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Spots Global Cancer Trial Database for Shared Decision Making With Breast Cancer Patients

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Shared Decision Making With Breast Cancer Patients

Official Title: Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy

Study ID: NCT04177628

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Karina D Steffensen, Professor

Affiliation: Vejle Hospital

Role: STUDY_CHAIR

Name: Stine R Sondergaard, M.D.

Affiliation: Vejle Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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