer patients in choosing an aftercare trajectory, a prospective before-and-after pilot study will be performed.
Method: fifty patients will be recruited to participate in the control group and another fifty to participate in the experimental group of the pilot study. First the fifty patients for the control group will be included and second the fifty patients for the experimental group.
The patients will fill out a short survey at three different measurement points. The surveys are meant to measure choice evaluation, shared decision making and locus of control.
The nurses will discuss the different aftercare options with the patients and will record the patientís ultimate choice.
Results:It is expected that the results will show that using the decision aid during a consultation increases the length of this consultation. Furthermore, patients that use the decision aid are expected to score higher on shared decision making than patients that do not. More over patients that use the decision aid are expected to score higher on decisional conflict than patients that do not use the decision aid. Finally, it is expected that patients that use the decision aid will have lower medical costs than patients that will not use the aid.
Discussion: Although using the decision aid will initially increase the lenght of the consultation, more patients are expected to choose a less intensive aftercare trajectory with lower medical costs. Furthermore the decision aid will stimulate shared decision making and increase patient involvement during a consultation. It will increase the patient's certainty about the choice for an aftercare trajectory and provide them with a higher sense of control over their life events.
|- Main changes (audit trail)|
|- RECORD||10-mei-2016 - 6-jul-2016|