|- candidate number||20877|
|- NTR Number||NTR4879|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-nov-2014|
|- Secondary IDs||2012.PS23 Pink Ribbon|
|- Public Title||Kwaliteit van communicatie in de spreekkamer.|
|- Scientific Title||Implementation of shared decision making in a clinical setting; how to make it fit in the daily workflow?|
|- hypothesis||With a multi-faceted strategy we are able to implement shared decision making so that it meets the needs and demands of both professionals and patients, without interfering in daily practice.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Shared decision making, Communication, Patient-caregiver communication|
|- Inclusion criteria||Patients diagnosed with stage I or II breast cancer, provided the two treatment options, mastectomy or breast conserving surgery with radiotherapy, are applicable. Eligible patient should speak and understand the Dutch language.|
|- Exclusion criteria||-Men diagnosed with breast cancer |
-Women not eligible to decide between having a mastectomy or lumpectomy with radiation.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-jun-2015|
|- Target number of participants||40|
|- Interventions||Implementing shared decision making (SDM) using a patient decision aid.|
|- Primary outcome||- Knowledge on treatment|
- Perceived shared decision making
- Decisional conflict
|- Secondary outcome||Patients and caregivers experiences with implementation of shared decision making and the patient decision aid.|
|- Timepoints||- Knowledge on treatment and perceived shared decision making are measured immediately after intervention.|
- Decisional conflict is measured two months after treatment.
- Patients and caregivers experiences are measured within three monts after the implementation.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| W. Savelberg|
|- CONTACT for SCIENTIFIC QUERIES|| W. Savelberg|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background and aim|
The majority of patients diagnosed with early stage breast cancer are eligible to decide between having a mastectomy or lumpectomy with radiation (breast conserving therapy). The long term survival for mastectomy versus lumpectomy and radiotherapy is comparable, therefore patientsí informed preferences are important in the decision making. Although most clinicians believe they involve patients in the decision making process, the information that women with breast cancer receive regarding the surgical options in breast cancer is often colored. Shared decision making can help patients to clarify their preferences. Patient decision aids support shared decision making.
The aim of this study is to pilot-test and optimize strategies for implementation of shared decision making on the treatment of early-stage breast cancer in the true clinical setting.
This study concerns a pre-post pilot implementation study, carried out from October 2014 to June 2015. The intervention consists of implementing shared decision making (SDM) using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge on treatment, perceived shared decision making and decisional conflict. We also will also conduct face-to-face interviews with a purposeful sample of these patients and their caregivers to assess their experiences on implementation of shared decision making and the patient decision aid.
The outcomes and findings of this study will be used as a basis to finalise a multi-faceted implementation strategy with the intention to test the implementation of shared decision making and a patient decision aid on cost-effectiveness in a multicentre cluster RCT.
Country of recruitment: The Netherlands.
|- Main changes (audit trail)|
|- RECORD||5-nov-2014 - 6-dec-2014|