Shared Decision Making With Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shared Decision Making, Breast Neoplasms, Radiotherapy, Adjuvant

Intervention / Treatment
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* Behavioral: Shared decision making supported by an in-consultation patient decision aid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Half the doctors at each center will receive training in SDM. These doctors will practice SDM supported by the in-consultation PtDA during every consultation in this study. The other half of the doctors will continue usual practice of informing the patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Shared decision making<br>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. | Behavioral: Shared decision making supported by an in-consultation patient decision aid<br>* After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.<br>|
| No Intervention: Arm B: Usual practice<br>Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 |