Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
678 participants
INTERVENTIONAL
2020-03-04
2023-07-31
Brief Summary
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Detailed Description
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In the shared decision making (SDM) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. A patient decision aid (PtDA) is instrumental in the SDM process.
This study is a multicenter, national trial randomizing doctors to either use or not use SDM and a PtDA when informing the patients about benefits and risks of receiving adjuvant radiotherapy.
It is not expected that significantly less patients will receive radiotherapy as a consequence of SDM. The primary aim of the study is to evaluate whether patient engagement in decision making is affected by SDM and the use of an in-consultation PtDA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A: Shared decision making
Patients will be informed by a doctor randomized to practice shared decision making and use the in-consultation PtDA during the consultation on adjuvant radiotherapy.
Shared decision making supported by an in-consultation patient decision aid
After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.
Arm B: Usual practice
Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice.
No interventions assigned to this group
Interventions
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Shared decision making supported by an in-consultation patient decision aid
After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.
Eligibility Criteria
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Inclusion Criteria
* Candidate for adjuvant radiotherapy Danish Breast Cancer Group type F after breast-conserving surgery for T1-2, N0-Nmi, M0 disease according to national guidelines.
* Signed confirmation of participation.
Exclusion Criteria
* Unable to understand the information, the planned treatment or follow-up for any reason.
* Earlier radiotherapy towards the thoracic region.
18 Years
FEMALE
No
Sponsors
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Danish Breast Cancer Cooperative Group
OTHER
University of Southern Denmark
OTHER
Danish Comprehensive Cancer Center
OTHER
Vejle Hospital
OTHER
Responsible Party
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Principal Investigators
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Karina D Steffensen, Professor
Role: STUDY_CHAIR
Vejle Hospital
Stine R Sondergaard, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vejle Hospital
Locations
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Aalborg Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev University Hospital
Herlev, , Denmark
Sjaellands University Hospital
Næstved, , Denmark
Odense University Hospital
Odense, , Denmark
Vejle Hospital
Vejle, , Denmark
Countries
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Other Identifiers
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DBCG RT SDM
Identifier Type: -
Identifier Source: org_study_id
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