Shared Decision Making With Breast Cancer Patients

Not Applicable

Completed

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

• Registration Number: NCT04177628
• Lead Sponsor: Vejle Hospital

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.

Study Timeline

• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2020-03-04
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 678

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9.	Within one week after the consultation	Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.

Secondary Outcome Measures

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

Trial Locations

Locations (7)

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