NCT04177628

Shared Decision Making With Breast Cancer Patients

Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.

Detailed 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, 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.

Conditions

• Shared Decision Making
• Breast Neoplasms
• Radiotherapy, Adjuvant

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2020-03-04
• Primary completion: 2022-12-31
• Completion: 2023-07-31
• First posted: 2019-11-26
• Last updated: 2023-11-01

Locations

7 sites across 1 country: Denmark