|- candidate number||24145|
|- NTR Number||NTR5721|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-mrt-2016|
|- Secondary IDs||2014-7024 KWf Ad6 shared decision making|
|- Public Title||Protocol implementation of Shared Decision Making in Dutch breast cancer care; a prospective process evaluation|
|- Scientific Title||Protocol implementation of Shared Decision Making in Dutch breast cancer care; a prospective process evaluation|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Shared decision making|
|- Inclusion criteria||Patients with newly diagnosed breast cancer, stage I or II who are eligible for breast conserving therapy or mastectomy|
|- Exclusion criteria||Not understanding the Dutch language|
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-mei-2016|
|- planned closingdate||1-jan-2017|
|- Target number of participants||150|
|- Interventions||The intervention consists of offering patients a personalized patient decision aid. |
|- Primary outcome||With respect to our hypotheses on frequency of registering indication for a patient decision aid in the Multidisciplinary Board, for handing out and actually logging in, and assuming that that we can include 150 patients in total (5 hospitals, 30 patients per hospital), we expect that:|
- in 120 patients the indication for the decision aid is registered in the Multidisciplinary tumor board, i.e. in 80%, with a 95% CI of 74-86%.
- in 105 patients the personalized decision aid will be handed out, i.e. in 70% with a 95% CI of 63-77%.
- 90 patients will actually log in to the patient decision aid, i.e. 60% with a 95% CI of 53-67%.
|- Secondary outcome||Evaluation experiences professionals of applying the Shared Decision Making and the use of the decision aid|
|- Timepoints||Audits and interviews: immediately after implementation
Patient questionnaires: during implementation. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| W. Savelberg|
|- CONTACT for SCIENTIFIC QUERIES|| W. Savelberg|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Practice variations in treatment of early-stage breast cancer should be determined by the preferences of well-informed patients. There is, however, substantial practice variation in type of surgery in breast cancer between Dutch hospitals. Involving patients in the decision making process is seen as an important strategy to reduce unwarranted variation in preference-sensitive care. In an earlier study, we developed a personalized patient decision aid, which was pilot tested in 4 hospitals. Based upon this pilot test, we adapted the implementation strategy. Currently, the decision aid is being implemented in the hospitals in the OncoZON region, and in the hospitals that had participated in the pilot study.|
Objectives: The main aim of the current study is to further investigate implementation challenges, by investigating the actual implementation rate at several levels, by investigating barrieres and facilitators for implementation, and by investigating patient-experiences on shared decision making.
Study design: This study concerns an observational study, a prospective process evaluation of the implementation of the decision aid.
Study population: Patients with newly diagnosed breast cancer, stage I or II who are eligible for breast conserving therapy or mastectomy can be included. We expect that 5 hospitals will each include 30 patients in a period of 6 months. In addition, in each hospital, all breast surgeons, medical oncologists, radiation oncologists, reconstructive surgeons, nurse practitioners and nurses taking part in the education and decision-making process are invited to participate in implementation of SDM.
|- Main changes (audit trail)|
|- RECORD||24-mrt-2016 - 2-mei-2016|