Shared Decision Making With Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:

Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177628
• Other study ID #: DBCG RT SDM
• Status: Completed
• Phase: N/A
• Start date: March 4, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: July 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Radiotherapy, Adjuvant
• Shared Decision Making

Intervention

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.

Locations

Country	Name	City	State
Denmark	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

Sponsors (4)

Lead Sponsor	Collaborator
Vejle Hospital	Danish Breast Cancer Cooperative Group, Danish Comprehensive Cancer Center, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9.	Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.	Within one week after the consultation
Secondary	The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9	Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.	Within one week after the consultation
Secondary	The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire	Minimum value: 0. Maximum value: 36. The higher the value the more fear of recurrence.	Within one week after the consultation and again after six months
Secondary	The participant's engagement in the decision making process as measured by the Shared Decision Making Process 4 questionnaire	Minimum score: 0. Maximum score: 4. The higher the score the more patient engagement.	Within one week after the consultation
Secondary	The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire	Minimum value: 0. Maximum value: 100. The higher the value the more effective decision making.	Before (12 items) and within one week after the consultation (all 16 items)
Secondary	The participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire	Minimum value: 0. Maximum value: 100. The higher the value the more regret.	Six months after the consultation
Secondary	The participant's engagement in the decision making process as measured by the CollaboRATE questionnaire	Minimum score: 0. Maximum score: 9. The higher the value the more patient engagement.	Within one week after the consultation
Secondary	The participant's quality of life as measured by the EORCT QLQ-C30 (version 3.0) questionnaire, only question 29 + 30	Minimum value: 0. Maximum value: 100. The higher the value the more quality of life.	Six months