Shared Decision Making With Breast Cancer Patients

Vejle Hospital

Status: Completed

Conditions: Shared Decision Making; Radiotherapy, Adjuvant; Breast Neoplasms

Treatments: Behavioral: Shared decision making supported by an in-consultation patient decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04177628

DBCG RT SDM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 678 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically verified breast cancer or ductal carcinoma in situ breast cancer
• 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

• Bilateral breast cancer or suspicion of disseminated cancer
• Unable to understand the information, the planned treatment or follow-up for any reason.
• Earlier radiotherapy towards the thoracic region.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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678 participants in 2 patient groups

Arm A: Shared decision making

Experimental group

Description:

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.

Treatment:

Behavioral: Shared decision making supported by an in-consultation patient decision aid

Arm B: Usual practice

No Intervention group

Description:

Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice.