Shared Decision Making With Breast Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Neoplasms
- Radiotherapy, Adjuvant
- Shared Decision Making
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Half the doctors at each center will receive training in SDM. These doctors will practice SDM supported by the in-consultation PtDA during every consultation in this study. The other half of the doctors will continue usual practice of informing the patients.Masking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation...
The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation. 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.
Tracking Information
- NCT #
- NCT04177628
- Collaborators
- Danish Breast Cancer Cooperative Group
- University of Southern Denmark
- Danish Comprehensive Cancer Center
- Investigators
- Study Chair: Karina D Steffensen, Professor Vejle Hospital Principal Investigator: Stine R Sondergaard, M.D. Vejle Hospital
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